Phase 3
Completed N=739
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT03158285 ↗
Enrolled (actual)
739
Serious AEs
5.3%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 — 32.9; 64.1; 63.7 percentage of participants — p=< 0.001
◆ Published Evidence
Emerging
4citations · ~2 / year
Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: results from a phase III randomized controlled trial.
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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Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: results from a phase III randomized controlled trial.
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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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Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data.
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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.
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Guselkumab Efficacy in Biologic-Naïve Participants with Psoriatic Arthritis and Severe Disease Activity: Post Hoc Analysis of a Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 |
32.9; 64.1; 63.7 | < 0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 |
-0.1300; -0.3672; -0.4004 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an ACR 50 Response at Week 24 |
14.2; 31.5; 33.1 | < 0.001 sig |
| 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 |
19.1; 70.5; 68.5 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 |
33.7; 55.2; 55.9 | < 0.001 sig |
| SECONDARY Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 |
0.95; 0.52; 0.29 | 0.072 |
| SECONDARY Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline |
29.4; 49.6; 44.9 | 0.030 sig |
| SECONDARY Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline |
42.2; 59.4; 63.5 | 0.030 sig |
| SECONDARY Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline |
-1.02; -1.52; -1.59 | < 0.001 sig |
| SECONDARY Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline |
-4.21; -6.10; -5.97 | < 0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 |
3.42; 7.39; 7.04 | 0.011 sig |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24 |
-0.97; -1.59; -1.62 | < 0.001 sig |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Week 24 |
2.14; 4.17; 4.22 | 0.072 |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16 |
9.3; 28.6; 20.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 24 |
4.1; 18.5; 13.1 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved ACR 20 Response Through Week 24 |
8.1; 10.1; 10.6; 11.8; 19.8; 21.6 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 50 Response Through Week 24 |
0.4; 1.6; 0.4; 1.2; 4.0; 3.3 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70 Response Through Week 24 |
0; 0; 0; 0.8; 0.4; 0.8 | — |
| SECONDARY Percent Change From Baseline in ACR Components at Weeks 2, 4, 8, 12, 16, 20 and 24 |
-18.9; -18.8; -18.5; -27.1; -30.5; -33.6 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Weeks 2, 4, 8, 12, 16, 20 and 24 |
-0.0594; -0.1423; -0.0795; -0.0722; -0.1472; -0.1605 | — |
| 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 |
19.9; 30.7; 23.2; 23.7; 32.0; 35.1 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Response Through Week 24 |
21.5; 23.8; 24.5; 32.9; 38.7; 40.8 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Remission Through Week 24 |
0.8; 2.4; 2.4; 2.0; 5.2; 4.9 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 8, 12, 16, 20 and 24 |
-0.29; -0.42; -0.43; -0.44; -0.62; -0.65 | — |
| SECONDARY Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) Through Week 24 |
13.0; 22.2; 18.0; 27.2; 32.7; 29.8 | — |
| SECONDARY Percentage of Participants With Resolution of Enthesitis Through Week 24 Among the Participants With Enthesitis at Baseline |
16.3; 17.7; 17.1; 18.0; 21.5; 25.3 | — |
| SECONDARY Percentage of Participants With Resolution of Dactylitis Through Week 24 Among the Participants With Dactylitis at Baseline |
12.1; 13.5; 13.2; 18.2; 19.8; 20.7 | — |
| 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 |
-0.33; -0.37; -0.49; -0.46; -0.56; -0.69 | — |
| SECONDARY Change From Baseline in Dactylitis Scores at Weeks 2, 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline |
-0.21; -1.11; -0.78; -1.10; -2.11; -1.56 | — |
| SECONDARY Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 8, 16 and 24 |
-0.863; -1.452; -1.413; -1.158; -2.110; -1.994 | — |
| SECONDARY Change From Baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score (GRACE) at Weeks 16 and 24 |
-1.029; -2.326; -2.214; -1.198; -2.593; -2.589 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Work Time Missed) at Weeks 16 and 24 |
-4.553; -3.451; -4.717; -3.491; -3.103; -3.827 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Impairment While Working) at Weeks 16 and 24 |
-10.281; -16.054; -15.083; -10.157; -19.366; -19.492 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Overall Work Impairment) at Weeks 16 and 24 |
-11.232; -15.926; -15.808; -10.869; -19.711; -20.023 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Scores (Percent Activity Impairment Outside of Work ) at Weeks 16 and 24 |
-10.569; -17.107; -17.029; -10.320; -21.467; -20.480 | — |
| SECONDARY Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Week 16 and 24 |
-1.18; -2.39; -2.57; -1.30; -2.94; -3.09 | — |
| SECONDARY Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, 16, 20 and 24 |
-4.6447; -6.7838; -6.3783; -7.6695; -9.9687; -10.2484 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Criteria Through Week 24 |
3.3; 16.9; 13.1; 6.1; 25.0; 18.8 | — |
| 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 |
38.0; 46.3; 53.0; 39.1; 58.2; 69.9 | — |
| 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 |
18.6; 73.3; 73.9; 23.0; 79.0; 78.3 | — |
| 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 |
8.2; 55.1; 53.8; 9.8; 68.8; 60.9 | — |
| 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 |
3.8; 27.3; 33.2; 2.7; 45.5; 44.6 | — |
| 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 |
6.0; 38.6; 40.8; 7.7; 50.0; 51.5 | — |
| 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 |
-3.482; -11.151; -11.278; -3.904; -11.407; -11.471 | — |
| 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 |
7.6; 33.5; 26.6; 10.0; 51.3; 45.1 | — |
| 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 |
30.1; 71.2; 69.7; 36.4; 79.5; 79.6 | — |
| 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 |
-1.653; -6.818; -6.396; -2.410; -8.545; -8.147 | — |
| 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 |
10.4; 48.9; 48.4; 11.5; 56.8; 57.1 | — |
| 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 |
13.1; 56.8; 54.3; 15.3; 65.3; 60.9 | — |
| SECONDARY Change From Baseline in Modified vdH-S Erosion Score at Week 24 |
0.58; 0.36; 0.13 | — |
| SECONDARY Change From Baseline in Modified vdH-S Joint Space Narrowing (JSN) Score at Week 24 |
0.37; 0.16; 0.16 | — |
| 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 |
0.40; 0.18; -0.03; 0.26; 0.10; 0.08 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 24 |
64.7; 63.5; 67.3; 72.1; 74.4; 78.0 | — |
| 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 |
66.8; 66.3; 71.4; 72.9; 76.8; 80.2 | — |
| 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 |
78.6; 78.8; 80.1; 85.5; 88.1; 88.3 | — |
| SECONDARY Percentage of Participants Without Radiographic Progression (Based on the Smallest Detectable Change [SDC]) From Baseline at Week 24 |
86.4; 87.8; 89.3 | — |
| SECONDARY Percentage of Participants Without Radiographic Joint Erosion Progression (Based on SDC) From Baseline at Week 24 |
84.0; 89.0; 89.9 | — |
| SECONDARY Percentage of Participants Without Radiographic JSN Progression (Based on the SDC) From Baseline at Week 24 |
91.3; 93.5; 91.7 | — |
| SECONDARY Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 24 |
4.5; 3.6; 3.7; 4.9; 3.6; 3.8 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 8, 16 and 24 |
2.75; 4.83; 4.34; 3.03; 6.65; 5.93 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 8, 16 and 24 |
1.11; 2.28; 2.87; 1.96; 4.28; 3.41 | — |
| SECONDARY Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24 |
2.095; 3.879; 3.936; 2.581; 6.124; 5.618 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score Through Week 24 |
26.4; 33.1; 27.3; 31.7; 42.3; 31.8 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score Through Week 24 |
37.8; 45.2; 41.2; 35.8; 59.3; 51.0 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24 |
2.451; 5.031; 4.850; 3.696; 6.977; 6.598 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement Through Week 24 |
45.9; 56.0; 51.8; 50.4; 60.9; 56.7 | — |
| SECONDARY Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) at Weeks 16 and 24: EQ-VAS |
6.477; 17.496; 14.646; 6.796; 18.371; 18.089 | — |
| SECONDARY Change From Baseline in EQ-5D-5L at Weeks 16 and 24: EQ-5D Index |
0.058; 0.112; 0.101; 0.053; 0.115; 0.116 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52 |
34.0; 66.8; 66.2; 48.3; 71.2; 72.0 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52 |
15.2; 32.8; 34.3; 22.7; 41.4; 40.5 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52 |
4.6; 19.3; 13.7; 7.6; 21.1; 21.1 | — |
| SECONDARY ACR Components at Weeks 24, 28, 36, 44 and 52 |
5.8; 3.4; 4.1; 4.1; 2.9; 3.2 | — |
| SECONDARY Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 |
-6.4; -8.2; -8.8; -8.1; -8.8; -9.6 | — |
| SECONDARY Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52 |
-53.44; -72.06; -73.17; -66.15; -78.02; -78.85 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24 |
91.7; 86.8 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24 |
87.2; 79.2 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24 |
82.6; 75.0 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 |
-0.1646; -0.4044; -0.4257; -0.2547; -0.4383; -0.4429 | — |
| 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 |
34.1; 52.5; 58.3; 42.4; 58.4; 63.4 | — |
| 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 |
92.0; 88.6 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52 |
55.5; 79.0; 83.8; 72.3; 85.0; 85.9 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52 |
9.3; 25.6; 24.4; 13.2; 27.5; 30.4 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52 |
-1.02; -1.63; -1.68; -1.38; -1.78; -1.86 | — |
| SECONDARY Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52 |
46.6; 76.4; 72.8; 64.6; 79.3; 83.1 | — |
| SECONDARY Percentage of Participants With Resolution of Enthesitis at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline |
32.6; 57.6; 45.5; 67.3; 65.5; 60.0 | — |
| SECONDARY Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24 and 52 Among the Participants With Enthesitis at Baseline |
-1.1; -1.6; -1.6; -2.1; -1.9; -2.0 | — |
| SECONDARY Percentage of Participants With Resolution of Dactylitis at Weeks 24 and 52 Among Participants With Dactylitis at Baseline |
41.1; 60.7; 68.1; 78.5; 81.9; 81.1 | — |
| SECONDARY Change From Baseline in Dactylitis Score at Weeks 24 and 52 Among the Participants With Dactylitis at Baseline |
-4.6; -6.1; -6.6; -7.4; -7.3; -7.4 | — |
| SECONDARY Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52 |
-1.399; -2.496; -2.506; -3.041; -3.197; -3.161 | — |
| SECONDARY Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 24 and 52 |
8.1; 31.6; 24.6; 38.5; 45.3; 46.3 | — |
| SECONDARY Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52 |
-1.260; -2.658; -2.672; -3.085; -3.271; -3.267 | — |
| 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 |
7.6; 29.5; 27.6; 34.9; 43.2; 43.0 | — |
| SECONDARY Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52 |
-16.377; -24.718; -26.578; -22.199; -26.573; -29.613 | — |
| SECONDARY Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 |
-1.34; -2.97; -3.32; -3.75; -3.84; -4.10 | — |
| SECONDARY Percentage of Participants With Low Disease Activity Based on Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 24 and 52 |
15.1; 48.9; 43.5; 56.3; 61.1; 60.1 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52 |
6.3; 26.5; 19.7; 31.6; 32.9; 36.8 | — |
| SECONDARY Percentage of Participants With Very Low Disease Activity (VLDA) at Weeks 24 and 52 |
1.3; 4.6; 5.1; 6.9; 17.1; 12.2 | — |
| 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 |
-1.374; -2.652; -2.674; -2.986; -2.883; -3.084 | — |
| 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 |
44.0; 62.5; 73.1; 71.6; 70.3; 79.7 | — |
| 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 |
-2.989; -11.685; -12.574; -11.016; -11.977; -12.857 | — |
| 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 |
39.8; 94.8; 93.8; 95.9; 97.1; 98.3 | — |
| 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 |
23.3; 80.8; 81.8; 88.4; 88.8; 91.9 | — |
| 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 |
10.2; 70.3; 63.6; 76.7; 77.1; 81.5 | — |
| 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 |
2.8; 46.5; 46.6; 55.2; 54.7; 61.3 | — |
| 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 |
11.4; 58.1; 59.7; 59.6; 73.5; 69.9 | — |
| 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 |
15.3; 66.9; 63.6; 70.9; 79.4; 76.3 | — |
| 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 |
19.9; 72.1; 71.0; 84.3; 77.1; 84.4 | — |
| 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 |
8.0; 51.2; 52.8; 66.9; 60.0; 66.5 | — |
| 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 |
12.1; 65.6; 61.4; 56.8; 68.6; 68.7 | — |
| 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 |
40.7; 85.4; 90.3; 84.8; 92.2; 89.4 | — |
| 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 |
-2.142; -8.901; -9.249; -8.815; -9.235; -9.839 | — |
| SECONDARY Change From Baseline in Modified vdH-S Score at Week 52 |
1.25; 0.97; 1.07 | — |
| SECONDARY Change in Total Modified vdH-S Score From Week 24 to Week 52 |
0.25; 0.23; 0.62 | — |
| SECONDARY Change From Baseline in Modified vdH-S Erosion Score at Week 52 |
0.92; 0.67; 0.70 | — |
| SECONDARY Change in Modified vdH-S Erosion Score From Week 24 to Week 52 |
0.17; 0.10; 0.39 | — |
| SECONDARY Change From Baseline in Modified vdH-S JSN Score at Week 52 |
0.33; 0.29; 0.38 | — |
| SECONDARY Change in Modified vdH-S JSN Score From Week 24 to Week 52 |
0.07; 0.13; 0.23 | — |
| 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 |
0.66; 0.37; 0.35; 0.29; 0.19; 0.22 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Score at Week 52 |
57.4; 55.7; 56.8; 67.4; 67.2; 72.1 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S Erosion Score at Week 52 |
58.3; 59.6; 60.3; 70.4; 71.1; 72.1 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline in Modified vdH-S JSN Score at Week 52 |
78.7; 75.3; 79.5; 88.3; 86.0; 86.5 | — |
| SECONDARY Percentage of Participants Without Radiographic Progression Based on the (SDC) From Baseline at Week 52 |
80.4; 82.6; 85.2 | — |
| SECONDARY Percentage of Participants Without Radiographic Joint Erosion Progression Based on (SDC) From Baseline at Week 52 |
82.2; 84.3; 87.3 | — |
| SECONDARY Percentage of Participants Without Radiographic JSN Progression Based on (SDC) From Baseline at Week 52 |
91.3; 91.5; 90.4 | — |
| SECONDARY Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline and Week 52 |
6.9; 4.6; 6.9; 7.8; 5.1; 7.0 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 24 and 52 |
3.782; 7.838; 7.183; 8.124; 9.511; 8.960 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 24 and 52 |
2.211; 4.452; 4.128; 4.297; 4.465; 4.076 | — |
| SECONDARY Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 24 and 52 |
3.602; 7.052; 6.772; 7.722; 8.489; 8.374 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 24 and 52 |
42.2; 63.4; 58.5; 63.0; 67.1; 65.5 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 24 and 52 |
32.5; 40.3; 36.8; 41.7; 44.9; 38.9 | — |
| SECONDARY Change From Baseline in FACIT-Fatigue Score at Weeks 24 and 52 |
3.844; 8.034; 6.970; 7.548; 8.927; 7.686 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score Improvement at Weeks 24 and 52 |
49.4; 63.9; 62.8; 68.3; 69.7; 68.6 | — |
| SECONDARY Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-VAS |
8.456; 19.282; 17.500; 21.474; 23.295; 19.983 | — |
| SECONDARY Change From Baseline in EQ-5D-5L at Weeks 24 and 52: EQ-5D Index |
0.060; 0.124; 0.117; 0.137; 0.146; 0.135 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores (Percent Work Time Missed) at Weeks 24 and 52 |
-5.64; -3.77; -1.20; -5.37; -4.47; -1.74 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 24 and 52 |
-12.14; -21.28; -20.08; -21.27; -27.93; -22.10 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 24 and 52 |
-13.42; -21.68; -20.90; -22.06; -28.19; -22.24 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) at Weeks 24 and 52 |
-10.80; -23.03; -21.07; -24.13; -27.14; -26.11 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 20 Response at Weeks 52, 68, 76, 84 and 100 |
68.7; 78.9; 77.0; 77.0; 85.2; 80.7 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 50 Response at Weeks 52, 68, 76, 84 and 100 |
44.3; 50.9; 49.6; 49.5; 60.8; 58.6 | — |
| SECONDARY Percentage of Participants Who Achieved ACR 70 Response at Weeks 52, 68, 76, 84 and 100 |
19.5; 29.7; 28.3; 27.8; 35.5; 36.1 | — |
| SECONDARY ACR Components at Weeks 52, 68, 76, 84 and 100 |
2.1; 2.1; 2.5; 1.6; 1.7; 2.0 | — |
| SECONDARY Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 |
-10.2; -9.6; -10.4; -10.7; -10.0; -10.9 | — |
| SECONDARY Percent Change From Baseline in ACR Components at Weeks 52, 68, 76, 84 and 100 |
-82.64; -83.03; -84.27; -87.41; -86.08; -86.41 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 20 Response at Week 100 Among Participants Who Achieved an ACR 20 Response at Week 52 |
94.6; 90.4; 93.0 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 50 Response at Week 100 Among Participants Who Achieved an ACR 50 Response at Week 52 |
81.3; 81.9; 83.8 | — |
| SECONDARY Percentage of Participants Who Maintained an ACR 70 Response at Week 100 Among Participants Who Achieved an ACR 70 Response at Week 52 |
65.1; 80.9; 71.9 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Weeks 52, 68, 76, 84 and 100 |
-0.3899; -0.4801; -0.5111; -0.4668; -0.5120; -0.5631 | — |
| 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 |
51.1; 60.6; 63.3; 57.2; 64.9; 69.4 | — |
| 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 |
91.6; 90.4; 88.5 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 52, 68, 76, 84 and 100 |
89.3; 89.7; 90.2; 92.7; 92.5; 92.7 | — |
| SECONDARY Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 52, 68, 76, 84 and 100 |
34.7; 39.7; 40.4; 39.0; 44.9; 49.1 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) Score at Weeks 52, 68, 76, 84 and 100 |
-2.14; -2.08; -2.14; -2.29; -2.25; -2.30 | — |
| SECONDARY Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 52, 68, 76, 84 and 100 |
81.4; 86.2; 83.6; 84.3; 89.9; 87.6 | — |
| SECONDARY Percentage of Participants With Resolution of Enthesitis (LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis (LEI) at Baseline |
67.3; 66.0; 61.0; 72.3; 71.8; 67.5 | — |
| SECONDARY Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 52, 76 and 100 Among the Participants With Enthesitis at Baseline |
-2.1; -1.9; -2.1; -2.3; -2.1; -2.2 | — |
| SECONDARY Percentage of Participants With Resolution of Dactylitis at Weeks 52, 76 and 100 Among Participants With Dactylitis at Baseline |
78.3; 81.7; 80.7; 80.2; 84.0; 82.4 | — |
| SECONDARY Change From Baseline in Dactylitis Scores at Weeks 52, 76 and 100 Among the Participants With Dactylitis at Baseline |
-7.4; -7.3; -7.4; -8.0; -7.8; -7.6 | — |
| SECONDARY Change From Baseline in PASDAS Score at Weeks 52, 76 and 100 |
-3.054; -3.189; -3.184; -3.503; -3.418; -3.436 | — |
| SECONDARY Percentage of Participants With Low or Very Low Disease Activity Based on PASDAS at Weeks 52, 76 and 100 |
39.0; 44.8; 46.7; 13.0; 22.0; 16.0 | — |
| SECONDARY Change From Baseline in GRAPPA Composite Score (GRACE) at Weeks 52, 76 and 100 |
-3.105; -3.266; -3.298; -3.499; -3.528; -3.541 | — |
| 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 |
35.4; 42.7; 43.8; 45.7; 48.9; 49.8 | — |
| SECONDARY Change From Baseline in DAPSA at Weeks 52, 68, 76, 84 and 100 |
-31.274; -30.604; -32.563; -33.918; -33.146; -34.900 | — |
| SECONDARY Percentage of Participants With Low Disease Activity or Remission Based on DAPSA at Weeks 52, 68, 76, 84 and 100 |
50.7; 55.2; 55.6; 10.2; 19.4; 17.3 | — |
| SECONDARY Change From Baseline in mCPDAI Score at Weeks 52, 76 and 100 |
-3.78; -3.83; -4.14; -4.39; -4.16; -4.47 | — |
| SECONDARY Percentage of Participants With Low Disease Activity Based on mCPDAI at Weeks 52, 76 and 100 |
56.6; 61.2; 60.6; 64.3; 63.7; 68.6 | — |
| SECONDARY Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 52, 76 and 100 |
32.0; 32.8; 37.2; 34.7; 40.0; 39.0 | — |
| SECONDARY Percentage of Participants With VLDA at Weeks 52, 76 and 100 |
7.0; 16.8; 12.4; 12.2; 19.6; 14.8 | — |
| 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 |
-2.986; -2.923; -3.084; -3.311; -3.377; -3.129 | — |
| 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 |
71.6; 69.8; 79.7; 74.1; 82.0; 81.8 | — |
| 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 |
-11.030; -11.991; -12.875; -11.313; -11.991; -13.242 | — |
| 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 |
95.9; 97.0; 98.3; 97.6; 96.4; 97.1 | — |
| 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 |
88.3; 88.8; 91.9; 92.8; 87.9; 93.0 | — |
| 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 |
76.6; 76.9; 81.5; 85.5; 75.8; 80.2 | — |
| 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 |
55.0; 54.4; 60.7; 65.1; 59.4; 68.0 | — |
| 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 |
59.4; 73.4; 70.5; 71.1; 75.8; 76.7 | — |
| 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 |
70.8; 79.3; 76.9; 78.3; 79.4; 82.6 | — |
| 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 |
84.2; 76.9; 84.4; 85.5; 77.6; 86.0 | — |
| 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 |
66.7; 59.8; 65.9; 72.9; 64.2; 72.1 | — |
| 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 |
56.5; 68.4; 68.5; 66.9; 66.7; 68.9 | — |
| 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 |
84.8; 92.2; 89.4; 91.9; 89.0; 90.1 | — |
| 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 |
-8.855; -9.272; -9.873; -10.090; -9.180; -9.610 | — |
| SECONDARY Change in Modified vdH-S Score From Baseline to Week 100 |
1.49; 1.50; 1.68 | — |
| SECONDARY Change in Total Modified vdH-S Score From Week 52 to Week 100 |
0.13; 0.46; 0.75 | — |
| SECONDARY Change in Modified vdH-s Erosion Score From Baseline to Week 100 |
1.01; 1.01; 1.02 | — |
| SECONDARY Change in Modified vdH-s Erosion Score From Week 52 to Week 100 |
0.09; 0.26; 0.45 | — |
| SECONDARY Change in Modified vdH-s JSN Score From Baseline to Week 100 |
0.49; 0.50; 0.66 | — |
| SECONDARY Change in Modified vdH-s JSN Score From Week 52 to Week 100 |
0.04; 0.20; 0.30 | — |
| 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) |
0.67; 0.67; 0.49; 0.35; 0.34; 0.32 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Score |
60.8; 55.6; 62.6; 72.1; 63.9; 72.5 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S Erosion Score |
64.2; 61.1; 65.4; 75.0; 73.1; 75.4 | — |
| SECONDARY Percentage of Participants With a Change of <=0 or <=0.5 From Baseline to Week 100 in Modified vdH-S JSN Score |
77.5; 68.5; 73.9; 84.3; 79.6; 81.0 | — |
| SECONDARY Percentage of Participants Without Radiographic Modified vdH-S Progression Based on (SDC) From Baseline to Week 100 |
86.8; 84.7; 87.2 | — |
| SECONDARY Percentage of Participants Without Radiographic Erosion Progression (Based on SDC) From Baseline to Week 100 |
86.8; 87.0; 88.6 | — |
| SECONDARY Percentage of Participants Without Radiographic JSN Progression (Based on SDC) From Baseline to Week 100 |
90.7; 89.4; 88.2 | — |
| SECONDARY Percentage of Participants With Pencil in Cup or Gross Osteolysis Deformities at Baseline, Weeks 24, 52, and 100 |
3.7; 3.9; 3.6; 3.7; 3.9; 4.1 | — |
| SECONDARY Change From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 |
8.170; 9.438; 9.023; 9.762; 10.814; 9.707 | — |
| SECONDARY Change From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 |
4.383; 4.540; 4.127; 4.838; 5.034; 5.194 | — |
| SECONDARY Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 52, 76 and 100 |
7.757; 8.406; 8.493; 8.824; 9.807; 9.294 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 PCS Score at Weeks 52, 76 and 100 |
63.4; 66.8; 65.9; 70.6; 73.8; 65.5 | — |
| SECONDARY Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score at Weeks 52, 76 and 100 |
42.3; 45.3; 38.9; 43.9; 44.4; 43.5 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 52, 76 and 100 |
7.692; 8.935; 7.699; 9.167; 9.596; 8.632 | — |
| SECONDARY Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 52, 76 and 100 |
68.7; 69.4; 68.1; 70.6; 69.3; 74.4 | — |
| SECONDARY Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-VAS |
21.608; 23.392; 20.190; 24.176; 25.053; 22.251 | — |
| SECONDARY Change From Baseline in EQ-5D-5L at Weeks 52, 76 and 100: EQ-5D Index |
0.138; 0.150; 0.138; 0.154; 0.169; 0.147 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Work Time Missed) at Weeks 52, 76 and 100 |
-5.45; -4.50; -1.83; -5.92; -6.22; -2.39 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Impairment While Working) at Weeks 52, 76 and 100 |
-21.81; -27.93; -22.62; -26.90; -29.91; -26.13 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Overall Work Impairment) at Weeks 52, 76 and 100 |
-22.61; -28.19; -22.79; -27.98; -30.27; -26.21 | — |
| SECONDARY Change From Baseline in WPAI Scores (Percent Activity Impairment Outside of Work) Weeks 52, 76 and 100 |
-24.67; -27.16; -26.24; -28.05; -31.38; -28.70 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03158285) 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.