Arthritis, Psoriatic
Conditions
Brief summary
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Detailed description
This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.
Interventions
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Participants will receive matching placebo as SC injection.
Sponsors
Study design
Eligibility
Inclusion criteria
* Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (\>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory * Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray \[single anterior-posterior view\] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented) * Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis * Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Exclusion criteria
* Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease * Has previously received any biologic treatment * Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor * Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent * Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate \[MTX\], sulfasalazine \[SSZ\], Hydroxychloroquine \[HCQ\], leflunomide \[LEF\]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent * Has received apremilast within 4 weeks prior to the first administration of study agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | Week 24 | ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | Baseline and Week 24 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function. |
| Percentage of Participants Who Achieved an ACR 50 Response at Week 24 | Week 24 | ACR 50 response was defined as greater than or equal to (\>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP). |
| Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline | Week 24 | A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 | Week 16 | ACR 20 response was defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | Baseline and Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline | Week 24 | Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies. |
| Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline | Week 24 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies. |
| Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline | Baseline and Week 24 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies. |
| Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline | Baseline and Week 24 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies. |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline and Week 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 | Baseline and Week 24 | The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis. |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 | Baseline and Week 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | Week 16 | ACR 50 response was defined as \>= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 | Week 24 | ACR 70 response was defined as \>= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | ACR 20 response was defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | ACR 50 response was defined as \>= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | ACR 70 response was defined as \>= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP. |
| Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment (PGA) of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (milligram/deciliter \[mg/dL\]). |
| Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 | HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function. |
| Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Weeks 2, 4, 8, 12, 16, 20 and 24 | HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value \<2.6 at the analysis visit. |
| Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis. |
| Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Weeks 2, 4, 8, 12, 16, 20 and 24 | The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. |
| Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Weeks 2, 4, 8, 16 and 24 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0. |
| Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Weeks 2, 4, 8, 16 and 24 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. |
| Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Baseline, Weeks 2, 4, 8, 16 and 24 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. |
| Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Baseline, Weeks 2, 4, 8, 16 and 24 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. |
| Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Baseline, Weeks 8, 16 and 24 | PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. |
| Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. |
| Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAi-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Baseline, Weeks 16 and 24 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Baseline, Weeks 16 and 24 | The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. |
| Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value \<lower limit of quantification \[LLOQ\] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound. |
| Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Weeks 16 and 24 | MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1). |
| Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Weeks 8, 16 and 24 | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week. |
| Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 16 and 24 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: \>=75% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 16 and 24 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: \>=90% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Weeks 16 and 24 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline. |
| Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 16 and 24 | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 16 and 24 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis. |
| Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 8, 16, 24 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 8, 16, 24 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful. |
| Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 8, 16 and 24 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis. |
| Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 16 and 24 | In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP. |
| Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 16 and 24 | In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria. |
| Change From Baseline in Modified vdH-S Erosion Score at Week 24 | Baseline and Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 | Baseline and Week 24 | The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing. |
| Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Baseline and Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Week 24 | The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score \<=0 (assessed by both readers) or \<=0.5 (assessed by at least one reader) was considered as no progression of JSN. |
| Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 | Week 24 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 2.18. |
| Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 | Week 24 | Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score \<=SDC of 1.83. |
| Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 | Week 24 | The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score \<=SDC of 1.11. |
| Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Baseline and Week 24 | Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis. |
| Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Baseline, Weeks 8, 16 and 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Baseline, Weeks 8, 16 and 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Baseline and Weeks 8, 16 and 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 8, 16 and 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 8, 16 and 24 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Baseline, Weeks 8, 16 and 24 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Weeks 8, 16 and 24 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Baseline, Weeks 16 and 24 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status |
| Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Baseline, Weeks 16 and 24 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health. |
| Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| ACR Components at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Baseline, Weeks 24, 28, 36, 44 and 52 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Baseline, Weeks 24, 28, 36, 44 and 52 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 | Week 52 | ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 | Week 52 | ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 | Week 52 | ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Baseline, Weeks 24, 28, 36, 44 and 52 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function. |
| Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Weeks 24, 28, 36, 44 and 52 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. |
| Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24 | Week 52 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value \<2.6 at the analysis visit. |
| Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Baseline, Weeks 24, 28, 36, 44 and 52 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis. |
| Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Weeks 24, 28, 36, 44 and 52 | The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. |
| Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Weeks 24 and 52 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0. |
| Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Baseline, Weeks 24 and 52 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. |
| Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Weeks 24 and 52 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. |
| Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Baseline, Weeks 24 and 52 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis. |
| Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. |
| Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Weeks 24 and 52 | PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. |
| Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + \[2.367\*HAQ-DI\] - \[0.234\*SF-PCS\] - \[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. |
| Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Weeks 24 and 52 | GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score \<=2.3 at the analysis visit. |
| Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Baseline, Weeks 24, 28, 36, 44 and 52 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound. |
| Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. |
| Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Weeks 24 and 52 | The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score \<=3.2 at the analysis visit. |
| Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Weeks 24 and 52 | MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1). |
| Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Weeks 24 and 52 | A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count \<=1; swollen joint count \<=1; PASI \<=1; patient pain VAS score of \<=15; patient global disease activity VAS \[arthritis and psoriasis\] score of \<=20; Health Assessment Questionnaire (HAQ) score \<=0.5; and tender entheseal points \<=1) at that visit. |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Baseline, Weeks 24 and 52 | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week. |
| Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Weeks 24 and 52 | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week. |
| Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 24 and 52 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis. |
| Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: \>=50% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: \>=90% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in SJC (66 joints)+TJC (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP. |
| Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria. |
| Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 24 and 52 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful. |
| Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 24 and 52 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis. |
| Change From Baseline in Modified vdH-S Score at Week 52 | Baseline and Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Total Modified vdH-S Score From Week 24 to Week 52 | From Week 24 to Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. |
| Change From Baseline in Modified vdH-S Erosion Score at Week 52 | Baseline and Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Modified vdH-S Erosion Score From Week 24 to Week 52 | From Week 24 to Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. |
| Change From Baseline in Modified vdH-S JSN Score at Week 52 | Baseline and Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Modified vdH-S JSN Score From Week 24 to Week 52 | From Week 24 to Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. |
| Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Baseline and Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 | Week 52 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 2.39. |
| Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 | Week 52 | Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score \<=SDC of 2.22. |
| Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 | Week 52 | Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as cut-off above which changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in modified vdH-S JSN score \<=SDC of 1.02. |
| Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Baseline and Week 52 | Percentage of Participants with Pencil in cup or Gross Osteolysis Deformities were reported. Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis. |
| Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Weeks 24 and 52 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Weeks 24 and 52 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Weeks 24 and 52 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Baseline, Weeks 24 and 52 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. |
| Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Baseline, Weeks 24 and 52 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health. |
| Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Baseline, Weeks 24 and 52 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| ACR Components at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Baseline, Weeks 52, 68, 76, 84 and 100 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Baseline, Weeks 52, 68, 76, 84 and 100 | ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL). |
| Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 | Week 100 | ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 | Week 100 | ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 | Week 100 | ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP. |
| Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Baseline, Weeks 52, 68, 76, 84 and 100 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function. |
| Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Weeks 52, 68, 76, 84 and 100 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. |
| Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52 | Week 100 | HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit. |
| Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value \<2.6 at the analysis visit. |
| Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Baseline, Weeks 52, 68, 76, 84 and 100 | DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis. |
| Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. |
| Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Weeks 52, 76, and 100 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0. |
| Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Baseline, Weeks 52, 76 and 100 | Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. |
| Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Weeks 52, 76 and 100 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. |
| Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Baseline, Weeks 52, 76 and 100 | The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. |
| Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. |
| Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), PGA of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Low: PASDAS \<= 3.2; Very low: PASDAS \<= 1.9. |
| Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. |
| Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score \<=2.3 at the analysis visit. |
| Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Baseline, Weeks 52, 68, 76, 84 and 100 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value \<lower limit of quantification \[LLOQ\] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound. |
| Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Weeks 52, 68, 76, 84 and 100 | DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Low: DAPSA\<=14; Remission: DAPSA\<=4. |
| Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. |
| Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score \<=3.2 at the analysis visit. |
| Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1). |
| Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count \<=1; swollen joint count \<=1; PASI \<=1; patient pain VAS score of \<=15; patient global disease activity VAS \[arthritis and psoriasis\] score of \<=20; Health Assessment Questionnaire (HAQ) score \<=0.5; and tender entheseal points \<=1) at that visit. |
| Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Baseline, Weeks 52, 76 and 100 | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week. |
| Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Weeks 52, 76 and 100 | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week. |
| Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 52, 76 and 100 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis. |
| Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: \>=50% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: \>=90% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline. |
| Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP. |
| Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria. |
| Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). IGA Response is defined as achieving IGA score of 0 or 1, and \>=2 grade reduction from baseline. |
| Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
| Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Weeks 52, 76 and 100 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful. |
| Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Baseline, Weeks 52, 76 and 100 | Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis. |
| Change in Modified vdH-S Score From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Total Modified vdH-S Score From Week 52 to Week 100 | From Week 52 to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. |
| Change in Modified vdH-s Erosion Score From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Modified vdH-s Erosion Score From Week 52 to Week 100 | From Week 52 to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Modified vdH-s JSN Score From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change in Modified vdH-s JSN Score From Week 52 to Week 100 | From Week 52 to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage. |
| Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 3.46. |
| Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic erosion progression was defined as change from baseline in the modified vdH-S erosion score \<=SDC of 2.66. |
| Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 | Baseline to Week 100 | Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score \<=SDC of 1.66. |
| Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Baseline, Weeks 24, 52, and 100 | Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis. |
| Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Weeks 52, 76 and 100 | The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. |
| Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Baseline, Weeks 52, 76 and 100 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status. |
| Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Baseline, Weeks 52, 76 and 100 | EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health "today". Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health. |
| Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
| Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Baseline, Weeks 52, 76 and 100 | Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment. |
Countries
Bulgaria, Czechia, Estonia, Latvia, Lithuania, Malaysia, Poland, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United States
Contacts
Janssen Research & Development, LLC
Participant flow
Pre-assignment details
A total of 741 participants were randomized and 739 participants received at least one dose of study drug: 246 in placebo group, 248 in guselkumab 100 mg q8w group, and 245 in guselkumab 100 mg q4w group. Two participants were randomized in error and were never treated. Disposition is presented till active treatment period (Week100).
Participants by arm
| Arm | Count |
|---|---|
| Placebo to Guselkumab 100 mg q4w Participants were randomized to receive placebo matched to guselkumab subcutaneous injections every 4 weeks through Week 20 in the placebo controlled period (PCP), then to receive guselkumab 100 milligrams (mg) subcutaneous injection from Week 24 every 4 weeks through Week 100 in the active treatment period. | 246 |
| Guselkumab 100 mg q8w Participants were randomized to receive guselkumab 100 mg subcutaneous injections at Weeks 0 and 4, then every 8 weeks (q8w) through Week 100 and placebo matched to guselkumab injections at Week 8 then q8w through Week 100. | 248 |
| Guselkumab 100 mg q4w Participants were randomized to receive guselkumab 100 mg subcutaneous injections every 4 weeks (q4w) through Week 100. | 245 |
| Total | 739 |
Baseline characteristics
| Characteristic | Placebo to Guselkumab 100 mg q4w | Guselkumab 100 mg q8w | Guselkumab 100 mg q4w | Total |
|---|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.68 | 44.9 years STANDARD_DEVIATION 11.89 | 45.9 years STANDARD_DEVIATION 11.47 | 45.7 years STANDARD_DEVIATION 11.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 245 Participants | 247 Participants | 245 Participants | 737 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 3 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 242 Participants | 240 Participants | 242 Participants | 724 Participants |
| Region of Enrollment BULGARIA | 14 participants | 9 participants | 6 participants | 29 participants |
| Region of Enrollment CZECH REPUBLIC | 13 participants | 5 participants | 15 participants | 33 participants |
| Region of Enrollment ESTONIA | 5 participants | 8 participants | 5 participants | 18 participants |
| Region of Enrollment LATVIA | 3 participants | 3 participants | 0 participants | 6 participants |
| Region of Enrollment LITHUANIA | 8 participants | 8 participants | 4 participants | 20 participants |
| Region of Enrollment MALAYSIA | 3 participants | 6 participants | 3 participants | 12 participants |
| Region of Enrollment POLAND | 35 participants | 27 participants | 23 participants | 85 participants |
| Region of Enrollment RUSSIAN FEDERATION | 92 participants | 77 participants | 104 participants | 273 participants |
| Region of Enrollment SPAIN | 3 participants | 12 participants | 4 participants | 19 participants |
| Region of Enrollment TAIWAN | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment TURKEY | 2 participants | 8 participants | 6 participants | 16 participants |
| Region of Enrollment UKRAINE | 65 participants | 83 participants | 73 participants | 221 participants |
| Region of Enrollment UNITED STATES | 3 participants | 1 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 129 Participants | 119 Participants | 103 Participants | 351 Participants |
| Sex: Female, Male Male | 117 Participants | 129 Participants | 142 Participants | 388 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 246 | 0 / 248 | 0 / 245 | 1 / 238 | 0 / 248 | 0 / 245 |
| other Total, other adverse events | 30 / 246 | 42 / 248 | 52 / 245 | 48 / 238 | 88 / 248 | 79 / 245 |
| serious Total, serious adverse events | 7 / 246 | 3 / 248 | 8 / 245 | 16 / 238 | 22 / 248 | 22 / 245 |
Outcome results
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.
Time frame: Week 24
Population: Analysis population is full analysis set 1 (FAS1). Participants who achieved ACR 20 response at Week 24 and did not meet any treatment failure (TF) criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | 32.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | 64.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 | 63.7 percentage of participants |
ACR Components at Weeks 24, 28, 36, 44 and 52
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | 4.1 units on a scale | Standard Deviation 5.17 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | 0.9117 units on a scale | Standard Deviation 0.63353 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | 3.78 units on a scale | Standard Deviation 2.297 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | 2.5 units on a scale | Standard Deviation 3.77 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | 1.120 units on a scale | Standard Deviation 1.514 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | 4.66 units on a scale | Standard Deviation 2.341 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | 2.1 units on a scale | Standard Deviation 3.19 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | 4.22 units on a scale | Standard Deviation 2.342 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | 5.21 units on a scale | Standard Deviation 2.368 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | 2.1 units on a scale | Standard Deviation 3.59 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | 0.9069 units on a scale | Standard Deviation 0.63695 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | 7.4 units on a scale | Standard Deviation 10.24 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | 14.4 units on a scale | Standard Deviation 13.16 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | 2.06 units on a scale | Standard Deviation 1.649 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | 7.5 units on a scale | Standard Deviation 9.42 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | 11.7 units on a scale | Standard Deviation 11.87 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | 3.68 units on a scale | Standard Deviation 2.318 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | 8.5 units on a scale | Standard Deviation 10 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | 1.543 units on a scale | Standard Deviation 2.1572 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | 1.0457 units on a scale | Standard Deviation 0.59051 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | 3.78 units on a scale | Standard Deviation 2.378 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | 1.90 units on a scale | Standard Deviation 1.654 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | 3.84 units on a scale | Standard Deviation 2.295 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | 0.920 units on a scale | Standard Deviation 1.4674 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | 2.28 units on a scale | Standard Deviation 1.594 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | 4.75 units on a scale | Standard Deviation 2.338 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | 0.858 units on a scale | Standard Deviation 1.0558 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | 0.9621 units on a scale | Standard Deviation 0.60695 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | 5.29 units on a scale | Standard Deviation 2.367 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | 0.907 units on a scale | Standard Deviation 1.5985 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | 1.1350 units on a scale | Standard Deviation 0.61984 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | 3.53 units on a scale | Standard Deviation 2.253 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | 5.8 units on a scale | Standard Deviation 6.99 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | 3.27 units on a scale | Standard Deviation 1.93 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | 3.67 units on a scale | Standard Deviation 2.312 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | 4.01 units on a scale | Standard Deviation 2.516 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | 0.8766 units on a scale | Standard Deviation 0.59893 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | 0.8497 units on a scale | Standard Deviation 0.61863 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | 0.8091 units on a scale | Standard Deviation 0.61588 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | 0.7927 units on a scale | Standard Deviation 0.59979 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | 0.7917 units on a scale | Standard Deviation 0.59527 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | 0.961 units on a scale | Standard Deviation 1.2868 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | 0.956 units on a scale | Standard Deviation 1.3749 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | 0.892 units on a scale | Standard Deviation 1.3109 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | 0.812 units on a scale | Standard Deviation 1.0139 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | 0.937 units on a scale | Standard Deviation 1.2422 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | 3.4 units on a scale | Standard Deviation 5.19 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | 2.9 units on a scale | Standard Deviation 4.95 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | 2.4 units on a scale | Standard Deviation 4.58 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | 2.3 units on a scale | Standard Deviation 4.42 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | 2.1 units on a scale | Standard Deviation 4.16 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | 9.1 units on a scale | Standard Deviation 9.94 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | 7.9 units on a scale | Standard Deviation 9.02 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | 7.0 units on a scale | Standard Deviation 8.72 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | 6.3 units on a scale | Standard Deviation 8.45 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | 6.2 units on a scale | Standard Deviation 8.18 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | 3.77 units on a scale | Standard Deviation 2.457 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | 3.50 units on a scale | Standard Deviation 2.311 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | 3.28 units on a scale | Standard Deviation 2.336 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | 3.22 units on a scale | Standard Deviation 2.37 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | 3.10 units on a scale | Standard Deviation 2.333 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | 1.77 units on a scale | Standard Deviation 1.645 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | 3.76 units on a scale | Standard Deviation 2.348 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | 3.52 units on a scale | Standard Deviation 2.39 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | 3.36 units on a scale | Standard Deviation 2.447 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | 3.23 units on a scale | Standard Deviation 2.383 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | 2.74 units on a scale | Standard Deviation 2.113 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | 2.44 units on a scale | Standard Deviation 1.941 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | 2.10 units on a scale | Standard Deviation 1.777 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | 1.97 units on a scale | Standard Deviation 1.842 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | 3.20 units on a scale | Standard Deviation 2.242 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | 4.1 units on a scale | Standard Deviation 5.77 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | 2.66 units on a scale | Standard Deviation 1.906 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | 3.24 units on a scale | Standard Deviation 2.277 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | 0.910 units on a scale | Standard Deviation 1.2756 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | 0.7376 units on a scale | Standard Deviation 0.56257 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | 3.21 units on a scale | Standard Deviation 2.371 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | 0.992 units on a scale | Standard Deviation 1.9875 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | 1.77 units on a scale | Standard Deviation 1.616 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | 3.93 units on a scale | Standard Deviation 2.276 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | 0.837 units on a scale | Standard Deviation 1.073 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | 2.33 units on a scale | Standard Deviation 1.668 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | 3.62 units on a scale | Standard Deviation 2.275 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | 0.885 units on a scale | Standard Deviation 1.0299 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | 0.7985 units on a scale | Standard Deviation 0.56677 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | 3.30 units on a scale | Standard Deviation 2.318 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | 0.790 units on a scale | Standard Deviation 0.839 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | 1.93 units on a scale | Standard Deviation 1.631 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | 8.6 units on a scale | Standard Deviation 10.03 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | 3.50 units on a scale | Standard Deviation 2.323 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | 7.5 units on a scale | Standard Deviation 9.25 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | 10.5 units on a scale | Standard Deviation 11.82 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | 0.7364 units on a scale | Standard Deviation 0.58655 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | 7.0 units on a scale | Standard Deviation 9.42 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | 2.5 units on a scale | Standard Deviation 4.83 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | 2.06 units on a scale | Standard Deviation 1.716 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | 7.3 units on a scale | Standard Deviation 9.46 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | 2.8 units on a scale | Standard Deviation 5.65 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | 3.28 units on a scale | Standard Deviation 2.354 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | 3.70 units on a scale | Standard Deviation 2.193 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | 2.7 units on a scale | Standard Deviation 4.67 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | 0.7804 units on a scale | Standard Deviation 0.57721 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | 3.45 units on a scale | Standard Deviation 2.259 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | 3.2 units on a scale | Standard Deviation 5.53 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | 0.8194 units on a scale | Standard Deviation 0.57287 |
ACR Components at Weeks 52, 68, 76, 84 and 100
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | 3.26 units on a scale | Standard Deviation 2.313 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | 0.880 units on a scale | Standard Deviation 1.3415 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | 1.45 units on a scale | Standard Deviation 1.469 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | 3.17 units on a scale | Standard Deviation 2.271 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | 0.861 units on a scale | Standard Deviation 1.1586 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | 2.97 units on a scale | Standard Deviation 2.15 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | 1.8 units on a scale | Standard Deviation 3.75 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | 1.63 units on a scale | Standard Deviation 1.514 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | 2.90 units on a scale | Standard Deviation 2.221 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | 1.6 units on a scale | Standard Deviation 3.1 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | 1.89 units on a scale | Standard Deviation 1.654 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | 3.68 units on a scale | Standard Deviation 2.331 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | 0.904 units on a scale | Standard Deviation 1.6039 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | 3.15 units on a scale | Standard Deviation 2.395 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | 3.50 units on a scale | Standard Deviation 2.355 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | 7.4 units on a scale | Standard Deviation 10.3 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | 3.09 units on a scale | Standard Deviation 2.273 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | 3.25 units on a scale | Standard Deviation 2.356 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | 2.1 units on a scale | Standard Deviation 3.58 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | 0.7692 units on a scale | Standard Deviation 0.5996 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | 6.0 units on a scale | Standard Deviation 8.83 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | 0.898 units on a scale | Standard Deviation 1.3229 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | 0.8311 units on a scale | Standard Deviation 0.62101 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | 5.7 units on a scale | Standard Deviation 8.31 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | 1.6 units on a scale | Standard Deviation 3.17 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | 0.8425 units on a scale | Standard Deviation 0.61757 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | 5.1 units on a scale | Standard Deviation 7.32 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | 0.8076 units on a scale | Standard Deviation 0.62465 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | 0.9073 units on a scale | Standard Deviation 0.63812 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | 5.5 units on a scale | Standard Deviation 8.44 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | 0.903 units on a scale | Standard Deviation 1.4624 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | 1.39 units on a scale | Standard Deviation 1.51 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | 3.53 units on a scale | Standard Deviation 2.267 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | 1.6 units on a scale | Standard Deviation 3.02 |
| Placebo to Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | 1.55 units on a scale | Standard Deviation 1.492 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | 1.56 units on a scale | Standard Deviation 1.538 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | 2.1 units on a scale | Standard Deviation 4.18 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | 1.7 units on a scale | Standard Deviation 3.87 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | 1.8 units on a scale | Standard Deviation 3.72 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | 1.6 units on a scale | Standard Deviation 3.82 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | 1.6 units on a scale | Standard Deviation 3.99 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | 6.3 units on a scale | Standard Deviation 8.2 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | 5.0 units on a scale | Standard Deviation 6.83 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | 5.2 units on a scale | Standard Deviation 7.18 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | 4.7 units on a scale | Standard Deviation 7.2 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | 4.7 units on a scale | Standard Deviation 6.8 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | 3.12 units on a scale | Standard Deviation 2.335 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | 2.68 units on a scale | Standard Deviation 2.24 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | 2.73 units on a scale | Standard Deviation 2.217 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | 2.67 units on a scale | Standard Deviation 2.181 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | 2.59 units on a scale | Standard Deviation 2.29 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | 3.25 units on a scale | Standard Deviation 2.38 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | 2.95 units on a scale | Standard Deviation 2.282 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | 2.90 units on a scale | Standard Deviation 2.273 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | 2.88 units on a scale | Standard Deviation 2.252 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | 2.85 units on a scale | Standard Deviation 2.378 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | 1.78 units on a scale | Standard Deviation 1.647 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | 1.67 units on a scale | Standard Deviation 1.66 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | 1.51 units on a scale | Standard Deviation 1.619 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | 1.49 units on a scale | Standard Deviation 1.581 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | 0.7942 units on a scale | Standard Deviation 0.59711 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | 0.7625 units on a scale | Standard Deviation 0.59524 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | 0.6978 units on a scale | Standard Deviation 0.56588 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | 0.7134 units on a scale | Standard Deviation 0.59528 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | 0.6747 units on a scale | Standard Deviation 0.57213 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | 0.930 units on a scale | Standard Deviation 1.2443 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | 0.884 units on a scale | Standard Deviation 1.352 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | 0.882 units on a scale | Standard Deviation 1.2504 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | 0.856 units on a scale | Standard Deviation 1.1926 |
| Guselkumab 100 mg q8w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | 0.826 units on a scale | Standard Deviation 1.2277 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | 3.17 units on a scale | Standard Deviation 2.343 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | 2.0 units on a scale | Standard Deviation 5.01 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | 1.50 units on a scale | Standard Deviation 1.558 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | 6.0 units on a scale | Standard Deviation 8.9 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | 0.872 units on a scale | Standard Deviation 1.3239 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | 1.41 units on a scale | Standard Deviation 1.405 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | 5.9 units on a scale | Standard Deviation 9.22 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | 0.796 units on a scale | Standard Deviation 1.1109 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | 0.7317 units on a scale | Standard Deviation 0.5843 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | 6.2 units on a scale | Standard Deviation 8.9 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | 2.3 units on a scale | Standard Deviation 4.59 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | 0.6836 units on a scale | Standard Deviation 0.56049 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | 6.3 units on a scale | Standard Deviation 9.27 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | 2.5 units on a scale | Standard Deviation 4.83 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | 0.6996 units on a scale | Standard Deviation 0.55988 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | 0.839 units on a scale | Standard Deviation 1.1693 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | 0.6775 units on a scale | Standard Deviation 0.5887 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | 7.2 units on a scale | Standard Deviation 9.49 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | 2.0 units on a scale | Standard Deviation 3.79 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | 2.95 units on a scale | Standard Deviation 2.222 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | 2.85 units on a scale | Standard Deviation 2.213 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | 0.6420 units on a scale | Standard Deviation 0.56838 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | 2.83 units on a scale | Standard Deviation 2.222 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | 3.24 units on a scale | Standard Deviation 2.322 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | 2.0 units on a scale | Standard Deviation 4.11 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | 2.60 units on a scale | Standard Deviation 2.165 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | 2.57 units on a scale | Standard Deviation 2.138 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | 0.820 units on a scale | Standard Deviation 1.1227 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | 1.77 units on a scale | Standard Deviation 1.617 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | 2.65 units on a scale | Standard Deviation 2.217 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | 2.70 units on a scale | Standard Deviation 2.115 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | 1.61 units on a scale | Standard Deviation 1.466 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | 2.64 units on a scale | Standard Deviation 2.105 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | 0.886 units on a scale | Standard Deviation 1.2366 |
| Guselkumab 100 mg q4w | ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | 1.57 units on a scale | Standard Deviation 1.524 |
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 | 2.14 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 | 4.17 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 | 4.22 units on a scale |
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | 3.42 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | 7.39 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | 7.04 units on a scale |
Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -2.75 units on a scale | Standard Deviation 2.659 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -9.7 units on a scale | Standard Deviation 10.78 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | -0.547 units on a scale | Standard Deviation 2.5657 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -4.39 units on a scale | Standard Deviation 2.052 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -7.0 units on a scale | Standard Deviation 10.91 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | -0.993 units on a scale | Standard Deviation 2.3669 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -2.76 units on a scale | Standard Deviation 2.741 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -10.2 units on a scale | Standard Deviation 6.79 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -1.202 units on a scale | Standard Deviation 2.3234 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -2.62 units on a scale | Standard Deviation 2.64 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -10.1 units on a scale | Standard Deviation 6.77 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -1.262 units on a scale | Standard Deviation 2.5377 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -4.61 units on a scale | Standard Deviation 2.043 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -9.9 units on a scale | Standard Deviation 6.47 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -1.237 units on a scale | Standard Deviation 2.8242 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -1.79 units on a scale | Standard Deviation 2.543 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -8.1 units on a scale | Standard Deviation 6.99 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -6.4 units on a scale | Standard Deviation 7.25 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -2.51 units on a scale | Standard Deviation 2.588 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -4.77 units on a scale | Standard Deviation 2.007 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -2.45 units on a scale | Standard Deviation 2.248 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -1.63 units on a scale | Standard Deviation 2.42 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -0.1646 units on a scale | Standard Deviation 0.53253 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -2.70 units on a scale | Standard Deviation 2.555 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -1.08 units on a scale | Standard Deviation 2.441 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -0.2547 units on a scale | Standard Deviation 0.50426 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -1.25 units on a scale | Standard Deviation 2.601 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -14.1 units on a scale | Standard Deviation 11.39 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -0.3423 units on a scale | Standard Deviation 0.52951 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -3.42 units on a scale | Standard Deviation 2.189 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -14.0 units on a scale | Standard Deviation 11.02 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -0.3868 units on a scale | Standard Deviation 0.57065 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -2.85 units on a scale | Standard Deviation 2.757 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -13.2 units on a scale | Standard Deviation 10.78 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -0.3848 units on a scale | Standard Deviation 0.58049 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -2.99 units on a scale | Standard Deviation 2.569 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -3.15 units on a scale | Standard Deviation 2.65 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -3.29 units on a scale | Standard Deviation 2.558 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -3.84 units on a scale | Standard Deviation 2.316 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -4.16 units on a scale | Standard Deviation 2.175 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -4.49 units on a scale | Standard Deviation 2.116 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -4.55 units on a scale | Standard Deviation 2.139 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -4.78 units on a scale | Standard Deviation 1.996 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -0.4044 units on a scale | Standard Deviation 0.54194 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -0.4383 units on a scale | Standard Deviation 0.55648 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -0.4702 units on a scale | Standard Deviation 0.55698 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -0.4824 units on a scale | Standard Deviation 0.57091 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -0.4824 units on a scale | Standard Deviation 0.56167 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | -1.038 units on a scale | Standard Deviation 2.0932 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | -1.028 units on a scale | Standard Deviation 2.0476 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -1.098 units on a scale | Standard Deviation 2.1102 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -1.145 units on a scale | Standard Deviation 2.1378 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -1.021 units on a scale | Standard Deviation 2.2289 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -8.2 units on a scale | Standard Deviation 6.09 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -8.8 units on a scale | Standard Deviation 5.98 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -9.2 units on a scale | Standard Deviation 5.81 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -9.3 units on a scale | Standard Deviation 6.24 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -9.6 units on a scale | Standard Deviation 6.28 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -10.4 units on a scale | Standard Deviation 9.51 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -11.7 units on a scale | Standard Deviation 9.24 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -12.5 units on a scale | Standard Deviation 9.68 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -13.3 units on a scale | Standard Deviation 9.56 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -13.4 units on a scale | Standard Deviation 10.03 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -2.55 units on a scale | Standard Deviation 2.477 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -2.83 units on a scale | Standard Deviation 2.519 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -3.02 units on a scale | Standard Deviation 2.534 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -3.07 units on a scale | Standard Deviation 2.644 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -3.20 units on a scale | Standard Deviation 2.555 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -2.52 units on a scale | Standard Deviation 2.49 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -2.79 units on a scale | Standard Deviation 2.56 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -0.5082 units on a scale | Standard Deviation 0.58255 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -4.28 units on a scale | Standard Deviation 2.054 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -13.7 units on a scale | Standard Deviation 10.53 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -0.4652 units on a scale | Standard Deviation 0.56121 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -2.70 units on a scale | Standard Deviation 2.382 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -14.6 units on a scale | Standard Deviation 10.31 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -0.5000 units on a scale | Standard Deviation 0.55438 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -2.89 units on a scale | Standard Deviation 2.681 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -15.2 units on a scale | Standard Deviation 10.25 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -0.4429 units on a scale | Standard Deviation 0.51556 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -3.93 units on a scale | Standard Deviation 2.227 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -15.0 units on a scale | Standard Deviation 10.51 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -0.4257 units on a scale | Standard Deviation 0.50337 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -2.86 units on a scale | Standard Deviation 2.559 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -2.41 units on a scale | Standard Deviation 2.335 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -4.81 units on a scale | Standard Deviation 2.12 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -2.40 units on a scale | Standard Deviation 2.383 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -2.66 units on a scale | Standard Deviation 2.416 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -4.70 units on a scale | Standard Deviation 2.084 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -8.8 units on a scale | Standard Deviation 5.5 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -0.937 units on a scale | Standard Deviation 2.4116 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -3.06 units on a scale | Standard Deviation 2.527 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -9.6 units on a scale | Standard Deviation 6.65 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -0.861 units on a scale | Standard Deviation 2.8133 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -2.89 units on a scale | Standard Deviation 2.54 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -10.2 units on a scale | Standard Deviation 6.76 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -1.020 units on a scale | Standard Deviation 2.1985 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -4.53 units on a scale | Standard Deviation 2.173 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -10.2 units on a scale | Standard Deviation 6.28 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | -0.976 units on a scale | Standard Deviation 2.1663 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -3.01 units on a scale | Standard Deviation 2.445 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -10.4 units on a scale | Standard Deviation 6.17 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | -1.052 units on a scale | Standard Deviation 2.1295 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -2.87 units on a scale | Standard Deviation 2.601 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -11.9 units on a scale | Standard Deviation 9.98 |
Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Baseline, Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | -1.283 units on a scale | Standard Deviation 2.8163 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -5.13 units on a scale | Standard Deviation 2.04 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -10.6 units on a scale | Standard Deviation 6.06 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -5.23 units on a scale | Standard Deviation 1.995 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -3.35 units on a scale | Standard Deviation 2.595 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -16.1 units on a scale | Standard Deviation 10.97 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -5.06 units on a scale | Standard Deviation 2.037 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -3.41 units on a scale | Standard Deviation 2.578 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -1.212 units on a scale | Standard Deviation 2.3061 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -4.79 units on a scale | Standard Deviation 1.992 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -2.87 units on a scale | Standard Deviation 2.761 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -10.6 units on a scale | Standard Deviation 6.15 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -3.40 units on a scale | Standard Deviation 2.846 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -3.08 units on a scale | Standard Deviation 2.786 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -1.244 units on a scale | Standard Deviation 2.5828 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -3.46 units on a scale | Standard Deviation 2.752 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -3.32 units on a scale | Standard Deviation 2.86 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -1.262 units on a scale | Standard Deviation 2.8315 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -14.1 units on a scale | Standard Deviation 11.38 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -10.7 units on a scale | Standard Deviation 6.76 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -0.5356 units on a scale | Standard Deviation 0.56707 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -15.7 units on a scale | Standard Deviation 10.94 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -0.5041 units on a scale | Standard Deviation 0.59716 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -3.18 units on a scale | Standard Deviation 2.724 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -0.4740 units on a scale | Standard Deviation 0.57852 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -16.6 units on a scale | Standard Deviation 11.33 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -1.230 units on a scale | Standard Deviation 2.4262 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -0.4668 units on a scale | Standard Deviation 0.59226 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -16.3 units on a scale | Standard Deviation 11.27 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -10.7 units on a scale | Standard Deviation 5.98 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -0.3899 units on a scale | Standard Deviation 0.5825 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -2.78 units on a scale | Standard Deviation 2.645 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -10.2 units on a scale | Standard Deviation 6.72 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -5.26 units on a scale | Standard Deviation 2.098 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -3.10 units on a scale | Standard Deviation 2.707 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -1.021 units on a scale | Standard Deviation 2.2301 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -9.6 units on a scale | Standard Deviation 6.3 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -10.0 units on a scale | Standard Deviation 6.5 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -10.0 units on a scale | Standard Deviation 6.33 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -10.1 units on a scale | Standard Deviation 6.34 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -10.2 units on a scale | Standard Deviation 6.88 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -13.5 units on a scale | Standard Deviation 10.04 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -14.7 units on a scale | Standard Deviation 10.22 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -15.3 units on a scale | Standard Deviation 10.5 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -15.3 units on a scale | Standard Deviation 11.1 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -3.20 units on a scale | Standard Deviation 2.557 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -3.62 units on a scale | Standard Deviation 2.53 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -3.57 units on a scale | Standard Deviation 2.566 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -3.64 units on a scale | Standard Deviation 2.568 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -3.69 units on a scale | Standard Deviation 2.625 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -3.29 units on a scale | Standard Deviation 2.553 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -3.58 units on a scale | Standard Deviation 2.446 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -3.63 units on a scale | Standard Deviation 2.512 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -3.67 units on a scale | Standard Deviation 2.572 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -3.67 units on a scale | Standard Deviation 2.612 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -4.77 units on a scale | Standard Deviation 2.001 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -4.98 units on a scale | Standard Deviation 1.992 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -4.86 units on a scale | Standard Deviation 2.044 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -5.06 units on a scale | Standard Deviation 2.074 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -5.05 units on a scale | Standard Deviation 2.011 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -0.4801 units on a scale | Standard Deviation 0.56246 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -0.5120 units on a scale | Standard Deviation 0.54928 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -0.5694 units on a scale | Standard Deviation 0.56421 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -0.5653 units on a scale | Standard Deviation 0.59488 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -0.5859 units on a scale | Standard Deviation 0.58199 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -14.8 units on a scale | Standard Deviation 10.15 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -1.081 units on a scale | Standard Deviation 2.1585 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | -1.098 units on a scale | Standard Deviation 2.3654 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -1.101 units on a scale | Standard Deviation 2.1216 |
| Guselkumab 100 mg q8w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -1.129 units on a scale | Standard Deviation 2.2261 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -10.7 units on a scale | Standard Deviation 7.08 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -5.09 units on a scale | Standard Deviation 2.142 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -2.92 units on a scale | Standard Deviation 2.686 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -0.940 units on a scale | Standard Deviation 2.3781 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -5.18 units on a scale | Standard Deviation 2.044 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -16.4 units on a scale | Standard Deviation 10.7 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -1.060 units on a scale | Standard Deviation 2.3334 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -0.5111 units on a scale | Standard Deviation 0.58347 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -16.0 units on a scale | Standard Deviation 11.22 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -10.7 units on a scale | Standard Deviation 6.18 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -0.5631 units on a scale | Standard Deviation 0.54528 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -16.1 units on a scale | Standard Deviation 10.91 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -10.4 units on a scale | Standard Deviation 6.16 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -0.5448 units on a scale | Standard Deviation 0.54739 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -16.0 units on a scale | Standard Deviation 11.02 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | -1.017 units on a scale | Standard Deviation 2.2801 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -0.5656 units on a scale | Standard Deviation 0.57921 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -15.2 units on a scale | Standard Deviation 10.45 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -3.38 units on a scale | Standard Deviation 2.501 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -3.49 units on a scale | Standard Deviation 2.5 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -10.9 units on a scale | Standard Deviation 7.22 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -3.50 units on a scale | Standard Deviation 2.579 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -3.09 units on a scale | Standard Deviation 2.523 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -0.6000 units on a scale | Standard Deviation 0.56858 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -3.73 units on a scale | Standard Deviation 2.493 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -3.52 units on a scale | Standard Deviation 2.615 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -10.8 units on a scale | Standard Deviation 6.66 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -4.82 units on a scale | Standard Deviation 2.117 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -3.42 units on a scale | Standard Deviation 2.669 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -1.042 units on a scale | Standard Deviation 2.06 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -5.01 units on a scale | Standard Deviation 2.105 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -3.38 units on a scale | Standard Deviation 2.62 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -0.959 units on a scale | Standard Deviation 2.4188 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -5.03 units on a scale | Standard Deviation 2.078 |
| Guselkumab 100 mg q4w | Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -3.46 units on a scale | Standard Deviation 2.574 |
Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI Score\>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 76 | -3.311 units on a scale | Standard Deviation 2.6106 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 52 | -2.986 units on a scale | Standard Deviation 2.4945 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 100 | -3.718 units on a scale | Standard Deviation 2.396 |
| Guselkumab 100 mg q8w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 76 | -3.377 units on a scale | Standard Deviation 2.5969 |
| Guselkumab 100 mg q8w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 52 | -2.923 units on a scale | Standard Deviation 2.5194 |
| Guselkumab 100 mg q8w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 100 | -3.472 units on a scale | Standard Deviation 2.5233 |
| Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 52 | -3.084 units on a scale | Standard Deviation 2.1843 |
| Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 100 | -3.330 units on a scale | Standard Deviation 2.1598 |
| Guselkumab 100 mg q4w | Change From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at Baseline | Week 76 | -3.129 units on a scale | Standard Deviation 2.1122 |
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 24 | -1.374 units on a scale | Standard Deviation 2.4269 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 52 | -2.986 units on a scale | Standard Deviation 2.4945 |
| Guselkumab 100 mg q8w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 24 | -2.652 units on a scale | Standard Deviation 2.3825 |
| Guselkumab 100 mg q8w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 52 | -2.883 units on a scale | Standard Deviation 2.5193 |
| Guselkumab 100 mg q4w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 24 | -2.674 units on a scale | Standard Deviation 1.9941 |
| Guselkumab 100 mg q4w | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at Baseline | Week 52 | -3.084 units on a scale | Standard Deviation 2.1843 |
Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 24 | -4.6 units on a scale | Standard Deviation 7.88 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 52 | -7.4 units on a scale | Standard Deviation 9.18 |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 24 | -6.1 units on a scale | Standard Deviation 7.83 |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 52 | -7.3 units on a scale | Standard Deviation 9.74 |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 24 | -6.6 units on a scale | Standard Deviation 7.84 |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline | Week 52 | -7.4 units on a scale | Standard Deviation 8.59 |
Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1 among participants with dactylitis at baseline pooled from both from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline | -4.21 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline | -6.10 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline | -5.97 units on a scale |
Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.
Time frame: Baseline, Weeks 2, 4, 8, 16 and 24
Population: Analysis population is FAS1 among participants with dactylitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 16 | -3.40 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 8 | -2.17 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 2 | -0.21 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 4 | -1.10 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 24 | -4.03 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 8 | -3.17 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 2 | -1.11 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 4 | -2.11 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 16 | -4.88 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 24 | -5.95 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 24 | -5.88 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 16 | -4.80 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 2 | -0.78 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 8 | -3.11 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline | Week 4 | -1.56 units on a scale |
Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement of dactylitis.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 76 | -8.0 units on a scale | Standard Deviation 9.55 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 100 | -8.1 units on a scale | Standard Deviation 9.63 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 52 | -7.4 units on a scale | Standard Deviation 9.22 |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 52 | -7.3 units on a scale | Standard Deviation 9.78 |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 76 | -7.8 units on a scale | Standard Deviation 10.24 |
| Guselkumab 100 mg q8w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 100 | -7.9 units on a scale | Standard Deviation 10.12 |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 100 | -7.9 units on a scale | Standard Deviation 9.14 |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 76 | -7.6 units on a scale | Standard Deviation 8.93 |
| Guselkumab 100 mg q4w | Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline | Week 52 | -7.4 units on a scale | Standard Deviation 8.66 |
Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value \<lower limit of quantification \[LLOQ\] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time frame: Baseline, Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84 | -35.240 units on a scale | Standard Deviation 17.7891 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76 | -34.391 units on a scale | Standard Deviation 17.4074 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52 | -31.274 units on a scale | Standard Deviation 18.89 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68 | -33.918 units on a scale | Standard Deviation 18.0463 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100 | -34.819 units on a scale | Standard Deviation 17.9807 |
| Guselkumab 100 mg q8w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76 | -33.062 units on a scale | Standard Deviation 17.5186 |
| Guselkumab 100 mg q8w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52 | -30.604 units on a scale | Standard Deviation 17.5366 |
| Guselkumab 100 mg q8w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68 | -33.146 units on a scale | Standard Deviation 18.1727 |
| Guselkumab 100 mg q8w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84 | -33.622 units on a scale | Standard Deviation 18.0612 |
| Guselkumab 100 mg q8w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100 | -34.019 units on a scale | Standard Deviation 19.2678 |
| Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100 | -35.549 units on a scale | Standard Deviation 16.5533 |
| Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84 | -34.570 units on a scale | Standard Deviation 18.2685 |
| Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52 | -32.563 units on a scale | Standard Deviation 16.4765 |
| Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76 | -34.590 units on a scale | Standard Deviation 16.5401 |
| Guselkumab 100 mg q4w | Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68 | -34.900 units on a scale | Standard Deviation 17.5749 |
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.44 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -0.88 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -0.85 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.29 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -0.97 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -1.00 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.59 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -1.27 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.42 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.62 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.99 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -1.39 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -1.52 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -1.59 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -1.37 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.65 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -1.62 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -1.56 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -1.22 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.98 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.43 units on a scale |
Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -2.04 units on a scale | Standard Deviation 1.098 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -1.92 units on a scale | Standard Deviation 1.086 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -1.02 units on a scale | Standard Deviation 1.101 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -1.38 units on a scale | Standard Deviation 1.099 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -2.14 units on a scale | Standard Deviation 1.142 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -1.97 units on a scale | Standard Deviation 1.114 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -1.63 units on a scale | Standard Deviation 1.051 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -1.78 units on a scale | Standard Deviation 1.038 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -2.09 units on a scale | Standard Deviation 1.107 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -2.08 units on a scale | Standard Deviation 1.121 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -2.11 units on a scale | Standard Deviation 1.128 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -2.08 units on a scale | Standard Deviation 1.063 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -1.68 units on a scale | Standard Deviation 0.976 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -2.08 units on a scale | Standard Deviation 1.088 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -1.86 units on a scale | Standard Deviation 1.066 |
Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time frame: Baseline, Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -2.14 units on a scale | Standard Deviation 1.142 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -2.29 units on a scale | Standard Deviation 1.132 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -2.35 units on a scale | Standard Deviation 1.11 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -2.40 units on a scale | Standard Deviation 1.087 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -2.42 units on a scale | Standard Deviation 1.144 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -2.25 units on a scale | Standard Deviation 1.17 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -2.24 units on a scale | Standard Deviation 1.147 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -2.37 units on a scale | Standard Deviation 1.215 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -2.35 units on a scale | Standard Deviation 1.181 |
| Guselkumab 100 mg q8w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -2.08 units on a scale | Standard Deviation 1.124 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -2.31 units on a scale | Standard Deviation 1.156 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -2.30 units on a scale | Standard Deviation 1.143 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -2.36 units on a scale | Standard Deviation 1.12 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -2.14 units on a scale | Standard Deviation 1.118 |
| Guselkumab 100 mg q4w | Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -2.24 units on a scale | Standard Deviation 1.087 |
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value \<lower limit of quantification \[LLOQ\] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -7.6695 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -14.8556 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -14.2915 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -4.6447 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -15.8489 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -16.1375 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -10.4480 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -18.9772 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -6.7838 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -9.9687 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -15.3303 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -21.6939 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -23.3163 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -24.0359 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -21.4722 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -10.2484 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -25.1583 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -24.6844 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -19.9687 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -15.8657 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -6.3783 units on a scale |
Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24
The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 | -0.97 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 | -1.59 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 | -1.62 units on a scale |
Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with \>=3% BSA psoriatic involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -2.142 units on a scale | Standard Deviation 6.4593 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -8.815 units on a scale | Standard Deviation 7.2714 |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -8.901 units on a scale | Standard Deviation 7.3657 |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -9.235 units on a scale | Standard Deviation 7.384 |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -9.249 units on a scale | Standard Deviation 7.0988 |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -9.839 units on a scale | Standard Deviation 6.8777 |
Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 among the participants with \>=3% BSA psoriatic involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -10.090 units on a scale | Standard Deviation 7.0888 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -8.855 units on a scale | Standard Deviation 7.2738 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -10.130 units on a scale | Standard Deviation 7.2798 |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -9.180 units on a scale | Standard Deviation 7.2977 |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -9.272 units on a scale | Standard Deviation 7.3903 |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -9.291 units on a scale | Standard Deviation 7.2851 |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -9.873 units on a scale | Standard Deviation 6.8832 |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -9.635 units on a scale | Standard Deviation 7.0884 |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -9.610 units on a scale | Standard Deviation 7.0383 |
Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. Negative changes from baseline indicate improvement of life quality impacted by psoriasis.
Time frame: Baseline, Weeks 8, 16 and 24
Population: Analysis population is FAS1 among participants with \>=3% BSA of psoriasis and an IGA score \>=2 (mild) at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. LS mean is based on MMRM model that included data from all visits for all participants included in model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -2.410 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | -1.653 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -2.129 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -8.545 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | -6.818 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -8.954 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | -6.396 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -8.853 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in DLQI Score at Weeks 8, 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -8.147 units on a scale |
Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1 among participants with enthesitis at baseline pooled from both CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline | -1.02 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline | -1.52 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline | -1.59 units on a scale |
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time frame: Baseline, Weeks 2, 4, 8, 16 and 24
Population: Analysis population is FAS1 among participants with enthesitis at baseline. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random and imputed using multiple imputation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 16 | -0.94 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 8 | -0.67 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 2 | -0.33 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 4 | -0.46 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 24 | -1.03 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 8 | -0.92 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 2 | -0.37 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 4 | -0.56 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 16 | -1.37 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 24 | -1.60 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 24 | -1.52 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 16 | -1.42 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 2 | -0.49 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 8 | -0.88 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline | Week 4 | -0.69 units on a scale |
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | -1.1 units on a scale | Standard Deviation 1.66 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | -2.1 units on a scale | Standard Deviation 1.61 |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | -1.6 units on a scale | Standard Deviation 1.75 |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | -1.9 units on a scale | Standard Deviation 1.65 |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | -1.6 units on a scale | Standard Deviation 1.63 |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | -2.0 units on a scale | Standard Deviation 1.78 |
Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicate improvement of enthesitis.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 52 | -2.1 units on a scale | Standard Deviation 1.59 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 100 | -2.4 units on a scale | Standard Deviation 1.7 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 76 | -2.3 units on a scale | Standard Deviation 1.52 |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 52 | -1.9 units on a scale | Standard Deviation 1.66 |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 76 | -2.1 units on a scale | Standard Deviation 1.66 |
| Guselkumab 100 mg q8w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 100 | -2.1 units on a scale | Standard Deviation 1.65 |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 100 | -2.2 units on a scale | Standard Deviation 1.8 |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 76 | -2.2 units on a scale | Standard Deviation 1.69 |
| Guselkumab 100 mg q4w | Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline | Week 52 | -2.1 units on a scale | Standard Deviation 1.72 |
Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 16 | 0.058 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 24 | 0.053 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 16 | 0.112 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 24 | 0.115 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 16 | 0.101 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index | Week 24 | 0.116 units on a scale |
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 24 | 0.060 units on a scale | Standard Deviation 0.1558 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 52 | 0.137 units on a scale | Standard Deviation 0.1605 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 52 | 0.146 units on a scale | Standard Deviation 0.1587 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 24 | 0.124 units on a scale | Standard Deviation 0.1476 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 24 | 0.117 units on a scale | Standard Deviation 0.1307 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index | Week 52 | 0.135 units on a scale | Standard Deviation 0.1469 |
Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 24 | 8.456 units on a scale | Standard Deviation 25.7204 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 52 | 21.474 units on a scale | Standard Deviation 25.5974 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 24 | 19.282 units on a scale | Standard Deviation 23.522 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 52 | 23.295 units on a scale | Standard Deviation 23.627 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 24 | 17.500 units on a scale | Standard Deviation 22.6981 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS | Week 52 | 19.983 units on a scale | Standard Deviation 24.7643 |
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a weighted summary index (EQ-5D index), which ranges from 0 (dead) to 1.00 (full health). A higher score indicates better health and positive changes from baseline indicate improvement of health.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 76 | 0.154 units on a scale | Standard Deviation 0.1744 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 52 | 0.138 units on a scale | Standard Deviation 0.1608 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 100 | 0.164 units on a scale | Standard Deviation 0.1605 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 76 | 0.169 units on a scale | Standard Deviation 0.1564 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 52 | 0.150 units on a scale | Standard Deviation 0.1445 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 100 | 0.164 units on a scale | Standard Deviation 0.1596 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 52 | 0.138 units on a scale | Standard Deviation 0.1458 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 100 | 0.156 units on a scale | Standard Deviation 0.1543 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index | Week 76 | 0.147 units on a scale | Standard Deviation 0.1471 |
Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 76 | 24.176 units on a scale | Standard Deviation 27.7205 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 52 | 21.608 units on a scale | Standard Deviation 25.5992 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 100 | 25.901 units on a scale | Standard Deviation 28.4028 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 76 | 25.053 units on a scale | Standard Deviation 26.0372 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 52 | 23.392 units on a scale | Standard Deviation 23.699 |
| Guselkumab 100 mg q8w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 100 | 27.152 units on a scale | Standard Deviation 26.5221 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 52 | 20.190 units on a scale | Standard Deviation 24.8348 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 100 | 25.909 units on a scale | Standard Deviation 26.0995 |
| Guselkumab 100 mg q4w | Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS | Week 76 | 22.251 units on a scale | Standard Deviation 24.6934 |
Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS
EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 16 | 6.477 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 24 | 6.796 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 16 | 17.496 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 24 | 18.371 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 16 | 14.646 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS | Week 24 | 18.089 units on a scale |
Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 24 | 3.844 units on a scale | Standard Deviation 9.044 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 52 | 7.548 units on a scale | Standard Deviation 9.3745 |
| Guselkumab 100 mg q8w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 24 | 8.034 units on a scale | Standard Deviation 9.8888 |
| Guselkumab 100 mg q8w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 52 | 8.927 units on a scale | Standard Deviation 9.4646 |
| Guselkumab 100 mg q4w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 24 | 6.970 units on a scale | Standard Deviation 8.6274 |
| Guselkumab 100 mg q4w | Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 | Week 52 | 7.686 units on a scale | Standard Deviation 9.0833 |
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 9.167 units on a scale | Standard Deviation 9.0455 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 7.692 units on a scale | Standard Deviation 9.3071 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 9.435 units on a scale | Standard Deviation 9.4513 |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 9.596 units on a scale | Standard Deviation 10.4788 |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 8.935 units on a scale | Standard Deviation 9.5033 |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 10.107 units on a scale | Standard Deviation 10.2076 |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 7.699 units on a scale | Standard Deviation 9.1417 |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 9.127 units on a scale | Standard Deviation 8.9948 |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 8.632 units on a scale | Standard Deviation 8.8429 |
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Baseline, Weeks 8, 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 16 | 3.696 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 8 | 2.451 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 24 | 3.559 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 16 | 6.977 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 8 | 5.031 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 24 | 7.550 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 8 | 4.850 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 24 | 7.111 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 | Week 16 | 6.598 units on a scale |
Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100
GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 76 | -3.499 units on a scale | Standard Deviation 1.6303 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 52 | -3.105 units on a scale | Standard Deviation 1.6208 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 100 | -3.561 units on a scale | Standard Deviation 1.6389 |
| Guselkumab 100 mg q8w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 76 | -3.528 units on a scale | Standard Deviation 1.5778 |
| Guselkumab 100 mg q8w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 52 | -3.266 units on a scale | Standard Deviation 1.6443 |
| Guselkumab 100 mg q8w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 100 | -3.656 units on a scale | Standard Deviation 1.6071 |
| Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 52 | -3.298 units on a scale | Standard Deviation 1.5457 |
| Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 100 | -3.664 units on a scale | Standard Deviation 1.5205 |
| Guselkumab 100 mg q4w | Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 | Week 76 | -3.541 units on a scale | Standard Deviation 1.5048 |
Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24
GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 16 | -1.029 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 24 | -1.198 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 16 | -2.326 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 24 | -2.593 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 16 | -2.214 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 | Week 24 | -2.589 units on a scale |
Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + \[2.367\*HAQ-DI\] - \[0.234\*SF-PCS\] - \[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | -1.260 units on a scale | Standard Deviation 1.4909 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | -3.085 units on a scale | Standard Deviation 1.6277 |
| Guselkumab 100 mg q8w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | -2.658 units on a scale | Standard Deviation 1.677 |
| Guselkumab 100 mg q8w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | -3.271 units on a scale | Standard Deviation 1.6453 |
| Guselkumab 100 mg q4w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | -2.672 units on a scale | Standard Deviation 1.4589 |
| Guselkumab 100 mg q4w | Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | -3.267 units on a scale | Standard Deviation 1.5646 |
Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -0.3868 units on a scale | Standard Deviation 0.57065 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -0.3423 units on a scale | Standard Deviation 0.52951 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -0.1646 units on a scale | Standard Deviation 0.53253 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -0.3848 units on a scale | Standard Deviation 0.58049 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -0.2547 units on a scale | Standard Deviation 0.50426 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -0.4702 units on a scale | Standard Deviation 0.55698 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -0.4383 units on a scale | Standard Deviation 0.55648 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -0.4044 units on a scale | Standard Deviation 0.54194 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -0.4824 units on a scale | Standard Deviation 0.57091 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -0.4824 units on a scale | Standard Deviation 0.56167 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -0.5082 units on a scale | Standard Deviation 0.58255 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -0.4652 units on a scale | Standard Deviation 0.56121 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -0.4257 units on a scale | Standard Deviation 0.50337 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -0.5000 units on a scale | Standard Deviation 0.55438 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -0.4429 units on a scale | Standard Deviation 0.51556 |
Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24
HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative changes from baseline indicate improvement of physical function.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.0722 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -0.1167 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -0.1332 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.0594 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -0.1300 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -0.1565 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.0942 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -0.2870 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.1423 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.1472 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.2294 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -0.3177 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -0.3536 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -0.3672 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16 | -0.3442 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4 | -0.1605 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24 | -0.4004 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20 | -0.4019 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12 | -0.3010 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8 | -0.2336 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2 | -0.0795 units on a scale |
Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time frame: Baseline, Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -0.5041 units on a scale | Standard Deviation 0.59716 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -0.4740 units on a scale | Standard Deviation 0.57852 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -0.3899 units on a scale | Standard Deviation 0.5825 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -0.4668 units on a scale | Standard Deviation 0.59226 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -0.5356 units on a scale | Standard Deviation 0.56707 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -0.5694 units on a scale | Standard Deviation 0.56421 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -0.4801 units on a scale | Standard Deviation 0.56246 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -0.5120 units on a scale | Standard Deviation 0.54928 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -0.5653 units on a scale | Standard Deviation 0.59488 |
| Guselkumab 100 mg q8w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -0.5859 units on a scale | Standard Deviation 0.58199 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 100 | -0.6000 units on a scale | Standard Deviation 0.56858 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 84 | -0.5656 units on a scale | Standard Deviation 0.57921 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 52 | -0.5111 units on a scale | Standard Deviation 0.58347 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 76 | -0.5448 units on a scale | Standard Deviation 0.54739 |
| Guselkumab 100 mg q4w | Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 | Week 68 | -0.5631 units on a scale | Standard Deviation 0.54528 |
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | -0.1300 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | -0.3672 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 | -0.4004 units on a scale |
Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100
The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 76 | -4.39 units on a scale | Standard Deviation 2.425 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 52 | -3.78 units on a scale | Standard Deviation 2.392 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 100 | -4.44 units on a scale | Standard Deviation 2.484 |
| Guselkumab 100 mg q8w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 76 | -4.16 units on a scale | Standard Deviation 2.539 |
| Guselkumab 100 mg q8w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 52 | -3.83 units on a scale | Standard Deviation 2.458 |
| Guselkumab 100 mg q8w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 100 | -4.38 units on a scale | Standard Deviation 2.433 |
| Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 52 | -4.14 units on a scale | Standard Deviation 2.358 |
| Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 100 | -4.52 units on a scale | Standard Deviation 2.519 |
| Guselkumab 100 mg q4w | Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 | Week 76 | -4.47 units on a scale | Standard Deviation 2.347 |
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24
The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 16 | -1.18 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 24 | -1.30 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 16 | -2.39 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 24 | -2.94 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 16 | -2.57 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 | Week 24 | -3.09 units on a scale |
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | -1.34 units on a scale | Standard Deviation 2.144 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | -3.75 units on a scale | Standard Deviation 2.391 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | -3.84 units on a scale | Standard Deviation 2.449 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | -2.97 units on a scale | Standard Deviation 2.382 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | -3.32 units on a scale | Standard Deviation 2.098 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | -4.10 units on a scale | Standard Deviation 2.387 |
Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline and Week 24
Population: FAS1 for structural damage (FAS1-SD) included all participants who received at least 1 dose (complete/partial) of study agent according to randomized treatment group regardless of treatment actually received. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be MAR and imputed using MI.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | 0.95 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | 0.52 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | 0.29 units on a scale |
Change From Baseline in Modified vdH-S Erosion Score at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Erosion Score at Week 24 | 0.58 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Erosion Score at Week 24 | 0.36 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Erosion Score at Week 24 | 0.13 units on a scale |
Change From Baseline in Modified vdH-S Erosion Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline and Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Erosion Score at Week 52 | 0.92 units on a scale | Standard Deviation 2.497 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Erosion Score at Week 52 | 0.67 units on a scale | Standard Deviation 2.707 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Erosion Score at Week 52 | 0.70 units on a scale | Standard Deviation 2.631 |
Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24
The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the total JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 to 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. A positive change from baseline in the modified vdH-S JSN score indicates progression of joint space narrowing.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 | 0.37 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 | 0.16 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 | 0.16 units on a scale |
Change From Baseline in Modified vdH-S JSN Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline and Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S JSN Score at Week 52 | 0.33 units on a scale | Standard Deviation 1.356 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S JSN Score at Week 52 | 0.29 units on a scale | Standard Deviation 1.272 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S JSN Score at Week 52 | 0.38 units on a scale | Standard Deviation 1.633 |
Change From Baseline in Modified vdH-S Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline and Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score at Week 52 | 1.25 units on a scale | Standard Deviation 3.508 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score at Week 52 | 0.97 units on a scale | Standard Deviation 3.623 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score at Week 52 | 1.07 units on a scale | Standard Deviation 3.843 |
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Erosion Score | 0.40 units on a scale | Standard Deviation 1.555 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand JSN Score | 0.26 units on a scale | Standard Deviation 1.106 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Score | 0.66 units on a scale | Standard Deviation 2.441 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Erosion Score | 0.14 units on a scale | Standard Deviation 0.801 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot JSN Score | 0.10 units on a scale | Standard Deviation 0.516 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Score | 0.24 units on a scale | Standard Deviation 1.116 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Score | 0.17 units on a scale | Standard Deviation 1.18 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Erosion Score | 0.18 units on a scale | Standard Deviation 1.28 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Erosion Score | 0.15 units on a scale | Standard Deviation 0.982 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot JSN Score | 0.02 units on a scale | Standard Deviation 0.516 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand JSN Score | 0.10 units on a scale | Standard Deviation 0.637 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Score | 0.28 units on a scale | Standard Deviation 1.649 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand JSN Score | 0.08 units on a scale | Standard Deviation 0.607 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Score | 0.05 units on a scale | Standard Deviation 1.881 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Score | 0.21 units on a scale | Standard Deviation 1.21 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot Erosion Score | 0.14 units on a scale | Standard Deviation 0.894 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Hand Erosion Score | -0.03 units on a scale | Standard Deviation 1.514 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 24 | Foot JSN Score | 0.07 units on a scale | Standard Deviation 0.632 |
Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time frame: Baseline and Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'n' (number analyzed) signifies the number of participants analyzed for a specified score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Erosion Score | 0.66 units on a scale | Standard Deviation 1.815 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand JSN Score | 0.29 units on a scale | Standard Deviation 1.181 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Score | 0.95 units on a scale | Standard Deviation 2.706 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Erosion Score | 0.26 units on a scale | Standard Deviation 1.014 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot JSN Score | 0.04 units on a scale | Standard Deviation 0.353 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Score | 0.30 units on a scale | Standard Deviation 1.22 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Score | 0.40 units on a scale | Standard Deviation 1.687 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Erosion Score | 0.37 units on a scale | Standard Deviation 1.969 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Erosion Score | 0.30 units on a scale | Standard Deviation 1.339 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot JSN Score | 0.10 units on a scale | Standard Deviation 0.66 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand JSN Score | 0.19 units on a scale | Standard Deviation 0.913 |
| Guselkumab 100 mg q8w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Score | 0.56 units on a scale | Standard Deviation 2.589 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand JSN Score | 0.22 units on a scale | Standard Deviation 1.235 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Score | 0.57 units on a scale | Standard Deviation 2.759 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Score | 0.50 units on a scale | Standard Deviation 1.939 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot Erosion Score | 0.34 units on a scale | Standard Deviation 1.413 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Hand Erosion Score | 0.35 units on a scale | Standard Deviation 1.83 |
| Guselkumab 100 mg q4w | Change From Baseline in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) at Week 52 | Foot JSN Score | 0.16 units on a scale | Standard Deviation 0.864 |
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Bodily Pain Score | 3.882 units on a scale | Standard Deviation 8.3009 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Physical Function Score | 7.722 units on a scale | Standard Deviation 8.948 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-physical Score | 3.695 units on a scale | Standard Deviation 7.595 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-physical Score | 6.560 units on a scale | Standard Deviation 8.5399 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Physical Function Score | 3.602 units on a scale | Standard Deviation 7.7388 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Bodily Pain Score | 8.460 units on a scale | Standard Deviation 8.4659 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: General Health Score | 2.255 units on a scale | Standard Deviation 7.2176 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: General Health Score | 6.396 units on a scale | Standard Deviation 8.5589 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Vitality Score | 4.224 units on a scale | Standard Deviation 9.0878 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Vitality Score | 7.879 units on a scale | Standard Deviation 9.416 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Social Function Score | 3.088 units on a scale | Standard Deviation 10.433 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Social Function Score | 6.278 units on a scale | Standard Deviation 10.9444 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-emotional Score | 1.910 units on a scale | Standard Deviation 10.0772 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-emotional Score | 4.057 units on a scale | Standard Deviation 10.8795 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Mental Health Score | 2.583 units on a scale | Standard Deviation 9.2222 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Mental Health Score | 5.153 units on a scale | Standard Deviation 10.0724 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Bodily Pain Score | 10.238 units on a scale | Standard Deviation 8.7185 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: General Health Score | 5.963 units on a scale | Standard Deviation 7.8794 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: General Health Score | 7.173 units on a scale | Standard Deviation 7.2703 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-emotional Score | 4.970 units on a scale | Standard Deviation 10.1685 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Vitality Score | 7.914 units on a scale | Standard Deviation 9.4638 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Vitality Score | 8.646 units on a scale | Standard Deviation 9.5131 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Mental Health Score | 4.829 units on a scale | Standard Deviation 9.3665 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Social Function Score | 6.551 units on a scale | Standard Deviation 9.7076 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Physical Function Score | 7.052 units on a scale | Standard Deviation 8.502 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Mental Health Score | 4.605 units on a scale | Standard Deviation 9.7905 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Physical Function Score | 8.489 units on a scale | Standard Deviation 8.8599 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Social Function Score | 7.199 units on a scale | Standard Deviation 10.1315 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-physical Score | 6.897 units on a scale | Standard Deviation 7.724 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-physical Score | 7.677 units on a scale | Standard Deviation 8.2995 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Bodily Pain Score | 8.333 units on a scale | Standard Deviation 8.3852 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-emotional Score | 4.535 units on a scale | Standard Deviation 10.1304 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Social Function Score | 5.892 units on a scale | Standard Deviation 8.551 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Bodily Pain Score | 9.457 units on a scale | Standard Deviation 9.7977 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-emotional Score | 4.107 units on a scale | Standard Deviation 8.9473 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Role-physical Score | 6.381 units on a scale | Standard Deviation 7.2203 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: General Health Score | 5.067 units on a scale | Standard Deviation 7.4182 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Mental Health Score | 4.741 units on a scale | Standard Deviation 9.3825 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Physical Function Score | 6.772 units on a scale | Standard Deviation 7.592 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: General Health Score | 6.366 units on a scale | Standard Deviation 8.4199 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Social Function Score | 6.787 units on a scale | Standard Deviation 9.5326 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Bodily Pain Score | 7.833 units on a scale | Standard Deviation 7.339 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Vitality Score | 6.970 units on a scale | Standard Deviation 9.4889 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-emotional Score | 4.607 units on a scale | Standard Deviation 8.7627 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Physical Function Score | 8.374 units on a scale | Standard Deviation 8.7884 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Vitality Score | 7.654 units on a scale | Standard Deviation 9.3905 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 52: Role-physical Score | 7.344 units on a scale | Standard Deviation 7.7145 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 | Week 24: Mental Health Score | 4.752 units on a scale | Standard Deviation 8.9336 |
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-emotional Score | 4.784 units on a scale | Standard Deviation 11.9482 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-physical Score | 9.181 units on a scale | Standard Deviation 8.6596 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Social Function Score | 7.825 units on a scale | Standard Deviation 10.8558 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-emotional Score | 4.111 units on a scale | Standard Deviation 10.9413 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-emotional Score | 5.199 units on a scale | Standard Deviation 11.1875 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Bodily Pain Score | 8.536 units on a scale | Standard Deviation 8.4602 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Social Function Score | 7.509 units on a scale | Standard Deviation 10.4249 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Mental Health Score | 5.209 units on a scale | Standard Deviation 10.0958 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Physical Function Score | 9.738 units on a scale | Standard Deviation 9.8405 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Mental Health Score | 5.481 units on a scale | Standard Deviation 10.5927 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Bodily Pain Score | 10.368 units on a scale | Standard Deviation 9.1058 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Mental Health Score | 5.514 units on a scale | Standard Deviation 10.6204 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Bodily Pain Score | 10.696 units on a scale | Standard Deviation 9.3854 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: General Health Score | 6.533 units on a scale | Standard Deviation 8.5245 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Physical Function Score | 7.757 units on a scale | Standard Deviation 8.9727 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: General Health Score | 7.203 units on a scale | Standard Deviation 8.3372 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-physical Score | 6.538 units on a scale | Standard Deviation 8.5151 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: General Health Score | 6.710 units on a scale | Standard Deviation 8.7265 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Vitality Score | 7.997 units on a scale | Standard Deviation 9.3878 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Physical Function Score | 8.824 units on a scale | Standard Deviation 9.6648 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Vitality Score | 8.859 units on a scale | Standard Deviation 9.4372 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-physical Score | 8.372 units on a scale | Standard Deviation 8.7202 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Vitality Score | 9.648 units on a scale | Standard Deviation 9.4778 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Social Function Score | 6.361 units on a scale | Standard Deviation 10.9927 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Social Function Score | 7.304 units on a scale | Standard Deviation 10.1003 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Social Function Score | 8.623 units on a scale | Standard Deviation 9.5176 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Bodily Pain Score | 11.585 units on a scale | Standard Deviation 10.3527 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Physical Function Score | 10.953 units on a scale | Standard Deviation 9.7761 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Social Function Score | 8.080 units on a scale | Standard Deviation 9.5383 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-physical Score | 9.342 units on a scale | Standard Deviation 9.1746 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Vitality Score | 8.695 units on a scale | Standard Deviation 9.5033 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-emotional Score | 4.998 units on a scale | Standard Deviation 10.1964 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Physical Function Score | 8.406 units on a scale | Standard Deviation 8.8407 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: General Health Score | 7.097 units on a scale | Standard Deviation 7.25 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-emotional Score | 5.757 units on a scale | Standard Deviation 10.0737 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Vitality Score | 9.827 units on a scale | Standard Deviation 9.9348 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-physical Score | 9.171 units on a scale | Standard Deviation 8.5844 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-emotional Score | 5.720 units on a scale | Standard Deviation 10.1991 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Bodily Pain Score | 10.201 units on a scale | Standard Deviation 8.7312 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: General Health Score | 7.470 units on a scale | Standard Deviation 7.6119 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Mental Health Score | 4.826 units on a scale | Standard Deviation 9.4038 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Vitality Score | 9.388 units on a scale | Standard Deviation 9.8618 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Physical Function Score | 9.807 units on a scale | Standard Deviation 9.5044 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Mental Health Score | 5.430 units on a scale | Standard Deviation 10.0802 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: General Health Score | 7.066 units on a scale | Standard Deviation 7.5829 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-physical Score | 7.665 units on a scale | Standard Deviation 8.2925 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Mental Health Score | 5.477 units on a scale | Standard Deviation 10.1202 |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Bodily Pain Score | 11.552 units on a scale | Standard Deviation 9.8591 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Mental Health Score | 6.148 units on a scale | Standard Deviation 8.8743 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Physical Function Score | 8.493 units on a scale | Standard Deviation 8.7691 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Physical Function Score | 9.294 units on a scale | Standard Deviation 8.202 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Physical Function Score | 10.126 units on a scale | Standard Deviation 8.9271 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-physical Score | 7.372 units on a scale | Standard Deviation 7.7581 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-physical Score | 8.579 units on a scale | Standard Deviation 7.6709 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-physical Score | 8.921 units on a scale | Standard Deviation 8.1775 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Bodily Pain Score | 9.525 units on a scale | Standard Deviation 9.8357 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Bodily Pain Score | 10.998 units on a scale | Standard Deviation 8.923 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: General Health Score | 6.450 units on a scale | Standard Deviation 8.4316 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: General Health Score | 6.761 units on a scale | Standard Deviation 7.9631 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: General Health Score | 7.132 units on a scale | Standard Deviation 8.4887 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Vitality Score | 7.637 units on a scale | Standard Deviation 9.4393 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Vitality Score | 8.659 units on a scale | Standard Deviation 9.6026 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Vitality Score | 9.155 units on a scale | Standard Deviation 9.3569 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Social Function Score | 6.810 units on a scale | Standard Deviation 9.5118 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Social Function Score | 7.914 units on a scale | Standard Deviation 9.5191 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Social Function Score | 8.113 units on a scale | Standard Deviation 9.4847 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Role-emotional Score | 4.699 units on a scale | Standard Deviation 8.7759 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Role-emotional Score | 5.433 units on a scale | Standard Deviation 9.2389 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 100: Role-emotional Score | 5.128 units on a scale | Standard Deviation 9.7998 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 52: Mental Health Score | 4.839 units on a scale | Standard Deviation 9.4029 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Mental Health Score | 6.124 units on a scale | Standard Deviation 8.793 |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 | Week 76: Bodily Pain Score | 10.300 units on a scale | Standard Deviation 9.0504 |
Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline and Weeks 8, 16 and 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Physical Function Score | 2.095 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Bodily Pain Score | 3.482 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Bodily Pain Score | 2.760 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Physical Function Score | 3.254 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: General Health Score | 1.662 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-emotional Score | 1.813 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-physical Score | 3.365 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: General Health Score | 2.520 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Mental Health Score | 1.081 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-emotional Score | 1.108 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: General Health Score | 2.290 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Social Function Score | 2.978 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-physical Score | 2.619 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Vitality Score | 2.505 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Mental Health Score | 2.195 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Physical Function Score | 2.581 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Vitality Score | 3.554 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Bodily Pain Score | 3.086 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Mental Health Score | 2.335 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Vitality Score | 3.835 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-emotional Score | 1.530 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-physical Score | 2.965 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Social Function Score | 1.929 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Social Function Score | 2.884 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Social Function Score | 3.337 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Social Function Score | 5.584 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Social Function Score | 5.806 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-physical Score | 6.549 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-emotional Score | 2.459 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-emotional Score | 4.497 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Bodily Pain Score | 5.456 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Mental Health Score | 2.380 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Physical Function Score | 6.124 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Mental Health Score | 4.529 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Mental Health Score | 4.490 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Bodily Pain Score | 7.485 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Bodily Pain Score | 7.811 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: General Health Score | 4.111 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Physical Function Score | 6.703 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: General Health Score | 5.719 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Physical Function Score | 3.879 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: General Health Score | 5.794 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Vitality Score | 4.286 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-physical Score | 3.599 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Vitality Score | 6.967 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-emotional Score | 4.382 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Vitality Score | 7.373 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-physical Score | 5.616 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Mental Health Score | 4.767 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Physical Function Score | 3.936 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Physical Function Score | 5.618 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Physical Function Score | 6.624 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-physical Score | 3.107 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-physical Score | 6.241 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Bodily Pain Score | 4.901 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Bodily Pain Score | 6.613 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Bodily Pain Score | 7.739 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: General Health Score | 4.174 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: General Health Score | 4.808 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: General Health Score | 5.269 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Vitality Score | 4.669 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Vitality Score | 5.901 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Vitality Score | 7.009 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Social Function Score | 4.306 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Social Function Score | 5.022 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Social Function Score | 5.922 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Role-emotional Score | 2.294 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-emotional Score | 3.596 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 24: Role-emotional Score | 4.255 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 8: Mental Health Score | 3.048 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Mental Health Score | 3.896 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 | Week 16: Role-physical Score | 4.942 units on a scale |
Change From Baseline in PASDAS Score at Weeks 52, 76 and 100
PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 76 | -3.503 units on a scale | Standard Deviation 1.4708 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 52 | -3.054 units on a scale | Standard Deviation 1.4954 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 100 | -3.574 units on a scale | Standard Deviation 1.4785 |
| Guselkumab 100 mg q8w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 76 | -3.418 units on a scale | Standard Deviation 1.5646 |
| Guselkumab 100 mg q8w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 52 | -3.189 units on a scale | Standard Deviation 1.5216 |
| Guselkumab 100 mg q8w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 100 | -3.586 units on a scale | Standard Deviation 1.5425 |
| Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 52 | -3.184 units on a scale | Standard Deviation 1.4576 |
| Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 100 | -3.549 units on a scale | Standard Deviation 1.4635 |
| Guselkumab 100 mg q4w | Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 | Week 76 | -3.436 units on a scale | Standard Deviation 1.4428 |
Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time frame: Baseline, Weeks 16 and 24
Population: FAS1 among participants who had \>=3% BSA of psoriatic involvement and IGA score \>=2 (mild) at baseline. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be MAR. The LS mean is based on MMRM model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -3.482 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -3.904 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -11.151 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -11.407 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | -11.278 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -11.471 units on a scale |
Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -2.989 units on a scale | Standard Deviation 6.1515 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -11.016 units on a scale | Standard Deviation 9.9801 |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -11.685 units on a scale | Standard Deviation 12.3496 |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -11.977 units on a scale | Standard Deviation 12.0847 |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | -12.574 units on a scale | Standard Deviation 11.8391 |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -12.857 units on a scale | Standard Deviation 11.3052 |
Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -11.313 units on a scale | Standard Deviation 10.0631 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -11.030 units on a scale | Standard Deviation 10.0077 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -11.089 units on a scale | Standard Deviation 10.0239 |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -11.991 units on a scale | Standard Deviation 12.2656 |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -11.991 units on a scale | Standard Deviation 12.1194 |
| Guselkumab 100 mg q8w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -12.101 units on a scale | Standard Deviation 12.1322 |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | -12.875 units on a scale | Standard Deviation 11.2905 |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | -13.274 units on a scale | Standard Deviation 11.9673 |
| Guselkumab 100 mg q4w | Change From Baseline in PASI Score at Weeks 52, 76 and 100 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | -13.242 units on a scale | Standard Deviation 11.8845 |
Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52
PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 24 | -1.399 units on a scale | Standard Deviation 1.3169 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 52 | -3.041 units on a scale | Standard Deviation 1.4979 |
| Guselkumab 100 mg q8w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 24 | -2.496 units on a scale | Standard Deviation 1.5024 |
| Guselkumab 100 mg q8w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 52 | -3.197 units on a scale | Standard Deviation 1.5212 |
| Guselkumab 100 mg q4w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 24 | -2.506 units on a scale | Standard Deviation 1.2578 |
| Guselkumab 100 mg q4w | Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 | Week 52 | -3.161 units on a scale | Standard Deviation 1.4646 |
Change From Baseline in SF-36 MCS Score at Weeks 24 and 52
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 2.211 units on a scale | Standard Deviation 10.1368 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 4.297 units on a scale | Standard Deviation 10.896 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 4.452 units on a scale | Standard Deviation 9.956 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 4.465 units on a scale | Standard Deviation 9.778 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 4.076 units on a scale | Standard Deviation 9.1101 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 4.128 units on a scale | Standard Deviation 9.1814 |
Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 4.838 units on a scale | Standard Deviation 11.0526 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 4.383 units on a scale | Standard Deviation 10.9402 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 4.610 units on a scale | Standard Deviation 11.2527 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 5.034 units on a scale | Standard Deviation 10.0334 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 4.540 units on a scale | Standard Deviation 9.7848 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 4.718 units on a scale | Standard Deviation 9.9014 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 4.127 units on a scale | Standard Deviation 9.1368 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 4.936 units on a scale | Standard Deviation 9.5935 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 5.194 units on a scale | Standard Deviation 9.4899 |
Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 8, 16 and 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 16 | 1.96 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 8 | 1.11 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 24 | 2.14 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 16 | 4.28 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 8 | 2.28 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 24 | 4.17 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 8 | 2.87 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 24 | 4.22 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 | Week 16 | 3.41 units on a scale |
Change From Baseline in SF-36 PCS Score at Weeks 24 and 52
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 3.782 units on a scale | Standard Deviation 7.1776 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 8.124 units on a scale | Standard Deviation 8.2192 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 7.838 units on a scale | Standard Deviation 8.0335 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 9.511 units on a scale | Standard Deviation 8.3176 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 7.183 units on a scale | Standard Deviation 6.9793 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 8.960 units on a scale | Standard Deviation 8.5891 |
Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 9.762 units on a scale | Standard Deviation 8.5908 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 8.170 units on a scale | Standard Deviation 8.2195 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 10.508 units on a scale | Standard Deviation 8.6819 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 10.814 units on a scale | Standard Deviation 9.029 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 9.438 units on a scale | Standard Deviation 8.2854 |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 11.282 units on a scale | Standard Deviation 9.2753 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 9.023 units on a scale | Standard Deviation 8.6263 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 10.559 units on a scale | Standard Deviation 8.7449 |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 9.707 units on a scale | Standard Deviation 8.501 |
Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Time frame: Baseline, Weeks 8, 16 and 24
Population: Analysis population is FAS1. Data after meeting one or more TF criteria were imputed as no change from baseline. Missing data were assumed to be missing at random (MAR) and imputed using multiple imputation (MI).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 16 | 3.03 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 8 | 2.75 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 24 | 3.42 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 16 | 6.65 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 8 | 4.83 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 24 | 7.39 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 8 | 4.34 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 24 | 7.04 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 | Week 16 | 5.93 units on a scale |
Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -30.754 units on a scale | Standard Deviation 18.5016 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -31.209 units on a scale | Standard Deviation 18.9981 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -22.199 units on a scale | Standard Deviation 17.9394 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -29.251 units on a scale | Standard Deviation 18.1137 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -16.377 units on a scale | Standard Deviation 19.1814 |
| Guselkumab 100 mg q8w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -26.573 units on a scale | Standard Deviation 15.5254 |
| Guselkumab 100 mg q8w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -30.108 units on a scale | Standard Deviation 16.6013 |
| Guselkumab 100 mg q8w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -24.718 units on a scale | Standard Deviation 16.7967 |
| Guselkumab 100 mg q8w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -30.512 units on a scale | Standard Deviation 17.5074 |
| Guselkumab 100 mg q8w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -28.889 units on a scale | Standard Deviation 16.4372 |
| Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 52 | -32.282 units on a scale | Standard Deviation 16.632 |
| Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 24 | -26.578 units on a scale | Standard Deviation 15.3393 |
| Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 28 | -29.613 units on a scale | Standard Deviation 17.6129 |
| Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 36 | -31.782 units on a scale | Standard Deviation 16.7698 |
| Guselkumab 100 mg q4w | Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 | Week 44 | -32.126 units on a scale | Standard Deviation 15.7605 |
Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24
PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time frame: Baseline, Weeks 8, 16 and 24
Population: Analysis population is FAS1. Data after meeting 1 or more TF criteria were imputed as no change from baseline. Missing data were assumed missing at random. The LS mean is based on Mixed-effect repeated measures (MMRM) model that included data from all visits for all participants included in the model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 16 | -1.158 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 8 | -0.863 units on a scale |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 24 | -1.336 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 16 | -2.110 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 8 | -1.452 units on a scale |
| Guselkumab 100 mg q8w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 24 | -2.403 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 8 | -1.413 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 24 | -2.399 units on a scale |
| Guselkumab 100 mg q4w | Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 | Week 16 | -1.994 units on a scale |
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 16 | -10.569 percentage of activity impairment |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 24 | -10.320 percentage of activity impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 16 | -17.107 percentage of activity impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 24 | -21.467 percentage of activity impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 16 | -17.029 percentage of activity impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 | Week 24 | -20.480 percentage of activity impairment |
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 16 | -10.281 percentage of impairment |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 24 | -10.157 percentage of impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 16 | -16.054 percentage of impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 24 | -19.366 percentage of impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 16 | -15.083 percentage of impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 | Week 24 | -19.492 percentage of impairment |
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAi-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 16 | -11.232 percentage of overall work impairment |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 24 | -10.869 percentage of overall work impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 16 | -15.926 percentage of overall work impairment |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 24 | -19.711 percentage of overall work impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 16 | -15.808 percentage of overall work impairment |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 | Week 24 | -20.023 percentage of overall work impairment |
Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 16 and 24
Population: Analysis population is FAS1. Data after meeting 1/more TF criteria imputed as no change from baseline. Missing data assumed MAR. LS mean is based on MMRM model that included data from all visits for all participants included in model. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 16 | -4.553 percentage of work time missed |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 24 | -3.491 percentage of work time missed |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 16 | -3.451 percentage of work time missed |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 24 | -3.103 percentage of work time missed |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 16 | -4.717 percentage of work time missed |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 | Week 24 | -3.827 percentage of work time missed |
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 24 | -5.64 units on a scale | Standard Deviation 28.355 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 52 | -5.37 units on a scale | Standard Deviation 25.365 |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 24 | -3.77 units on a scale | Standard Deviation 28.029 |
| Guselkumab 100 mg q8w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 52 | -4.47 units on a scale | Standard Deviation 20.454 |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 24 | -1.20 units on a scale | Standard Deviation 17.127 |
| Guselkumab 100 mg q4w | Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 | Week 52 | -1.74 units on a scale | Standard Deviation 17.084 |
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 24 | -10.80 units on a scale | Standard Deviation 26.131 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 52 | -24.13 units on a scale | Standard Deviation 27.436 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 24 | -23.03 units on a scale | Standard Deviation 25.559 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 52 | -27.14 units on a scale | Standard Deviation 25.657 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 52 | -26.11 units on a scale | Standard Deviation 25.361 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 | Week 24 | -21.07 units on a scale | Standard Deviation 21.493 |
Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 76 | -28.05 units on a scale | Standard Deviation 26.411 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 52 | -24.67 units on a scale | Standard Deviation 27.106 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 100 | -30.70 units on a scale | Standard Deviation 28.632 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 76 | -31.38 units on a scale | Standard Deviation 25.449 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 100 | -30.98 units on a scale | Standard Deviation 26.65 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 52 | -27.16 units on a scale | Standard Deviation 25.662 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 76 | -28.70 units on a scale | Standard Deviation 24.635 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 52 | -26.24 units on a scale | Standard Deviation 25.113 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 | Week 100 | -30.68 units on a scale | Standard Deviation 25.305 |
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 52 | -21.27 units on a scale | Standard Deviation 31.502 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 24 | -12.14 units on a scale | Standard Deviation 29.027 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 52 | -27.93 units on a scale | Standard Deviation 25.263 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 24 | -21.28 units on a scale | Standard Deviation 25.621 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 24 | -20.08 units on a scale | Standard Deviation 22.084 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 | Week 52 | -22.10 units on a scale | Standard Deviation 26.172 |
Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 76 | -26.90 units on a scale | Standard Deviation 28.965 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 52 | -21.81 units on a scale | Standard Deviation 31.391 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 100 | -30.73 units on a scale | Standard Deviation 30.933 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 76 | -29.91 units on a scale | Standard Deviation 24.549 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 52 | -27.93 units on a scale | Standard Deviation 25.263 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 100 | -30.65 units on a scale | Standard Deviation 24.771 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 52 | -22.62 units on a scale | Standard Deviation 26.058 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 100 | -27.77 units on a scale | Standard Deviation 26.119 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 | Week 76 | -26.13 units on a scale | Standard Deviation 25.412 |
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 24 and 52
Population: Analysis population is FAS2. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 24 | -13.42 units on a scale | Standard Deviation 29.916 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 52 | -22.06 units on a scale | Standard Deviation 32.092 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 24 | -21.68 units on a scale | Standard Deviation 27.065 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 52 | -28.19 units on a scale | Standard Deviation 25.536 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 24 | -20.90 units on a scale | Standard Deviation 22.814 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 | Week 52 | -22.24 units on a scale | Standard Deviation 26.92 |
Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 76 | -27.98 units on a scale | Standard Deviation 29.709 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 52 | -22.61 units on a scale | Standard Deviation 31.979 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 100 | -31.87 units on a scale | Standard Deviation 31.013 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 76 | -30.27 units on a scale | Standard Deviation 26.058 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 52 | -28.19 units on a scale | Standard Deviation 25.536 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 100 | -31.75 units on a scale | Standard Deviation 25.615 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 52 | -22.79 units on a scale | Standard Deviation 26.793 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 100 | -25.21 units on a scale | Standard Deviation 26.317 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 | Week 76 | -26.21 units on a scale | Standard Deviation 28.115 |
Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100
Work Productivity and Activity Impairment was assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) of PsA (WPAI-PsA). The WPAI-PsA consisted of 6 questions to determine employment status, hours missed from work due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which PsA affected work productivity while at work and the degree to which PsA affected activities outside of work during the past 7 days. WPAI outcomes included percent work time missed due to PsA, percent impairment while working due to PsA, percent overall work impairment due to PsA, and percent activity impairment outside of work due to PsA. These WPAI outcomes were expressed as impairment percentages (0-100, 0=no impairment and 100=100% impaired), with higher numbers indicating greater impairment and less productivity. Negative changes from baseline indicate improvement of work productivity and activity impairment.
Time frame: Baseline, Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 76 | -5.92 units on a scale | Standard Deviation 26.032 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 52 | -5.45 units on a scale | Standard Deviation 25.544 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 100 | -8.81 units on a scale | Standard Deviation 24.313 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 76 | -6.22 units on a scale | Standard Deviation 23.133 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 52 | -4.50 units on a scale | Standard Deviation 20.53 |
| Guselkumab 100 mg q8w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 100 | -5.81 units on a scale | Standard Deviation 21.606 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 52 | -1.83 units on a scale | Standard Deviation 17.191 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 100 | -1.56 units on a scale | Standard Deviation 16.956 |
| Guselkumab 100 mg q4w | Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 | Week 76 | -2.39 units on a scale | Standard Deviation 19.277 |
Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores)
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand (Hand erosion score) scored according to 0 (no erosion) to 5 (complete collapse of bone) for a maximum hand erosion score of 200, and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum foot erosion score of 120. Higher scores indicate more joint damage. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum Hand JSN score of 160 and maximum Foot JSN score of 48. Higher scores indicate more joint damage. Hand Score (sum of Hand Erosion Score and Hand JSN Score) scored as 0-360 and Foot score (sum of foot erosion score and foot JSN score) scored as 0-168. Higher scores indicate more joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Erosion Score | 0.67 units on a scale | Standard Deviation 2.917 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand JSN Score | 0.35 units on a scale | Standard Deviation 2.443 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Score | 1.02 units on a scale | Standard Deviation 5.244 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Erosion Score | 0.34 units on a scale | Standard Deviation 1.596 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot JSN Score | 0.13 units on a scale | Standard Deviation 0.912 |
| Placebo to Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Score | 0.48 units on a scale | Standard Deviation 2.373 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Score | 0.48 units on a scale | Standard Deviation 1.652 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Erosion Score | 0.67 units on a scale | Standard Deviation 2.807 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Erosion Score | 0.33 units on a scale | Standard Deviation 1.362 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot JSN Score | 0.15 units on a scale | Standard Deviation 0.652 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand JSN Score | 0.34 units on a scale | Standard Deviation 1.247 |
| Guselkumab 100 mg q8w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Score | 1.02 units on a scale | Standard Deviation 3.815 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand JSN Score | 0.32 units on a scale | Standard Deviation 1.845 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Score | 0.81 units on a scale | Standard Deviation 4.532 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Score | 0.87 units on a scale | Standard Deviation 3.761 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot Erosion Score | 0.53 units on a scale | Standard Deviation 2.436 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Hand Erosion Score | 0.49 units on a scale | Standard Deviation 3.007 |
| Guselkumab 100 mg q4w | Change From Baseline to Week 100 in Modified vdH-S Score by Region and Type of Damage (ie, Hand Erosion, Hand JSN, Foot Erosion, Foot JSN Subscores) | Foot JSN Score | 0.34 units on a scale | Standard Deviation 1.608 |
Change in Modified vdH-s Erosion Score From Baseline to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-s Erosion Score From Baseline to Week 100 | 1.01 units on a scale | Standard Deviation 4.034 |
| Guselkumab 100 mg q8w | Change in Modified vdH-s Erosion Score From Baseline to Week 100 | 1.01 units on a scale | Standard Deviation 3.355 |
| Guselkumab 100 mg q4w | Change in Modified vdH-s Erosion Score From Baseline to Week 100 | 1.02 units on a scale | Standard Deviation 4.676 |
Change in Modified vdH-S Erosion Score From Week 24 to Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time frame: From Week 24 to Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-S Erosion Score From Week 24 to Week 52 | 0.17 units on a scale | Standard Deviation 1.277 |
| Guselkumab 100 mg q8w | Change in Modified vdH-S Erosion Score From Week 24 to Week 52 | 0.10 units on a scale | Standard Deviation 1.422 |
| Guselkumab 100 mg q4w | Change in Modified vdH-S Erosion Score From Week 24 to Week 52 | 0.39 units on a scale | Standard Deviation 1.725 |
Change in Modified vdH-s Erosion Score From Week 52 to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: From Week 52 to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-s Erosion Score From Week 52 to Week 100 | 0.09 units on a scale | Standard Deviation 1.978 |
| Guselkumab 100 mg q8w | Change in Modified vdH-s Erosion Score From Week 52 to Week 100 | 0.26 units on a scale | Standard Deviation 1.751 |
| Guselkumab 100 mg q4w | Change in Modified vdH-s Erosion Score From Week 52 to Week 100 | 0.45 units on a scale | Standard Deviation 2.9 |
Change in Modified vdH-s JSN Score From Baseline to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-s JSN Score From Baseline to Week 100 | 0.49 units on a scale | Standard Deviation 2.984 |
| Guselkumab 100 mg q8w | Change in Modified vdH-s JSN Score From Baseline to Week 100 | 0.50 units on a scale | Standard Deviation 1.387 |
| Guselkumab 100 mg q4w | Change in Modified vdH-s JSN Score From Baseline to Week 100 | 0.66 units on a scale | Standard Deviation 2.722 |
Change in Modified vdH-S JSN Score From Week 24 to Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time frame: From Week 24 to Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-S JSN Score From Week 24 to Week 52 | 0.07 units on a scale | Standard Deviation 0.635 |
| Guselkumab 100 mg q8w | Change in Modified vdH-S JSN Score From Week 24 to Week 52 | 0.13 units on a scale | Standard Deviation 0.705 |
| Guselkumab 100 mg q4w | Change in Modified vdH-S JSN Score From Week 24 to Week 52 | 0.23 units on a scale | Standard Deviation 1.088 |
Change in Modified vdH-s JSN Score From Week 52 to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: From Week 52 to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-s JSN Score From Week 52 to Week 100 | 0.04 units on a scale | Standard Deviation 1.904 |
| Guselkumab 100 mg q8w | Change in Modified vdH-s JSN Score From Week 52 to Week 100 | 0.20 units on a scale | Standard Deviation 0.917 |
| Guselkumab 100 mg q4w | Change in Modified vdH-s JSN Score From Week 52 to Week 100 | 0.30 units on a scale | Standard Deviation 1.319 |
Change in Modified vdH-S Score From Baseline to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Modified vdH-S Score From Baseline to Week 100 | 1.49 units on a scale | Standard Deviation 6.859 |
| Guselkumab 100 mg q8w | Change in Modified vdH-S Score From Baseline to Week 100 | 1.50 units on a scale | Standard Deviation 4.393 |
| Guselkumab 100 mg q4w | Change in Modified vdH-S Score From Baseline to Week 100 | 1.68 units on a scale | Standard Deviation 7.018 |
Change in Total Modified vdH-S Score From Week 24 to Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time frame: From Week 24 to Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Total Modified vdH-S Score From Week 24 to Week 52 | 0.25 units on a scale | Standard Deviation 1.635 |
| Guselkumab 100 mg q8w | Change in Total Modified vdH-S Score From Week 24 to Week 52 | 0.23 units on a scale | Standard Deviation 1.808 |
| Guselkumab 100 mg q4w | Change in Total Modified vdH-S Score From Week 24 to Week 52 | 0.62 units on a scale | Standard Deviation 2.53 |
Change in Total Modified vdH-S Score From Week 52 to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage.
Time frame: From Week 52 to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Change in Total Modified vdH-S Score From Week 52 to Week 100 | 0.13 units on a scale | Standard Deviation 3.742 |
| Guselkumab 100 mg q8w | Change in Total Modified vdH-S Score From Week 52 to Week 100 | 0.46 units on a scale | Standard Deviation 2.419 |
| Guselkumab 100 mg q4w | Change in Total Modified vdH-S Score From Week 52 to Week 100 | 0.75 units on a scale | Standard Deviation 4.021 |
Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline
HAQ-DI score assess functional status of participant. It is a 20 question instrument that assess the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: FAS1 among participants with HAQ-DI \>=0.35 at baseline. Participants with HAQ-DI \>=0.35 improvement from baseline at specific timepoint and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 8 | 28.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 20 | 38.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 16 | 30.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 4 | 23.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 2 | 19.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 31.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 12 | 31.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 16 | 50.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 4 | 32.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 8 | 43.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 12 | 47.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 20 | 48.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 50.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 2 | 30.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 20 | 53.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 8 | 42.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 2 | 23.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 56.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 16 | 51.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 12 | 46.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=0.35 Improvement From Baseline in HAQ-DI Score Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 4 | 35.1 percentage of participants |
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 44.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 71.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 22.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 50.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 8.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 23.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 2.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 6.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 40.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 1.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 42.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 21.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 26.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 62.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 70.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 10.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 39.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 79.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 73.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 50.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 3.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 30.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 16.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 8.9 percentage of participants |
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with spondylitis and peripheral arthritis and BASDAI score \>0 at Baseline. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=70% Improvement | 32.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 71.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 6.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 50.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=90% Improvement | 11.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=90% Improvement | 18.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=70% Improvement | 31.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=20% Improvement | 74.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=50% Improvement | 52.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=50% Improvement | 59.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 23.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=20% Improvement | 87.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=70% Improvement | 31.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=70% Improvement | 39.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 27.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=50% Improvement | 52.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 11.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=20% Improvement | 82.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=20% Improvement | 77.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=90% Improvement | 13.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 42.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=50% Improvement | 57.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=90% Improvement | 11.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 69.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=90% Improvement | 9.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=20% Improvement | 79.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=20% Improvement | 81.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=20% Improvement | 82.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=50% Improvement | 50.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=50% Improvement | 50.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=50% Improvement | 55.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=70% Improvement | 30.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=70% Improvement | 26.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 100: Participants with >=70% Improvement | 32.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 52: Participants with >=90% Improvement | 8.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 76: Participants with >=90% Improvement | 7.8 percentage of participants |
Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis and peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.
Time frame: Weeks 8, 16 and 24
Population: FAS1 with spondylitis and peripheral arthritis and BASDAI score \>0 at baseline. Participants with the specified improvement in BASDAI at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=20% Improvement | 38.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=20% Improvement | 39.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 42.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=50% Improvement | 6.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=50% Improvement | 17.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 21.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=70% Improvement | 3.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=70% Improvement | 5.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 8.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=90% Improvement | 0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=90% Improvement | 1.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 2.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 1.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=20% Improvement | 46.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=70% Improvement | 11.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 20.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=20% Improvement | 58.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 38.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=90% Improvement | 0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 59.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=70% Improvement | 23.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=50% Improvement | 37.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=50% Improvement | 17.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=90% Improvement | 1.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=50% Improvement | 18.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=50% Improvement | 26.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=90% Improvement | 0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=50% Improvement | 37.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=70% Improvement | 4.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=70% Improvement | 9.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=90% Improvement | 2.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 8: Participants with >=20% Improvement | 53.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 16: Participants with >=20% Improvement | 69.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=70% Improvement | 15.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=20% Improvement | 68.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline | Week 24: Participants with >=90% Improvement | 3.6 percentage of participants |
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 70.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 68.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 72.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 69.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 69.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 72.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 52 | 68.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 100 | 74.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 | Week 76 | 74.4 percentage of participants |
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 24 | 49.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 52 | 68.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 24 | 63.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 52 | 69.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 52 | 68.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 | Week 24 | 62.8 percentage of participants |
Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24
The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores \[4 - score\]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time frame: Weeks 8, 16 and 24
Population: Analysis population is FAS1. Participants who achieved \>=4-point improvement from baseline in FACIT-fatigue score at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 16 | 50.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 8 | 45.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 24 | 45.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 16 | 60.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 8 | 56.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 24 | 60.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 8 | 51.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 24 | 59.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 | Week 16 | 56.7 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with DLQI score \>=5, \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 40.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 85.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 92.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 90.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 24 and 52 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 89.4 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among the participants with DLQI score \>=5, \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 91.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 91.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 89.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 92.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 94.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 89.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 88.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score at Weeks 52, 76 and 100 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 90.1 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. An improvement of 5 points was considered clinically meaningful.
Time frame: Weeks 8, 16, 24
Population: FAS1 with DLQI\>=5, \>=3% BSA of psoriasis and IGA score \>=2 (mild) at baseline. Participants with \>=5-point improvement from baseline in DLQI score at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 36.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 30.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 37.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 79.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 71.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 83.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 69.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 86.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in DLQI Score Through Week 24 Among the Participants With DLQI Score >=5, >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 79.6 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 32.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 41.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 40.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 44.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 24 | 36.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 | Week 52 | 38.9 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 43.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 42.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 42.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 44.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 45.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 46.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 52 | 38.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 100 | 43.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 | Week 76 | 43.5 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Week 8, 16 and 24
Population: Analysis population is FAS1. Participants who achieved \>=5-point improvement from baseline in SF-36 MCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 16 | 31.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 8 | 26.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 24 | 30.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 24 | 37.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 8 | 33.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 16 | 42.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 16 | 31.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 8 | 27.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 | Week 24 | 34.3 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 42.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 63.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 63.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 67.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 52 | 65.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 | Week 24 | 58.5 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 70.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 63.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 72.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 73.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 66.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 70.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 52 | 65.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 100 | 68.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 | Week 76 | 65.5 percentage of participants |
Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.
Time frame: Week 8, 16 and 24
Population: Analysis population is FAS1. Participants who achieved \>=5-point improvement from baseline in SF-36 PCS score at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 16 | 35.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 8 | 37.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 24 | 40.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 16 | 59.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 8 | 45.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 24 | 60.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 8 | 41.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 24 | 55.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 | Week 16 | 51.0 percentage of participants |
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2 among participants with HAQ-DI score \>=0.35 at baseline and who achieved a HAQ-DI response at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 44 | 50.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 36 | 48.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 34.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 28 | 42.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 50.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 36 | 58.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 52.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 28 | 58.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 44 | 60.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 60.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 62.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 44 | 61.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 24 | 58.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 36 | 61.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 28 | 63.4 percentage of participants |
Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 among participants with HAQ-DI score \>=0.35 at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 76 | 59.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 68 | 57.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 84 | 58.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 100 | 63.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 51.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 84 | 66.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 100 | 70.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 60.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 68 | 64.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 76 | 68.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 68 | 69.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 76 | 64.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 84 | 65.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 100 | 70.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 Among Participants With HAQ-DI Score >=0.35 at Baseline | Week 52 | 63.3 percentage of participants |
Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52
ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Full analysis set 2 (FAS2) included all randomized participants who were still on study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 69.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 68.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 34.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 48.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 68.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 77.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 66.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 71.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 79.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 79.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 75.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 76.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 66.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 78.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 72.0 percentage of participants |
Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100
ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is full analysis set 3 (FAS3) which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 80.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 75.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 68.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 77.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 79.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 83.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 78.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 85.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 85.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 82.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 84.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 80.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 77.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 82.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 80.7 percentage of participants |
Percentage of Participants Who Achieved ACR 20 Response Through Week 24
ACR 20 response was defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved ACR 20 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 4 | 11.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 16 | 33.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 12 | 26.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 2 | 8.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 24 | 32.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 20 | 29.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 8 | 17.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 12 | 49.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 2 | 10.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 4 | 19.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 8 | 39.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 16 | 55.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 20 | 62.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 24 | 64.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 16 | 55.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 4 | 21.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 24 | 63.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 20 | 58.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 12 | 51.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 8 | 40.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 20 Response Through Week 24 | Week 2 | 10.6 percentage of participants |
Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52
ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 15.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 43.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 39.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 43.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 22.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 44.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 32.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 41.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 48.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 51.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 49.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 48.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 34.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 45.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 40.5 percentage of participants |
Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100
ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 44.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 56.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 50.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 55.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 49.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 56.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 50.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 60.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 63.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 60.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 62.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 57.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 49.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 58.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 58.6 percentage of participants |
Percentage of Participants Who Achieved ACR 50 Response Through Week 24
ACR 50 response was defined as \>= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved ACR 50 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 4 | 1.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 16 | 9.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 12 | 6.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 2 | 0.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 24 | 14.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 20 | 16.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 8 | 4.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 12 | 19.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 2 | 1.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 4 | 4.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 8 | 10.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 16 | 28.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 20 | 31.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 24 | 31.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 16 | 20.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 4 | 3.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 24 | 33.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 20 | 29.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 12 | 16.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 8 | 11.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 50 Response Through Week 24 | Week 2 | 0.4 percentage of participants |
Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52
ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 20.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 15.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 4.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 7.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 19.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 27.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 19.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 21.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 29.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 29.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 28.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 24.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 13.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 24.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 21.1 percentage of participants |
Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100
ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 29.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 27.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 19.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 27.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 34.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 36.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 29.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 35.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 42.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 39.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 38.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 39.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 28.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 32.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 36.1 percentage of participants |
Percentage of Participants Who Achieved ACR 70 Response Through Week 24
ACR 70 response was defined as \>= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved ACR 70 response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 4 | 0.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 16 | 0.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 12 | 0.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 2 | 0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 24 | 4.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 20 | 3.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 8 | 0.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 12 | 8.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 2 | 0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 4 | 0.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 8 | 3.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 16 | 13.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 20 | 15.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 24 | 18.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 16 | 8.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 4 | 0.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 24 | 13.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 20 | 13.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 12 | 4.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 8 | 2.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved ACR 70 Response Through Week 24 | Week 2 | 0 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value \<2.6 at the analysis visit.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 44 | 30.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 36 | 25.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 24 | 9.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 28 | 13.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 52 | 34.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 36 | 36.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 24 | 25.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 28 | 27.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 44 | 38.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 52 | 39.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 52 | 39.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 44 | 38.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 24 | 24.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 36 | 39.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 | Week 28 | 30.4 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission was defined as DAS28 (CRP) value \<2.6 at the analysis visit.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 84 | 41.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 76 | 43.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 52 | 34.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 68 | 39.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 100 | 42.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 76 | 44.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 52 | 39.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 68 | 44.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 84 | 50.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 100 | 47.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 100 | 51.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 84 | 48.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 52 | 40.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 76 | 43.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 | Week 68 | 49.1 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS 28 (CRP) remission was defined as DAS 28 (CRP) value \<2.6 at the analysis visit.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved a DAS28 (CRP) remission at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 4 | 2.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 16 | 6.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 12 | 6.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 2 | 0.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 24 | 8.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 20 | 9.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 8 | 0.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 12 | 14.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 2 | 2.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 4 | 5.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 8 | 10.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 16 | 18.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 20 | 23.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 24 | 24.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 16 | 16.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 4 | 4.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 24 | 23.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 20 | 21.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 12 | 11.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 8 | 9.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 | Week 2 | 2.4 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 91.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 86.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 55.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 72.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 89.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 86.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 79.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 85.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 91.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 89.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 52 | 89.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 44 | 91.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 24 | 83.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 36 | 92.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 | Week 28 | 85.9 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 89.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 92.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 94.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 94.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 94.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 92.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 92.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 90.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 90.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 89.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 100 | 92.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 68 | 92.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 52 | 90.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 76 | 93.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 | Week 84 | 92.5 percentage of participants |
Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24
DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS 28 (CRP) response criteria was defined as follows: Good response: \<=3.2 at visit and \>1.2 improvement; Moderate response: \>3.2 at visit and \>1.2 improvement or \<=5.1 at visit and \>0.6-1.2 improvement; No response: \<=0.6 improvement, or \>5.1 at visit and \<=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder is defined as achieving a good or moderate DAS28 response at a specific visit.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved a DAS28 (CRP) response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 24 | 52.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 2 | 21.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 12 | 51.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 20 | 50.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 8 | 38.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 16 | 51.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 4 | 32.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 16 | 69.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 20 | 75.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 4 | 38.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 24 | 75.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 8 | 56.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 12 | 67.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 2 | 23.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 24 | 80.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 4 | 40.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 8 | 54.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 12 | 65.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 16 | 72.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 20 | 76.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 | Week 2 | 24.5 percentage of participants |
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with DLQI Score \>1, with \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 12.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 56.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 65.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 68.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 61.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 24 and 52 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 68.7 percentage of participants |
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among the participants with DLQI Score \>1, with \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 66.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 56.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 74.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 66.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 68.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 69.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 68.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 64.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 at Weeks 52, 76 and 100 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 68.9 percentage of participants |
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Dermatology Life Quality Index (DLQI) is a 10-item instrument questionnaire used to assess the patient's perspective of the impact of psoriasis on daily living. Each item was scored on a 4-point scale (0 =not at all /not relevant; 1 =a little; 2 =a lot; 3 =very much), and the total score (0-30) is the sum of the 10 items. The higher the score, the more quality of life is impaired. A DLQI score of 0 or 1 indicates psoriasis had no effect at all on patient's life.
Time frame: Weeks 8, 16, 24
Population: FAS1 among participants with DLQI \>1, \>=3% BSA of psoriasis and IGA score \>=2 (mild) at baseline. Participants with DLQI score of 0/1 at specific time point and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 10.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 7.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 11.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 51.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 33.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 63.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 8 | 26.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 59.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Through Week 24 Among the Participants With DLQI Score >1, With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 45.1 percentage of participants |
Percentage of Participants Who Achieved an ACR 50 Response at Week 24
ACR 50 response was defined as greater than or equal to (\>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).
Time frame: Week 24
Population: Analysis population is FAS1. Participants who achieved ACR 50 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an ACR 50 Response at Week 24 | 14.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an ACR 50 Response at Week 24 | 31.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an ACR 50 Response at Week 24 | 33.1 percentage of participants |
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
ACR 20 response was defined as \>= 20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Week 16
Population: Analysis population is FAS1. Participants who achieved ACR 20 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria before Week 16 or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 | 33.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 | 55.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 | 55.9 percentage of participants |
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16
ACR 50 response was defined as \>= 50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Week 16
Population: Analysis population is FAS1. Participants who achieved ACR 50 response at Week 16 and did not meet any TF criteria before Week 16 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | 9.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | 28.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 | 20.8 percentage of participants |
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24
ACR 70 response was defined as \>= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.
Time frame: Week 24
Population: Analysis population is FAS1. Participants who achieved ACR 70 response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 | 4.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 | 18.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 | 13.1 percentage of participants |
Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 19.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 72.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 77.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 71.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Response at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.4 percentage of participants |
Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 8.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 66.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 51.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 60.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 52.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved an IGA Score of 0 (Cleared) at Weeks 24 and 52 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 66.5 percentage of participants |
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52
The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time frame: Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 44 | 77.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 36 | 78.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 24 | 46.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 28 | 64.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 52 | 81.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 36 | 82.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 24 | 76.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 28 | 79.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 44 | 83.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 52 | 86.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 52 | 82.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 44 | 82.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 24 | 72.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 36 | 84.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 | Week 28 | 83.1 percentage of participants |
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100
The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 100 | 86.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 68 | 84.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 52 | 81.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 76 | 84.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 84 | 87.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 76 | 88.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 100 | 89.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 84 | 87.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 68 | 89.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 52 | 86.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 100 | 88.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 68 | 87.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 76 | 90.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 84 | 87.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 | Week 52 | 83.6 percentage of participants |
Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24
The modified PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Participants who achieved a modified PsARC response at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 4 | 27.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 16 | 44.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 12 | 40.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 2 | 13.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 24 | 44.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 20 | 46.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 8 | 35.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 12 | 60.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 2 | 22.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 4 | 32.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 8 | 48.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 16 | 66.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 20 | 72.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 24 | 72.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 16 | 66.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 4 | 29.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 24 | 68.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 20 | 69.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 12 | 60.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 8 | 50.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 | Week 2 | 18.0 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in SJC (66 joints)+TJC (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 11.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 59.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 58.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 73.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 59.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 69.9 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 71.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 59.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 73.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 75.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 73.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 76.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 70.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 77.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 76.7 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: \>=75% improvement in PASI score from baseline. ACR 20: \>=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and \>=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.
Time frame: Weeks 16 and 24
Population: FAS1 participants with \>=3% BSA psoriatic involvement and IGA score \>=2 at baseline. Participants with both PASI75 and ACR20 responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 10.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 11.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 48.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 56.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 48.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 57.1 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 15.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 70.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 66.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 79.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 63.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.3 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 78.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 70.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 78.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 79.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 79.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 81.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 78.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 52, 76, and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 82.6 percentage of participants |
Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: \>=30% decrease in SJC and TJC, \>=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), \>=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.
Time frame: Weeks 16 and 24
Population: FAS1 with \>=3% BSA psoriatic involvement and IGA score \>=2 at baseline. Participants with both PASI 75 and modified PsARC responses at specific timepoint and did not meet TF criteria before, considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 13.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 15.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 56.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 65.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 54.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 60.9 percentage of participants |
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52
MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1).
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 24 | 6.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 52 | 31.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 24 | 26.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 52 | 32.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 24 | 19.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 | Week 52 | 36.8 percentage of participants |
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100
MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1).
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 76 | 34.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 52 | 32.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 100 | 42.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 76 | 40.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 52 | 32.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 100 | 44.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 52 | 37.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 100 | 42.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 | Week 76 | 39.0 percentage of participants |
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24
MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)\<=1, Swollen joint count (66 joints) \<=1, Psoriasis activity and severity index \<=1, Patient's Assessment of Pain \<=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) \<=20 on a 100-unit VAS, HAQ-DI score \<=0.5, and Tender entheseal points \<= 1 (LEI index score \<= 1).
Time frame: Weeks 16 and 24
Population: Analysis population is FAS1. Participants who achieved MDA at a specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 16 | 3.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 24 | 6.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 16 | 16.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 24 | 25.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 16 | 13.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 | Week 24 | 18.8 percentage of participants |
Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 2.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 55.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 46.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 54.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 46.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 61.3 percentage of participants |
Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 65.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 55.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 69.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 59.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 54.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 57.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 60.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 64.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 68.0 percentage of participants |
Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.
Time frame: Weeks 16 and 24
Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 100 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 16 | 3.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 24 | 2.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 16 | 27.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 24 | 45.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 16 | 33.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline | Week 24 | 44.6 percentage of participants |
Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: \>=50% improvement in PASI score from baseline.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 95.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 39.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 94.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 97.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 93.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 98.3 percentage of participants |
Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 50 response: \>=50% improvement in PASI score from baseline.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 97.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 95.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 95.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 96.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 97.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 97.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 98.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 98.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 50 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 97.1 percentage of participants |
Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 23.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 88.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 80.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 88.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 81.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 91.9 percentage of participants |
Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: \>=75% improvement in PASI score from baseline.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 92.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 88.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 91.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 87.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 88.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 87.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 91.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 89.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 93.0 percentage of participants |
Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: \>=75% improvement in PASI score from baseline.
Time frame: Weeks 16 and 24
Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 75 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 18.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 23.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 73.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 79.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 73.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 75 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 78.3 percentage of participants |
Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: \>=90% improvement in PASI score from baseline.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants who had \>=3% BSA of psoriatic involvement and an IGA score \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 10.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 70.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 77.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 63.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 81.5 percentage of participants |
Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: \>=90% improvement in PASI score from baseline.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 85.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 87.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 75.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 75.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 81.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 80.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 80.2 percentage of participants |
Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: \>=90% improvement in PASI score from baseline.
Time frame: Weeks 16 and 24
Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with PASI 90 response at specific time point and did not meet any TF criteria before, were considered responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 8.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 9.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 55.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 68.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 53.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved PASI 90 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 60.9 percentage of participants |
Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time frame: Week 24
Population: FAS1 among participants with \>=3% BSA psoriatic involvement and an IGA score \>=2 (mild) at baseline. Participants who achieved psoriasis IGA response at Week 24 and did not meet any TF criteria before Week 24 were considered as responders. Participants who met 1 or more TF criteria or with missing data were considered as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline | 19.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline | 70.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline | 68.5 percentage of participants |
Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time frame: Week 100
Population: Analysis population is FAS3 among participants with HAQ-DI Score \>=0.35 at Baseline and who achieved a HAQ-DI response at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52 | 91.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52 | 90.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 100 Among Participants Who Achieved a HAQ-DI Response at Week 52 | 88.5 percentage of participants |
Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.
Time frame: Week 52
Population: Analysis population is FAS2 among participants who achieved a HAQ-DI response at Week 24. The OM was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24 | 92.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24 | 88.6 percentage of participants |
Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52
ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 100
Population: FAS3 among participants who achieved ACR20 response at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 | 94.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 | 90.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 | 93.0 percentage of participants |
Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24
ACR 20 response was defined as \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 52
Population: FAS2 among participants achieved ACR20 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100mg q8w and guselkumab 100mg q4w arms only and not for placebo arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 | 91.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 | 86.8 percentage of participants |
Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52
ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 100
Population: FAS3 among participants who achieved ACR50 response at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 | 81.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 | 81.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 | 83.8 percentage of participants |
Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24
ACR 50 response was defined as \>=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 52
Population: FAS2 among participants achieved ACR50 response at Week 24. Here, N (number of participants analyzed) signifies number of participants analyzed for this OM. The OM was planned to assess maintenance of guselkumab effect only through Week 52, hence data is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 | 87.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 | 79.2 percentage of participants |
Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52
ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 100
Population: FAS3 among participants who achieved ACR70 response at Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 | 65.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 | 80.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 | 71.9 percentage of participants |
Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24
ACR 70 response was defined as \>=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters \[mm\], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.
Time frame: Week 52
Population: Analysis population is FAS2 among participants who achieved ACR 70 response at Week 24. The outcome measure was planned to assess the maintenance of guselkumab effect only through Week 52, hence the data in this outcome measure is reported for guselkumab 100 mg q8w and guselkumab 100 mg q4w arms only and not for placebo arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 | 82.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 | 75.0 percentage of participants |
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0 from Baseline | 66.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0.5 from Baseline | 72.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0 from Baseline | 66.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0.5 from Baseline | 76.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0 from Baseline | 71.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24 | Change of <=0.5 from Baseline | 80.2 percentage of participants |
Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24
The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. Change from baseline in the modified vdH-S JSN score \<=0 (assessed by both readers) or \<=0.5 (assessed by at least one reader) was considered as no progression of JSN.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0 from Baseline | 78.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0.5 from Baseline | 85.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0 from Baseline | 78.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0.5 from Baseline | 88.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0 from Baseline | 80.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24 | Change of <=0.5 from Baseline | 88.3 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0 from Baseline | 58.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0.5 from Baseline | 70.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0 from Baseline | 59.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0.5 from Baseline | 71.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0 from Baseline | 60.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 | Change of <=0.5 from Baseline | 72.1 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0 from Baseline | 78.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0.5 from Baseline | 88.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0 from Baseline | 75.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0.5 from Baseline | 86.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0 from Baseline | 79.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 | Change of <=0.5 from Baseline | 86.5 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0 from Baseline | 64.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0.5 from Baseline | 72.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0 from Baseline | 63.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0.5 from Baseline | 74.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0 from Baseline | 67.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 | Change of <=0.5 from Baseline | 78.0 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0 from Baseline | 57.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0.5 from Baseline | 67.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0 from Baseline | 55.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0.5 from Baseline | 67.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0 from Baseline | 56.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 | Change of <=0.5 from Baseline | 72.1 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0 from Baseline | 64.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0.5 from Baseline | 75.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0 from Baseline | 61.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0.5 from Baseline | 73.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0 from Baseline | 65.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score | Change of <=0.5 from Baseline | 75.4 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0 from Baseline | 77.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0.5 from Baseline | 84.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0 from Baseline | 68.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0.5 from Baseline | 79.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0 from Baseline | 73.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score | Change of <=0.5 from Baseline | 81.0 percentage of participants |
Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of the foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0 from Baseline | 60.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0.5 from Baseline | 72.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0 from Baseline | 55.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0.5 from Baseline | 63.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0 from Baseline | 62.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score | Change of <=0.5 from Baseline | 72.5 percentage of participants |
Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). IGA Response is defined as achieving IGA score of 0 or 1, and \>=2 grade reduction from baseline.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 85.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 88.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 77.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 76.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 76.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 84.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 82.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Response at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 86.0 percentage of participants |
Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with \>=3% BSA Psoriatic Involvement and an IGA Score of \>=2 (mild) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 72.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 66.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 76.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 64.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 59.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 58.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 52 | 65.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 100 | 67.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 52, 76 and 100 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 76 | 72.1 percentage of participants |
Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and \>=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time frame: Weeks 16 and 24
Population: FAS1 among participants with \>=3% BSA of psoriasis and IGA score \>=2 at baseline. Participants with IGA score of 0(cleared) at specific time point and did not meet TF criteria before, were considered responders at that time point. Participants who met 1/more TF criteria before or with missing data at that time point were considered non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 6.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 7.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 38.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 50.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 16 | 40.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With an IGA Score of 0 (Cleared) Through Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline | Week 24 | 51.5 percentage of participants |
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52
GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score \<=2.3 at the analysis visit.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | 7.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | 34.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | 29.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | 43.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 24 | 27.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 | Week 52 | 43.0 percentage of participants |
Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100
GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), PtGA of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), PtGA of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + \[2.367\*HAQ-DI\]-\[0.234\*SF-PCS\]-\[0.244\*SF-MCS\]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score range= 0-100, higher scores= better quality of life) and SF-MCS (score range=0-100, higher scores= better quality of life). Total score is 0-10, lower score=better response. Higher score= more active disease activity. Negative change from baseline indicates improvement of PsA disease activity. GRACE low disease activity is GRACE score \<=2.3 at the analysis visit.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 76 | 45.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 52 | 35.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 100 | 48.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 76 | 48.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 52 | 42.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 100 | 51.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 52 | 43.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 100 | 54.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 52, 76 and 100 | Week 76 | 49.8 percentage of participants |
Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100
The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score \<=3.2 at the analysis visit.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 100 | 67.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 52 | 56.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 76 | 64.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 76 | 63.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 100 | 71.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 52 | 61.2 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 52 | 60.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 100 | 68.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 | Week 76 | 68.6 percentage of participants |
Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52
The mCPDAI assessed 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores were calculated using the following assessments: joints (66 swollen and 68 tender joint counts), HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0-3) was assigned, where 0= Not involved, 1= Mild, 2= Moderate and 3= Severe. The scores for each domain were then added together to give a final score range of 0 to 12. A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. mCPDAI low disease activity is defined as mCPDAI score \<=3.2 at the analysis visit.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | 15.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | 56.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | 48.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | 61.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 24 | 43.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 | Week 52 | 60.1 percentage of participants |
Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100
DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound. Low: DAPSA\<=14; Remission: DAPSA\<=4.
Time frame: Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Remission | 15.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Low Disease Activity | 50.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Remission | 10.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Low Disease Activity | 54.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Low Disease Activity | 58.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Remission | 16.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Low Disease Activity | 60.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Remission | 17.8 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Low Disease Activity | 61.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Remission | 18.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Low Disease Activity | 65.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Remission | 26.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Low Disease Activity | 55.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Low Disease Activity | 61.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Remission | 28.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Remission | 19.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Remission | 26.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Low Disease Activity | 66.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Low Disease Activity | 64.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Remission | 23.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Low Disease Activity | 63.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 68: Remission | 23.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Low Disease Activity | 61.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 76: Remission | 19.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Low Disease Activity | 68.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Low Disease Activity | 64.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 100: Remission | 23.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Low Disease Activity | 55.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 52: Remission | 17.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 | Week 84: Remission | 23.6 percentage of participants |
Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100
PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining PtGA of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), PGA of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity. Low: PASDAS \<= 3.2; Very low: PASDAS \<= 1.9.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Low | 39.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Low | 52.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Very Low | 19.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Low | 55.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Very Low | 18.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Very Low | 13.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Very Low | 23.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Very Low | 22.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Very Low | 26.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Low | 50.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Low | 44.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Low | 54.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Very Low | 23.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Low | 46.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 52: Very Low | 16.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Low | 49.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 76: Very Low | 22.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 | Week 100: Low | 57.8 percentage of participants |
Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52
PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a composite score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS \[0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS \[0-100 mm, 0=no arthritis activity and 100=extremely active arthritis\]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0= 0 sites with tenderness to 6= worst possible score; 6 sites with tenderness), tender dactylitis count (scoring each digit from 0-3 \[where 0= no tenderness and 3= extreme tenderness\] and recoding to 0-1, where any score \> 0 equaled 1), and the PCS score with score range 0-100 (higher score-better quality of life) of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 24 | 8.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 52 | 38.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 24 | 31.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 52 | 45.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 24 | 24.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 | Week 52 | 46.3 percentage of participants |
Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100
Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic erosion progression was defined as change from baseline in the modified vdH-S erosion score \<=SDC of 2.66.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 | 86.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 | 87.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 | 88.6 percentage of participants |
Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24
Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC defined as the cut-off above which changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score \<=SDC of 1.83.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 | 84.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 | 89.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 | 89.9 percentage of participants |
Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52
Modified vdH-S score is sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic joint erosion progression was defined as change from baseline in modified vdH-S erosion score \<=SDC of 2.22.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 | 82.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 | 84.3 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 | 87.3 percentage of participants |
Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52
Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is total JSN score in same 52 joints as above, each joint scored according to subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as cut-off above which changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in modified vdH-S JSN score \<=SDC of 1.02.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 | 91.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 | 91.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 | 90.4 percentage of participants |
Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100
Modified vdH-S score is sum of erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is summary of erosion severity in 40 joints of hand scored according to surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score \<=SDC of 1.66.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 | 90.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 | 89.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 | 88.2 percentage of participants |
Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24
The modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). The JSN score is the sum of JSN score in 40 joints of the two hands and 12 joints of the 2 feet. Each joint is scored from 0 - 4 with 0 indicating no JSN, and 4 indicating a complete loss of joint space, bony ankylosis, or complete luxation, for a maximum JSN score of 208. Higher score indicates more severe joint space narrowing. The smallest detectable change (SDC) was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic JSN progression was defined as change from baseline in the modified vdH-S JSN score \<=SDC of 1.11.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 | 91.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 | 93.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 | 91.7 percentage of participants |
Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 3.46.
Time frame: Baseline to Week 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 | 86.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 | 84.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 | 87.2 percentage of participants |
Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 2.39.
Time frame: Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 | 80.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 | 82.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 | 85.2 percentage of participants |
Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and JSN score (hand, feet). Joint erosion score is the summary of erosion severity in 40 joints of hand scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) and 12 joints of 2 feet (each side of foot joint is graded on same 0-5 scale, thus maximum erosion score for a foot joint is 10), for a maximum erosion score of 320. JSN score is the total JSN score in same 52 joints as above, each joint scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation), for a maximum JSN score of 208. Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. SDC was defined as the cut-off above which the changes can be detected beyond measurement error. Without radiographic progression was defined as change from baseline in the modified vdH-S score \<=SDC of 2.18.
Time frame: Week 24
Population: Analysis population is FAS1-SD. Observed data were used regardless if 1 or more TF criteria were met. Missing data were assumed to be missing at random and imputed using multiple imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 | 86.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 | 87.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 | 89.3 percentage of participants |
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24
Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time frame: Baseline and Week 24
Population: Analysis population is FAS1-SD. Observed data were summarized regardless if 1 or more TF criteria were met.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Baseline | 4.5 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Week 24 | 4.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Baseline | 3.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Week 24 | 3.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Baseline | 3.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 | Week 24 | 3.8 percentage of participants |
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52
Percentage of Participants with Pencil in cup or Gross Osteolysis Deformities were reported. Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time frame: Baseline and Week 52
Population: FAS2 for structural damage (FAS2-SD) among all randomized participants who were continuing study treatment at Week 24. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Baseline | 6.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Week 52 | 7.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Week 52 | 5.1 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Baseline | 4.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Baseline | 6.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 | Week 52 | 7.0 percentage of participants |
Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100
Pencil in Cup or Gross Osteolytis Deformities are radiographic features specific for psoriatic arthritis.
Time frame: Baseline, Weeks 24, 52, and 100
Population: FAS3 for structural damage (FAS3-SD) included all randomized participants who were continuing study treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 52 | 4.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Baseline | 3.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 100 | 4.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 24 | 3.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 52 | 4.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 24 | 3.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 100 | 4.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Baseline | 3.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 100 | 3.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Baseline | 3.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 24 | 4.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 | Week 52 | 3.6 percentage of participants |
Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time frame: Week 24
Population: FAS1 among participants with dactylitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with dactylitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline | 42.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline | 59.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline | 63.5 percentage of participants |
Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 24 | 41.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 52 | 78.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 24 | 60.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 52 | 81.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 24 | 68.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline | Week 52 | 81.1 percentage of participants |
Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 among participants with dactylitis at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 100 | 83.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 52 | 78.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 76 | 80.2 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 76 | 84.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 52 | 81.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 100 | 91.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 52 | 80.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 100 | 82.9 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline | Week 76 | 82.4 percentage of participants |
Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline
The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score \>0.
Time frame: Weeks 2, 4, 8, 16 and 24
Population: FAS1 among participants with dactylitis at baseline. Participants who achieved dactylitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 24 | 38.4 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 2 | 12.1 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 4 | 18.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 8 | 29.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 16 | 36.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 8 | 30.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 16 | 45.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 2 | 13.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 24 | 56.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 4 | 19.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 16 | 52.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 4 | 20.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 8 | 31.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 24 | 63.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline | Week 2 | 13.2 percentage of participants |
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0. The outcome measure was planned to be reported for pooled population from CNTO1959PSA3001 and CNTO1959PSA3002 studies.
Time frame: Week 24
Population: FAS1 among participants with enthesitis at baseline pooled from CNTO1959PSA3001 (NCT03162796) and CNTO1959PSA3002 (NCT03158285) studies. Participants with enthesitis resolution at Week 24 and did not meet any TF criteria before Week 24 considered responders. Participants who met 1/more TF criteria or with missing data considered non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline | 29.4 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline | 49.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline | 44.9 percentage of participants |
Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants evaluable for enthesitis resolution at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | 32.6 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | 67.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | 57.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | 65.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 24 | 45.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline | Week 52 | 60.0 percentage of participants |
Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0.
Time frame: Weeks 52, 76, and 100
Population: Analysis population is FAS3 among the participants with enthesitis (LEI) at baseline. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 100 | 75.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 52 | 67.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 76 | 72.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 76 | 71.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 100 | 77.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 52 | 66.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 52 | 61.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 100 | 67.7 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline | Week 76 | 67.5 percentage of participants |
Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline
Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI\>0.
Time frame: Weeks 2, 4, 8, 16 and 24
Population: FAS1 among participants with enthesitis at baseline. Participants with enthesitis resolution at specific time point and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 16 | 30.9 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 8 | 24.7 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 2 | 16.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 4 | 18.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 24 | 30.3 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 8 | 31.0 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 2 | 17.7 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 4 | 21.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 16 | 47.5 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 24 | 53.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 24 | 43.5 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 16 | 40.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 2 | 17.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 8 | 27.6 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline | Week 4 | 25.3 percentage of participants |
Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52
A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count \<=1; swollen joint count \<=1; PASI \<=1; patient pain VAS score of \<=15; patient global disease activity VAS \[arthritis and psoriasis\] score of \<=20; Health Assessment Questionnaire (HAQ) score \<=0.5; and tender entheseal points \<=1) at that visit.
Time frame: Weeks 24 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 24 | 1.3 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 52 | 6.9 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 24 | 4.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 52 | 17.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 24 | 5.1 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 | Week 52 | 12.2 percentage of participants |
Percentage of Participants With VLDA at Weeks 52, 76 and 100
A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count \<=1; swollen joint count \<=1; PASI \<=1; patient pain VAS score of \<=15; patient global disease activity VAS \[arthritis and psoriasis\] score of \<=20; Health Assessment Questionnaire (HAQ) score \<=0.5; and tender entheseal points \<=1) at that visit.
Time frame: Weeks 52, 76 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 52 | 7.0 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 76 | 12.2 percentage of participants |
| Placebo to Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 100 | 14.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 100 | 18.8 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 76 | 19.6 percentage of participants |
| Guselkumab 100 mg q8w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 52 | 16.8 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 52 | 12.4 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 100 | 15.0 percentage of participants |
| Guselkumab 100 mg q4w | Percentage of Participants With VLDA at Weeks 52, 76 and 100 | Week 76 | 14.8 percentage of participants |
Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Population: Analysis population is FAS2. Here, n (number analyzed) signifies the number of participants analyzed at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -71.05 percent change | Standard Deviation 25.056 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -35.65 percent change | Standard Deviation 43.207 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -81.85 percent change | Standard Deviation 26.328 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -68.32 percent change | Standard Deviation 25.56 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -37.45 percent change | Standard Deviation 43.534 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -62.21 percent change | Standard Deviation 34.292 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -64.57 percent change | Standard Deviation 25.695 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -38.23 percent change | Standard Deviation 47.43 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -0.25 percent change | Standard Deviation 208.267 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -49.72 percent change | Standard Deviation 30.129 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -13.78 percent change | Standard Deviation 45.943 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | 19.81 percent change | Standard Deviation 150.274 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -36.13 percent change | Standard Deviation 33.383 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -23.78 percent change | Standard Deviation 40.895 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -82.34 percent change | Standard Deviation 30.494 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -39.34 percent change | Standard Deviation 44.933 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -38.82 percent change | Standard Deviation 37.114 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -8.33 percent change | Standard Deviation 143.843 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -38.45 percent change | Standard Deviation 43.993 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -26.83 percent change | Standard Deviation 54.38 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -32.53 percent change | Standard Deviation 44.85 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -66.15 percent change | Standard Deviation 37.305 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -53.44 percent change | Standard Deviation 45.655 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -27.01 percent change | Standard Deviation 49.683 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -65.88 percent change | Standard Deviation 33.344 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -6.70 percent change | Standard Deviation 183.299 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -23.34 percent change | Standard Deviation 46.393 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -67.29 percent change | Standard Deviation 35.583 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -80.38 percent change | Standard Deviation 28.144 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -15.66 percent change | Standard Deviation 49.522 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -11.52 percent change | Standard Deviation 48.647 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -45.52 percent change | Standard Deviation 41.132 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -6.86 percent change | Standard Deviation 54.753 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -22.20 percent change | Standard Deviation 42.404 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | -0.80 percent change | Standard Deviation 155.637 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | -26.90 percent change | Standard Deviation 110.466 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -62.48 percent change | Standard Deviation 32.82 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -72.06 percent change | Standard Deviation 33.971 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -78.02 percent change | Standard Deviation 30.197 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -82.82 percent change | Standard Deviation 26.054 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -82.10 percent change | Standard Deviation 27.742 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -83.18 percent change | Standard Deviation 30.121 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -54.81 percent change | Standard Deviation 37.134 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -66.12 percent change | Standard Deviation 32.829 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -70.90 percent change | Standard Deviation 29.688 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -70.29 percent change | Standard Deviation 31.985 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -38.44 percent change | Standard Deviation 40.734 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -42.17 percent change | Standard Deviation 41.66 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -45.89 percent change | Standard Deviation 40.125 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -46.48 percent change | Standard Deviation 41.725 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -49.00 percent change | Standard Deviation 39.082 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -37.18 percent change | Standard Deviation 38.628 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -39.92 percent change | Standard Deviation 40.228 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -44.21 percent change | Standard Deviation 36.982 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -46.64 percent change | Standard Deviation 38.228 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -48.73 percent change | Standard Deviation 38.925 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -57.60 percent change | Standard Deviation 32.634 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -62.89 percent change | Standard Deviation 28.027 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -67.98 percent change | Standard Deviation 25.989 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -69.79 percent change | Standard Deviation 26.949 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -73.09 percent change | Standard Deviation 24.133 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -25.47 percent change | Standard Deviation 63.639 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -28.82 percent change | Standard Deviation 73.93 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -31.95 percent change | Standard Deviation 78.348 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -33.84 percent change | Standard Deviation 60.164 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -33.49 percent change | Standard Deviation 63.823 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | -21.09 percent change | Standard Deviation 144.287 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -25.47 percent change | Standard Deviation 157.839 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -37.54 percent change | Standard Deviation 76.302 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -23.15 percent change | Standard Deviation 104.461 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: CRP | -17.44 percent change | Standard Deviation 127.594 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PGA of Disease Activity | -70.27 percent change | Standard Deviation 24.516 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Patient's Assessment of Pain | -41.02 percent change | Standard Deviation 39.624 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: CRP | 15.69 percent change | Standard Deviation 468.613 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PGA of Disease Activity | -72.46 percent change | Standard Deviation 24.485 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Patient's Assessment of Pain | -36.64 percent change | Standard Deviation 38.086 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Swollen Joint Count | -78.85 percent change | Standard Deviation 28.109 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: HAQ-DI score | -33.72 percent change | Standard Deviation 51.766 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Tender Joint Count | -69.82 percent change | Standard Deviation 32.122 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Swollen Joint Count | -73.17 percent change | Standard Deviation 30.614 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: HAQ-DI score | -33.91 percent change | Standard Deviation 59.31 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Tender Joint Count | -72.10 percent change | Standard Deviation 27.67 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: CRP | -23.97 percent change | Standard Deviation 104.641 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: HAQ-DI score | -37.74 percent change | Standard Deviation 56.329 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Tender Joint Count | -68.50 percent change | Standard Deviation 30 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: Tender Joint Count | -64.31 percent change | Standard Deviation 31.767 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: HAQ-DI score | -32.45 percent change | Standard Deviation 72.337 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Swollen Joint Count | -84.07 percent change | Standard Deviation 24.07 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: CRP | -0.99 percent change | Standard Deviation 193.429 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PtGA of Disease Activity | -45.52 percent change | Standard Deviation 38.659 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: HAQ-DI score | -35.02 percent change | Standard Deviation 65.765 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: PtGA of Disease Activity | -42.45 percent change | Standard Deviation 39.243 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PtGA of Disease Activity | -40.70 percent change | Standard Deviation 36.587 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Swollen Joint Count | -83.32 percent change | Standard Deviation 24.289 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: PtGA of Disease Activity | -45.50 percent change | Standard Deviation 40.653 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PtGA of Disease Activity | -33.90 percent change | Standard Deviation 51.672 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: Tender Joint Count | -57.11 percent change | Standard Deviation 35.073 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: PGA of Disease Activity | -59.06 percent change | Standard Deviation 28.137 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 52: Patient's Assessment of Pain | -43.51 percent change | Standard Deviation 45.742 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 24: CRP | -28.35 percent change | Standard Deviation 88.038 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 28: PGA of Disease Activity | -64.14 percent change | Standard Deviation 25.784 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 44: Patient's Assessment of Pain | -43.60 percent change | Standard Deviation 42.56 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Swollen Joint Count | -81.49 percent change | Standard Deviation 27.338 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: PGA of Disease Activity | -67.74 percent change | Standard Deviation 28.029 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 | Week 36: Patient's Assessment of Pain | -43.29 percent change | Standard Deviation 44.442 |
Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment (PGA) of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (milligram/deciliter \[mg/dL\]).
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Population: Analysis population is FAS1. Here 'n' (number analyzed) signifies number of participants with observed data regardless meeting TF criteria at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PGA of Disease Activity | -31.11 percent change | Standard Deviation 32.023 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Patient's Assessment of Pain | -6.76 percent change | Standard Deviation 34.213 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Swollen Joint Count | -54.2 percent change | Standard Deviation 41.7 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PGA of Disease Activity | -27.63 percent change | Standard Deviation 32.379 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Patient's Assessment of Pain | -9.01 percent change | Standard Deviation 36.061 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: CRP | 42.282 percent change | Standard Deviation 284.133 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PGA of Disease Activity | -23.29 percent change | Standard Deviation 28.416 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Patient's Assessment of Pain(0-10cm) | -9.70 percent change | Standard Deviation 41.673 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: CRP | 28.042 percent change | Standard Deviation 208.6385 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PGA of Disease Activity | -16.63 percent change | Standard Deviation 27.573 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Patient's Assessment of Pain | -10.85 percent change | Standard Deviation 46.497 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Swollen Joint Count | -53.9 percent change | Standard Deviation 45.54 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PGA of Disease Activity | -9.79 percent change | Standard Deviation 25.687 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Patient's Assessment of Pain | -11.84 percent change | Standard Deviation 48.324 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Swollen Joint Count | -37.4 percent change | Standard Deviation 39.03 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PtGA of Disease Activity | -13.87 percent change | Standard Deviation 45.65 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PtGA of Disease Activity | -1.12 percent change | Standard Deviation 35.882 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: CRP | 86.677 percent change | Standard Deviation 645.0281 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PtGA of Disease Activity | -12.52 percent change | Standard Deviation 42.498 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PtGA of Disease Activity | -2.27 percent change | Standard Deviation 34.291 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Tender Joint Count | -9.4 percent change | Standard Deviation 25.99 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PtGA of Disease Activity | -12.34 percent change | Standard Deviation 39.207 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PtGA of Disease Activity | -6.51 percent change | Standard Deviation 35.908 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: CRP | 19.263 percent change | Standard Deviation 149.512 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PtGA of Disease Activity | -9.30 percent change | Standard Deviation 37.185 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: HAQ-DI Score | -6.7995 percent change | Standard Deviation 54.78602 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Tender Joint Count | -14.1 percent change | Standard Deviation 36.04 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: CRP | 28.595 percent change | Standard Deviation 237.666 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: HAQ-DI Score | -10.4296 percent change | Standard Deviation 50.87958 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Tender Joint Count | -21.9 percent change | Standard Deviation 37.83 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Swollen Joint Count | -46.1 percent change | Standard Deviation 41.2 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: HAQ-DI Score | -7.1776 percent change | Standard Deviation 48.33253 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Tender Joint Count | -30.4 percent change | Standard Deviation 37.57 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Swollen Joint Count | -27.1 percent change | Standard Deviation 37.29 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: HAQ-DI Score | -8.0811 percent change | Standard Deviation 46.90093 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Tender Joint Count | -30.6 percent change | Standard Deviation 41.87 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: HAQ-DI Score | -5.0965 percent change | Standard Deviation 39.89566 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: HAQ-DI Score | -2.8744 percent change | Standard Deviation 46.90795 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Tender Joint Count | -33.9 percent change | Standard Deviation 44.22 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: CRP | 47.034 percent change | Standard Deviation 313.9875 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: HAQ-DI Score | -0.3191 percent change | Standard Deviation 36.62364 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Tender Joint Count | -33.3 percent change | Standard Deviation 44.87 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Swollen Joint Count | -48.6 percent change | Standard Deviation 43.01 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PGA of Disease Activity | -36.59 percent change | Standard Deviation 33.74 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Patient's Assessment of Pain | 0.05 percent change | Standard Deviation 35.794 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Swollen Joint Count | -18.9 percent change | Standard Deviation 32.16 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PGA of Disease Activity | -34.13 percent change | Standard Deviation 36.576 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Patient's Assessment of Pain | -0.64 percent change | Standard Deviation 35.849 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: CRP | 45.451 percent change | Standard Deviation 322.4433 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Tender Joint Count | -47.0 percent change | Standard Deviation 40.96 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: CRP | -13.551 percent change | Standard Deviation 193.3814 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Swollen Joint Count | -18.8 percent change | Standard Deviation 39.68 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Swollen Joint Count | -30.5 percent change | Standard Deviation 36.92 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Swollen Joint Count | -46.8 percent change | Standard Deviation 40.68 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Swollen Joint Count | -57.6 percent change | Standard Deviation 39.22 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Swollen Joint Count | -64.1 percent change | Standard Deviation 35.46 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Swollen Joint Count | -69.3 percent change | Standard Deviation 33.63 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Swollen Joint Count | -71.3 percent change | Standard Deviation 34.06 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Tender Joint Count | -10.4 percent change | Standard Deviation 40.31 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Tender Joint Count | -15.0 percent change | Standard Deviation 41.57 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Tender Joint Count | -31.0 percent change | Standard Deviation 42.36 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Tender Joint Count | -40.9 percent change | Standard Deviation 42.73 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Tender Joint Count | -53.9 percent change | Standard Deviation 37.83 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Tender Joint Count | -54.2 percent change | Standard Deviation 37.15 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Patient's Assessment of Pain | -8.92 percent change | Standard Deviation 32.374 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Patient's Assessment of Pain | -12.58 percent change | Standard Deviation 33.065 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Patient's Assessment of Pain | -21.61 percent change | Standard Deviation 36.705 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Patient's Assessment of Pain | -26.26 percent change | Standard Deviation 40.223 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Patient's Assessment of Pain(0-10cm) | -31.94 percent change | Standard Deviation 42.882 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Patient's Assessment of Pain | -35.16 percent change | Standard Deviation 39.471 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Patient's Assessment of Pain | -38.06 percent change | Standard Deviation 40.565 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PtGA of Disease Activity | -10.15 percent change | Standard Deviation 31.06 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PtGA of Disease Activity | -12.71 percent change | Standard Deviation 34.44 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PtGA of Disease Activity | -21.58 percent change | Standard Deviation 33.697 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PtGA of Disease Activity | -27.86 percent change | Standard Deviation 38.9 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PtGA of Disease Activity | -32.25 percent change | Standard Deviation 40.056 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PtGA of Disease Activity | -35.31 percent change | Standard Deviation 36.205 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PtGA of Disease Activity | -37.05 percent change | Standard Deviation 38.372 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PGA of Disease Activity | -15.06 percent change | Standard Deviation 27.15 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PGA of Disease Activity | -23.72 percent change | Standard Deviation 27.658 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PGA of Disease Activity | -36.54 percent change | Standard Deviation 31.224 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PGA of Disease Activity | -46.54 percent change | Standard Deviation 30.489 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PGA of Disease Activity | -52.02 percent change | Standard Deviation 31.915 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PGA of Disease Activity | -54.32 percent change | Standard Deviation 30.941 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PGA of Disease Activity | -57.22 percent change | Standard Deviation 32.48 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: HAQ-DI Score | -6.3577 percent change | Standard Deviation 50.8198 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: HAQ-DI Score | -9.1272 percent change | Standard Deviation 53.41051 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: HAQ-DI Score | -12.7684 percent change | Standard Deviation 67.23239 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: HAQ-DI Score | -18.0336 percent change | Standard Deviation 66.96524 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: HAQ-DI Score | -19.3627 percent change | Standard Deviation 70.83578 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: HAQ-DI Score | -24.9496 percent change | Standard Deviation 64.8682 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: HAQ-DI Score | -25.2578 percent change | Standard Deviation 63.1545 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: CRP | 0.935 percent change | Standard Deviation 91.3783 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: CRP | -16.885 percent change | Standard Deviation 79.3501 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: CRP | -11.214 percent change | Standard Deviation 150.1689 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: CRP | -25.620 percent change | Standard Deviation 97.1384 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: CRP | -19.874 percent change | Standard Deviation 134.521 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: CRP | -27.470 percent change | Standard Deviation 109.5239 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Patient's Assessment of Pain | -7.96 percent change | Standard Deviation 37.958 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Swollen Joint Count | -71.4 percent change | Standard Deviation 30.42 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PGA of Disease Activity | -49.18 percent change | Standard Deviation 31.383 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Patient's Assessment of Pain | -4.66 percent change | Standard Deviation 32.229 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Swollen Joint Count | -33.6 percent change | Standard Deviation 37.57 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PGA of Disease Activity | -54.59 percent change | Standard Deviation 29.336 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Tender Joint Count | -57.3 percent change | Standard Deviation 34.98 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: CRP | 1.128 percent change | Standard Deviation 168.9301 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PGA of Disease Activity | -58.70 percent change | Standard Deviation 28.255 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Tender Joint Count | -54.2 percent change | Standard Deviation 35.43 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Swollen Joint Count | -63.7 percent change | Standard Deviation 34.42 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: HAQ-DI Score | -0.2385 percent change | Standard Deviation 57.44896 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Tender Joint Count | -48.1 percent change | Standard Deviation 37.01 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: CRP | -28.701 percent change | Standard Deviation 83.0912 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: HAQ-DI Score | -5.1209 percent change | Standard Deviation 85.16625 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: CRP | -17.474 percent change | Standard Deviation 112.3803 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Swollen Joint Count | -58.3 percent change | Standard Deviation 35.42 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: HAQ-DI Score | -9.8081 percent change | Standard Deviation 86.78973 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Tender Joint Count | -43.0 percent change | Standard Deviation 35.9 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Swollen Joint Count | -18.5 percent change | Standard Deviation 38.38 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: HAQ-DI Score | -17.7758 percent change | Standard Deviation 67.44643 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Tender Joint Count | -33.8 percent change | Standard Deviation 37.58 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: CRP | -22.277 percent change | Standard Deviation 122.3489 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: HAQ-DI Score | -26.6732 percent change | Standard Deviation 53.14973 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: Tender Joint Count | -22.6 percent change | Standard Deviation 32.91 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PtGA of Disease Activity | -19.13 percent change | Standard Deviation 40.545 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Swollen Joint Count | -46.7 percent change | Standard Deviation 37.69 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PtGA of Disease Activity | -28.33 percent change | Standard Deviation 34.058 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PtGA of Disease Activity | -11.02 percent change | Standard Deviation 33.605 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: HAQ-DI Score | -28.9317 percent change | Standard Deviation 60.67279 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: PtGA of Disease Activity | -28.60 percent change | Standard Deviation 39.759 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PtGA of Disease Activity | -5.25 percent change | Standard Deviation 32.658 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: Tender Joint Count | -14.8 percent change | Standard Deviation 28.31 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: PtGA of Disease Activity | -35.11 percent change | Standard Deviation 37.791 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Patient's Assessment of Pain | -36.52 percent change | Standard Deviation 38.423 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: CRP | -28.125 percent change | Standard Deviation 87.7229 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: PtGA of Disease Activity | -34.13 percent change | Standard Deviation 51.445 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 20: Patient's Assessment of Pain | -35.35 percent change | Standard Deviation 39.016 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: HAQ-DI Score | -33.8837 percent change | Standard Deviation 51.59441 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: PGA of Disease Activity | -13.85 percent change | Standard Deviation 23.307 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: Patient's Assessment of Pain(0-10cm) | -27.85 percent change | Standard Deviation 38.913 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 24: Swollen Joint Count | -73.1 percent change | Standard Deviation 30.67 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 4: PGA of Disease Activity | -22.32 percent change | Standard Deviation 28.183 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: Patient's Assessment of Pain | -25.91 percent change | Standard Deviation 37.862 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 16: CRP | -26.592 percent change | Standard Deviation 86.8465 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: PGA of Disease Activity | -37.99 percent change | Standard Deviation 29.97 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 8: Patient's Assessment of Pain | -17.05 percent change | Standard Deviation 44.783 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 2: CRP | 10.664 percent change | Standard Deviation 132.5947 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 | Week 12: PGA of Disease Activity | -42.84 percent change | Standard Deviation 31.305 |
Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100
ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-10 cm, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-10 cm, 0=excellent and 10= poor), physician's global assessment of disease activity (VAS; 0-10 cm, 0=no arthritis activity and 10=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP (mg/dL).
Time frame: Baseline, Weeks 52, 68, 76, 84 and 100
Population: Analysis population is FAS3 which included all participants still on treatment at Week 52. Here, n (number analyzed) signifies the number of participants analyzed for specified categories at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -44.91 percent change | Standard Deviation 44.371 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -87.72 percent change | Standard Deviation 22.243 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -77.68 percent change | Standard Deviation 23.015 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -46.02 percent change | Standard Deviation 44.989 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -4.33 percent change | Standard Deviation 196.246 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -74.76 percent change | Standard Deviation 23.29 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -49.64 percent change | Standard Deviation 40.991 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -87.61 percent change | Standard Deviation 21.214 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -71.24 percent change | Standard Deviation 24.771 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -50.82 percent change | Standard Deviation 42.97 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | -10.76 percent change | Standard Deviation 226.332 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -48.17 percent change | Standard Deviation 44.804 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -39.70 percent change | Standard Deviation 44.981 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -40.36 percent change | Standard Deviation 44.407 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -49.38 percent change | Standard Deviation 42.315 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -42.93 percent change | Standard Deviation 44.22 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -67.29 percent change | Standard Deviation 35.725 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -46.42 percent change | Standard Deviation 45.106 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -87.41 percent change | Standard Deviation 24.049 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -36.73 percent change | Standard Deviation 47.541 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -74.28 percent change | Standard Deviation 29.764 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -0.72 percent change | Standard Deviation 387.986 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -34.38 percent change | Standard Deviation 47.311 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -75.71 percent change | Standard Deviation 27.653 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -1.68 percent change | Standard Deviation 330.574 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -33.34 percent change | Standard Deviation 49.027 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -77.21 percent change | Standard Deviation 27.045 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -87.98 percent change | Standard Deviation 20.617 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -27.27 percent change | Standard Deviation 54.587 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -77.04 percent change | Standard Deviation 27.51 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -82.64 percent change | Standard Deviation 30.161 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -78.11 percent change | Standard Deviation 24.049 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -39.52 percent change | Standard Deviation 44.939 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -2.67 percent change | Standard Deviation 205.761 |
| Placebo to Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -75.77 percent change | Standard Deviation 23.674 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -33.28 percent change | Standard Deviation 64.067 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -83.03 percent change | Standard Deviation 30.21 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -86.08 percent change | Standard Deviation 29.764 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -86.05 percent change | Standard Deviation 21.096 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -87.68 percent change | Standard Deviation 23.304 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -86.19 percent change | Standard Deviation 40.865 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -70.18 percent change | Standard Deviation 32.062 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -75.63 percent change | Standard Deviation 29.437 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -74.71 percent change | Standard Deviation 29.728 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -78.01 percent change | Standard Deviation 26.112 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -75.96 percent change | Standard Deviation 32.6 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -48.81 percent change | Standard Deviation 39.191 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -55.77 percent change | Standard Deviation 38.78 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -54.38 percent change | Standard Deviation 39.135 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -55.28 percent change | Standard Deviation 40.388 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -56.36 percent change | Standard Deviation 41.31 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -48.48 percent change | Standard Deviation 38.982 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -53.84 percent change | Standard Deviation 35.096 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -54.41 percent change | Standard Deviation 35.276 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -54.17 percent change | Standard Deviation 37.132 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -55.08 percent change | Standard Deviation 37.052 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -72.95 percent change | Standard Deviation 24.168 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -76.00 percent change | Standard Deviation 22.55 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -74.42 percent change | Standard Deviation 25.014 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -76.77 percent change | Standard Deviation 24.433 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -77.15 percent change | Standard Deviation 23.217 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -37.47 percent change | Standard Deviation 57.37 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -40.08 percent change | Standard Deviation 58.932 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -40.10 percent change | Standard Deviation 58.703 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -42.84 percent change | Standard Deviation 54.187 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -23.41 percent change | Standard Deviation 104.622 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -28.38 percent change | Standard Deviation 138.159 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | 7.85 percent change | Standard Deviation 502.17 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -26.87 percent change | Standard Deviation 114.471 |
| Guselkumab 100 mg q8w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -23.99 percent change | Standard Deviation 150.816 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PGA of Disease Activity | -75.56 percent change | Standard Deviation 23.613 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Patient's Assessment of Pain | -43.86 percent change | Standard Deviation 45.891 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: CRP | -1.34 percent change | Standard Deviation 194.673 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PGA of Disease Activity | -76.49 percent change | Standard Deviation 24.355 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Tender Joint Count | -76.21 percent change | Standard Deviation 27.345 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Swollen Joint Count | -86.41 percent change | Standard Deviation 22.642 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PGA of Disease Activity | -77.82 percent change | Standard Deviation 22.733 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Tender Joint Count | -75.45 percent change | Standard Deviation 32.489 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Swollen Joint Count | -87.16 percent change | Standard Deviation 24.888 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: HAQ-DI score | -35.17 percent change | Standard Deviation 66.105 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Tender Joint Count | -75.11 percent change | Standard Deviation 28.559 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: CRP | -13.91 percent change | Standard Deviation 174.522 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: HAQ-DI score | -44.33 percent change | Standard Deviation 44.064 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Tender Joint Count | -74.40 percent change | Standard Deviation 29.76 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Swollen Joint Count | -84.27 percent change | Standard Deviation 23.698 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: HAQ-DI score | -41.84 percent change | Standard Deviation 47.877 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: Tender Joint Count | -70.54 percent change | Standard Deviation 31.311 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: CRP | -19.89 percent change | Standard Deviation 131.695 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PtGA of Disease Activity | -52.47 percent change | Standard Deviation 38.155 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: HAQ-DI score | -43.18 percent change | Standard Deviation 52.116 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: PtGA of Disease Activity | -50.66 percent change | Standard Deviation 40.992 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PtGA of Disease Activity | -46.07 percent change | Standard Deviation 40.614 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Swollen Joint Count | -86.31 percent change | Standard Deviation 24.106 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: PtGA of Disease Activity | -51.86 percent change | Standard Deviation 44.532 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: Patient's Assessment of Pain | -54.27 percent change | Standard Deviation 40.819 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: CRP | -24.22 percent change | Standard Deviation 110.486 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: PtGA of Disease Activity | -57.09 percent change | Standard Deviation 34.97 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 84: Patient's Assessment of Pain | -52.59 percent change | Standard Deviation 43.131 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: HAQ-DI score | -47.54 percent change | Standard Deviation 47.265 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 52: PGA of Disease Activity | -72.58 percent change | Standard Deviation 24.579 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Patient's Assessment of Pain | -51.34 percent change | Standard Deviation 41.903 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 76: Swollen Joint Count | -85.82 percent change | Standard Deviation 22.291 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: PGA of Disease Activity | -74.48 percent change | Standard Deviation 26.28 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 68: Patient's Assessment of Pain | -52.43 percent change | Standard Deviation 41.186 |
| Guselkumab 100 mg q4w | Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 | Week 100: CRP | -14.35 percent change | Standard Deviation 171.666 |