Lupus & antiphospholipid syndrome
Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II)
Authors' conclusion
Although phase 2 data suggested baricitinib as a potential treatment for patients with SLE, which was supported in SLE-BRAVE-I, this result was not replicated in SLE-BRAVE-II. No new safety signals were observed.
Study context
- Population
- Patients (aged ≥18 years) with active systemic lupus erythematosus (SLE) receiving stable background therapyrandomised and dosed
- Participants
- 775 patients
- Comparison
- Baricitinib 4 mg or 2 mg once daily vs placebo for 52 weeks, on stable background therapy
- Baricitinib 4 mgn = 258
- Baricitinib 2 mgn = 261
- Placebon = 256reference
- Primary endpoint
- Proportion with SRI-4 response, baricitinib 4 mg vs placebo
- Follow-up
- Week 52
Methodological detailsphase 3, double-blind, placebo-controlled, 1:1:1 randomisation
- Phase 3
- Double-blind
- Placebo-controlled
- 1:1:1 randomisation
Primary result
As reported in the abstract
SRI-4 response
Each group vs placeboOdds ratio (95% CI)
Baricitinib 4 mg
1.07(0.75–1.53)
Baricitinib 2 mg
1.05(0.73–1.50)
Each group vs placeboDifference (95% CI)
Baricitinib 4 mg
1.5(−7.1 to 10.2)
Baricitinib 2 mg
0.8(−7.9 to 9.4)
Secondary outcomes
Major secondary endpoints (incl. GC tapering, time to first severe flare)
- None of the major secondary endpoints were met
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-II). Lancet. Published 24 February 2023. doi:10.
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