Lilly has decided to discontinue the phase 3 development program for baricitinib in adults with active systemic lupus erythematosus.
The decision was made based on data from 2 pivotal phase 3 trials, SLE-BRAVE-I (ClinicalTrials.gov Identifier: NCT03616912) and II (ClinicalTrials.gov Identifier: NCT03616964), which evaluated the efficacy and safety of baricitinib in adults with active systemic lupus erythematosus. The primary endpoint for both trials was the proportion of patients achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) response at week 52.
Results from SLE-BRAVE-I showed that baricitinib met the primary endpoint demonstrating a statistically significant reduction in disease activity compared with placebo. However, in SLE-BRAVE-II, treatment with baricitinib did not meet the primary endpoint. Both trials also failed to meet key secondary endpoints. The safety profile of baricitinib was consistent with previously published data and did not influence the decision to discontinue the program.
According to the Company, study findings will be published at a later date following further analysis of the data. The Company is working with investigators to conclude the phase 3 long-term extension trial, SLE-BRAVE-X (ClinicalTrials.gov Identifier: NCT03843125).
With regard to the supplemental New Drug Application (sNDA) for baricitinib for moderate to severe atopic dermatitis, the Company announced that a Complete Response Letter from the Food and Drug Administration (FDA) could be a possibility, as questions still remain about the indicated population.
The sNDA submission included data from 8 clinical trials, including 6 double-blind, randomized, placebo-controlled studies and 2 long-term extension studies, in patients whose disease was not adequately controlled with topical prescription therapies or when those therapies were not advisable.
Baricitinib, a Janus kinase inhibitor, is currently marketed under the brand name Olumiant and is approved for the treatment of rheumatoid arthritis. It is also authorized for emergency use for the treatment of COVID-19 in hospitalized patients 2 years of age and older requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Updates on Olumiant® (baricitinib) phase 3 lupus program and FDA review for atopic dermatitis. News release. Eli Lilly and Company and Incyte. Accessed January 28, 2022. https://www.prnewswire.com/news-releases/updates-on-olumiant-baricitinib-phase-3-lupus-program-and-fda-review-for-atopic-dermatitis-301470359.html