Spondyloarthritis & psoriatic arthritis
Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial
Authors' conclusion
Treatment with brepocitinib at dosages of 30 mg and 60 mg once daily was superior to placebo at reducing signs and symptoms of PsA. Brepocitinib was generally well tolerated throughout the 52-week study, with a safety profile consistent with those found in other brepocitinib clinical trials.
Study context
- Population
- Participants with moderately-to-severely active psoriatic arthritis (PsA)randomized and treated
- Participants
- 218 participants
- Comparison
- Brepocitinib 10 mg, 30 mg or 60 mg once daily vs placebo
- Primary endpoint
- ACR20 response rate
- Follow-up
- Week 16
Methodological detailsplacebo-controlled, dose-ranging, phase IIb
- Placebo-controlled
- Dose-ranging
- Phase IIb
Primary result
As reported in the abstract
Brepocitinib 30 mg vs Placebo: P = 0.0197 · Brepocitinib 60 mg vs Placebo: P = 0.0006
Secondary outcomes
ACR50/ACR70, PASI75/PASI90 and minimal disease activity (MDA) response rates · week 16
- Significantly higher with brepocitinib 30 mg and 60 mg vs placebo
Response rates through week 52
- Response rates were maintained or improved through week 52
MACE and deaths
- None occurred
- 0
Safety
- Serious adverse events (15) in participants, overall
- 12 (5.5%)
- Serious infections in brepocitinib 30 mg and 60 mg groups
- 6 (2.8%)
- Adverse events were mostly mild/moderate
Original publication
Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial. Arthritis Rheumatol. Published 22 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →