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A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03158285
Enrollment
741
Registered
2017-05-18
Start date
2017-07-12
Completion date
2020-11-10
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic

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

DRUGGuselkumab

Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.

DRUGPlacebo

Participants will receive matching placebo as SC injection.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24Week 24ACR 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

MeasureTime frameDescription
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24Baseline and Week 24HAQ-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 24Week 24ACR 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 BaselineWeek 24A 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 16Week 16ACR 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 24Baseline and Week 24Modified 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 BaselineWeek 24Enthesitis 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 BaselineWeek 24The 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 BaselineBaseline and Week 24Enthesitis 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 BaselineBaseline and Week 24The 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 24Baseline and Week 24SF-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 24Baseline and Week 24The 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 24Baseline and Week 24SF-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 16Week 16ACR 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 24Week 24ACR 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 24Weeks 2, 4, 8, 12, 16, 20 and 24ACR 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 24Weeks 2, 4, 8, 12, 16, 20 and 24ACR 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 24Weeks 2, 4, 8, 12, 16, 20 and 24ACR 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 24Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24ACR 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 24Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24HAQ-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 BaselineWeeks 2, 4, 8, 12, 16, 20 and 24HAQ-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 24Weeks 2, 4, 8, 12, 16, 20 and 24DAS28 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 24Weeks 2, 4, 8, 12, 16, 20 and 24DAS28 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 24Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24DAS28 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 24Weeks 2, 4, 8, 12, 16, 20 and 24The 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 BaselineWeeks 2, 4, 8, 16 and 24Enthesitis 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 BaselineWeeks 2, 4, 8, 16 and 24The 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 BaselineBaseline, Weeks 2, 4, 8, 16 and 24Enthesitis 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 BaselineBaseline, Weeks 2, 4, 8, 16 and 24The 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 24Baseline, Weeks 8, 16 and 24PASDAS (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 24Baseline, Weeks 16 and 24GRACE 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 24Baseline, Weeks 16 and 24Work 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 24Baseline, Weeks 16 and 24Work 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 24Baseline, Weeks 16 and 24Work 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 24Baseline, Weeks 16 and 24Work 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 24Baseline, Weeks 16 and 24The 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 24Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24DAPSA 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 24Weeks 16 and 24MDA 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 BaselineWeeks 8, 16 and 24Bath 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 BaselineWeeks 16 and 24PASI 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 BaselineWeeks 16 and 24PASI 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 BaselineWeeks 16 and 24PASI 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 BaselineWeeks 16 and 24A 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 BaselineBaseline, Weeks 16 and 24PASI 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 BaselineWeeks 8, 16, 24Dermatology 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 BaselineWeeks 8, 16, 24Dermatology 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 BaselineBaseline, Weeks 8, 16 and 24Dermatology 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 BaselineWeeks 16 and 24In 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 BaselineWeeks 16 and 24In 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 24Baseline and Week 24Modified 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 24Baseline and Week 24The 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 24Baseline and Week 24Modified 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 24Week 24Modified 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 24Week 24Modified 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 24Week 24The 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 24Week 24Modified 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 24Week 24Modified 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 24Week 24The 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 24Baseline and Week 24Pencil 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 24Baseline, Weeks 8, 16 and 24SF-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 24Baseline, Weeks 8, 16 and 24SF-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 24Baseline and Weeks 8, 16 and 24SF-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 24Week 8, 16 and 24SF-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 24Week 8, 16 and 24SF-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 24Baseline, Weeks 8, 16 and 24The 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 24Weeks 8, 16 and 24The 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-VASBaseline, Weeks 16 and 24EQ-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 IndexBaseline, Weeks 16 and 24EQ-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 52Weeks 24, 28, 36, 44 and 52ACR 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 52Weeks 24, 28, 36, 44 and 52ACR 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 52Weeks 24, 28, 36, 44 and 52ACR 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 52Weeks 24, 28, 36, 44 and 52ACR 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 52Baseline, Weeks 24, 28, 36, 44 and 52ACR 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 52Baseline, Weeks 24, 28, 36, 44 and 52ACR 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 24Week 52ACR 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 24Week 52ACR 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 24Week 52ACR 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 52Baseline, Weeks 24, 28, 36, 44 and 52HAQ-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 BaselineWeeks 24, 28, 36, 44 and 52HAQ-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 24Week 52HAQ-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 52Weeks 24, 28, 36, 44 and 52DAS28 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 52Weeks 24, 28, 36, 44 and 52DAS28 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 52Baseline, Weeks 24, 28, 36, 44 and 52DAS28 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 52Weeks 24, 28, 36, 44 and 52The 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 BaselineWeeks 24 and 52Enthesitis 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 BaselineBaseline, Weeks 24 and 52Enthesitis 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 BaselineWeeks 24 and 52The 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 BaselineBaseline, Weeks 24 and 52The 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 52Baseline, Weeks 24 and 52PASDAS (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 52Weeks 24 and 52PASDAS (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 52Baseline, Weeks 24 and 52GRACE 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 52Weeks 24 and 52GRACE 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 52Baseline, Weeks 24, 28, 36, 44 and 52DAPSA 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 52Baseline, Weeks 24 and 52The 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 52Weeks 24 and 52The 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 52Weeks 24 and 52MDA 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 52Weeks 24 and 52A 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 BaselineBaseline, Weeks 24 and 52Bath 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 BaselineWeeks 24 and 52Bath 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 BaselineBaseline, Weeks 24 and 52PASI 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 BaselineWeeks 24 and 52PASI 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 BaselineWeeks 24 and 52PASI 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 BaselineWeeks 24 and 52PASI 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 BaselineWeeks 24 and 52PASI 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 BaselineWeeks 24 and 52In 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 BaselineWeeks 24 and 52In 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 BaselineWeeks 24 and 52A 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 BaselineWeeks 24 and 52A 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 BaselineWeeks 24 and 52Dermatology 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 BaselineWeeks 24 and 52Dermatology 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 BaselineBaseline, Weeks 24 and 52Dermatology 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 52Baseline and Week 52Modified 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 52From Week 24 to Week 52Modified 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 52Baseline and Week 52Modified 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 52From Week 24 to Week 52Modified 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 52Baseline and Week 52Modified 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 52From Week 24 to Week 52Modified 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 52Baseline and Week 52Modified 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 52Week 52Modified 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 52Week 52Modified 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 52Week 52Modified 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 52Week 52Modified 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 52Week 52Modified 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 52Week 52Modified 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 52Baseline and Week 52Percentage 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 52Baseline, Weeks 24 and 52SF-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 52Baseline, Weeks 24 and 52SF-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 52Baseline, Weeks 24 and 52SF-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 52Weeks 24 and 52SF-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 52Weeks 24 and 52SF-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 52Baseline, Weeks 24 and 52The 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 52Weeks 24 and 52The 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-VASBaseline, Weeks 24 and 52EQ-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 IndexBaseline, Weeks 24 and 52EQ-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 52Baseline, Weeks 24 and 52Work 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 52Baseline, Weeks 24 and 52Work 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 52Baseline, Weeks 24 and 52Work 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 52Baseline, Weeks 24 and 52Work 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 100Weeks 52, 68, 76, 84 and 100ACR 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 100Weeks 52, 68, 76, 84 and 100ACR 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 100Weeks 52, 68, 76, 84 and 100ACR 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 100Weeks 52, 68, 76, 84 and 100ACR 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 100Baseline, Weeks 52, 68, 76, 84 and 100ACR 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 100Baseline, Weeks 52, 68, 76, 84 and 100ACR 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 52Week 100ACR 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 52Week 100ACR 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 52Week 100ACR 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 100Baseline, Weeks 52, 68, 76, 84 and 100HAQ-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 BaselineWeeks 52, 68, 76, 84 and 100HAQ-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 52Week 100HAQ-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 100Weeks 52, 68, 76, 84 and 100DAS28 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 100Weeks 52, 68, 76, 84 and 100DAS28 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 100Baseline, Weeks 52, 68, 76, 84 and 100DAS28 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 100Weeks 52, 68, 76, 84 and 100The 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 BaselineWeeks 52, 76, and 100Enthesitis 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 BaselineBaseline, Weeks 52, 76 and 100Enthesitis 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 BaselineWeeks 52, 76 and 100The 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 BaselineBaseline, Weeks 52, 76 and 100The 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 100Baseline, Weeks 52, 76 and 100PASDAS (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 100Weeks 52, 76 and 100PASDAS (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 100Baseline, Weeks 52, 76 and 100GRACE 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 100Weeks 52, 76 and 100GRACE 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 100Baseline, Weeks 52, 68, 76, 84 and 100DAPSA 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 100Weeks 52, 68, 76, 84 and 100DAPSA 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 100Baseline, Weeks 52, 76 and 100The 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 100Weeks 52, 76 and 100The 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 100Weeks 52, 76 and 100MDA 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 100Weeks 52, 76 and 100A 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 BaselineBaseline, Weeks 52, 76 and 100Bath 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 BaselineWeeks 52, 76 and 100Bath 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 BaselineBaseline, Weeks 52, 76 and 100PASI 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 BaselineWeeks 52, 76 and 100PASI 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 BaselineWeeks 52, 76 and 100PASI 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 BaselineWeeks 52, 76 and 100PASI 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 BaselineWeeks 52, 76 and 100PASI 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 BaselineWeeks 52, 76 and 100In 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 BaselineWeeks 52, 76 and 100In 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 BaselineWeeks 52, 76 and 100A 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 BaselineWeeks 52, 76 and 100A 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 BaselineWeeks 52, 76 and 100Dermatology 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 BaselineWeeks 52, 76 and 100Dermatology 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 BaselineBaseline, Weeks 52, 76 and 100Dermatology 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 100Baseline to Week 100Modified 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 100From Week 52 to Week 100Modified 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 100Baseline to Week 100Modified 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 100From Week 52 to Week 100Modified 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 100Baseline to Week 100Modified 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 100From Week 52 to Week 100Modified 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 100Modified 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 ScoreBaseline to Week 100Modified 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 ScoreBaseline to Week 100Modified 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 ScoreBaseline to Week 100Modified 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 100Baseline to Week 100Modified 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 100Baseline to Week 100Modified 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 100Baseline to Week 100Modified 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 100Baseline, Weeks 24, 52, and 100Pencil 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 100Baseline, Weeks 52, 76 and 100SF-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 100Baseline, Weeks 52, 76 and 100SF-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 100Baseline, Weeks 52, 76 and 100SF-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 100Weeks 52, 76 and 100SF-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 100Weeks 52, 76 and 100SF-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 100Baseline, Weeks 52, 76 and 100The 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 100Weeks 52, 76 and 100The 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-VASBaseline, Weeks 52, 76 and 100EQ-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 IndexBaseline, Weeks 52, 76 and 100EQ-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 100Baseline, Weeks 52, 76 and 100Work 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 100Baseline, Weeks 52, 76 and 100Work 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 100Baseline, Weeks 52, 76 and 100Work 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 100Baseline, Weeks 52, 76 and 100Work 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

STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial

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

ArmCount
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
Total739

Baseline characteristics

CharacteristicPlacebo to Guselkumab 100 mg q4wGuselkumab 100 mg q8wGuselkumab 100 mg q4wTotal
Age, Continuous46.3 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 Participants1 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
245 Participants247 Participants245 Participants737 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants8 Participants3 Participants15 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
242 Participants240 Participants242 Participants724 Participants
Region of Enrollment
BULGARIA
14 participants9 participants6 participants29 participants
Region of Enrollment
CZECH REPUBLIC
13 participants5 participants15 participants33 participants
Region of Enrollment
ESTONIA
5 participants8 participants5 participants18 participants
Region of Enrollment
LATVIA
3 participants3 participants0 participants6 participants
Region of Enrollment
LITHUANIA
8 participants8 participants4 participants20 participants
Region of Enrollment
MALAYSIA
3 participants6 participants3 participants12 participants
Region of Enrollment
POLAND
35 participants27 participants23 participants85 participants
Region of Enrollment
RUSSIAN FEDERATION
92 participants77 participants104 participants273 participants
Region of Enrollment
SPAIN
3 participants12 participants4 participants19 participants
Region of Enrollment
TAIWAN
0 participants1 participants0 participants1 participants
Region of Enrollment
TURKEY
2 participants8 participants6 participants16 participants
Region of Enrollment
UKRAINE
65 participants83 participants73 participants221 participants
Region of Enrollment
UNITED STATES
3 participants1 participants2 participants6 participants
Sex: Female, Male
Female
129 Participants119 Participants103 Participants351 Participants
Sex: Female, Male
Male
117 Participants129 Participants142 Participants388 Participants

Adverse events

Event typeEG000
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 / 2460 / 2480 / 2451 / 2380 / 2480 / 245
other
Total, other adverse events
30 / 24642 / 24852 / 24548 / 23888 / 24879 / 245
serious
Total, serious adverse events
7 / 2463 / 2488 / 24516 / 23822 / 24822 / 245

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 2432.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 2464.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 2463.7 percentage of participants
p-value: <0.00195% CI: [22.9, 39.5]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [22.4, 39.1]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count4.1 units on a scaleStandard Deviation 5.17
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score0.9117 units on a scaleStandard Deviation 0.63353
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain3.78 units on a scaleStandard Deviation 2.297
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count2.5 units on a scaleStandard Deviation 3.77
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP1.120 units on a scaleStandard Deviation 1.514
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain4.66 units on a scaleStandard Deviation 2.341
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count2.1 units on a scaleStandard Deviation 3.19
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity4.22 units on a scaleStandard Deviation 2.342
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain5.21 units on a scaleStandard Deviation 2.368
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count2.1 units on a scaleStandard Deviation 3.59
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score0.9069 units on a scaleStandard Deviation 0.63695
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count7.4 units on a scaleStandard Deviation 10.24
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count14.4 units on a scaleStandard Deviation 13.16
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity2.06 units on a scaleStandard Deviation 1.649
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count7.5 units on a scaleStandard Deviation 9.42
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count11.7 units on a scaleStandard Deviation 11.87
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity3.68 units on a scaleStandard Deviation 2.318
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count8.5 units on a scaleStandard Deviation 10
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP1.543 units on a scaleStandard Deviation 2.1572
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score1.0457 units on a scaleStandard Deviation 0.59051
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity3.78 units on a scaleStandard Deviation 2.378
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity1.90 units on a scaleStandard Deviation 1.654
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity3.84 units on a scaleStandard Deviation 2.295
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP0.920 units on a scaleStandard Deviation 1.4674
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity2.28 units on a scaleStandard Deviation 1.594
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity4.75 units on a scaleStandard Deviation 2.338
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP0.858 units on a scaleStandard Deviation 1.0558
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score0.9621 units on a scaleStandard Deviation 0.60695
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity5.29 units on a scaleStandard Deviation 2.367
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP0.907 units on a scaleStandard Deviation 1.5985
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score1.1350 units on a scaleStandard Deviation 0.61984
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain3.53 units on a scaleStandard Deviation 2.253
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count5.8 units on a scaleStandard Deviation 6.99
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity3.27 units on a scaleStandard Deviation 1.93
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain3.67 units on a scaleStandard Deviation 2.312
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity4.01 units on a scaleStandard Deviation 2.516
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score0.8766 units on a scaleStandard Deviation 0.59893
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score0.8497 units on a scaleStandard Deviation 0.61863
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score0.8091 units on a scaleStandard Deviation 0.61588
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score0.7927 units on a scaleStandard Deviation 0.59979
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score0.7917 units on a scaleStandard Deviation 0.59527
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP0.961 units on a scaleStandard Deviation 1.2868
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP0.956 units on a scaleStandard Deviation 1.3749
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP0.892 units on a scaleStandard Deviation 1.3109
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP0.812 units on a scaleStandard Deviation 1.0139
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP0.937 units on a scaleStandard Deviation 1.2422
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count3.4 units on a scaleStandard Deviation 5.19
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count2.9 units on a scaleStandard Deviation 4.95
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count2.4 units on a scaleStandard Deviation 4.58
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count2.3 units on a scaleStandard Deviation 4.42
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count2.1 units on a scaleStandard Deviation 4.16
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count9.1 units on a scaleStandard Deviation 9.94
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count7.9 units on a scaleStandard Deviation 9.02
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count7.0 units on a scaleStandard Deviation 8.72
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count6.3 units on a scaleStandard Deviation 8.45
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count6.2 units on a scaleStandard Deviation 8.18
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain3.77 units on a scaleStandard Deviation 2.457
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain3.50 units on a scaleStandard Deviation 2.311
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain3.28 units on a scaleStandard Deviation 2.336
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain3.22 units on a scaleStandard Deviation 2.37
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain3.10 units on a scaleStandard Deviation 2.333
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity1.77 units on a scaleStandard Deviation 1.645
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity3.76 units on a scaleStandard Deviation 2.348
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity3.52 units on a scaleStandard Deviation 2.39
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity3.36 units on a scaleStandard Deviation 2.447
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity3.23 units on a scaleStandard Deviation 2.383
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity2.74 units on a scaleStandard Deviation 2.113
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity2.44 units on a scaleStandard Deviation 1.941
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity2.10 units on a scaleStandard Deviation 1.777
Guselkumab 100 mg q8wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity1.97 units on a scaleStandard Deviation 1.842
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain3.20 units on a scaleStandard Deviation 2.242
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count4.1 units on a scaleStandard Deviation 5.77
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity2.66 units on a scaleStandard Deviation 1.906
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain3.24 units on a scaleStandard Deviation 2.277
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP0.910 units on a scaleStandard Deviation 1.2756
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score0.7376 units on a scaleStandard Deviation 0.56257
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain3.21 units on a scaleStandard Deviation 2.371
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP0.992 units on a scaleStandard Deviation 1.9875
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity1.77 units on a scaleStandard Deviation 1.616
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity3.93 units on a scaleStandard Deviation 2.276
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP0.837 units on a scaleStandard Deviation 1.073
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity2.33 units on a scaleStandard Deviation 1.668
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity3.62 units on a scaleStandard Deviation 2.275
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP0.885 units on a scaleStandard Deviation 1.0299
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score0.7985 units on a scaleStandard Deviation 0.56677
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity3.30 units on a scaleStandard Deviation 2.318
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP0.790 units on a scaleStandard Deviation 0.839
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity1.93 units on a scaleStandard Deviation 1.631
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count8.6 units on a scaleStandard Deviation 10.03
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity3.50 units on a scaleStandard Deviation 2.323
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count7.5 units on a scaleStandard Deviation 9.25
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count10.5 units on a scaleStandard Deviation 11.82
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score0.7364 units on a scaleStandard Deviation 0.58655
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count7.0 units on a scaleStandard Deviation 9.42
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count2.5 units on a scaleStandard Deviation 4.83
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity2.06 units on a scaleStandard Deviation 1.716
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count7.3 units on a scaleStandard Deviation 9.46
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count2.8 units on a scaleStandard Deviation 5.65
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity3.28 units on a scaleStandard Deviation 2.354
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain3.70 units on a scaleStandard Deviation 2.193
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count2.7 units on a scaleStandard Deviation 4.67
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score0.7804 units on a scaleStandard Deviation 0.57721
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain3.45 units on a scaleStandard Deviation 2.259
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count3.2 units on a scaleStandard Deviation 5.53
Guselkumab 100 mg q4wACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score0.8194 units on a scaleStandard Deviation 0.57287
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain3.26 units on a scaleStandard Deviation 2.313
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP0.880 units on a scaleStandard Deviation 1.3415
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity1.45 units on a scaleStandard Deviation 1.469
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain3.17 units on a scaleStandard Deviation 2.271
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP0.861 units on a scaleStandard Deviation 1.1586
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain2.97 units on a scaleStandard Deviation 2.15
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count1.8 units on a scaleStandard Deviation 3.75
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity1.63 units on a scaleStandard Deviation 1.514
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain2.90 units on a scaleStandard Deviation 2.221
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count1.6 units on a scaleStandard Deviation 3.1
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity1.89 units on a scaleStandard Deviation 1.654
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity3.68 units on a scaleStandard Deviation 2.331
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP0.904 units on a scaleStandard Deviation 1.6039
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity3.15 units on a scaleStandard Deviation 2.395
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity3.50 units on a scaleStandard Deviation 2.355
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count7.4 units on a scaleStandard Deviation 10.3
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity3.09 units on a scaleStandard Deviation 2.273
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity3.25 units on a scaleStandard Deviation 2.356
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count2.1 units on a scaleStandard Deviation 3.58
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score0.7692 units on a scaleStandard Deviation 0.5996
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count6.0 units on a scaleStandard Deviation 8.83
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP0.898 units on a scaleStandard Deviation 1.3229
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score0.8311 units on a scaleStandard Deviation 0.62101
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count5.7 units on a scaleStandard Deviation 8.31
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count1.6 units on a scaleStandard Deviation 3.17
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score0.8425 units on a scaleStandard Deviation 0.61757
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count5.1 units on a scaleStandard Deviation 7.32
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score0.8076 units on a scaleStandard Deviation 0.62465
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score0.9073 units on a scaleStandard Deviation 0.63812
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count5.5 units on a scaleStandard Deviation 8.44
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP0.903 units on a scaleStandard Deviation 1.4624
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity1.39 units on a scaleStandard Deviation 1.51
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain3.53 units on a scaleStandard Deviation 2.267
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count1.6 units on a scaleStandard Deviation 3.02
Placebo to Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity1.55 units on a scaleStandard Deviation 1.492
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity1.56 units on a scaleStandard Deviation 1.538
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count2.1 units on a scaleStandard Deviation 4.18
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count1.7 units on a scaleStandard Deviation 3.87
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count1.8 units on a scaleStandard Deviation 3.72
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count1.6 units on a scaleStandard Deviation 3.82
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count1.6 units on a scaleStandard Deviation 3.99
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count6.3 units on a scaleStandard Deviation 8.2
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count5.0 units on a scaleStandard Deviation 6.83
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count5.2 units on a scaleStandard Deviation 7.18
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count4.7 units on a scaleStandard Deviation 7.2
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count4.7 units on a scaleStandard Deviation 6.8
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain3.12 units on a scaleStandard Deviation 2.335
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain2.68 units on a scaleStandard Deviation 2.24
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain2.73 units on a scaleStandard Deviation 2.217
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain2.67 units on a scaleStandard Deviation 2.181
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain2.59 units on a scaleStandard Deviation 2.29
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity3.25 units on a scaleStandard Deviation 2.38
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity2.95 units on a scaleStandard Deviation 2.282
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity2.90 units on a scaleStandard Deviation 2.273
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity2.88 units on a scaleStandard Deviation 2.252
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity2.85 units on a scaleStandard Deviation 2.378
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity1.78 units on a scaleStandard Deviation 1.647
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity1.67 units on a scaleStandard Deviation 1.66
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity1.51 units on a scaleStandard Deviation 1.619
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity1.49 units on a scaleStandard Deviation 1.581
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score0.7942 units on a scaleStandard Deviation 0.59711
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score0.7625 units on a scaleStandard Deviation 0.59524
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score0.6978 units on a scaleStandard Deviation 0.56588
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score0.7134 units on a scaleStandard Deviation 0.59528
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score0.6747 units on a scaleStandard Deviation 0.57213
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP0.930 units on a scaleStandard Deviation 1.2443
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP0.884 units on a scaleStandard Deviation 1.352
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP0.882 units on a scaleStandard Deviation 1.2504
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP0.856 units on a scaleStandard Deviation 1.1926
Guselkumab 100 mg q8wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP0.826 units on a scaleStandard Deviation 1.2277
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain3.17 units on a scaleStandard Deviation 2.343
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count2.0 units on a scaleStandard Deviation 5.01
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity1.50 units on a scaleStandard Deviation 1.558
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count6.0 units on a scaleStandard Deviation 8.9
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP0.872 units on a scaleStandard Deviation 1.3239
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity1.41 units on a scaleStandard Deviation 1.405
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count5.9 units on a scaleStandard Deviation 9.22
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP0.796 units on a scaleStandard Deviation 1.1109
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score0.7317 units on a scaleStandard Deviation 0.5843
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count6.2 units on a scaleStandard Deviation 8.9
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count2.3 units on a scaleStandard Deviation 4.59
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score0.6836 units on a scaleStandard Deviation 0.56049
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count6.3 units on a scaleStandard Deviation 9.27
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count2.5 units on a scaleStandard Deviation 4.83
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score0.6996 units on a scaleStandard Deviation 0.55988
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP0.839 units on a scaleStandard Deviation 1.1693
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score0.6775 units on a scaleStandard Deviation 0.5887
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count7.2 units on a scaleStandard Deviation 9.49
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count2.0 units on a scaleStandard Deviation 3.79
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity2.95 units on a scaleStandard Deviation 2.222
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity2.85 units on a scaleStandard Deviation 2.213
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score0.6420 units on a scaleStandard Deviation 0.56838
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity2.83 units on a scaleStandard Deviation 2.222
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity3.24 units on a scaleStandard Deviation 2.322
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count2.0 units on a scaleStandard Deviation 4.11
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity2.60 units on a scaleStandard Deviation 2.165
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain2.57 units on a scaleStandard Deviation 2.138
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP0.820 units on a scaleStandard Deviation 1.1227
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity1.77 units on a scaleStandard Deviation 1.617
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain2.65 units on a scaleStandard Deviation 2.217
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain2.70 units on a scaleStandard Deviation 2.115
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity1.61 units on a scaleStandard Deviation 1.466
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain2.64 units on a scaleStandard Deviation 2.105
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP0.886 units on a scaleStandard Deviation 1.2366
Guselkumab 100 mg q4wACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity1.57 units on a scaleStandard Deviation 1.524
Secondary

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).

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 242.14 units on a scale
Guselkumab 100 mg q8wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 244.17 units on a scale
Guselkumab 100 mg q4wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 244.22 units on a scale
p-value: 0.07295% CI: [0.56, 3.49]ANCOVA
p-value: 0.07295% CI: [0.6, 3.54]ANCOVA
Secondary

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).

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 243.42 units on a scale
Guselkumab 100 mg q8wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 247.39 units on a scale
Guselkumab 100 mg q4wChange From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 247.04 units on a scale
p-value: 0.01195% CI: [2.75, 5.2]ANCOVA
p-value: 0.01195% CI: [2.39, 4.85]ANCOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-2.75 units on a scaleStandard Deviation 2.659
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-9.7 units on a scaleStandard Deviation 10.78
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP-0.547 units on a scaleStandard Deviation 2.5657
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-4.39 units on a scaleStandard Deviation 2.052
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-7.0 units on a scaleStandard Deviation 10.91
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP-0.993 units on a scaleStandard Deviation 2.3669
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-2.76 units on a scaleStandard Deviation 2.741
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-10.2 units on a scaleStandard Deviation 6.79
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-1.202 units on a scaleStandard Deviation 2.3234
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-2.62 units on a scaleStandard Deviation 2.64
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-10.1 units on a scaleStandard Deviation 6.77
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-1.262 units on a scaleStandard Deviation 2.5377
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-4.61 units on a scaleStandard Deviation 2.043
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-9.9 units on a scaleStandard Deviation 6.47
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-1.237 units on a scaleStandard Deviation 2.8242
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-1.79 units on a scaleStandard Deviation 2.543
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-8.1 units on a scaleStandard Deviation 6.99
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-6.4 units on a scaleStandard Deviation 7.25
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-2.51 units on a scaleStandard Deviation 2.588
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-4.77 units on a scaleStandard Deviation 2.007
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-2.45 units on a scaleStandard Deviation 2.248
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-1.63 units on a scaleStandard Deviation 2.42
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-0.1646 units on a scaleStandard Deviation 0.53253
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-2.70 units on a scaleStandard Deviation 2.555
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-1.08 units on a scaleStandard Deviation 2.441
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-0.2547 units on a scaleStandard Deviation 0.50426
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-1.25 units on a scaleStandard Deviation 2.601
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-14.1 units on a scaleStandard Deviation 11.39
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-0.3423 units on a scaleStandard Deviation 0.52951
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-3.42 units on a scaleStandard Deviation 2.189
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-14.0 units on a scaleStandard Deviation 11.02
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-0.3868 units on a scaleStandard Deviation 0.57065
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-2.85 units on a scaleStandard Deviation 2.757
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-13.2 units on a scaleStandard Deviation 10.78
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-0.3848 units on a scaleStandard Deviation 0.58049
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-2.99 units on a scaleStandard Deviation 2.569
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-3.15 units on a scaleStandard Deviation 2.65
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-3.29 units on a scaleStandard Deviation 2.558
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-3.84 units on a scaleStandard Deviation 2.316
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-4.16 units on a scaleStandard Deviation 2.175
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-4.49 units on a scaleStandard Deviation 2.116
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-4.55 units on a scaleStandard Deviation 2.139
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-4.78 units on a scaleStandard Deviation 1.996
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-0.4044 units on a scaleStandard Deviation 0.54194
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-0.4383 units on a scaleStandard Deviation 0.55648
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-0.4702 units on a scaleStandard Deviation 0.55698
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-0.4824 units on a scaleStandard Deviation 0.57091
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-0.4824 units on a scaleStandard Deviation 0.56167
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP-1.038 units on a scaleStandard Deviation 2.0932
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP-1.028 units on a scaleStandard Deviation 2.0476
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-1.098 units on a scaleStandard Deviation 2.1102
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-1.145 units on a scaleStandard Deviation 2.1378
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-1.021 units on a scaleStandard Deviation 2.2289
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-8.2 units on a scaleStandard Deviation 6.09
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-8.8 units on a scaleStandard Deviation 5.98
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-9.2 units on a scaleStandard Deviation 5.81
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-9.3 units on a scaleStandard Deviation 6.24
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-9.6 units on a scaleStandard Deviation 6.28
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-10.4 units on a scaleStandard Deviation 9.51
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-11.7 units on a scaleStandard Deviation 9.24
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-12.5 units on a scaleStandard Deviation 9.68
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-13.3 units on a scaleStandard Deviation 9.56
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-13.4 units on a scaleStandard Deviation 10.03
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-2.55 units on a scaleStandard Deviation 2.477
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-2.83 units on a scaleStandard Deviation 2.519
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-3.02 units on a scaleStandard Deviation 2.534
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-3.07 units on a scaleStandard Deviation 2.644
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-3.20 units on a scaleStandard Deviation 2.555
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-2.52 units on a scaleStandard Deviation 2.49
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-2.79 units on a scaleStandard Deviation 2.56
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-0.5082 units on a scaleStandard Deviation 0.58255
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-4.28 units on a scaleStandard Deviation 2.054
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-13.7 units on a scaleStandard Deviation 10.53
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-0.4652 units on a scaleStandard Deviation 0.56121
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-2.70 units on a scaleStandard Deviation 2.382
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-14.6 units on a scaleStandard Deviation 10.31
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-0.5000 units on a scaleStandard Deviation 0.55438
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-2.89 units on a scaleStandard Deviation 2.681
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-15.2 units on a scaleStandard Deviation 10.25
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-0.4429 units on a scaleStandard Deviation 0.51556
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-3.93 units on a scaleStandard Deviation 2.227
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-15.0 units on a scaleStandard Deviation 10.51
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-0.4257 units on a scaleStandard Deviation 0.50337
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-2.86 units on a scaleStandard Deviation 2.559
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-2.41 units on a scaleStandard Deviation 2.335
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-4.81 units on a scaleStandard Deviation 2.12
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-2.40 units on a scaleStandard Deviation 2.383
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-2.66 units on a scaleStandard Deviation 2.416
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-4.70 units on a scaleStandard Deviation 2.084
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-8.8 units on a scaleStandard Deviation 5.5
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-0.937 units on a scaleStandard Deviation 2.4116
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-3.06 units on a scaleStandard Deviation 2.527
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-9.6 units on a scaleStandard Deviation 6.65
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-0.861 units on a scaleStandard Deviation 2.8133
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-2.89 units on a scaleStandard Deviation 2.54
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-10.2 units on a scaleStandard Deviation 6.76
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-1.020 units on a scaleStandard Deviation 2.1985
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-4.53 units on a scaleStandard Deviation 2.173
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-10.2 units on a scaleStandard Deviation 6.28
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP-0.976 units on a scaleStandard Deviation 2.1663
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-3.01 units on a scaleStandard Deviation 2.445
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-10.4 units on a scaleStandard Deviation 6.17
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP-1.052 units on a scaleStandard Deviation 2.1295
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-2.87 units on a scaleStandard Deviation 2.601
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-11.9 units on a scaleStandard Deviation 9.98
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP-1.283 units on a scaleStandard Deviation 2.8163
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-5.13 units on a scaleStandard Deviation 2.04
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-10.6 units on a scaleStandard Deviation 6.06
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-5.23 units on a scaleStandard Deviation 1.995
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-3.35 units on a scaleStandard Deviation 2.595
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-16.1 units on a scaleStandard Deviation 10.97
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-5.06 units on a scaleStandard Deviation 2.037
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-3.41 units on a scaleStandard Deviation 2.578
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-1.212 units on a scaleStandard Deviation 2.3061
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-4.79 units on a scaleStandard Deviation 1.992
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-2.87 units on a scaleStandard Deviation 2.761
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-10.6 units on a scaleStandard Deviation 6.15
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-3.40 units on a scaleStandard Deviation 2.846
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-3.08 units on a scaleStandard Deviation 2.786
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-1.244 units on a scaleStandard Deviation 2.5828
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-3.46 units on a scaleStandard Deviation 2.752
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-3.32 units on a scaleStandard Deviation 2.86
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-1.262 units on a scaleStandard Deviation 2.8315
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-14.1 units on a scaleStandard Deviation 11.38
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-10.7 units on a scaleStandard Deviation 6.76
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-0.5356 units on a scaleStandard Deviation 0.56707
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-15.7 units on a scaleStandard Deviation 10.94
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-0.5041 units on a scaleStandard Deviation 0.59716
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-3.18 units on a scaleStandard Deviation 2.724
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-0.4740 units on a scaleStandard Deviation 0.57852
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-16.6 units on a scaleStandard Deviation 11.33
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-1.230 units on a scaleStandard Deviation 2.4262
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-0.4668 units on a scaleStandard Deviation 0.59226
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-16.3 units on a scaleStandard Deviation 11.27
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-10.7 units on a scaleStandard Deviation 5.98
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-0.3899 units on a scaleStandard Deviation 0.5825
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-2.78 units on a scaleStandard Deviation 2.645
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-10.2 units on a scaleStandard Deviation 6.72
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-5.26 units on a scaleStandard Deviation 2.098
Placebo to Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-3.10 units on a scaleStandard Deviation 2.707
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-1.021 units on a scaleStandard Deviation 2.2301
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-9.6 units on a scaleStandard Deviation 6.3
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-10.0 units on a scaleStandard Deviation 6.5
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-10.0 units on a scaleStandard Deviation 6.33
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-10.1 units on a scaleStandard Deviation 6.34
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-10.2 units on a scaleStandard Deviation 6.88
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-13.5 units on a scaleStandard Deviation 10.04
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-14.7 units on a scaleStandard Deviation 10.22
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-15.3 units on a scaleStandard Deviation 10.5
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-15.3 units on a scaleStandard Deviation 11.1
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-3.20 units on a scaleStandard Deviation 2.557
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-3.62 units on a scaleStandard Deviation 2.53
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-3.57 units on a scaleStandard Deviation 2.566
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-3.64 units on a scaleStandard Deviation 2.568
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-3.69 units on a scaleStandard Deviation 2.625
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-3.29 units on a scaleStandard Deviation 2.553
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-3.58 units on a scaleStandard Deviation 2.446
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-3.63 units on a scaleStandard Deviation 2.512
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-3.67 units on a scaleStandard Deviation 2.572
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-3.67 units on a scaleStandard Deviation 2.612
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-4.77 units on a scaleStandard Deviation 2.001
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-4.98 units on a scaleStandard Deviation 1.992
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-4.86 units on a scaleStandard Deviation 2.044
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-5.06 units on a scaleStandard Deviation 2.074
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-5.05 units on a scaleStandard Deviation 2.011
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-0.4801 units on a scaleStandard Deviation 0.56246
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-0.5120 units on a scaleStandard Deviation 0.54928
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-0.5694 units on a scaleStandard Deviation 0.56421
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-0.5653 units on a scaleStandard Deviation 0.59488
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-0.5859 units on a scaleStandard Deviation 0.58199
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-14.8 units on a scaleStandard Deviation 10.15
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-1.081 units on a scaleStandard Deviation 2.1585
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP-1.098 units on a scaleStandard Deviation 2.3654
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-1.101 units on a scaleStandard Deviation 2.1216
Guselkumab 100 mg q8wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-1.129 units on a scaleStandard Deviation 2.2261
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-10.7 units on a scaleStandard Deviation 7.08
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-5.09 units on a scaleStandard Deviation 2.142
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-2.92 units on a scaleStandard Deviation 2.686
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-0.940 units on a scaleStandard Deviation 2.3781
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-5.18 units on a scaleStandard Deviation 2.044
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-16.4 units on a scaleStandard Deviation 10.7
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-1.060 units on a scaleStandard Deviation 2.3334
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-0.5111 units on a scaleStandard Deviation 0.58347
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-16.0 units on a scaleStandard Deviation 11.22
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-10.7 units on a scaleStandard Deviation 6.18
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-0.5631 units on a scaleStandard Deviation 0.54528
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-16.1 units on a scaleStandard Deviation 10.91
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-10.4 units on a scaleStandard Deviation 6.16
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-0.5448 units on a scaleStandard Deviation 0.54739
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-16.0 units on a scaleStandard Deviation 11.02
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP-1.017 units on a scaleStandard Deviation 2.2801
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-0.5656 units on a scaleStandard Deviation 0.57921
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-15.2 units on a scaleStandard Deviation 10.45
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-3.38 units on a scaleStandard Deviation 2.501
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-3.49 units on a scaleStandard Deviation 2.5
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-10.9 units on a scaleStandard Deviation 7.22
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-3.50 units on a scaleStandard Deviation 2.579
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-3.09 units on a scaleStandard Deviation 2.523
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-0.6000 units on a scaleStandard Deviation 0.56858
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-3.73 units on a scaleStandard Deviation 2.493
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-3.52 units on a scaleStandard Deviation 2.615
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-10.8 units on a scaleStandard Deviation 6.66
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-4.82 units on a scaleStandard Deviation 2.117
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-3.42 units on a scaleStandard Deviation 2.669
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-1.042 units on a scaleStandard Deviation 2.06
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-5.01 units on a scaleStandard Deviation 2.105
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-3.38 units on a scaleStandard Deviation 2.62
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-0.959 units on a scaleStandard Deviation 2.4188
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-5.03 units on a scaleStandard Deviation 2.078
Guselkumab 100 mg q4wChange From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-3.46 units on a scaleStandard Deviation 2.574
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 76-3.311 units on a scaleStandard Deviation 2.6106
Placebo to Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 52-2.986 units on a scaleStandard Deviation 2.4945
Placebo to Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 100-3.718 units on a scaleStandard Deviation 2.396
Guselkumab 100 mg q8wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 76-3.377 units on a scaleStandard Deviation 2.5969
Guselkumab 100 mg q8wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 52-2.923 units on a scaleStandard Deviation 2.5194
Guselkumab 100 mg q8wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 100-3.472 units on a scaleStandard Deviation 2.5233
Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 52-3.084 units on a scaleStandard Deviation 2.1843
Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 100-3.330 units on a scaleStandard Deviation 2.1598
Guselkumab 100 mg q4wChange From Baseline in BASDAI Score at Weeks 52, 76 and 100 Among Participants With Spondylitis and Peripheral Arthritis and BASDAI Score>0 at BaselineWeek 76-3.129 units on a scaleStandard Deviation 2.1122
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 24-1.374 units on a scaleStandard Deviation 2.4269
Placebo to Guselkumab 100 mg q4wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 52-2.986 units on a scaleStandard Deviation 2.4945
Guselkumab 100 mg q8wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 24-2.652 units on a scaleStandard Deviation 2.3825
Guselkumab 100 mg q8wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 52-2.883 units on a scaleStandard Deviation 2.5193
Guselkumab 100 mg q4wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 24-2.674 units on a scaleStandard Deviation 1.9941
Guselkumab 100 mg q4wChange From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis at BaselineWeek 52-3.084 units on a scaleStandard Deviation 2.1843
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 24-4.6 units on a scaleStandard Deviation 7.88
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 52-7.4 units on a scaleStandard Deviation 9.18
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 24-6.1 units on a scaleStandard Deviation 7.83
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 52-7.3 units on a scaleStandard Deviation 9.74
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 24-6.6 units on a scaleStandard Deviation 7.84
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at BaselineWeek 52-7.4 units on a scaleStandard Deviation 8.59
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline-4.21 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline-6.10 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline-5.97 units on a scale
p-value: <0.00195% CI: [-2.99, -0.79]ANCOVA
p-value: 0.00295% CI: [-2.87, -0.66]ANCOVA
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 16-3.40 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 8-2.17 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 2-0.21 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 4-1.10 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 24-4.03 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 8-3.17 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 2-1.11 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 4-2.11 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 16-4.88 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 24-5.95 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 24-5.88 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 16-4.80 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 2-0.78 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 8-3.11 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at BaselineWeek 4-1.56 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 76-8.0 units on a scaleStandard Deviation 9.55
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 100-8.1 units on a scaleStandard Deviation 9.63
Placebo to Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 52-7.4 units on a scaleStandard Deviation 9.22
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 52-7.3 units on a scaleStandard Deviation 9.78
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 76-7.8 units on a scaleStandard Deviation 10.24
Guselkumab 100 mg q8wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 100-7.9 units on a scaleStandard Deviation 10.12
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 100-7.9 units on a scaleStandard Deviation 9.14
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 76-7.6 units on a scaleStandard Deviation 8.93
Guselkumab 100 mg q4wChange From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at BaselineWeek 52-7.4 units on a scaleStandard Deviation 8.66
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 84-35.240 units on a scaleStandard Deviation 17.7891
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 76-34.391 units on a scaleStandard Deviation 17.4074
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 52-31.274 units on a scaleStandard Deviation 18.89
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 68-33.918 units on a scaleStandard Deviation 18.0463
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 100-34.819 units on a scaleStandard Deviation 17.9807
Guselkumab 100 mg q8wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 76-33.062 units on a scaleStandard Deviation 17.5186
Guselkumab 100 mg q8wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 52-30.604 units on a scaleStandard Deviation 17.5366
Guselkumab 100 mg q8wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 68-33.146 units on a scaleStandard Deviation 18.1727
Guselkumab 100 mg q8wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 84-33.622 units on a scaleStandard Deviation 18.0612
Guselkumab 100 mg q8wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 100-34.019 units on a scaleStandard Deviation 19.2678
Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 100-35.549 units on a scaleStandard Deviation 16.5533
Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 84-34.570 units on a scaleStandard Deviation 18.2685
Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 52-32.563 units on a scaleStandard Deviation 16.4765
Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 76-34.590 units on a scaleStandard Deviation 16.5401
Guselkumab 100 mg q4wChange From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100Week 68-34.900 units on a scaleStandard Deviation 17.5749
Secondary

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).

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.44 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-0.88 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-0.85 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.29 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-0.97 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-1.00 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.59 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-1.27 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.42 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.62 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.99 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-1.39 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-1.52 units on a scale
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-1.59 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-1.37 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.65 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-1.62 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-1.56 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-1.22 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.98 units on a scale
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.43 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 44-2.04 units on a scaleStandard Deviation 1.098
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 36-1.92 units on a scaleStandard Deviation 1.086
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 24-1.02 units on a scaleStandard Deviation 1.101
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 28-1.38 units on a scaleStandard Deviation 1.099
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 52-2.14 units on a scaleStandard Deviation 1.142
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 36-1.97 units on a scaleStandard Deviation 1.114
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 24-1.63 units on a scaleStandard Deviation 1.051
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 28-1.78 units on a scaleStandard Deviation 1.038
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 44-2.09 units on a scaleStandard Deviation 1.107
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 52-2.08 units on a scaleStandard Deviation 1.121
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 52-2.11 units on a scaleStandard Deviation 1.128
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 44-2.08 units on a scaleStandard Deviation 1.063
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 24-1.68 units on a scaleStandard Deviation 0.976
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 36-2.08 units on a scaleStandard Deviation 1.088
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52Week 28-1.86 units on a scaleStandard Deviation 1.066
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 52-2.14 units on a scaleStandard Deviation 1.142
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 68-2.29 units on a scaleStandard Deviation 1.132
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 76-2.35 units on a scaleStandard Deviation 1.11
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 84-2.40 units on a scaleStandard Deviation 1.087
Placebo to Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 100-2.42 units on a scaleStandard Deviation 1.144
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 68-2.25 units on a scaleStandard Deviation 1.17
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 76-2.24 units on a scaleStandard Deviation 1.147
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 100-2.37 units on a scaleStandard Deviation 1.215
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 84-2.35 units on a scaleStandard Deviation 1.181
Guselkumab 100 mg q8wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 52-2.08 units on a scaleStandard Deviation 1.124
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 84-2.31 units on a scaleStandard Deviation 1.156
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 68-2.30 units on a scaleStandard Deviation 1.143
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 100-2.36 units on a scaleStandard Deviation 1.12
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 52-2.14 units on a scaleStandard Deviation 1.118
Guselkumab 100 mg q4wChange From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100Week 76-2.24 units on a scaleStandard Deviation 1.087
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-7.6695 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-14.8556 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-14.2915 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-4.6447 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-15.8489 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-16.1375 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-10.4480 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-18.9772 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-6.7838 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-9.9687 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-15.3303 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-21.6939 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-23.3163 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-24.0359 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-21.4722 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-10.2484 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-25.1583 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-24.6844 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-19.9687 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-15.8657 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-6.3783 units on a scale
Secondary

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).

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24-0.97 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24-1.59 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24-1.62 units on a scale
p-value: <0.00195% CI: [-0.8, -0.43]ANCOVA
p-value: <0.00195% CI: [-0.83, -0.47]ANCOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 24-2.142 units on a scaleStandard Deviation 6.4593
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 52-8.815 units on a scaleStandard Deviation 7.2714
Guselkumab 100 mg q8wChange 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 BaselineWeek 24-8.901 units on a scaleStandard Deviation 7.3657
Guselkumab 100 mg q8wChange 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 BaselineWeek 52-9.235 units on a scaleStandard Deviation 7.384
Guselkumab 100 mg q4wChange 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 BaselineWeek 24-9.249 units on a scaleStandard Deviation 7.0988
Guselkumab 100 mg q4wChange 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 BaselineWeek 52-9.839 units on a scaleStandard Deviation 6.8777
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 76-10.090 units on a scaleStandard Deviation 7.0888
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 52-8.855 units on a scaleStandard Deviation 7.2738
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 100-10.130 units on a scaleStandard Deviation 7.2798
Guselkumab 100 mg q8wChange 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 BaselineWeek 76-9.180 units on a scaleStandard Deviation 7.2977
Guselkumab 100 mg q8wChange 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 BaselineWeek 52-9.272 units on a scaleStandard Deviation 7.3903
Guselkumab 100 mg q8wChange 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 BaselineWeek 100-9.291 units on a scaleStandard Deviation 7.2851
Guselkumab 100 mg q4wChange 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 BaselineWeek 52-9.873 units on a scaleStandard Deviation 6.8832
Guselkumab 100 mg q4wChange 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 BaselineWeek 100-9.635 units on a scaleStandard Deviation 7.0884
Guselkumab 100 mg q4wChange 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 BaselineWeek 76-9.610 units on a scaleStandard Deviation 7.0383
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 16-2.410 units on a scale
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 8-1.653 units on a scale
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 24-2.129 units on a scale
Guselkumab 100 mg q8wChange 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 BaselineWeek 16-8.545 units on a scale
Guselkumab 100 mg q8wChange 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 BaselineWeek 8-6.818 units on a scale
Guselkumab 100 mg q8wChange 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 BaselineWeek 24-8.954 units on a scale
Guselkumab 100 mg q4wChange 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 BaselineWeek 8-6.396 units on a scale
Guselkumab 100 mg q4wChange 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 BaselineWeek 24-8.853 units on a scale
Guselkumab 100 mg q4wChange 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 BaselineWeek 16-8.147 units on a scale
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange 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 q8wChange 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 q4wChange From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline-1.59 units on a scale
p-value: <0.00195% CI: [-0.77, -0.23]ANCOVA
p-value: <0.00195% CI: [-0.83, -0.31]ANCOVA
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 16-0.94 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 8-0.67 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 2-0.33 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 4-0.46 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 24-1.03 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 8-0.92 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 2-0.37 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 4-0.56 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 16-1.37 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 24-1.60 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 24-1.52 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 16-1.42 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 2-0.49 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 8-0.88 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 2, 4, 8, 16, and 24 Among the Participants With Enthesitis at BaselineWeek 4-0.69 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 24-1.1 units on a scaleStandard Deviation 1.66
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 52-2.1 units on a scaleStandard Deviation 1.61
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 24-1.6 units on a scaleStandard Deviation 1.75
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 52-1.9 units on a scaleStandard Deviation 1.65
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 24-1.6 units on a scaleStandard Deviation 1.63
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 52-2.0 units on a scaleStandard Deviation 1.78
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 52-2.1 units on a scaleStandard Deviation 1.59
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 100-2.4 units on a scaleStandard Deviation 1.7
Placebo to Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 76-2.3 units on a scaleStandard Deviation 1.52
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 52-1.9 units on a scaleStandard Deviation 1.66
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 76-2.1 units on a scaleStandard Deviation 1.66
Guselkumab 100 mg q8wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 100-2.1 units on a scaleStandard Deviation 1.65
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 100-2.2 units on a scaleStandard Deviation 1.8
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 76-2.2 units on a scaleStandard Deviation 1.69
Guselkumab 100 mg q4wChange From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at BaselineWeek 52-2.1 units on a scaleStandard Deviation 1.72
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 160.058 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 240.053 units on a scale
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 160.112 units on a scale
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 240.115 units on a scale
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 160.101 units on a scale
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D IndexWeek 240.116 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 240.060 units on a scaleStandard Deviation 0.1558
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 520.137 units on a scaleStandard Deviation 0.1605
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 520.146 units on a scaleStandard Deviation 0.1587
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 240.124 units on a scaleStandard Deviation 0.1476
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 240.117 units on a scaleStandard Deviation 0.1307
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D IndexWeek 520.135 units on a scaleStandard Deviation 0.1469
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 248.456 units on a scaleStandard Deviation 25.7204
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 5221.474 units on a scaleStandard Deviation 25.5974
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 2419.282 units on a scaleStandard Deviation 23.522
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 5223.295 units on a scaleStandard Deviation 23.627
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 2417.500 units on a scaleStandard Deviation 22.6981
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VASWeek 5219.983 units on a scaleStandard Deviation 24.7643
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 760.154 units on a scaleStandard Deviation 0.1744
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 520.138 units on a scaleStandard Deviation 0.1608
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 1000.164 units on a scaleStandard Deviation 0.1605
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 760.169 units on a scaleStandard Deviation 0.1564
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 520.150 units on a scaleStandard Deviation 0.1445
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 1000.164 units on a scaleStandard Deviation 0.1596
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 520.138 units on a scaleStandard Deviation 0.1458
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 1000.156 units on a scaleStandard Deviation 0.1543
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D IndexWeek 760.147 units on a scaleStandard Deviation 0.1471
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 7624.176 units on a scaleStandard Deviation 27.7205
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 5221.608 units on a scaleStandard Deviation 25.5992
Placebo to Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 10025.901 units on a scaleStandard Deviation 28.4028
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 7625.053 units on a scaleStandard Deviation 26.0372
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 5223.392 units on a scaleStandard Deviation 23.699
Guselkumab 100 mg q8wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 10027.152 units on a scaleStandard Deviation 26.5221
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 5220.190 units on a scaleStandard Deviation 24.8348
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 10025.909 units on a scaleStandard Deviation 26.0995
Guselkumab 100 mg q4wChange From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VASWeek 7622.251 units on a scaleStandard Deviation 24.6934
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 166.477 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 246.796 units on a scale
Guselkumab 100 mg q8wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 1617.496 units on a scale
Guselkumab 100 mg q8wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 2418.371 units on a scale
Guselkumab 100 mg q4wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 1614.646 units on a scale
Guselkumab 100 mg q4wChange From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VASWeek 2418.089 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 243.844 units on a scaleStandard Deviation 9.044
Placebo to Guselkumab 100 mg q4wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 527.548 units on a scaleStandard Deviation 9.3745
Guselkumab 100 mg q8wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 248.034 units on a scaleStandard Deviation 9.8888
Guselkumab 100 mg q8wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 528.927 units on a scaleStandard Deviation 9.4646
Guselkumab 100 mg q4wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 246.970 units on a scaleStandard Deviation 8.6274
Guselkumab 100 mg q4wChange From Baseline in FACIT-Fatigue Score at Weeks 24 and 52Week 527.686 units on a scaleStandard Deviation 9.0833
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 769.167 units on a scaleStandard Deviation 9.0455
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 527.692 units on a scaleStandard Deviation 9.3071
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 1009.435 units on a scaleStandard Deviation 9.4513
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 769.596 units on a scaleStandard Deviation 10.4788
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 528.935 units on a scaleStandard Deviation 9.5033
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 10010.107 units on a scaleStandard Deviation 10.2076
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 527.699 units on a scaleStandard Deviation 9.1417
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 1009.127 units on a scaleStandard Deviation 8.9948
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100Week 768.632 units on a scaleStandard Deviation 8.8429
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 163.696 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 82.451 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 243.559 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 166.977 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 85.031 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 247.550 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 84.850 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 247.111 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24Week 166.598 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 76-3.499 units on a scaleStandard Deviation 1.6303
Placebo to Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 52-3.105 units on a scaleStandard Deviation 1.6208
Placebo to Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 100-3.561 units on a scaleStandard Deviation 1.6389
Guselkumab 100 mg q8wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 76-3.528 units on a scaleStandard Deviation 1.5778
Guselkumab 100 mg q8wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 52-3.266 units on a scaleStandard Deviation 1.6443
Guselkumab 100 mg q8wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 100-3.656 units on a scaleStandard Deviation 1.6071
Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 52-3.298 units on a scaleStandard Deviation 1.5457
Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 100-3.664 units on a scaleStandard Deviation 1.5205
Guselkumab 100 mg q4wChange From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100Week 76-3.541 units on a scaleStandard Deviation 1.5048
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 16-1.029 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 24-1.198 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 16-2.326 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 24-2.593 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 16-2.214 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24Week 24-2.589 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 24-1.260 units on a scaleStandard Deviation 1.4909
Placebo to Guselkumab 100 mg q4wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 52-3.085 units on a scaleStandard Deviation 1.6277
Guselkumab 100 mg q8wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 24-2.658 units on a scaleStandard Deviation 1.677
Guselkumab 100 mg q8wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 52-3.271 units on a scaleStandard Deviation 1.6453
Guselkumab 100 mg q4wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 24-2.672 units on a scaleStandard Deviation 1.4589
Guselkumab 100 mg q4wChange From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52Week 52-3.267 units on a scaleStandard Deviation 1.5646
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 44-0.3868 units on a scaleStandard Deviation 0.57065
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 36-0.3423 units on a scaleStandard Deviation 0.52951
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 24-0.1646 units on a scaleStandard Deviation 0.53253
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 52-0.3848 units on a scaleStandard Deviation 0.58049
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 28-0.2547 units on a scaleStandard Deviation 0.50426
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 36-0.4702 units on a scaleStandard Deviation 0.55698
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 28-0.4383 units on a scaleStandard Deviation 0.55648
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 24-0.4044 units on a scaleStandard Deviation 0.54194
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 44-0.4824 units on a scaleStandard Deviation 0.57091
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 52-0.4824 units on a scaleStandard Deviation 0.56167
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 52-0.5082 units on a scaleStandard Deviation 0.58255
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 44-0.4652 units on a scaleStandard Deviation 0.56121
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 24-0.4257 units on a scaleStandard Deviation 0.50337
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 36-0.5000 units on a scaleStandard Deviation 0.55438
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52Week 28-0.4429 units on a scaleStandard Deviation 0.51556
Secondary

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).

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.0722 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-0.1167 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-0.1332 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.0594 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-0.1300 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-0.1565 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.0942 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-0.2870 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.1423 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.1472 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.2294 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-0.3177 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-0.3536 units on a scale
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-0.3672 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16-0.3442 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4-0.1605 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24-0.4004 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20-0.4019 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12-0.3010 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8-0.2336 units on a scale
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2-0.0795 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 84-0.5041 units on a scaleStandard Deviation 0.59716
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 76-0.4740 units on a scaleStandard Deviation 0.57852
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 52-0.3899 units on a scaleStandard Deviation 0.5825
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 68-0.4668 units on a scaleStandard Deviation 0.59226
Placebo to Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 100-0.5356 units on a scaleStandard Deviation 0.56707
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 76-0.5694 units on a scaleStandard Deviation 0.56421
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 52-0.4801 units on a scaleStandard Deviation 0.56246
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 68-0.5120 units on a scaleStandard Deviation 0.54928
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 84-0.5653 units on a scaleStandard Deviation 0.59488
Guselkumab 100 mg q8wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 100-0.5859 units on a scaleStandard Deviation 0.58199
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 100-0.6000 units on a scaleStandard Deviation 0.56858
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 84-0.5656 units on a scaleStandard Deviation 0.57921
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 52-0.5111 units on a scaleStandard Deviation 0.58347
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 76-0.5448 units on a scaleStandard Deviation 0.54739
Guselkumab 100 mg q4wChange From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100Week 68-0.5631 units on a scaleStandard Deviation 0.54528
Secondary

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).

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24-0.1300 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24-0.3672 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24-0.4004 units on a scale
p-value: <0.00195% CI: [-0.321, -0.1534]ANCOVA
p-value: <0.00195% CI: [-0.3544, -0.1864]ANCOVA
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 76-4.39 units on a scaleStandard Deviation 2.425
Placebo to Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 52-3.78 units on a scaleStandard Deviation 2.392
Placebo to Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 100-4.44 units on a scaleStandard Deviation 2.484
Guselkumab 100 mg q8wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 76-4.16 units on a scaleStandard Deviation 2.539
Guselkumab 100 mg q8wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 52-3.83 units on a scaleStandard Deviation 2.458
Guselkumab 100 mg q8wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 100-4.38 units on a scaleStandard Deviation 2.433
Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 52-4.14 units on a scaleStandard Deviation 2.358
Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 100-4.52 units on a scaleStandard Deviation 2.519
Guselkumab 100 mg q4wChange From Baseline in mCPDAI Score at Weeks 52, 76 and 100Week 76-4.47 units on a scaleStandard Deviation 2.347
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 16-1.18 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 24-1.30 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 16-2.39 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 24-2.94 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 16-2.57 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24Week 24-3.09 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 24-1.34 units on a scaleStandard Deviation 2.144
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 52-3.75 units on a scaleStandard Deviation 2.391
Guselkumab 100 mg q8wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 52-3.84 units on a scaleStandard Deviation 2.449
Guselkumab 100 mg q8wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 24-2.97 units on a scaleStandard Deviation 2.382
Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 24-3.32 units on a scaleStandard Deviation 2.098
Guselkumab 100 mg q4wChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 52-4.10 units on a scaleStandard Deviation 2.387
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 240.95 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 240.52 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 240.29 units on a scale
p-value: 0.07295% CI: [-0.9, 0.03]ANCOVA
p-value: 0.01195% CI: [-1.13, -0.19]ANCOVA
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Erosion Score at Week 240.58 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Modified vdH-S Erosion Score at Week 240.36 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Erosion Score at Week 240.13 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Erosion Score at Week 520.92 units on a scaleStandard Deviation 2.497
Guselkumab 100 mg q8wChange From Baseline in Modified vdH-S Erosion Score at Week 520.67 units on a scaleStandard Deviation 2.707
Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Erosion Score at Week 520.70 units on a scaleStandard Deviation 2.631
Secondary

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.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 240.37 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 240.16 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 240.16 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S JSN Score at Week 520.33 units on a scaleStandard Deviation 1.356
Guselkumab 100 mg q8wChange From Baseline in Modified vdH-S JSN Score at Week 520.29 units on a scaleStandard Deviation 1.272
Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S JSN Score at Week 520.38 units on a scaleStandard Deviation 1.633
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Score at Week 521.25 units on a scaleStandard Deviation 3.508
Guselkumab 100 mg q8wChange From Baseline in Modified vdH-S Score at Week 520.97 units on a scaleStandard Deviation 3.623
Guselkumab 100 mg q4wChange From Baseline in Modified vdH-S Score at Week 521.07 units on a scaleStandard Deviation 3.843
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 24Hand Erosion Score0.40 units on a scaleStandard Deviation 1.555
Placebo to Guselkumab 100 mg q4wChange 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 24Hand JSN Score0.26 units on a scaleStandard Deviation 1.106
Placebo to Guselkumab 100 mg q4wChange 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 24Hand Score0.66 units on a scaleStandard Deviation 2.441
Placebo to Guselkumab 100 mg q4wChange 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 24Foot Erosion Score0.14 units on a scaleStandard Deviation 0.801
Placebo to Guselkumab 100 mg q4wChange 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 24Foot JSN Score0.10 units on a scaleStandard Deviation 0.516
Placebo to Guselkumab 100 mg q4wChange 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 24Foot Score0.24 units on a scaleStandard Deviation 1.116
Guselkumab 100 mg q8wChange 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 24Foot Score0.17 units on a scaleStandard Deviation 1.18
Guselkumab 100 mg q8wChange 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 24Hand Erosion Score0.18 units on a scaleStandard Deviation 1.28
Guselkumab 100 mg q8wChange 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 24Foot Erosion Score0.15 units on a scaleStandard Deviation 0.982
Guselkumab 100 mg q8wChange 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 24Foot JSN Score0.02 units on a scaleStandard Deviation 0.516
Guselkumab 100 mg q8wChange 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 24Hand JSN Score0.10 units on a scaleStandard Deviation 0.637
Guselkumab 100 mg q8wChange 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 24Hand Score0.28 units on a scaleStandard Deviation 1.649
Guselkumab 100 mg q4wChange 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 24Hand JSN Score0.08 units on a scaleStandard Deviation 0.607
Guselkumab 100 mg q4wChange 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 24Hand Score0.05 units on a scaleStandard Deviation 1.881
Guselkumab 100 mg q4wChange 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 24Foot Score0.21 units on a scaleStandard Deviation 1.21
Guselkumab 100 mg q4wChange 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 24Foot Erosion Score0.14 units on a scaleStandard Deviation 0.894
Guselkumab 100 mg q4wChange 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 24Hand Erosion Score-0.03 units on a scaleStandard Deviation 1.514
Guselkumab 100 mg q4wChange 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 24Foot JSN Score0.07 units on a scaleStandard Deviation 0.632
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 52Hand Erosion Score0.66 units on a scaleStandard Deviation 1.815
Placebo to Guselkumab 100 mg q4wChange 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 52Hand JSN Score0.29 units on a scaleStandard Deviation 1.181
Placebo to Guselkumab 100 mg q4wChange 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 52Hand Score0.95 units on a scaleStandard Deviation 2.706
Placebo to Guselkumab 100 mg q4wChange 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 52Foot Erosion Score0.26 units on a scaleStandard Deviation 1.014
Placebo to Guselkumab 100 mg q4wChange 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 52Foot JSN Score0.04 units on a scaleStandard Deviation 0.353
Placebo to Guselkumab 100 mg q4wChange 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 52Foot Score0.30 units on a scaleStandard Deviation 1.22
Guselkumab 100 mg q8wChange 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 52Foot Score0.40 units on a scaleStandard Deviation 1.687
Guselkumab 100 mg q8wChange 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 52Hand Erosion Score0.37 units on a scaleStandard Deviation 1.969
Guselkumab 100 mg q8wChange 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 52Foot Erosion Score0.30 units on a scaleStandard Deviation 1.339
Guselkumab 100 mg q8wChange 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 52Foot JSN Score0.10 units on a scaleStandard Deviation 0.66
Guselkumab 100 mg q8wChange 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 52Hand JSN Score0.19 units on a scaleStandard Deviation 0.913
Guselkumab 100 mg q8wChange 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 52Hand Score0.56 units on a scaleStandard Deviation 2.589
Guselkumab 100 mg q4wChange 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 52Hand JSN Score0.22 units on a scaleStandard Deviation 1.235
Guselkumab 100 mg q4wChange 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 52Hand Score0.57 units on a scaleStandard Deviation 2.759
Guselkumab 100 mg q4wChange 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 52Foot Score0.50 units on a scaleStandard Deviation 1.939
Guselkumab 100 mg q4wChange 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 52Foot Erosion Score0.34 units on a scaleStandard Deviation 1.413
Guselkumab 100 mg q4wChange 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 52Hand Erosion Score0.35 units on a scaleStandard Deviation 1.83
Guselkumab 100 mg q4wChange 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 52Foot JSN Score0.16 units on a scaleStandard Deviation 0.864
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Bodily Pain Score3.882 units on a scaleStandard Deviation 8.3009
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Physical Function Score7.722 units on a scaleStandard Deviation 8.948
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-physical Score3.695 units on a scaleStandard Deviation 7.595
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-physical Score6.560 units on a scaleStandard Deviation 8.5399
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Physical Function Score3.602 units on a scaleStandard Deviation 7.7388
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Bodily Pain Score8.460 units on a scaleStandard Deviation 8.4659
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: General Health Score2.255 units on a scaleStandard Deviation 7.2176
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: General Health Score6.396 units on a scaleStandard Deviation 8.5589
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Vitality Score4.224 units on a scaleStandard Deviation 9.0878
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Vitality Score7.879 units on a scaleStandard Deviation 9.416
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Social Function Score3.088 units on a scaleStandard Deviation 10.433
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Social Function Score6.278 units on a scaleStandard Deviation 10.9444
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-emotional Score1.910 units on a scaleStandard Deviation 10.0772
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-emotional Score4.057 units on a scaleStandard Deviation 10.8795
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Mental Health Score2.583 units on a scaleStandard Deviation 9.2222
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Mental Health Score5.153 units on a scaleStandard Deviation 10.0724
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Bodily Pain Score10.238 units on a scaleStandard Deviation 8.7185
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: General Health Score5.963 units on a scaleStandard Deviation 7.8794
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: General Health Score7.173 units on a scaleStandard Deviation 7.2703
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-emotional Score4.970 units on a scaleStandard Deviation 10.1685
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Vitality Score7.914 units on a scaleStandard Deviation 9.4638
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Vitality Score8.646 units on a scaleStandard Deviation 9.5131
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Mental Health Score4.829 units on a scaleStandard Deviation 9.3665
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Social Function Score6.551 units on a scaleStandard Deviation 9.7076
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Physical Function Score7.052 units on a scaleStandard Deviation 8.502
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Mental Health Score4.605 units on a scaleStandard Deviation 9.7905
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Physical Function Score8.489 units on a scaleStandard Deviation 8.8599
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Social Function Score7.199 units on a scaleStandard Deviation 10.1315
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-physical Score6.897 units on a scaleStandard Deviation 7.724
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-physical Score7.677 units on a scaleStandard Deviation 8.2995
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Bodily Pain Score8.333 units on a scaleStandard Deviation 8.3852
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-emotional Score4.535 units on a scaleStandard Deviation 10.1304
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Social Function Score5.892 units on a scaleStandard Deviation 8.551
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Bodily Pain Score9.457 units on a scaleStandard Deviation 9.7977
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-emotional Score4.107 units on a scaleStandard Deviation 8.9473
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Role-physical Score6.381 units on a scaleStandard Deviation 7.2203
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: General Health Score5.067 units on a scaleStandard Deviation 7.4182
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Mental Health Score4.741 units on a scaleStandard Deviation 9.3825
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Physical Function Score6.772 units on a scaleStandard Deviation 7.592
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: General Health Score6.366 units on a scaleStandard Deviation 8.4199
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Social Function Score6.787 units on a scaleStandard Deviation 9.5326
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Bodily Pain Score7.833 units on a scaleStandard Deviation 7.339
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Vitality Score6.970 units on a scaleStandard Deviation 9.4889
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-emotional Score4.607 units on a scaleStandard Deviation 8.7627
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Physical Function Score8.374 units on a scaleStandard Deviation 8.7884
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Vitality Score7.654 units on a scaleStandard Deviation 9.3905
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 52: Role-physical Score7.344 units on a scaleStandard Deviation 7.7145
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52Week 24: Mental Health Score4.752 units on a scaleStandard Deviation 8.9336
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-emotional Score4.784 units on a scaleStandard Deviation 11.9482
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-physical Score9.181 units on a scaleStandard Deviation 8.6596
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Social Function Score7.825 units on a scaleStandard Deviation 10.8558
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-emotional Score4.111 units on a scaleStandard Deviation 10.9413
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-emotional Score5.199 units on a scaleStandard Deviation 11.1875
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Bodily Pain Score8.536 units on a scaleStandard Deviation 8.4602
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Social Function Score7.509 units on a scaleStandard Deviation 10.4249
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Mental Health Score5.209 units on a scaleStandard Deviation 10.0958
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Physical Function Score9.738 units on a scaleStandard Deviation 9.8405
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Mental Health Score5.481 units on a scaleStandard Deviation 10.5927
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Bodily Pain Score10.368 units on a scaleStandard Deviation 9.1058
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Mental Health Score5.514 units on a scaleStandard Deviation 10.6204
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Bodily Pain Score10.696 units on a scaleStandard Deviation 9.3854
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: General Health Score6.533 units on a scaleStandard Deviation 8.5245
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Physical Function Score7.757 units on a scaleStandard Deviation 8.9727
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: General Health Score7.203 units on a scaleStandard Deviation 8.3372
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-physical Score6.538 units on a scaleStandard Deviation 8.5151
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: General Health Score6.710 units on a scaleStandard Deviation 8.7265
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Vitality Score7.997 units on a scaleStandard Deviation 9.3878
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Physical Function Score8.824 units on a scaleStandard Deviation 9.6648
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Vitality Score8.859 units on a scaleStandard Deviation 9.4372
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-physical Score8.372 units on a scaleStandard Deviation 8.7202
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Vitality Score9.648 units on a scaleStandard Deviation 9.4778
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Social Function Score6.361 units on a scaleStandard Deviation 10.9927
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Social Function Score7.304 units on a scaleStandard Deviation 10.1003
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Social Function Score8.623 units on a scaleStandard Deviation 9.5176
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Bodily Pain Score11.585 units on a scaleStandard Deviation 10.3527
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Physical Function Score10.953 units on a scaleStandard Deviation 9.7761
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Social Function Score8.080 units on a scaleStandard Deviation 9.5383
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-physical Score9.342 units on a scaleStandard Deviation 9.1746
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Vitality Score8.695 units on a scaleStandard Deviation 9.5033
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-emotional Score4.998 units on a scaleStandard Deviation 10.1964
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Physical Function Score8.406 units on a scaleStandard Deviation 8.8407
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: General Health Score7.097 units on a scaleStandard Deviation 7.25
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-emotional Score5.757 units on a scaleStandard Deviation 10.0737
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Vitality Score9.827 units on a scaleStandard Deviation 9.9348
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-physical Score9.171 units on a scaleStandard Deviation 8.5844
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-emotional Score5.720 units on a scaleStandard Deviation 10.1991
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Bodily Pain Score10.201 units on a scaleStandard Deviation 8.7312
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: General Health Score7.470 units on a scaleStandard Deviation 7.6119
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Mental Health Score4.826 units on a scaleStandard Deviation 9.4038
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Vitality Score9.388 units on a scaleStandard Deviation 9.8618
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Physical Function Score9.807 units on a scaleStandard Deviation 9.5044
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Mental Health Score5.430 units on a scaleStandard Deviation 10.0802
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: General Health Score7.066 units on a scaleStandard Deviation 7.5829
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-physical Score7.665 units on a scaleStandard Deviation 8.2925
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Mental Health Score5.477 units on a scaleStandard Deviation 10.1202
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Bodily Pain Score11.552 units on a scaleStandard Deviation 9.8591
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Mental Health Score6.148 units on a scaleStandard Deviation 8.8743
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Physical Function Score8.493 units on a scaleStandard Deviation 8.7691
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Physical Function Score9.294 units on a scaleStandard Deviation 8.202
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Physical Function Score10.126 units on a scaleStandard Deviation 8.9271
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-physical Score7.372 units on a scaleStandard Deviation 7.7581
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-physical Score8.579 units on a scaleStandard Deviation 7.6709
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-physical Score8.921 units on a scaleStandard Deviation 8.1775
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Bodily Pain Score9.525 units on a scaleStandard Deviation 9.8357
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Bodily Pain Score10.998 units on a scaleStandard Deviation 8.923
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: General Health Score6.450 units on a scaleStandard Deviation 8.4316
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: General Health Score6.761 units on a scaleStandard Deviation 7.9631
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: General Health Score7.132 units on a scaleStandard Deviation 8.4887
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Vitality Score7.637 units on a scaleStandard Deviation 9.4393
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Vitality Score8.659 units on a scaleStandard Deviation 9.6026
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Vitality Score9.155 units on a scaleStandard Deviation 9.3569
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Social Function Score6.810 units on a scaleStandard Deviation 9.5118
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Social Function Score7.914 units on a scaleStandard Deviation 9.5191
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Social Function Score8.113 units on a scaleStandard Deviation 9.4847
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Role-emotional Score4.699 units on a scaleStandard Deviation 8.7759
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Role-emotional Score5.433 units on a scaleStandard Deviation 9.2389
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 100: Role-emotional Score5.128 units on a scaleStandard Deviation 9.7998
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 52: Mental Health Score4.839 units on a scaleStandard Deviation 9.4029
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Mental Health Score6.124 units on a scaleStandard Deviation 8.793
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100Week 76: Bodily Pain Score10.300 units on a scaleStandard Deviation 9.0504
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Physical Function Score2.095 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Bodily Pain Score3.482 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Bodily Pain Score2.760 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Physical Function Score3.254 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: General Health Score1.662 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-emotional Score1.813 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-physical Score3.365 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: General Health Score2.520 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Mental Health Score1.081 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-emotional Score1.108 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: General Health Score2.290 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Social Function Score2.978 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-physical Score2.619 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Vitality Score2.505 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Mental Health Score2.195 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Physical Function Score2.581 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Vitality Score3.554 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Bodily Pain Score3.086 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Mental Health Score2.335 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Vitality Score3.835 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-emotional Score1.530 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-physical Score2.965 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Social Function Score1.929 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Social Function Score2.884 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Social Function Score3.337 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Social Function Score5.584 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Social Function Score5.806 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-physical Score6.549 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-emotional Score2.459 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-emotional Score4.497 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Bodily Pain Score5.456 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Mental Health Score2.380 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Physical Function Score6.124 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Mental Health Score4.529 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Mental Health Score4.490 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Bodily Pain Score7.485 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Bodily Pain Score7.811 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: General Health Score4.111 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Physical Function Score6.703 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: General Health Score5.719 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Physical Function Score3.879 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: General Health Score5.794 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Vitality Score4.286 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-physical Score3.599 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Vitality Score6.967 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-emotional Score4.382 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Vitality Score7.373 units on a scale
Guselkumab 100 mg q8wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-physical Score5.616 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Mental Health Score4.767 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Physical Function Score3.936 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Physical Function Score5.618 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Physical Function Score6.624 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-physical Score3.107 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-physical Score6.241 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Bodily Pain Score4.901 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Bodily Pain Score6.613 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Bodily Pain Score7.739 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: General Health Score4.174 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: General Health Score4.808 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: General Health Score5.269 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Vitality Score4.669 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Vitality Score5.901 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Vitality Score7.009 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Social Function Score4.306 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Social Function Score5.022 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Social Function Score5.922 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Role-emotional Score2.294 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-emotional Score3.596 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 24: Role-emotional Score4.255 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 8: Mental Health Score3.048 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Mental Health Score3.896 units on a scale
Guselkumab 100 mg q4wChange From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24Week 16: Role-physical Score4.942 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 76-3.503 units on a scaleStandard Deviation 1.4708
Placebo to Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 52-3.054 units on a scaleStandard Deviation 1.4954
Placebo to Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 100-3.574 units on a scaleStandard Deviation 1.4785
Guselkumab 100 mg q8wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 76-3.418 units on a scaleStandard Deviation 1.5646
Guselkumab 100 mg q8wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 52-3.189 units on a scaleStandard Deviation 1.5216
Guselkumab 100 mg q8wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 100-3.586 units on a scaleStandard Deviation 1.5425
Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 52-3.184 units on a scaleStandard Deviation 1.4576
Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 100-3.549 units on a scaleStandard Deviation 1.4635
Guselkumab 100 mg q4wChange From Baseline in PASDAS Score at Weeks 52, 76 and 100Week 76-3.436 units on a scaleStandard Deviation 1.4428
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 16-3.482 units on a scale
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 24-3.904 units on a scale
Guselkumab 100 mg q8wChange 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 BaselineWeek 16-11.151 units on a scale
Guselkumab 100 mg q8wChange 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 BaselineWeek 24-11.407 units on a scale
Guselkumab 100 mg q4wChange 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 BaselineWeek 16-11.278 units on a scale
Guselkumab 100 mg q4wChange 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 BaselineWeek 24-11.471 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 24-2.989 units on a scaleStandard Deviation 6.1515
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 52-11.016 units on a scaleStandard Deviation 9.9801
Guselkumab 100 mg q8wChange 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 BaselineWeek 24-11.685 units on a scaleStandard Deviation 12.3496
Guselkumab 100 mg q8wChange 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 BaselineWeek 52-11.977 units on a scaleStandard Deviation 12.0847
Guselkumab 100 mg q4wChange 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 BaselineWeek 24-12.574 units on a scaleStandard Deviation 11.8391
Guselkumab 100 mg q4wChange 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 BaselineWeek 52-12.857 units on a scaleStandard Deviation 11.3052
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 76-11.313 units on a scaleStandard Deviation 10.0631
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 52-11.030 units on a scaleStandard Deviation 10.0077
Placebo to Guselkumab 100 mg q4wChange 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 BaselineWeek 100-11.089 units on a scaleStandard Deviation 10.0239
Guselkumab 100 mg q8wChange 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 BaselineWeek 76-11.991 units on a scaleStandard Deviation 12.2656
Guselkumab 100 mg q8wChange 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 BaselineWeek 52-11.991 units on a scaleStandard Deviation 12.1194
Guselkumab 100 mg q8wChange 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 BaselineWeek 100-12.101 units on a scaleStandard Deviation 12.1322
Guselkumab 100 mg q4wChange 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 BaselineWeek 52-12.875 units on a scaleStandard Deviation 11.2905
Guselkumab 100 mg q4wChange 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 BaselineWeek 100-13.274 units on a scaleStandard Deviation 11.9673
Guselkumab 100 mg q4wChange 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 BaselineWeek 76-13.242 units on a scaleStandard Deviation 11.8845
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 24-1.399 units on a scaleStandard Deviation 1.3169
Placebo to Guselkumab 100 mg q4wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 52-3.041 units on a scaleStandard Deviation 1.4979
Guselkumab 100 mg q8wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 24-2.496 units on a scaleStandard Deviation 1.5024
Guselkumab 100 mg q8wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 52-3.197 units on a scaleStandard Deviation 1.5212
Guselkumab 100 mg q4wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 24-2.506 units on a scaleStandard Deviation 1.2578
Guselkumab 100 mg q4wChange From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52Week 52-3.161 units on a scaleStandard Deviation 1.4646
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 242.211 units on a scaleStandard Deviation 10.1368
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 524.297 units on a scaleStandard Deviation 10.896
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 244.452 units on a scaleStandard Deviation 9.956
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 524.465 units on a scaleStandard Deviation 9.778
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 524.076 units on a scaleStandard Deviation 9.1101
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 244.128 units on a scaleStandard Deviation 9.1814
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 764.838 units on a scaleStandard Deviation 11.0526
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 524.383 units on a scaleStandard Deviation 10.9402
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 1004.610 units on a scaleStandard Deviation 11.2527
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 765.034 units on a scaleStandard Deviation 10.0334
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 524.540 units on a scaleStandard Deviation 9.7848
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 1004.718 units on a scaleStandard Deviation 9.9014
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 524.127 units on a scaleStandard Deviation 9.1368
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 1004.936 units on a scaleStandard Deviation 9.5935
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 765.194 units on a scaleStandard Deviation 9.4899
Secondary

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).

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 161.96 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 81.11 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 242.14 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 164.28 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 82.28 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 244.17 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 82.87 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 244.22 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24Week 163.41 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 243.782 units on a scaleStandard Deviation 7.1776
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 528.124 units on a scaleStandard Deviation 8.2192
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 247.838 units on a scaleStandard Deviation 8.0335
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 529.511 units on a scaleStandard Deviation 8.3176
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 247.183 units on a scaleStandard Deviation 6.9793
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 528.960 units on a scaleStandard Deviation 8.5891
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 769.762 units on a scaleStandard Deviation 8.5908
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 528.170 units on a scaleStandard Deviation 8.2195
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10010.508 units on a scaleStandard Deviation 8.6819
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 7610.814 units on a scaleStandard Deviation 9.029
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 529.438 units on a scaleStandard Deviation 8.2854
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10011.282 units on a scaleStandard Deviation 9.2753
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 529.023 units on a scaleStandard Deviation 8.6263
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10010.559 units on a scaleStandard Deviation 8.7449
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 769.707 units on a scaleStandard Deviation 8.501
Secondary

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).

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 163.03 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 82.75 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 243.42 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 166.65 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 84.83 units on a scale
Guselkumab 100 mg q8wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 247.39 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 84.34 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 247.04 units on a scale
Guselkumab 100 mg q4wChange From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24Week 165.93 units on a scale
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 44-30.754 units on a scaleStandard Deviation 18.5016
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 52-31.209 units on a scaleStandard Deviation 18.9981
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 28-22.199 units on a scaleStandard Deviation 17.9394
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 36-29.251 units on a scaleStandard Deviation 18.1137
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 24-16.377 units on a scaleStandard Deviation 19.1814
Guselkumab 100 mg q8wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 28-26.573 units on a scaleStandard Deviation 15.5254
Guselkumab 100 mg q8wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 44-30.108 units on a scaleStandard Deviation 16.6013
Guselkumab 100 mg q8wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 24-24.718 units on a scaleStandard Deviation 16.7967
Guselkumab 100 mg q8wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 52-30.512 units on a scaleStandard Deviation 17.5074
Guselkumab 100 mg q8wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 36-28.889 units on a scaleStandard Deviation 16.4372
Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 52-32.282 units on a scaleStandard Deviation 16.632
Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 24-26.578 units on a scaleStandard Deviation 15.3393
Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 28-29.613 units on a scaleStandard Deviation 17.6129
Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 36-31.782 units on a scaleStandard Deviation 16.7698
Guselkumab 100 mg q4wChange From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52Week 44-32.126 units on a scaleStandard Deviation 15.7605
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 16-1.158 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 8-0.863 units on a scale
Placebo to Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 24-1.336 units on a scale
Guselkumab 100 mg q8wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 16-2.110 units on a scale
Guselkumab 100 mg q8wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 8-1.452 units on a scale
Guselkumab 100 mg q8wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 24-2.403 units on a scale
Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 8-1.413 units on a scale
Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 24-2.399 units on a scale
Guselkumab 100 mg q4wChange From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24Week 16-1.994 units on a scale
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 16-10.569 percentage of activity impairment
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 24-10.320 percentage of activity impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 16-17.107 percentage of activity impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 24-21.467 percentage of activity impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 16-17.029 percentage of activity impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24Week 24-20.480 percentage of activity impairment
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 16-10.281 percentage of impairment
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 24-10.157 percentage of impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 16-16.054 percentage of impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 24-19.366 percentage of impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 16-15.083 percentage of impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24Week 24-19.492 percentage of impairment
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 16-11.232 percentage of overall work impairment
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 24-10.869 percentage of overall work impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 16-15.926 percentage of overall work impairment
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 24-19.711 percentage of overall work impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 16-15.808 percentage of overall work impairment
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24Week 24-20.023 percentage of overall work impairment
Secondary

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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 16-4.553 percentage of work time missed
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 24-3.491 percentage of work time missed
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 16-3.451 percentage of work time missed
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 24-3.103 percentage of work time missed
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 16-4.717 percentage of work time missed
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24Week 24-3.827 percentage of work time missed
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 24-5.64 units on a scaleStandard Deviation 28.355
Placebo to Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 52-5.37 units on a scaleStandard Deviation 25.365
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 24-3.77 units on a scaleStandard Deviation 28.029
Guselkumab 100 mg q8wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 52-4.47 units on a scaleStandard Deviation 20.454
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 24-1.20 units on a scaleStandard Deviation 17.127
Guselkumab 100 mg q4wChange From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52Week 52-1.74 units on a scaleStandard Deviation 17.084
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 24-10.80 units on a scaleStandard Deviation 26.131
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 52-24.13 units on a scaleStandard Deviation 27.436
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 24-23.03 units on a scaleStandard Deviation 25.559
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 52-27.14 units on a scaleStandard Deviation 25.657
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 52-26.11 units on a scaleStandard Deviation 25.361
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52Week 24-21.07 units on a scaleStandard Deviation 21.493
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 76-28.05 units on a scaleStandard Deviation 26.411
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 52-24.67 units on a scaleStandard Deviation 27.106
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 100-30.70 units on a scaleStandard Deviation 28.632
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 76-31.38 units on a scaleStandard Deviation 25.449
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 100-30.98 units on a scaleStandard Deviation 26.65
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 52-27.16 units on a scaleStandard Deviation 25.662
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 76-28.70 units on a scaleStandard Deviation 24.635
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 52-26.24 units on a scaleStandard Deviation 25.113
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100Week 100-30.68 units on a scaleStandard Deviation 25.305
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 52-21.27 units on a scaleStandard Deviation 31.502
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 24-12.14 units on a scaleStandard Deviation 29.027
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 52-27.93 units on a scaleStandard Deviation 25.263
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 24-21.28 units on a scaleStandard Deviation 25.621
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 24-20.08 units on a scaleStandard Deviation 22.084
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52Week 52-22.10 units on a scaleStandard Deviation 26.172
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 76-26.90 units on a scaleStandard Deviation 28.965
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 52-21.81 units on a scaleStandard Deviation 31.391
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 100-30.73 units on a scaleStandard Deviation 30.933
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 76-29.91 units on a scaleStandard Deviation 24.549
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 52-27.93 units on a scaleStandard Deviation 25.263
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 100-30.65 units on a scaleStandard Deviation 24.771
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 52-22.62 units on a scaleStandard Deviation 26.058
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 100-27.77 units on a scaleStandard Deviation 26.119
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100Week 76-26.13 units on a scaleStandard Deviation 25.412
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 24-13.42 units on a scaleStandard Deviation 29.916
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 52-22.06 units on a scaleStandard Deviation 32.092
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 24-21.68 units on a scaleStandard Deviation 27.065
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 52-28.19 units on a scaleStandard Deviation 25.536
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 24-20.90 units on a scaleStandard Deviation 22.814
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52Week 52-22.24 units on a scaleStandard Deviation 26.92
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 76-27.98 units on a scaleStandard Deviation 29.709
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 52-22.61 units on a scaleStandard Deviation 31.979
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 100-31.87 units on a scaleStandard Deviation 31.013
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 76-30.27 units on a scaleStandard Deviation 26.058
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 52-28.19 units on a scaleStandard Deviation 25.536
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 100-31.75 units on a scaleStandard Deviation 25.615
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 52-22.79 units on a scaleStandard Deviation 26.793
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 100-25.21 units on a scaleStandard Deviation 26.317
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100Week 76-26.21 units on a scaleStandard Deviation 28.115
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 76-5.92 units on a scaleStandard Deviation 26.032
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 52-5.45 units on a scaleStandard Deviation 25.544
Placebo to Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 100-8.81 units on a scaleStandard Deviation 24.313
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 76-6.22 units on a scaleStandard Deviation 23.133
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 52-4.50 units on a scaleStandard Deviation 20.53
Guselkumab 100 mg q8wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 100-5.81 units on a scaleStandard Deviation 21.606
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 52-1.83 units on a scaleStandard Deviation 17.191
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 100-1.56 units on a scaleStandard Deviation 16.956
Guselkumab 100 mg q4wChange From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100Week 76-2.39 units on a scaleStandard Deviation 19.277
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange 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 Score0.67 units on a scaleStandard Deviation 2.917
Placebo to Guselkumab 100 mg q4wChange 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 Score0.35 units on a scaleStandard Deviation 2.443
Placebo to Guselkumab 100 mg q4wChange 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 Score1.02 units on a scaleStandard Deviation 5.244
Placebo to Guselkumab 100 mg q4wChange 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 Score0.34 units on a scaleStandard Deviation 1.596
Placebo to Guselkumab 100 mg q4wChange 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 Score0.13 units on a scaleStandard Deviation 0.912
Placebo to Guselkumab 100 mg q4wChange 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 Score0.48 units on a scaleStandard Deviation 2.373
Guselkumab 100 mg q8wChange 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 Score0.48 units on a scaleStandard Deviation 1.652
Guselkumab 100 mg q8wChange 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 Score0.67 units on a scaleStandard Deviation 2.807
Guselkumab 100 mg q8wChange 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 Score0.33 units on a scaleStandard Deviation 1.362
Guselkumab 100 mg q8wChange 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 Score0.15 units on a scaleStandard Deviation 0.652
Guselkumab 100 mg q8wChange 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 Score0.34 units on a scaleStandard Deviation 1.247
Guselkumab 100 mg q8wChange 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 Score1.02 units on a scaleStandard Deviation 3.815
Guselkumab 100 mg q4wChange 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 Score0.32 units on a scaleStandard Deviation 1.845
Guselkumab 100 mg q4wChange 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 Score0.81 units on a scaleStandard Deviation 4.532
Guselkumab 100 mg q4wChange 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 Score0.87 units on a scaleStandard Deviation 3.761
Guselkumab 100 mg q4wChange 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 Score0.53 units on a scaleStandard Deviation 2.436
Guselkumab 100 mg q4wChange 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 Score0.49 units on a scaleStandard Deviation 3.007
Guselkumab 100 mg q4wChange 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 Score0.34 units on a scaleStandard Deviation 1.608
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-s Erosion Score From Baseline to Week 1001.01 units on a scaleStandard Deviation 4.034
Guselkumab 100 mg q8wChange in Modified vdH-s Erosion Score From Baseline to Week 1001.01 units on a scaleStandard Deviation 3.355
Guselkumab 100 mg q4wChange in Modified vdH-s Erosion Score From Baseline to Week 1001.02 units on a scaleStandard Deviation 4.676
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-S Erosion Score From Week 24 to Week 520.17 units on a scaleStandard Deviation 1.277
Guselkumab 100 mg q8wChange in Modified vdH-S Erosion Score From Week 24 to Week 520.10 units on a scaleStandard Deviation 1.422
Guselkumab 100 mg q4wChange in Modified vdH-S Erosion Score From Week 24 to Week 520.39 units on a scaleStandard Deviation 1.725
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-s Erosion Score From Week 52 to Week 1000.09 units on a scaleStandard Deviation 1.978
Guselkumab 100 mg q8wChange in Modified vdH-s Erosion Score From Week 52 to Week 1000.26 units on a scaleStandard Deviation 1.751
Guselkumab 100 mg q4wChange in Modified vdH-s Erosion Score From Week 52 to Week 1000.45 units on a scaleStandard Deviation 2.9
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-s JSN Score From Baseline to Week 1000.49 units on a scaleStandard Deviation 2.984
Guselkumab 100 mg q8wChange in Modified vdH-s JSN Score From Baseline to Week 1000.50 units on a scaleStandard Deviation 1.387
Guselkumab 100 mg q4wChange in Modified vdH-s JSN Score From Baseline to Week 1000.66 units on a scaleStandard Deviation 2.722
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-S JSN Score From Week 24 to Week 520.07 units on a scaleStandard Deviation 0.635
Guselkumab 100 mg q8wChange in Modified vdH-S JSN Score From Week 24 to Week 520.13 units on a scaleStandard Deviation 0.705
Guselkumab 100 mg q4wChange in Modified vdH-S JSN Score From Week 24 to Week 520.23 units on a scaleStandard Deviation 1.088
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-s JSN Score From Week 52 to Week 1000.04 units on a scaleStandard Deviation 1.904
Guselkumab 100 mg q8wChange in Modified vdH-s JSN Score From Week 52 to Week 1000.20 units on a scaleStandard Deviation 0.917
Guselkumab 100 mg q4wChange in Modified vdH-s JSN Score From Week 52 to Week 1000.30 units on a scaleStandard Deviation 1.319
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Modified vdH-S Score From Baseline to Week 1001.49 units on a scaleStandard Deviation 6.859
Guselkumab 100 mg q8wChange in Modified vdH-S Score From Baseline to Week 1001.50 units on a scaleStandard Deviation 4.393
Guselkumab 100 mg q4wChange in Modified vdH-S Score From Baseline to Week 1001.68 units on a scaleStandard Deviation 7.018
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Total Modified vdH-S Score From Week 24 to Week 520.25 units on a scaleStandard Deviation 1.635
Guselkumab 100 mg q8wChange in Total Modified vdH-S Score From Week 24 to Week 520.23 units on a scaleStandard Deviation 1.808
Guselkumab 100 mg q4wChange in Total Modified vdH-S Score From Week 24 to Week 520.62 units on a scaleStandard Deviation 2.53
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wChange in Total Modified vdH-S Score From Week 52 to Week 1000.13 units on a scaleStandard Deviation 3.742
Guselkumab 100 mg q8wChange in Total Modified vdH-S Score From Week 52 to Week 1000.46 units on a scaleStandard Deviation 2.419
Guselkumab 100 mg q4wChange in Total Modified vdH-S Score From Week 52 to Week 1000.75 units on a scaleStandard Deviation 4.021
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 828.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2038.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1630.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 423.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 219.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2431.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1231.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1650.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 432.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 843.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1247.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2048.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2450.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 230.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2053.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 842.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 223.2 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2456.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1651.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1246.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 435.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement44.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement71.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement22.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement50.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement8.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement23.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement2.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement6.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement40.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement1.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement42.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement21.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement26.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement62.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement70.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement10.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement39.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement79.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement73.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement50.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement3.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement30.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement16.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement8.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=70% Improvement32.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement71.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement6.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement50.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=90% Improvement11.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=90% Improvement18.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=70% Improvement31.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=20% Improvement74.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=50% Improvement52.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=50% Improvement59.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement23.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=20% Improvement87.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 76: Participants with >=70% Improvement31.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 100: Participants with >=70% Improvement39.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement27.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 76: Participants with >=50% Improvement52.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement11.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 76: Participants with >=20% Improvement82.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 100: Participants with >=20% Improvement77.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 76: Participants with >=90% Improvement13.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement42.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 100: Participants with >=50% Improvement57.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 100: Participants with >=90% Improvement11.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement69.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=90% Improvement9.2 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=20% Improvement79.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=20% Improvement81.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=20% Improvement82.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=50% Improvement50.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=50% Improvement50.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=50% Improvement55.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=70% Improvement30.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=70% Improvement26.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 100: Participants with >=70% Improvement32.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 52: Participants with >=90% Improvement8.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 76: Participants with >=90% Improvement7.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=20% Improvement38.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=20% Improvement39.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement42.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=50% Improvement6.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=50% Improvement17.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement21.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=70% Improvement3.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=70% Improvement5.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement8.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=90% Improvement0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=90% Improvement1.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement2.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement1.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 8: Participants with >=20% Improvement46.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 8: Participants with >=70% Improvement11.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement20.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 16: Participants with >=20% Improvement58.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement38.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 16: Participants with >=90% Improvement0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement59.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 16: Participants with >=70% Improvement23.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 16: Participants with >=50% Improvement37.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 8: Participants with >=50% Improvement17.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 8: Participants with >=90% Improvement1.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=50% Improvement18.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=50% Improvement26.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=90% Improvement0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=50% Improvement37.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=70% Improvement4.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=70% Improvement9.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=90% Improvement2.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8: Participants with >=20% Improvement53.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 16: Participants with >=20% Improvement69.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=70% Improvement15.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=20% Improvement68.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 24: Participants with >=90% Improvement3.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 7670.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 5268.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 10072.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 5269.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 7669.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 10072.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 5268.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 10074.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100Week 7674.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 2449.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 5268.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 2463.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 5269.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 5268.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52Week 2462.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 1650.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 845.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 2445.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 1660.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 856.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 2460.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 851.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 2459.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24Week 1656.7 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2440.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2485.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5292.2 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2490.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5289.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7691.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10091.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7689.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5292.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10094.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5289.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10088.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7690.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1636.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 830.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2437.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1679.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 871.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2483.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 869.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2486.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1679.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 2432.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 5241.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 2440.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 5244.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 2436.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52Week 5238.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 7643.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 5242.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 10042.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 7644.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 5245.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 10046.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 5238.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 10043.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100Week 7643.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 1631.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 826.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 2430.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 2437.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 833.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 1642.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 1631.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 827.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24Week 2434.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 2442.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 5263.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 2463.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 5267.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 5265.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52Week 2458.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 7670.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 5263.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10072.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 7673.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 5266.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10070.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 5265.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 10068.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100Week 7665.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 1635.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 837.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 2440.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 1659.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 845.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 2460.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 841.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 2455.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24Week 1651.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 4450.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 3648.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2434.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2842.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5250.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 3658.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2452.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2858.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 4460.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5260.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5262.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 4461.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2458.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 3661.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2863.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7659.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 6857.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8458.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10063.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5251.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 8466.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10070.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5260.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 6864.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7668.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 6869.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7664.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 8465.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10070.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5263.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 4469.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 3668.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2434.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2848.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 5268.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 3677.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2466.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2871.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 4479.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 5279.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 5275.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 4476.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2466.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 3678.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52Week 2872.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 8480.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 7675.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 5268.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 6877.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 10079.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 7683.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 5278.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 6885.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 8485.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 10082.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 10084.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 8480.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 5277.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 7682.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100Week 6880.7 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 411.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1633.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1226.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 28.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2432.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2029.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 817.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1249.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 210.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 419.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 839.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1655.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2062.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2464.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1655.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 421.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2463.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 2058.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 1251.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 840.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 20 Response Through Week 24Week 210.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2415.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 4443.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 3639.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 5243.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2822.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 3644.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2432.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2841.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 4448.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 5251.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 5249.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 4448.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2434.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 3645.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52Week 2840.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 5244.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 8456.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 7650.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 10055.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 6849.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 7656.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 5250.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 6860.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 8463.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 10060.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 10062.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 8457.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 5249.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 7658.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100Week 6858.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 41.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 169.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 126.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 20.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2414.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2016.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 84.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 1219.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 21.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 44.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 810.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 1628.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2031.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2431.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 1620.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 43.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2433.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 2029.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 1216.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 811.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 50 Response Through Week 24Week 20.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 4420.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 3615.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 244.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 287.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 5219.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 3627.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 2419.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 2821.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 4429.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 5229.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 5228.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 4424.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 2413.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 3624.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52Week 2821.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 8429.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 7627.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 5219.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 6827.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 10034.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 7636.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 5229.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 6835.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 8442.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 10039.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 10038.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 8439.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 5228.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 7632.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100Week 6836.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 40.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 160.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 120.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 20 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 244.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 203.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 80.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 128.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 20 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 40.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 83.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 1613.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 2015.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 2418.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 168.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 40.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 2413.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 2013.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 124.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 82.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved ACR 70 Response Through Week 24Week 20 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 4430.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 3625.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 249.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 2813.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 5234.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 3636.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 2425.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 2827.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 4438.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 5239.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 5239.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 4438.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 2424.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 3639.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52Week 2830.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 8441.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 7643.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 5234.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 6839.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 10042.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 7644.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 5239.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 6844.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 8450.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 10047.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 10051.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 8448.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 5240.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 7643.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100Week 6849.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 42.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 166.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 126.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 20.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 248.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 209.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 80.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 1214.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 22.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 45.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 810.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 1618.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 2023.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 2424.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 1616.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 44.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 2423.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 2021.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 1211.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 89.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24Week 22.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 4491.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 3686.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2455.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2872.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 5289.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 3686.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2479.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2885.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 4491.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 5289.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 5289.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 4491.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2483.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 3692.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52Week 2885.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 5289.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 6892.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 7694.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 8494.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 10094.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 6892.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 8492.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 7690.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 10090.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 5289.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 10092.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 6892.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 5290.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 7693.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100Week 8492.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2452.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 221.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1251.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2050.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 838.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1651.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 432.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1669.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2075.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 438.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2475.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 856.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1267.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 223.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2480.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 440.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 854.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1265.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 1672.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 2076.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24Week 224.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2412.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5256.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2465.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5268.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2461.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5268.7 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7666.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5256.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10074.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7666.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5268.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10069.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5268.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10064.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7668.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1610.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 87.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2411.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1651.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 833.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2463.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 826.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2459.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1645.1 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved an ACR 50 Response at Week 2414.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved an ACR 50 Response at Week 2431.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved an ACR 50 Response at Week 2433.1 percentage of participants
p-value: <0.00195% CI: [10, 24.4]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [11.5, 26.1]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 1633.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 1655.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 1655.9 percentage of participants
p-value: <0.00195% CI: [13.1, 30]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [13.7, 30.7]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 169.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 1628.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 1620.8 percentage of participants
p-value: <0.00195% CI: [12.6, 25.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [5.2, 17.7]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 244.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 2418.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 2413.1 percentage of participants
p-value: <0.00195% CI: [9.1, 19.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [4.1, 13.8]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2419.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2472.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5277.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2471.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 248.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5266.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2451.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5260.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2452.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5266.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 4477.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 3678.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2446.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2864.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 5281.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 3682.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2476.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2879.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 4483.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 5286.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 5282.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 4482.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2472.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 3684.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52Week 2883.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 10086.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 6884.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 5281.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 7684.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 8487.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 7688.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 10089.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 8487.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 6889.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 5286.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 10088.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 6887.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 7690.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 8487.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100Week 5283.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 427.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1644.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1240.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 213.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2444.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2046.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 835.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1260.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 222.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 432.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 848.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1666.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2072.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2472.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1666.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 429.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2468.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 2069.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 1260.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 850.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24Week 218.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2411.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5259.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2458.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5273.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2459.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5269.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7671.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5259.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10073.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7675.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5273.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10076.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5270.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10077.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7676.7 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1610.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2411.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1648.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2456.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1648.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2457.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2415.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5270.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2466.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5279.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2463.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5276.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7678.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5270.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10078.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7679.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5279.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10081.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5276.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10078.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7682.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1613.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2415.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1656.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2465.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1654.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2460.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 246.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 5231.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 2426.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 5232.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 2419.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52Week 5236.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 7634.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 5232.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 10042.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 7640.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 5232.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 10044.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 5237.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 10042.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100Week 7639.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 163.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 246.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 1616.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 2425.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 1613.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24Week 2418.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 242.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5255.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2446.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5254.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2446.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5261.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7665.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5255.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10069.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7659.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5254.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10057.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5260.7 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10064.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7668.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 163.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 242.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 1627.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 2445.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 1633.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Achieved PASI 100 Response Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at BaselineWeek 2444.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5295.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2439.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2494.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5297.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2493.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5298.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7697.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5295.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10095.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7696.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5297.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10097.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5298.3 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10098.2 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7697.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2423.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5288.4 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2480.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5288.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2481.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5291.9 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7692.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5288.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10091.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7687.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5288.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10087.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5291.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10089.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7693.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1618.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2423.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1673.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2479.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1673.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2478.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2410.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5276.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2470.3 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5277.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2463.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5281.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7685.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5276.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10087.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7675.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5276.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10075.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5281.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10080.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7680.2 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 168.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 249.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1655.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2468.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1653.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2460.9 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 Baseline19.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 Baseline70.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 Baseline68.5 percentage of participants
p-value: <0.00195% CI: [42.2, 59.7]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [41.2, 58.4]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 5291.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 5290.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 5288.5 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 2492.0 percentage of participants
Guselkumab 100 mg q8wPercentage 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 2488.6 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 5294.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 5290.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 5293.0 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 2491.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 2486.8 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 5281.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 5281.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 5283.8 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 2487.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 2479.2 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 5265.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 5280.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 5271.9 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 2482.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 2475.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0 from Baseline66.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0.5 from Baseline72.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0 from Baseline66.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0.5 from Baseline76.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0 from Baseline71.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 24Change of <=0.5 from Baseline80.2 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0 from Baseline78.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0.5 from Baseline85.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0 from Baseline78.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0.5 from Baseline88.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0 from Baseline80.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 From Baseline and <=0.5 From Baseline in Modified vdH-S JSN Score at Week 24Change of <=0.5 from Baseline88.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0 from Baseline58.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0.5 from Baseline70.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0 from Baseline59.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0.5 from Baseline71.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0 from Baseline60.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52Change of <=0.5 from Baseline72.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0 from Baseline78.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0.5 from Baseline88.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0 from Baseline75.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0.5 from Baseline86.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0 from Baseline79.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52Change of <=0.5 from Baseline86.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0 from Baseline64.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0.5 from Baseline72.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0 from Baseline63.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0.5 from Baseline74.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0 from Baseline67.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24Change of <=0.5 from Baseline78.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0 from Baseline57.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0.5 from Baseline67.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0 from Baseline55.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0.5 from Baseline67.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0 from Baseline56.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52Change of <=0.5 from Baseline72.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0 from Baseline64.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0.5 from Baseline75.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0 from Baseline61.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0.5 from Baseline73.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0 from Baseline65.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion ScoreChange of <=0.5 from Baseline75.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0 from Baseline77.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0.5 from Baseline84.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0 from Baseline68.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0.5 from Baseline79.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0 from Baseline73.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN ScoreChange of <=0.5 from Baseline81.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0 from Baseline60.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0.5 from Baseline72.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0 from Baseline55.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0.5 from Baseline63.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0 from Baseline62.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S ScoreChange of <=0.5 from Baseline72.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7685.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10088.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7677.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5276.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10076.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5284.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10082.4 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7686.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7672.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5266.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10076.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 7664.2 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 5259.8 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 10058.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 5265.9 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 10067.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 7672.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 166.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 BaselineWeek 247.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 1638.6 percentage of participants
Guselkumab 100 mg q8wPercentage 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 BaselineWeek 2450.0 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 1640.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 BaselineWeek 2451.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 52Week 247.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 52Week 5234.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 52Week 2429.5 percentage of participants
Guselkumab 100 mg q8wPercentage 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 52Week 5243.2 percentage of participants
Guselkumab 100 mg q4wPercentage 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 52Week 2427.6 percentage of participants
Guselkumab 100 mg q4wPercentage 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 52Week 5243.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage 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 100Week 7645.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 100Week 5235.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage 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 100Week 10048.1 percentage of participants
Guselkumab 100 mg q8wPercentage 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 100Week 7648.9 percentage of participants
Guselkumab 100 mg q8wPercentage 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 100Week 5242.7 percentage of participants
Guselkumab 100 mg q8wPercentage 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 100Week 10051.1 percentage of participants
Guselkumab 100 mg q4wPercentage 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 100Week 5243.8 percentage of participants
Guselkumab 100 mg q4wPercentage 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 100Week 10054.5 percentage of participants
Guselkumab 100 mg q4wPercentage 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 100Week 7649.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 10067.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 5256.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 7664.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 7663.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 10071.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 5261.2 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 5260.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 10068.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100Week 7668.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 2415.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 5256.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 2448.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 5261.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 2443.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52Week 5260.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Remission15.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Low Disease Activity50.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Remission10.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Low Disease Activity54.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Low Disease Activity58.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Remission16.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Low Disease Activity60.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Remission17.8 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Low Disease Activity61.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Remission18.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Low Disease Activity65.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Remission26.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Low Disease Activity55.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Low Disease Activity61.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Remission28.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Remission19.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Remission26.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Low Disease Activity66.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Low Disease Activity64.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Remission23.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Low Disease Activity63.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 68: Remission23.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Low Disease Activity61.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 76: Remission19.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Low Disease Activity68.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Low Disease Activity64.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 100: Remission23.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Low Disease Activity55.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 52: Remission17.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100Week 84: Remission23.6 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Low39.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Low52.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Very Low19.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Low55.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Very Low18.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Very Low13.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Very Low23.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Very Low22.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Very Low26.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Low50.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Low44.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Low54.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Very Low23.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Low46.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 52: Very Low16.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Low49.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 76: Very Low22.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100Week 100: Low57.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 248.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 5238.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 2431.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 5245.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 2424.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52Week 5246.3 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 10086.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 10087.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 10088.6 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 2484.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 2489.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 2489.9 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 5282.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 5284.3 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 5287.3 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 5291.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 5291.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 5290.4 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 10090.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 10089.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 10088.2 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 2491.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 2493.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 2491.7 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 10086.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 10084.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 10087.2 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 5280.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 5282.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 5285.2 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 2486.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 2487.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 2489.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Baseline4.5 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Week 244.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Baseline3.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Week 243.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Baseline3.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24Week 243.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Baseline6.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Week 527.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Week 525.1 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Baseline4.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Baseline6.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52Week 527.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 524.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Baseline3.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 1004.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 243.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 524.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 243.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 1004.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Baseline3.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 1003.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Baseline3.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 244.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100Week 523.6 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline42.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline59.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline63.5 percentage of participants
p-value: 0.0395% CI: [7.4, 28.6]Cochran-Mantel-Haenszel
p-value: 0.01195% CI: [10.5, 32]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 2441.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 5278.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 2460.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 5281.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 2468.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at BaselineWeek 5281.1 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 10083.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 5278.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 7680.2 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 7684.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 5281.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 10091.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 5280.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 10082.9 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at BaselineWeek 7682.4 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 2438.4 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 212.1 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 418.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 829.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 1636.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 830.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 1645.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 213.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 2456.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 419.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 1652.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 420.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 831.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 2463.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at BaselineWeek 213.2 percentage of participants
Secondary

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.

ArmMeasureValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline29.4 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline49.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline44.9 percentage of participants
p-value: 0.0395% CI: [11.8, 28.5]Cochran-Mantel-Haenszel
p-value: 0.0395% CI: [6.4, 22.7]Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 2432.6 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 5267.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 2457.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 5265.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 2445.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at BaselineWeek 5260.0 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 10075.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 5267.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 7672.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 7671.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 10077.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 5266.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 5261.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 10067.7 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at BaselineWeek 7667.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 1630.9 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 824.7 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 216.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 418.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 2430.3 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 831.0 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 217.7 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 421.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 1647.5 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 2453.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 2443.5 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 1640.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 217.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 827.6 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at BaselineWeek 425.3 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 241.3 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 526.9 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 244.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 5217.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 245.1 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52Week 5212.2 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Placebo to Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 527.0 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 7612.2 percentage of participants
Placebo to Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 10014.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 10018.8 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 7619.6 percentage of participants
Guselkumab 100 mg q8wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 5216.8 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 5212.4 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 10015.0 percentage of participants
Guselkumab 100 mg q4wPercentage of Participants With VLDA at Weeks 52, 76 and 100Week 7614.8 percentage of participants
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-71.05 percent changeStandard Deviation 25.056
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-35.65 percent changeStandard Deviation 43.207
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-81.85 percent changeStandard Deviation 26.328
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-68.32 percent changeStandard Deviation 25.56
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-37.45 percent changeStandard Deviation 43.534
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-62.21 percent changeStandard Deviation 34.292
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-64.57 percent changeStandard Deviation 25.695
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-38.23 percent changeStandard Deviation 47.43
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-0.25 percent changeStandard Deviation 208.267
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-49.72 percent changeStandard Deviation 30.129
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-13.78 percent changeStandard Deviation 45.943
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP19.81 percent changeStandard Deviation 150.274
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-36.13 percent changeStandard Deviation 33.383
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-23.78 percent changeStandard Deviation 40.895
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-82.34 percent changeStandard Deviation 30.494
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-39.34 percent changeStandard Deviation 44.933
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-38.82 percent changeStandard Deviation 37.114
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-8.33 percent changeStandard Deviation 143.843
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-38.45 percent changeStandard Deviation 43.993
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-26.83 percent changeStandard Deviation 54.38
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-32.53 percent changeStandard Deviation 44.85
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-66.15 percent changeStandard Deviation 37.305
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-53.44 percent changeStandard Deviation 45.655
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-27.01 percent changeStandard Deviation 49.683
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-65.88 percent changeStandard Deviation 33.344
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-6.70 percent changeStandard Deviation 183.299
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-23.34 percent changeStandard Deviation 46.393
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-67.29 percent changeStandard Deviation 35.583
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-80.38 percent changeStandard Deviation 28.144
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-15.66 percent changeStandard Deviation 49.522
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-11.52 percent changeStandard Deviation 48.647
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-45.52 percent changeStandard Deviation 41.132
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-6.86 percent changeStandard Deviation 54.753
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-22.20 percent changeStandard Deviation 42.404
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP-0.80 percent changeStandard Deviation 155.637
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP-26.90 percent changeStandard Deviation 110.466
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-62.48 percent changeStandard Deviation 32.82
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-72.06 percent changeStandard Deviation 33.971
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-78.02 percent changeStandard Deviation 30.197
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-82.82 percent changeStandard Deviation 26.054
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-82.10 percent changeStandard Deviation 27.742
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-83.18 percent changeStandard Deviation 30.121
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-54.81 percent changeStandard Deviation 37.134
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-66.12 percent changeStandard Deviation 32.829
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-70.90 percent changeStandard Deviation 29.688
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-70.29 percent changeStandard Deviation 31.985
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-38.44 percent changeStandard Deviation 40.734
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-42.17 percent changeStandard Deviation 41.66
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-45.89 percent changeStandard Deviation 40.125
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-46.48 percent changeStandard Deviation 41.725
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-49.00 percent changeStandard Deviation 39.082
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-37.18 percent changeStandard Deviation 38.628
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-39.92 percent changeStandard Deviation 40.228
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-44.21 percent changeStandard Deviation 36.982
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-46.64 percent changeStandard Deviation 38.228
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-48.73 percent changeStandard Deviation 38.925
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-57.60 percent changeStandard Deviation 32.634
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-62.89 percent changeStandard Deviation 28.027
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-67.98 percent changeStandard Deviation 25.989
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-69.79 percent changeStandard Deviation 26.949
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-73.09 percent changeStandard Deviation 24.133
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-25.47 percent changeStandard Deviation 63.639
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-28.82 percent changeStandard Deviation 73.93
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-31.95 percent changeStandard Deviation 78.348
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-33.84 percent changeStandard Deviation 60.164
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-33.49 percent changeStandard Deviation 63.823
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP-21.09 percent changeStandard Deviation 144.287
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-25.47 percent changeStandard Deviation 157.839
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-37.54 percent changeStandard Deviation 76.302
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-23.15 percent changeStandard Deviation 104.461
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: CRP-17.44 percent changeStandard Deviation 127.594
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PGA of Disease Activity-70.27 percent changeStandard Deviation 24.516
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Patient's Assessment of Pain-41.02 percent changeStandard Deviation 39.624
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: CRP15.69 percent changeStandard Deviation 468.613
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PGA of Disease Activity-72.46 percent changeStandard Deviation 24.485
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Patient's Assessment of Pain-36.64 percent changeStandard Deviation 38.086
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Swollen Joint Count-78.85 percent changeStandard Deviation 28.109
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: HAQ-DI score-33.72 percent changeStandard Deviation 51.766
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Tender Joint Count-69.82 percent changeStandard Deviation 32.122
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Swollen Joint Count-73.17 percent changeStandard Deviation 30.614
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: HAQ-DI score-33.91 percent changeStandard Deviation 59.31
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Tender Joint Count-72.10 percent changeStandard Deviation 27.67
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: CRP-23.97 percent changeStandard Deviation 104.641
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: HAQ-DI score-37.74 percent changeStandard Deviation 56.329
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Tender Joint Count-68.50 percent changeStandard Deviation 30
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: Tender Joint Count-64.31 percent changeStandard Deviation 31.767
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: HAQ-DI score-32.45 percent changeStandard Deviation 72.337
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Swollen Joint Count-84.07 percent changeStandard Deviation 24.07
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: CRP-0.99 percent changeStandard Deviation 193.429
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PtGA of Disease Activity-45.52 percent changeStandard Deviation 38.659
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: HAQ-DI score-35.02 percent changeStandard Deviation 65.765
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: PtGA of Disease Activity-42.45 percent changeStandard Deviation 39.243
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PtGA of Disease Activity-40.70 percent changeStandard Deviation 36.587
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Swollen Joint Count-83.32 percent changeStandard Deviation 24.289
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: PtGA of Disease Activity-45.50 percent changeStandard Deviation 40.653
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PtGA of Disease Activity-33.90 percent changeStandard Deviation 51.672
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: Tender Joint Count-57.11 percent changeStandard Deviation 35.073
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: PGA of Disease Activity-59.06 percent changeStandard Deviation 28.137
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 52: Patient's Assessment of Pain-43.51 percent changeStandard Deviation 45.742
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 24: CRP-28.35 percent changeStandard Deviation 88.038
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 28: PGA of Disease Activity-64.14 percent changeStandard Deviation 25.784
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 44: Patient's Assessment of Pain-43.60 percent changeStandard Deviation 42.56
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Swollen Joint Count-81.49 percent changeStandard Deviation 27.338
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: PGA of Disease Activity-67.74 percent changeStandard Deviation 28.029
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52Week 36: Patient's Assessment of Pain-43.29 percent changeStandard Deviation 44.442
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PGA of Disease Activity-31.11 percent changeStandard Deviation 32.023
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Patient's Assessment of Pain-6.76 percent changeStandard Deviation 34.213
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Swollen Joint Count-54.2 percent changeStandard Deviation 41.7
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PGA of Disease Activity-27.63 percent changeStandard Deviation 32.379
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Patient's Assessment of Pain-9.01 percent changeStandard Deviation 36.061
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: CRP42.282 percent changeStandard Deviation 284.133
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PGA of Disease Activity-23.29 percent changeStandard Deviation 28.416
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Patient's Assessment of Pain(0-10cm)-9.70 percent changeStandard Deviation 41.673
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: CRP28.042 percent changeStandard Deviation 208.6385
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PGA of Disease Activity-16.63 percent changeStandard Deviation 27.573
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Patient's Assessment of Pain-10.85 percent changeStandard Deviation 46.497
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Swollen Joint Count-53.9 percent changeStandard Deviation 45.54
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PGA of Disease Activity-9.79 percent changeStandard Deviation 25.687
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Patient's Assessment of Pain-11.84 percent changeStandard Deviation 48.324
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Swollen Joint Count-37.4 percent changeStandard Deviation 39.03
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PtGA of Disease Activity-13.87 percent changeStandard Deviation 45.65
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PtGA of Disease Activity-1.12 percent changeStandard Deviation 35.882
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: CRP86.677 percent changeStandard Deviation 645.0281
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PtGA of Disease Activity-12.52 percent changeStandard Deviation 42.498
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PtGA of Disease Activity-2.27 percent changeStandard Deviation 34.291
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Tender Joint Count-9.4 percent changeStandard Deviation 25.99
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PtGA of Disease Activity-12.34 percent changeStandard Deviation 39.207
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PtGA of Disease Activity-6.51 percent changeStandard Deviation 35.908
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: CRP19.263 percent changeStandard Deviation 149.512
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PtGA of Disease Activity-9.30 percent changeStandard Deviation 37.185
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: HAQ-DI Score-6.7995 percent changeStandard Deviation 54.78602
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Tender Joint Count-14.1 percent changeStandard Deviation 36.04
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: CRP28.595 percent changeStandard Deviation 237.666
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: HAQ-DI Score-10.4296 percent changeStandard Deviation 50.87958
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Tender Joint Count-21.9 percent changeStandard Deviation 37.83
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Swollen Joint Count-46.1 percent changeStandard Deviation 41.2
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: HAQ-DI Score-7.1776 percent changeStandard Deviation 48.33253
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Tender Joint Count-30.4 percent changeStandard Deviation 37.57
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Swollen Joint Count-27.1 percent changeStandard Deviation 37.29
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: HAQ-DI Score-8.0811 percent changeStandard Deviation 46.90093
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Tender Joint Count-30.6 percent changeStandard Deviation 41.87
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: HAQ-DI Score-5.0965 percent changeStandard Deviation 39.89566
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: HAQ-DI Score-2.8744 percent changeStandard Deviation 46.90795
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Tender Joint Count-33.9 percent changeStandard Deviation 44.22
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: CRP47.034 percent changeStandard Deviation 313.9875
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: HAQ-DI Score-0.3191 percent changeStandard Deviation 36.62364
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Tender Joint Count-33.3 percent changeStandard Deviation 44.87
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Swollen Joint Count-48.6 percent changeStandard Deviation 43.01
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PGA of Disease Activity-36.59 percent changeStandard Deviation 33.74
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Patient's Assessment of Pain0.05 percent changeStandard Deviation 35.794
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Swollen Joint Count-18.9 percent changeStandard Deviation 32.16
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PGA of Disease Activity-34.13 percent changeStandard Deviation 36.576
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Patient's Assessment of Pain-0.64 percent changeStandard Deviation 35.849
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: CRP45.451 percent changeStandard Deviation 322.4433
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Tender Joint Count-47.0 percent changeStandard Deviation 40.96
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: CRP-13.551 percent changeStandard Deviation 193.3814
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Swollen Joint Count-18.8 percent changeStandard Deviation 39.68
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Swollen Joint Count-30.5 percent changeStandard Deviation 36.92
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Swollen Joint Count-46.8 percent changeStandard Deviation 40.68
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Swollen Joint Count-57.6 percent changeStandard Deviation 39.22
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Swollen Joint Count-64.1 percent changeStandard Deviation 35.46
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Swollen Joint Count-69.3 percent changeStandard Deviation 33.63
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Swollen Joint Count-71.3 percent changeStandard Deviation 34.06
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Tender Joint Count-10.4 percent changeStandard Deviation 40.31
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Tender Joint Count-15.0 percent changeStandard Deviation 41.57
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Tender Joint Count-31.0 percent changeStandard Deviation 42.36
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Tender Joint Count-40.9 percent changeStandard Deviation 42.73
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Tender Joint Count-53.9 percent changeStandard Deviation 37.83
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Tender Joint Count-54.2 percent changeStandard Deviation 37.15
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Patient's Assessment of Pain-8.92 percent changeStandard Deviation 32.374
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Patient's Assessment of Pain-12.58 percent changeStandard Deviation 33.065
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Patient's Assessment of Pain-21.61 percent changeStandard Deviation 36.705
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Patient's Assessment of Pain-26.26 percent changeStandard Deviation 40.223
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Patient's Assessment of Pain(0-10cm)-31.94 percent changeStandard Deviation 42.882
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Patient's Assessment of Pain-35.16 percent changeStandard Deviation 39.471
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Patient's Assessment of Pain-38.06 percent changeStandard Deviation 40.565
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PtGA of Disease Activity-10.15 percent changeStandard Deviation 31.06
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PtGA of Disease Activity-12.71 percent changeStandard Deviation 34.44
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PtGA of Disease Activity-21.58 percent changeStandard Deviation 33.697
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PtGA of Disease Activity-27.86 percent changeStandard Deviation 38.9
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PtGA of Disease Activity-32.25 percent changeStandard Deviation 40.056
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PtGA of Disease Activity-35.31 percent changeStandard Deviation 36.205
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PtGA of Disease Activity-37.05 percent changeStandard Deviation 38.372
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PGA of Disease Activity-15.06 percent changeStandard Deviation 27.15
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PGA of Disease Activity-23.72 percent changeStandard Deviation 27.658
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PGA of Disease Activity-36.54 percent changeStandard Deviation 31.224
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PGA of Disease Activity-46.54 percent changeStandard Deviation 30.489
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PGA of Disease Activity-52.02 percent changeStandard Deviation 31.915
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PGA of Disease Activity-54.32 percent changeStandard Deviation 30.941
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PGA of Disease Activity-57.22 percent changeStandard Deviation 32.48
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: HAQ-DI Score-6.3577 percent changeStandard Deviation 50.8198
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: HAQ-DI Score-9.1272 percent changeStandard Deviation 53.41051
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: HAQ-DI Score-12.7684 percent changeStandard Deviation 67.23239
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: HAQ-DI Score-18.0336 percent changeStandard Deviation 66.96524
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: HAQ-DI Score-19.3627 percent changeStandard Deviation 70.83578
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: HAQ-DI Score-24.9496 percent changeStandard Deviation 64.8682
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: HAQ-DI Score-25.2578 percent changeStandard Deviation 63.1545
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: CRP0.935 percent changeStandard Deviation 91.3783
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: CRP-16.885 percent changeStandard Deviation 79.3501
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: CRP-11.214 percent changeStandard Deviation 150.1689
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: CRP-25.620 percent changeStandard Deviation 97.1384
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: CRP-19.874 percent changeStandard Deviation 134.521
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: CRP-27.470 percent changeStandard Deviation 109.5239
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Patient's Assessment of Pain-7.96 percent changeStandard Deviation 37.958
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Swollen Joint Count-71.4 percent changeStandard Deviation 30.42
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PGA of Disease Activity-49.18 percent changeStandard Deviation 31.383
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Patient's Assessment of Pain-4.66 percent changeStandard Deviation 32.229
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Swollen Joint Count-33.6 percent changeStandard Deviation 37.57
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PGA of Disease Activity-54.59 percent changeStandard Deviation 29.336
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Tender Joint Count-57.3 percent changeStandard Deviation 34.98
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: CRP1.128 percent changeStandard Deviation 168.9301
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PGA of Disease Activity-58.70 percent changeStandard Deviation 28.255
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Tender Joint Count-54.2 percent changeStandard Deviation 35.43
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Swollen Joint Count-63.7 percent changeStandard Deviation 34.42
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: HAQ-DI Score-0.2385 percent changeStandard Deviation 57.44896
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Tender Joint Count-48.1 percent changeStandard Deviation 37.01
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: CRP-28.701 percent changeStandard Deviation 83.0912
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: HAQ-DI Score-5.1209 percent changeStandard Deviation 85.16625
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: CRP-17.474 percent changeStandard Deviation 112.3803
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Swollen Joint Count-58.3 percent changeStandard Deviation 35.42
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: HAQ-DI Score-9.8081 percent changeStandard Deviation 86.78973
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Tender Joint Count-43.0 percent changeStandard Deviation 35.9
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Swollen Joint Count-18.5 percent changeStandard Deviation 38.38
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: HAQ-DI Score-17.7758 percent changeStandard Deviation 67.44643
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Tender Joint Count-33.8 percent changeStandard Deviation 37.58
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: CRP-22.277 percent changeStandard Deviation 122.3489
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: HAQ-DI Score-26.6732 percent changeStandard Deviation 53.14973
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: Tender Joint Count-22.6 percent changeStandard Deviation 32.91
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PtGA of Disease Activity-19.13 percent changeStandard Deviation 40.545
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Swollen Joint Count-46.7 percent changeStandard Deviation 37.69
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PtGA of Disease Activity-28.33 percent changeStandard Deviation 34.058
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PtGA of Disease Activity-11.02 percent changeStandard Deviation 33.605
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: HAQ-DI Score-28.9317 percent changeStandard Deviation 60.67279
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: PtGA of Disease Activity-28.60 percent changeStandard Deviation 39.759
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PtGA of Disease Activity-5.25 percent changeStandard Deviation 32.658
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: Tender Joint Count-14.8 percent changeStandard Deviation 28.31
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: PtGA of Disease Activity-35.11 percent changeStandard Deviation 37.791
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Patient's Assessment of Pain-36.52 percent changeStandard Deviation 38.423
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: CRP-28.125 percent changeStandard Deviation 87.7229
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: PtGA of Disease Activity-34.13 percent changeStandard Deviation 51.445
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 20: Patient's Assessment of Pain-35.35 percent changeStandard Deviation 39.016
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: HAQ-DI Score-33.8837 percent changeStandard Deviation 51.59441
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: PGA of Disease Activity-13.85 percent changeStandard Deviation 23.307
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: Patient's Assessment of Pain(0-10cm)-27.85 percent changeStandard Deviation 38.913
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 24: Swollen Joint Count-73.1 percent changeStandard Deviation 30.67
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 4: PGA of Disease Activity-22.32 percent changeStandard Deviation 28.183
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: Patient's Assessment of Pain-25.91 percent changeStandard Deviation 37.862
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 16: CRP-26.592 percent changeStandard Deviation 86.8465
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: PGA of Disease Activity-37.99 percent changeStandard Deviation 29.97
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 8: Patient's Assessment of Pain-17.05 percent changeStandard Deviation 44.783
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 2: CRP10.664 percent changeStandard Deviation 132.5947
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24Week 12: PGA of Disease Activity-42.84 percent changeStandard Deviation 31.305
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-44.91 percent changeStandard Deviation 44.371
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-87.72 percent changeStandard Deviation 22.243
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-77.68 percent changeStandard Deviation 23.015
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-46.02 percent changeStandard Deviation 44.989
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-4.33 percent changeStandard Deviation 196.246
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-74.76 percent changeStandard Deviation 23.29
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-49.64 percent changeStandard Deviation 40.991
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-87.61 percent changeStandard Deviation 21.214
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-71.24 percent changeStandard Deviation 24.771
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-50.82 percent changeStandard Deviation 42.97
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP-10.76 percent changeStandard Deviation 226.332
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-48.17 percent changeStandard Deviation 44.804
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-39.70 percent changeStandard Deviation 44.981
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-40.36 percent changeStandard Deviation 44.407
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-49.38 percent changeStandard Deviation 42.315
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-42.93 percent changeStandard Deviation 44.22
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-67.29 percent changeStandard Deviation 35.725
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-46.42 percent changeStandard Deviation 45.106
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-87.41 percent changeStandard Deviation 24.049
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-36.73 percent changeStandard Deviation 47.541
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-74.28 percent changeStandard Deviation 29.764
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-0.72 percent changeStandard Deviation 387.986
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-34.38 percent changeStandard Deviation 47.311
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-75.71 percent changeStandard Deviation 27.653
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-1.68 percent changeStandard Deviation 330.574
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-33.34 percent changeStandard Deviation 49.027
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-77.21 percent changeStandard Deviation 27.045
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-87.98 percent changeStandard Deviation 20.617
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-27.27 percent changeStandard Deviation 54.587
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-77.04 percent changeStandard Deviation 27.51
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-82.64 percent changeStandard Deviation 30.161
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-78.11 percent changeStandard Deviation 24.049
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-39.52 percent changeStandard Deviation 44.939
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-2.67 percent changeStandard Deviation 205.761
Placebo to Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-75.77 percent changeStandard Deviation 23.674
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-33.28 percent changeStandard Deviation 64.067
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-83.03 percent changeStandard Deviation 30.21
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-86.08 percent changeStandard Deviation 29.764
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-86.05 percent changeStandard Deviation 21.096
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-87.68 percent changeStandard Deviation 23.304
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-86.19 percent changeStandard Deviation 40.865
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-70.18 percent changeStandard Deviation 32.062
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-75.63 percent changeStandard Deviation 29.437
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-74.71 percent changeStandard Deviation 29.728
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-78.01 percent changeStandard Deviation 26.112
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-75.96 percent changeStandard Deviation 32.6
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-48.81 percent changeStandard Deviation 39.191
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-55.77 percent changeStandard Deviation 38.78
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-54.38 percent changeStandard Deviation 39.135
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-55.28 percent changeStandard Deviation 40.388
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-56.36 percent changeStandard Deviation 41.31
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-48.48 percent changeStandard Deviation 38.982
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-53.84 percent changeStandard Deviation 35.096
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-54.41 percent changeStandard Deviation 35.276
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-54.17 percent changeStandard Deviation 37.132
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-55.08 percent changeStandard Deviation 37.052
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-72.95 percent changeStandard Deviation 24.168
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-76.00 percent changeStandard Deviation 22.55
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-74.42 percent changeStandard Deviation 25.014
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-76.77 percent changeStandard Deviation 24.433
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-77.15 percent changeStandard Deviation 23.217
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-37.47 percent changeStandard Deviation 57.37
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-40.08 percent changeStandard Deviation 58.932
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-40.10 percent changeStandard Deviation 58.703
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-42.84 percent changeStandard Deviation 54.187
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-23.41 percent changeStandard Deviation 104.622
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-28.38 percent changeStandard Deviation 138.159
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP7.85 percent changeStandard Deviation 502.17
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-26.87 percent changeStandard Deviation 114.471
Guselkumab 100 mg q8wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-23.99 percent changeStandard Deviation 150.816
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PGA of Disease Activity-75.56 percent changeStandard Deviation 23.613
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Patient's Assessment of Pain-43.86 percent changeStandard Deviation 45.891
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: CRP-1.34 percent changeStandard Deviation 194.673
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PGA of Disease Activity-76.49 percent changeStandard Deviation 24.355
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Tender Joint Count-76.21 percent changeStandard Deviation 27.345
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Swollen Joint Count-86.41 percent changeStandard Deviation 22.642
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PGA of Disease Activity-77.82 percent changeStandard Deviation 22.733
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Tender Joint Count-75.45 percent changeStandard Deviation 32.489
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Swollen Joint Count-87.16 percent changeStandard Deviation 24.888
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: HAQ-DI score-35.17 percent changeStandard Deviation 66.105
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Tender Joint Count-75.11 percent changeStandard Deviation 28.559
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: CRP-13.91 percent changeStandard Deviation 174.522
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: HAQ-DI score-44.33 percent changeStandard Deviation 44.064
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Tender Joint Count-74.40 percent changeStandard Deviation 29.76
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Swollen Joint Count-84.27 percent changeStandard Deviation 23.698
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: HAQ-DI score-41.84 percent changeStandard Deviation 47.877
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: Tender Joint Count-70.54 percent changeStandard Deviation 31.311
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: CRP-19.89 percent changeStandard Deviation 131.695
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PtGA of Disease Activity-52.47 percent changeStandard Deviation 38.155
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: HAQ-DI score-43.18 percent changeStandard Deviation 52.116
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: PtGA of Disease Activity-50.66 percent changeStandard Deviation 40.992
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PtGA of Disease Activity-46.07 percent changeStandard Deviation 40.614
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Swollen Joint Count-86.31 percent changeStandard Deviation 24.106
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: PtGA of Disease Activity-51.86 percent changeStandard Deviation 44.532
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: Patient's Assessment of Pain-54.27 percent changeStandard Deviation 40.819
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: CRP-24.22 percent changeStandard Deviation 110.486
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: PtGA of Disease Activity-57.09 percent changeStandard Deviation 34.97
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 84: Patient's Assessment of Pain-52.59 percent changeStandard Deviation 43.131
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: HAQ-DI score-47.54 percent changeStandard Deviation 47.265
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 52: PGA of Disease Activity-72.58 percent changeStandard Deviation 24.579
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Patient's Assessment of Pain-51.34 percent changeStandard Deviation 41.903
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 76: Swollen Joint Count-85.82 percent changeStandard Deviation 22.291
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: PGA of Disease Activity-74.48 percent changeStandard Deviation 26.28
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 68: Patient's Assessment of Pain-52.43 percent changeStandard Deviation 41.186
Guselkumab 100 mg q4wPercent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100Week 100: CRP-14.35 percent changeStandard Deviation 171.666

Source: ClinicalTrials.gov · Data processed: Aug 3, 2026