Phase 3
N=204
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03486457 ↗Enrolled (actual)
204
Serious AEs
2.5%
Results posted
Feb 2024
Primary outcome: Primary: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3 — 38.24; 5.88 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tofacitinib (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3 |
38.24; 5.88 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6 |
22.79; 7.35; 38.97; 8.82; 61.76; 10.29 | 0.0013 sig |
| SECONDARY Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6 |
1.47; 0; 2.21; 0; 8.82; 1.47 | 0.4730 |
| SECONDARY Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6 |
4.41; 1.47; 9.56; 1.47; 30.15; 2.94 | 0.1985 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6 |
-0.14; -0.03; -0.18; -0.05; -0.28; -0.07 | 0.0097 sig |
| SECONDARY HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6 |
36.14; 23.08; 37.35; 33.33; 60.24; 38.46 | 0.1270 |
| SECONDARY HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6 |
36.14; 23.08; 37.35; 33.33; 60.24; 38.46 | 0.1270 |
| SECONDARY Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6 |
-3.04; -0.34; -4.06; -0.27; -5.55; -0.66 | <0.0001 sig |
| SECONDARY Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6 |
-3.19; 0.21; -5.38; -0.35; -7.44; -1.76 | 0.0010 sig |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6 |
-9.7; -3.13; -14.07; -2.37; -18.80; -2.66 | 0.0087 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 |
-13.67; -7.52; -17.89; -4.80; -22.49; -9.33 | 0.0211 sig |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6 |
-11.94; -2.30; -17.10; -7.58; -25.16; -8.19 | <0.0001 sig |
| SECONDARY Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6 |
-8.63; -1.42; -9.37; -1.50; -9.24; -1.83 | <0.0001 sig |
| SECONDARY Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6 |
0.94; 0.00; 9.43; 1.96; 10.38; 21.57 | 0.8032 |
| SECONDARY Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6 |
-0.66; -0.31; -1.12; -0.52; -1.25; -1.26 | 0.0020 sig |
| SECONDARY Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0 |
18.67; 3.70; 36.00; 11.11; 41.33; 59.26 | 0.0097 sig |
| SECONDARY Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 |
-42.23; -16.34; -60.86; -25.95; -62.72; -68.03 | 0.0014 sig |
| SECONDARY Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0 |
-44.53; -4.89; -39.91; -14.73; -37.25; -15.94 | 0.0004 sig |
| SECONDARY Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0% |
-34.82; -6.13; -51.91; -5.44; -67.68; -40.91 | 0.0008 sig |
| SECONDARY Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6 |
-17.94; -7.19; -30.29; -10.84; -38.75; -32.05 | <0.0001 sig |
| SECONDARY Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0 |
21.51; 7.32; 45.16; 19.51; 64.52; 41.46 | 0.0160 sig |
| SECONDARY Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6 |
-4.26; -1.17; -6.55; -2.49; -7.80; -6.83 | 0.0156 sig |
| SECONDARY Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0 |
38.03; 25.00; 49.30; 25.00; 64.79; 60.71 | 0.1930 |
| SECONDARY Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6 |
-1.04; -0.74; -1.36; -0.99; -1.87; -1.61 | 0.2811 |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0 |
-0.26; -0.25; -1.03; -0.80; -2.43; -2.10 | 0.9407 |
| SECONDARY Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6 |
33.09; 11.76; 56.62; 20.59; 65.44; 13.24 | 0.0001 sig |
| SECONDARY Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6 |
-0.68; -0.05; -0.92; -0.12; -1.13; -0.26 | <0.0001 sig |
| SECONDARY Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6 |
3.53; -0.19; 3.93; 0.75; 5.58; 2.47 | 0.0003 sig |
| SECONDARY Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6 |
-0.14; -0.02; -0.15; 0.01; -0.19; -0.05 | 0.0722 |
| SECONDARY Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6 |
9.88; 3.87; 12.48; 1.68; 18.52; 17.60 | 0.0044 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment |
-1.01; -1.86; -16.11; -9.77; -16.67; -10.45 | 0.7228 |
| SECONDARY Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment |
-17.20; -4.39; -21.91; -22.97 | <0.0001 sig |
Summary
This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.
Eligibility Criteria
Inclusion Criteria
- Chinese patients
- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
- Active plaque psoriasis at screening
- Inadequate response to at least one conventional synthetic DMARD
Exclusion Criteria
- Non-plaque forms of psoriasis (with exception of nail psoriasis)
- History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
Data sourced from ClinicalTrials.gov (NCT03486457). 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.