Phase 3
Completed N=422
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Source: ClinicalTrials.gov NCT01877668 ↗Enrolled (actual)
422
Serious AEs
6.6%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 — 50.47; 60.58; 51.89; 33.33 Percentage or participants — p=0.0102
◆ Published Evidence
Emerging
2citations · ~1 / year
Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis.
Summary
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Linked Publications (5)
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Efficacy and safety of tofacitinib in an open-label, long-term extension study in patients with psoriatic arthritis who received adalimumab or tofacitinib in a Phase 3 randomized controlled study: a post hoc analysis.
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Exposure-Response Analysis of Tofacitinib in Active Psoriatic Arthritis: Results from Two Phase 3 Studies.
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Identification of distinct disease activity trajectories in patients with psoriatic arthritis receiving tofacitinib: a post hoc analysis of two phase 3 studies.
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Response to Tofacitinib in Patients with Psoriatic Arthritis and Probable Anxiety/Depressive Disorder: A Post Hoc Analysis of Phase 3 Trials.
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Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3 |
50.47; 60.58; 51.89; 33.33 | 0.0102 sig |
| PRIMARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
-0.1842; -0.2089; -0.2129; NA; NA; -0.0837 | — |
| SECONDARY Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis |
0.01; -0.01; -0.07; 0.00; 0.09 | — |
| SECONDARY Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12 |
4.08; 5.05; 2.11; 4.17; 8.89 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
6.54; 6.73; 4.72; NA; NA; 0.95 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
0.00; 2.88; 0.94; NA; NA; 0.00 | — |
| SECONDARY Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12 |
22.43; 31.73; 21.70; NA; NA; 5.71 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
-0.1842; -0.2089; -0.2129; NA; NA; -0.0837 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels |
-5.5981; -6.6004; -7.8955; -0.8643 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain |
-21.49; -27.10; -21.87; -10.22 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis |
-20.08; -25.50; -21.47; -11.40 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis |
-27.44; -33.74; -29.02; -22.26 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count |
-6.5; -7.6; -6.5; -4.8 | — |
| SECONDARY Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count |
-8.7; -11.0; -7.6; -6.9 | — |
| SECONDARY Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12 |
31.78; 40.38; 21.70; NA; NA; 9.52 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response |
-0.7; -0.8; -0.5; NA; NA; -0.2 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12 |
23.17; 27.14; 14.29; NA; NA; 4.88 | — |
| SECONDARY Change From Baseline in Dactylitis Severity Score (DSS) |
-1.8; -3.1; -2.1; NA; NA; 0.6 | — |
| SECONDARY Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index |
-0.83; -1.27; -0.95; NA; NA; -0.58 | — |
| SECONDARY Change From Baseline in the Leeds Enthesitis Index (LEI) |
-0.41; -0.57; -0.42; NA; NA; -0.26 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score |
3.39; 4.66; 4.00; NA; NA; 1.54 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score |
4.12; 3.63; 2.13; NA; NA; 3.19 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain |
2.43; 3.89; 2.81; NA; NA; 1.10 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain |
4.05; 3.72; 4.09; NA; NA; 1.98 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain |
5.53; 7.16; 6.42; NA; NA; 3.44 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain |
3.29; 3.87; 1.96; NA; NA; 2.15 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain |
3.64; 4.59; 2.42; NA; NA; 2.16 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain |
4.51; 4.46; 3.34; NA; NA; 2.96 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain |
4.77; 3.87; 2.93; NA; NA; 4.52 | — |
| SECONDARY Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain |
3.32; 3.87; 2.79; NA; NA; 1.57 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility |
-0.07; -0.19; -0.15; NA; NA; -0.10 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care |
-0.11; -0.16; -0.16; NA; NA; -0.09 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities |
-0.17; -0.19; -0.21; NA; NA; -0.06 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort |
-0.14; -0.25; -0.19; NA; NA; -0.08 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression |
-0.25; -0.22; -0.27; NA; NA; -0.21 | — |
| SECONDARY Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today |
10.75; 10.81; 10.27; NA; NA; 6.59 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score |
5.2; 4.4; 4.2; NA; NA; 2.7 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score |
2.4; 2.1; 2.1; NA; NA; 1.2 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score |
2.9; 2.3; 2.1; NA; NA; 1.5 | — |
| SECONDARY Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI) |
-1.23; -1.60; -2.30; NA; NA; -1.27 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females, aged >= 18 years at time of consent.
- Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
- Meet the Classification Criteria of PsA (CASPAR) at time of screening
- Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
- Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- Must have 3 or more swollen joints AND 3 or more tender joints
- Must have active psoriasis skin lesions
Exclusion Criteria
- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
- Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- New York Heart Association Class III and IV congestive heart failure
- History of hypersensitivity or infusion reaction to biologic agents
- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Data sourced from ClinicalTrials.gov (NCT01877668) 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.