Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

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.

Time frame: At Week 24

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

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 (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using Multiple Imputation (MI) after applying the Intercurrent Event (ICE) strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation.

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 (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses. Missing data were imputed using MI after applying the ICE strategies. N (overall number of participants analyzed) included all participants with change data at Week 24 after applying the ICE Strategy and Missing Data Imputation.

The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 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 (pre dose Week 0) and Week 24

Population: FAS included all participants who were randomized in the study and included in the analyses.

Number of participants with antibodies to guselkumab (ADA) were reported. A validated immunoassay was used to detect ADA.

Time frame: Baseline (pre dose Week 0) up to Week 24

Population: Immunogenicity analysis set included all participants who received at least one (complete or partial) administration of guselkumab and who had at least 1 sample obtained after their first administration of guselkumab.

Time frame: From first administration of study drug (Week 0) up to Week 112

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.

Time frame: At Week 16

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

ACR 50 response: \>=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 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.

Time frame: At Week 16

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

ACR 50 response: \>=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 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.

Time frame: At Week 24

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

ACR 70 response: \>=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 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.

Time frame: At Week 24

Population: Full analysis set (FAS) included all participants who were randomized in the study and included in the analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and greater than equal to (\>=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: At Week 24

Population: Full analysis set included all participants who were randomized in the study and included in the analyses among the participants who had \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

MDA is a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 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: At Week 24

Population: Full analysis set included all participants who were randomized in the study and were included in analyses. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

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: At Week 24

Population: Full analysis set included all participants who were randomized in the study and included in the analyses among the participants who had \>=3% BSA psoriatic involvement and an IGA score of \>=2 (mild) at baseline. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Time frame: From first administration of study drug (Week 0) up to Week 112

Time frame: From first administration of study drug (Week 0) up to Week 112

Time frame: From first administration of study drug (Week 0) up to Week 112

Time frame: From first administration of study drug (Week 0) up to Week 112

Time frame: From first administration of study drug (Week 0) up to Week 112

Time frame: From first administration of study drug (Week 0) up to Week 112

Population: Safety Analysis Set included all participants who received at least one (complete or partial) administration of any study intervention, i.e. the treated population.

Serum concentrations of guselkumab over time was reported.

Time frame: At Weeks 0, 4, 8, 12, 16, 20,and 24

Population: Pharmacokinetics (PK) analysis set all participants who received at least one complete administration of guselkumab and had at least one valid blood sample drawn for PK analysis. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Time frame: From first administration of study drug (Week 0) up to Week 112