Baricitinib for Systemic Lupus Erythematosus: a Double-blind, Randomised, Placebo-controlled, Phase 3 trial (SLE-BRAVE-II)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02546-6
Negative results of SLE-BRAVE-II trial show that evidence for the efficacy of baricitinib in SLE is inconclusive.
SLE-BRAVE-II was the second double-blind, randomised, placebo-controlled, Phase 3 clinical trial that investigated the efficacy and safety of once-daily oral baricitinib 4 mg or 2 mg treatment versus placebo in participants with active SLE plus standard of care.
Following primary and major secondary endpoints not being met, Petri, et al. conclude that the SLE-BRAVE-II trial does not replicate results previously seen in Phase 2 and the Phase 3 SLE-BRAVE-I trials.
