Sjögren's disease & overlap diseases
Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren’s syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial
Primary result · Change from baseline in ESSDAIResult — go to the resultΔESSDAI −2.86Authors' conclusion
These data show preliminary efficacy and favourable safety of remibrutinib in a phase 2 trial for SjS.
Study context
- Population
- Patients with moderate-to-severe Sjögren's syndrome (SjS) fulfilling 2016 ACR/EULAR criteria, anti-Ro/SSA positive, EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 5 and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) ≥ 5
- Comparison
- Remibrutinib 100 mg once or twice daily vs placebo for 24 weeks
- Primary endpoint
- Change from baseline in ESSDAI
- Follow-up
- Week 24
Methodological detailsphase 2, double-blind, placebo-controlled
- Phase 2
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
24 weeks
ΔESSDAI
−2.86
P = 0.003
Secondary outcomes
Change from baseline in ESSPRI · 24 weeks
- No treatment effect observed in ESSPRI score (ΔESSPRI; p=0.663)
- 0.17
Unstimulated salivary flow (exploratory) · 24 weeks
- Trend towards improvement with remibrutinib vs placebo
Blood gene expression and serum protein abundance (exploratory)
- Significant changes induced by remibrutinib vs placebo
Original publication
Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren’s syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial. Ann Rheum Dis. Published 15 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →