Efficacy and safety of branebrutinib (BMS-986195), an irreversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2a, randomised, double-blind, placebo-controlled study
An erratum to this article was published (Lancet Rheumatol, Oct 2026 ↗)
Authors' conclusion
There was no significant difference between branebrutinib and placebo for any clinical efficacy measures.
Study context
- Population
- Patients aged 18–75 years with RA (2010 ACR-EULAR criteria), disease duration <4 years and inadequate response to MTX; USA, Poland and Spain63 (74%) female
- Participants
- 85 patients
- Comparison
- Branebrutinib 9 mg once daily vs placebo for 12 weeks
- Branebrutinibn = 64
- Placebon = 21reference
- Primary endpoint
- Proportion with ACR50 response (full analysis set)
- Follow-up
- Week 12
Methodological detailsphase 2a, double-blind, placebo-controlled, multicentre (24 sites), 3:1 randomisation, Only the 12-week double-blind period reported; followed by 12-week open-label abatacept period
- Phase 2a
- Double-blind
- Placebo-controlled
- Multicentre (24 sites)
- 3:1 randomisation
- Only the 12-week double-blind period reported; followed by 12-week open-label abatacept period
Primary result
As reported in the abstract
ACR50 response
P = 0.16
Further findings
- No significant difference between branebrutinib and placebo for any clinical efficacy measures
Safety
Adverse events · 12 weeks · similar between groups
Serious adverse events or deaths
- None reported
Original publication
Efficacy and safety of branebrutinib (BMS-986195), an irreversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Rheumatol. Published 1 May 2026. doi:10.
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