Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).
RA-BEGIN is a randomized, Phase 3 study including nearly 600 patients who had limited or no prior treatment with methotrexate, and were naïve to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs). Patients received either methotrexate once weekly, baricitinib 4mg once daily, or combination of baricitinib and methotrexate regimen. The study met its primary endpoint of demonstrating non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment. Additionally, baricitinib demonstrated superiority to methotrexate based on ACR20 response.
The clinical trial program for baricitinib in moderately-to-severely active RA includes five Phase 3 trials conducted in a wide range of patients including those who are methotrexate naïve, inadequate responders to methotrexate, inadequate responders to conventional DMARDs, or inadequate responders to TNF inhibitors. Four of the trials are expected to be completed by the end of 2015.
Baricitinib is a once-daily, oral, selective JAK1 and JAK2 inhibitor.
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