Results of the phase III SLE-BRAVE-I trial were recently published by Morand et al in The Lancet. In the trial, investigators sought to evaluate the efficacy and safety of baricitinib in patients with active systemic lupus erythematosus (SLE) over 52 weeks, based on a previous 24-week phase II trial that showed the agent improved disease activity in patients with SLE. A total of 760 patients were randomly assigned 1:1:1 to receive 4 mg of baricitinib, 2 mg of baricitinib, or placebo once daily for 52 weeks with standard of care. More patients receiving the 4-mg dose were found to reach the study’s primary endpoint—an SLE Responder Index–4 response at week 52—than those receiving 2 mg or placebo. However, key secondary endpoints of the trial were not reached among patients receiving baricitinib. Though this study was positive, a companion study evaluating baricitinib in this patient population was negative.
In a companion press release on the findings from Monash University, first study author Eric F. Morand, MBBS, commented, “In many ways, this has sent us back to the drawing board, but all results help us know where to go from here…. As lupus is a disease where no two patients are alike, measurement of treatment effects is complex and complicated.”