Eli Lilly Discontinues Baricitinib Development for Systemic Lupus Erythematosus Following Mixed Phase 3 Trial Results

On January 28, Eli Lilly announced the decision to terminate the development of JAK inhibitor Olumiant (baricitinib) for lupus indications based on the key results from two pivotal Phase III trials (SLE-BRAVE-I and SLE-BRAVE-II).

In the SLE-BRAVE-I study, the baricitinib 4mg dose group reached the primary endpoint of the study, significantly reducing disease activity compared to placebo at week 52, with a markedly higher proportion of active lupus patients achieving an SRI-4 response. The SLE-BRAVE-II study also enrolled active lupus patients but did not achieve the primary endpoint of SRI-4 response improvement. Neither study met the key secondary endpoints. The safety profile of baricitinib was consistent with findings from previous studies.

Eli Lilly plans to further analyze the relevant data and intends to publish the research results in a paper later.