Spondyloarthritis & psoriatic arthritis
Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study
Authors' conclusion
In Chinese patients with PsA, tofacitinib efficacy was greater than placebo (primary and secondary endpoints).
Study context
- Population
- Chinese patients with active (polyarthritic) psoriatic arthritis (PsA) and inadequate response to ≥1 csDMARD
- Participants
- 136 vs 68
- Comparison
- Tofacitinib 5 mg twice daily vs placebo
- Tofacitinib 5 mg twice dailyn = 136
- Placebon = 68reference
- Primary endpoint
- American College of Rheumatology (ACR50) response
- Follow-up
- M3
Methodological detailsphase 3, double-blind, placebo-controlled, 2:1 randomisation, switch to tofacitinib after M3 (blinded)
- Phase 3
- Double-blind
- Placebo-controlled
- 2:1 randomisation
- Switch to tofacitinib after M3 (blinded)
Primary result
As reported in the abstract
P < 0.0001
Secondary outcomes
ACR20/ACR70/Psoriasis Area and Severity Index (PASI75) responses, enthesitis and dactylitis resolution, Health Assessment Questionnaire-Disability Index (HAQ-DI) reduction · M3
- Responses and resolution rates higher and HAQ-DI reduction greater with tofacitinib 5 mg twice daily vs placebo
Deaths
- Death with placebo→tofacitinib 5 mg twice daily (due to accident)
- 1
Safety
| Outcome | Tofacitinib 5 mg twice daily | Placebo |
|---|---|---|
| AEs / serious AEs · M0-3 | 68.4%/0% | 75.0%/4.4% |
Serious infection, herpes zoster, lung cancer · M0-6
- Tofacitinib 5 mg twice daily: serious infection
- 1
- Tofacitinib 5 mg twice daily: non-serious herpes zoster
- 1
- Tofacitinib 5 mg twice daily: lung cancer
- 1
- Placebo→tofacitinib: serious infections
- 4
- Placebo→tofacitinib: non-serious herpes zoster
- 1
Non-melanoma skin cancer, MACE, thromboembolism events
- None reported
- 0
Original publication
Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. Published 31 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →