Baricitinib for Systemic Lupus Erythematosus: a Double-blind, Randomised, Placebo-controlled, Phase 3 Trial (SLE-BRAVE-I)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02607-1
Primary endpoint in SLE-BRAVE-I study was met for the 4 mg baricitinib group, however, key secondary endpoints were not.
Following Phase 2 study results showing that baricitinib 4 mg significantly improved SLE disease activity, compared with placebo at 24 weeks, Morand, et al. sought to evaluate the efficacy and safety of baricitinib in patients with active SLE in a 52-week Phase 3 study.
Although a significantly greater proportion of participants who received baricitinib 4 mg reached SRI-4 response, a lack of achievement with major secondary endpoints means the efficacy of baricitinib in addition to existing SOC for the treatment of patients with moderate-to-severe active SLE is unclear. The phase 3 development programme for baricitinib in SLE has, therefore, been discontinued.
