Eli Lilly and Company and their partner Incyte announced they discontinued development of Olumiant® (baricitinib) as a treatment for lupus. The company announced its decision after reviewing data from two large phase-3 clinical trials (SLE-BRAVE 1 and SLE-BRAVE 2) of Olumiant involving more than 1,000 adults with active lupus.

While the first phase-3 trial of Olumiant reached its primary endpoint of demonstrating a statistically significant reduction in lupus disease activity, the follow-up trial did not. Neither trial achieved key secondary endpoints, as well. The company is working with clinical investigators to wind down a long-term extension trial involving participants who successfully completed the earlier phase-3 trials.

Olumiant is an oral medication that inhibits the activity of one or more of the Janus kinase (JAK) family of enzymes involved in interactions among immune cell proteins. It is approved in the US and Europe for treating rheumatoid arthritis in adults with moderately to severely active rheumatoid arthritis who have failed to respond to other treatments. Lilly is also conducting trials of Olumiant for other immune-related conditions and as a potential COVID-19 therapy.

Despite this disappointing decision, there remains excellent momentum to develop new therapies for lupus. Two new medications received FDA approval in 2021 for use in lupus and lupus nephritis, while another previously approved lupus therapy received expanded authorization for treating lupus nephritis. There is a robust pipeline of potential lupus treatments. Learn more about how you can become involved in research and help propel the development of new and more effective therapies.

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