Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial
Authors' conclusion
The primary endpoint was not achieved. TAS5315 appears to have some bleeding risks, but nevertheless demonstrated numerical differences, compared with placebo, in the improvement rates of all measures of RA disease activity.
Study context
- Population
- Japanese patients with rheumatoid arthritis (RA) refractory to MTX84 entered part B
- Participants
- 91 patients
- Comparison
- TAS5315 4 or 2 mg once daily vs placebo for 12 weeks (part A); all patients TAS5315 for another 24 weeks (part B)
- Primary endpoint
- Proportion of patients achieving ACR20
- Follow-up
- Week 12
Methodological detailsphase IIa, double-blind, placebo-controlled
- Phase IIa
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
ACR20
P = 0.053
Further findings
| Outcome | TAS5315 combined | Placebo | P value |
|---|---|---|---|
| ACR50 · week 12TAS5315 combined vs Placebo | 33.3% | 13.3% | P = 0.072 |
| ACR70 · week 12TAS5315 combined vs Placebo | 7.0% | 0.0% | P = 0.294 |
Low disease activity or remission · week 12
- More patients receiving TAS5315 than placebo had low disease activity or remission
Clinical and biomarker improvements · part B
- Maintained during part B
Safety
| Outcome | TAS5315 combined |
|---|---|
| Common AEs with TAS5315 | |
| Nasopharyngitis | 10.3% |
| Pruritus | 6.9% |
| Cystitis | 5.2% |
Adverse event (AE) incidence (part A)
- AE incidence with TAS5315 similar to placebo
Bleeding events · 36 weeks
- Patients with bleeding events
- 9
- Recovered with drug continuation
- 4
- Recovered with drug interruption
- 2
- Recovered after TAS5315 discontinuation
- 3
Original publication
Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. Published 22 May 2023. doi:10.
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