Evaluation of BMS-986142, a reversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2, randomised, double-blind, dose-ranging, placebo-controlled, adaptive design study
- 350 mg dose discontinued at pre-specified interim analysis (elevated liver enzymes, absence of benefit vs placebo)
Study context
- Population
- Adults (≥18 years) with RA diagnosed ≥16 weeks before screening and inadequate response to MTX, with or without inadequate response to up to two TNFione post-randomisation exclusion
- Participants
- 248 adults
- Comparison
- Oral BMS-986142 vs placebo once daily for 12 weeks, on background MTX
- BMS-986142 100 mgn = 73
- BMS-986142 200 mgn = 73
- BMS-986142 350 mgn = 26
- Placebon = 75reference
- Primary endpoint
- Co-primary: ACR20 and ACR70 response
- Follow-up
- Week 12
Methodological detailsphase 2, double-blind, dose-ranging, placebo-controlled, adaptive design, multicentre (14 countries, 79 sites), stratified by prior treatment status and geographical region, pre-specified interim analysis
- Phase 2
- Double-blind
- Dose-ranging
- Placebo-controlled
- Adaptive design
- Multicentre (14 countries, 79 sites)
- Stratified by prior treatment status and geographical region
- Pre-specified interim analysis
Primary result
As reported in the abstract
Co-primary: ACR20 response
Each group vs placeboEstimate of difference (95% CI)P value
100 mg
4.9(−10.2 to 20.1)
P = 0.52200 mg
11.8(−3.6 to 27.2)
P = 0.14Further findings
| Outcome | BMS-986142 100 mg | BMS-986142 200 mg | Placebo | Estimate of difference (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Co-primary: ACR70 response · week 12100 mgvs Placebo | 4% | 10% | 4% | 0.1 (−16.0 to 16.5) | nominal p=1.00 | |
| Co-primary: ACR70 response · week 12200 mgvs Placebo | 5.6 (−10.5 to 21.9) | nominal p=0.21 | ||||
| −20−100102030Difference (linear scale) |
Deaths
- No deaths
Safety
Events
| Outcome | BMS-986142 100 mg | Placebo |
|---|---|---|
| Serious adverse events | 2 | 4 |
- Serious adverse events: placebo: mouth ulceration, open globe injury, RA flare, endometrial adenocarcinoma; 100 mg: angina pectoris, intestinal obstruction
Elevated liver enzymes, 350 mg
- 350 mg dose discontinued at pre-specified interim analysis due to elevated liver enzymes and absence of benefit vs placebo
Original publication
Evaluation of BMS-986142, a reversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2, randomised, double-blind, dose-ranging, placebo-controlled, adaptive design study. Lancet Rheumatol. Published May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →