Lupus & antiphospholipid syndrome
Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I)
Authors' conclusion
The primary endpoint in this study was met for the 4 mg baricitinib group. However, key secondary endpoints were not. No new safety signals were observed.
Study context
- Population
- Patients (aged ≥18 years) with active systemic lupus erythematosus (SLE) receiving stable background therapyrandomised and received ≥1 dose
- Participants
- 760 patients
- Comparison
- Baricitinib 4 mg or 2 mg once daily vs placebo for 52 weeks with standard of care
- Baricitinib 4 mgn = 252
- Baricitinib 2 mgn = 255
- Placebon = 253reference
- Primary endpoint
- Proportion reaching SRI-4 response, baricitinib 4 mg vs placebo
- Follow-up
- Week 52
Methodological detailsmulticentre, double-blind, placebo-controlled, parallel-group, phase 3
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- Phase 3
Primary result
As reported in the abstract
SRI-4 response
Each group vs placeboOdds ratio (95% CI)P value
Baricitinib 4 mg
1.57(1.09–2.27)
P = 0.016Baricitinib 2 mg
1.14(0.79–1.65)
P = 0.47Each group vs placeboDifference (95% CI)P value
Baricitinib 4 mg
10.8(2.0–19.6)
P = 0.016Baricitinib 2 mg
3.9(−4.9 to 12.6)
P = 0.47Secondary outcomes
Major secondary endpoints, incl. GC tapering and time to first severe flare
- No significant differences in either baricitinib group vs placebo
Safety
Serious adverse events
Serious adverse events
- Safety profile consistent with the known baricitinib safety profile
Original publication
Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). Lancet. Published 24 February 2023. doi:10.
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