Phase 3
Completed N=381
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT03162796 ↗
Enrolled (actual)
381
Serious AEs
3.3%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 — 22.2; 52.0; 59.4 percentage of participants — p=< 0.001
◆ Published Evidence
Established
53citations · ~27 / year
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis.
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.
Linked Publications (5)
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Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis.
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BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies.
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Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.
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Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials.
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Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 |
22.2; 52.0; 59.4 | < 0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 |
-0.0743; -0.3225; -0.3968 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 |
8.7; 29.9; 35.9 | < 0.001 sig |
| SECONDARY Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline |
15.4; 57.3; 75.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 |
25.4; 52.0; 60.2 | < 0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 |
-0.70; -1.43; -1.61 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24 |
5.6; 11.8; 20.3 | 0.069 |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 |
12.7; 22.8; 26.6 | 0.036 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 |
1.96; 6.10; 6.87 | < 0.001 sig |
| SECONDARY Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline |
27.3; 40.3; 47.9 | 0.094 |
| SECONDARY Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline |
-1.01; -1.35; -1.75 | 0.185 |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24 |
2.37; 3.20; 3.60 | 0.398 |
| SECONDARY Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline |
49.1; 65.3; 63.2 | 0.088 |
| SECONDARY Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline |
-4.30; -6.11; -5.82 | 0.121 |
| SECONDARY Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24 |
7.9; 15.7; 20.3; 18.3; 36.2; 39.1 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24 |
2.4; 1.6; 3.1; 7.9; 7.9; 10.9 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24 |
0; 0.8; 0; 1.6; 3.1; 2.3 | — |
| SECONDARY ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24 |
8.0; 7.7; 5.7; 6.6; 6.2; 4.4 | — |
| SECONDARY ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24 |
5.74; 5.49; 5.18; 5.06; 4.90; 4.54 | — |
| SECONDARY ACR Component- C-reactive Protein (CRP) Through Week 24 |
1.220; 1.159; 0.785; 1.184; 1.059; 0.720 | — |
| SECONDARY ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24 |
1.2188; 1.1371; 0.9824; 1.1331; 1.0188; 0.9150 | — |
| SECONDARY Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24 |
-22.4; -27.5; -29.3; -29.4; -45.3; -46.5 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24 |
0.0043; -0.0571; -0.1095; -0.0781; -0.1711; -0.1907 | — |
| SECONDARY Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline |
20.0; 26.8; 30.9; 25.5; 40.2; 38.2 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24 |
27.0; 33.1; 40.6; 35.7; 59.1; 54.7 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24 |
3.2; 7.9; 7.8; 7.9; 11.0; 11.7 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-0.35; -0.53; -0.56; -0.55; -0.83; -0.88 | — |
| SECONDARY Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24 |
20.6; 29.1; 33.6; 32.5; 56.7; 48.4 | — |
| SECONDARY Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline |
22.1; 18.1; 27.4; 23.4; 30.6; 30.1 | — |
| SECONDARY Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline |
-0.37; -0.45; -0.96; -0.65; -0.83; -1.11 | — |
| SECONDARY Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline |
41.8; 34.7; 31.6; 41.8; 40.8; 44.7 | — |
| SECONDARY Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline |
-2.77; -2.24; -2.63; -2.92; -4.00; -3.92 | — |
| SECONDARY Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24 |
-0.759; -1.315; -1.428; -0.980; -1.779; -2.083 | — |
| SECONDARY Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24 |
-0.918; -2.024; -2.368; -0.854; -2.368; -2.735 | — |
| SECONDARY Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24 |
-4.826; -7.815; -8.574; -8.776; -13.601; -13.231 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24 |
7.1; 15.7; 18.0; 11.1; 22.8; 30.5 | — |
| 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 |
26.1; 58.3; 55.0; 52.2; 75.0; 65.0 | — |
| SECONDARY Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline |
-0.595; -1.577; -1.976; -1.604; -2.419; -2.469 | — |
| SECONDARY Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24 |
4.0; 10.2; 14.8; 8.7; 22.0; 27.3 | — |
| SECONDARY Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24 |
10.3; 22.0; 28.9; 11.9; 30.7; 42.2 | — |
| SECONDARY Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24 |
1.6; 2.4; 0.8; 10.3; 8.7; 13.3 | — |
| SECONDARY Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24 |
2.4; 3.1; 3.1; 1.6; 3.9; 9.4 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline |
20.5; 63.4; 73.0; 14.1; 75.6; 86.5 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline |
10.3; 45.1; 52.8; 11.5; 50.0; 62.9 | — |
| SECONDARY Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline |
7.7; 23.2; 32.6; 6.4; 25.6; 44.9 | — |
| SECONDARY Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline |
6.4; 35.4; 48.3; 6.4; 40.2; 52.8 | — |
| SECONDARY Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline |
9.0; 48.8; 55.1; 5.1; 50.0; 62.9 | — |
| SECONDARY Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline |
9.0; 32.9; 40.4; 7.7; 37.8; 53.9 | — |
| 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 |
-2.910; -9.631; -10.096; -2.317; -9.974; -10.915 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24 |
2.15; 2.87; 4.46; 2.50; 5.26; 6.72 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24 |
1.99; 2.72; 2.46; 2.25; 2.61; 3.04 | — |
| SECONDARY Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 |
1.362; 2.616; 4.082; 1.901; 5.143; 6.190 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24 |
27.0; 33.9; 35.2; 31.0; 32.3; 39.8 | — |
| SECONDARY Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24 |
31.0; 33.9; 46.1; 29.4; 48.0; 50.0 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 |
2.356; 3.643; 3.576; 2.164; 4.853; 4.544 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24 |
35.7; 44.1; 43.8; 34.1; 50.4; 52.3 | — |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24 |
-1.98; -2.19; -1.83; -2.30; -3.08; -2.23 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 |
8.571; 9.242; 6.684; 0.316; 1.984; 3.635 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24 |
67.9; 68.2; 73.7; 25.5; 37.7; 48.1 | — |
| SECONDARY Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 |
41.3; 41.7; 39.1; -34.9; 42.5; 41.4 | — |
| SECONDARY Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24 |
33.3; 37.0; 29.7; 29.4; 34.6; 33.6 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 |
27.2; 54.5; 60.8; 50.0; 68.9; 74.4 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 |
9.6; 30.9; 36.8; 21.4; 42.6; 39.2 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 |
6.1; 12.2; 20.8; 9.8; 20.5; 24.8 | — |
| SECONDARY Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 |
-48.33; -66.62; -73.23; -59.95; -75.42; -80.93 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 |
-0.1217; -0.3374; -0.3740; -0.2241; -0.4004; -0.3850 | — |
| 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 |
36.0; 53.2; 57.8; 40.2; 61.5; 61.5 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 |
-0.84; -1.49; -1.57; -1.33; -1.71; -1.67 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 |
51.8; 74.6; 78.4; 73.6; 83.3; 83.9 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 |
14.9; 24.6; 36.8; 26.4; 37.5; 38.7 | — |
| 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 |
84.9; 87.3 | — |
| SECONDARY Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 |
37.2; 63.1; 74.4; 64.9; 78.7; 82.3 | — |
| SECONDARY Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 |
-12.962; -23.373; -20.530; -18.632; -26.790; -22.766 | — |
| 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 at Baseline |
8.8; 50.6; 63.6; 69.2; 70.7; 79.5 | — |
| 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 at Baseline |
10.3; 40.7; 53.4; 64.6; 58.7; 73.9 | — |
| SECONDARY Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline |
-3.046; -9.968; -11.614; -10.565; -10.431; -11.988 | — |
| 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 at Baseline |
20.6; 76.5; 87.5; 84.8; 80.0; 94.3 | — |
| 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 at Baseline |
13.2; 50.6; 63.6; 72.7; 66.7; 76.1 | — |
| 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 at Baseline |
7.4; 25.9; 45.5; 62.1; 48.0; 64.8 | — |
| SECONDARY Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52 |
35.1; 53.7; 55.6; 44.9; 53.8; 55.0 | — |
| SECONDARY Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52 |
29.8; 39.0; 44.4; 39.3; 39.5; 49.2 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 |
12.3; 23.6; 31.2; 31.1; 33.9; 40.3 | — |
| SECONDARY Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 |
-0.998; -2.493; -2.751; -2.829; -3.112; -3.364 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 |
-1.140; -2.246; -2.413; -2.748; -2.897; -3.026 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 |
88.5; 90.8 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 |
83.8; 91.3 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 |
80.0; 84.6 | — |
| SECONDARY Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA |
38.1; 70.8; 65.0; 66.7; 72.7; 85.0 | — |
| SECONDARY Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline |
31.0; 40.8; 49.3; 49.3; 52.9; 58.0 | — |
| SECONDARY Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline |
61.7; 67.3; 64.9; 79.5; 67.4; 82.9 | — |
| SECONDARY Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline |
-1.9; -2.7; -3.0; -3.1; -3.4; -3.6 | — |
| SECONDARY Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline |
-1.0; -1.2; -1.8; -1.4; -1.3; -2.0 | — |
| SECONDARY Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline |
-4.0; -6.2; -6.6; -6.0; -6.4; -7.7 | — |
| SECONDARY Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline |
8.8; 38.3; 54.5; 66.2; 53.3; 67.0 | — |
| SECONDARY Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52 |
2.700; 6.505; 6.560; 5.456; 7.439; 7.162 | — |
| SECONDARY Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52 |
1.827; 3.027; 3.796; 3.612; 4.300; 4.326 | — |
| SECONDARY Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52 |
1.914; 6.006; 6.652; 5.008; 6.900; 7.114 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52 |
2.605; 5.862; 5.576; 5.981; 7.252; 5.917 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52 |
41.2; 55.3; 64.8; 60.7; 58.0; 66.1 | — |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52 |
-1.482; -3.680; -3.115; -2.410; -3.929; -2.961 | — |
Eligibility Criteria
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 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 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
- 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 drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
- Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation
Exclusion Criteria
- Has other inflammatory diseases that might confound the evaluations of 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 ever received more than 2 anti-TNFalpha agents
- Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
- Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
- Has received apremilast within 4 weeks prior to the first administration of study agent
- Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
Data sourced from ClinicalTrials.gov (NCT03162796) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.