A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis
Primary result · Change from baseline in DAS28-CRP, least-squares meanResult — go to the resultDifference in change −1.09 95% CI −1.73 to −0.46Authors' conclusion
Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis.
Study context
- Population
- Adults with moderate-to-severe RA with inadequate response to, loss of response to, or unacceptable side effects with csDMARDs or b/tsDMARDsrandomised 2:1:1
- Comparison
- Peresolimab 700 mg or 300 mg IV every 4 weeks vs placebo
- Primary endpoint
- Change from baseline in DAS28-CRP (range 0 to 9.4, higher scores more severe); primary comparison 700 mg vs placebo
- Follow-up
- Week 12
Methodological detailsphase 2a, double-blind, placebo-controlled
- Phase 2a
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Change from baseline in DAS28-CRP, least-squares mean
Difference in change
−1.09
95% CI −1.73 to −0.46
P < 0.001
Change by group
Peresolimab 700 mg
−2.09
least-squares mean · SE 0.18
Placebo
−0.99
least-squares mean · SE 0.26
Peresolimab 700 mgvs Placebo
difference in change −1.09 (95% CI −1.73 to −0.46); P < 0.001
Secondary outcomes
ACR20, ACR50 and ACR70 responses · week 12
- Favored 700 mg over placebo for ACR20 response but not for ACR50 and ACR70 responses
Safety
Adverse events
- Similar in the peresolimab and placebo groups
Original publication
A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. N Engl J Med. Published 18 May 2023. doi:10.
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