Investigational Oral Arthritis Tx Tops Adalimumab in Phase 3 Study

Eli Lilly and Incyte announced positive topline results of RA-BEAM, the fourth Phase 3 study of baricitinib for patients with moderately-to-severely active rheumatoid arthritis (RA).

RA-BEAM evaluated the safety and efficacy of baricitinib in more than 1,300 patients with active RA despite treatment with methotrexate, compared to placebo for 24 weeks or adalimumab for 52 weeks. Patients were randomized to receive either 4mg once daily baricitinib on background methotrexate, 40mg every 2 weeks adalimumab on background methotrexate or placebo on background methotrexate.

The study met its primary endpoint of demonstrating superiority to placebo after 12 weeks of treatment based on ACR20 response, a standard clinical measure that represents at least a 20% improvement in RA disease activity. Baricitinib was also superior to adalimumab on key secondary endpoints of ACR20 response. Following 24 weeks of treatment, baricitinib also demonstrated superiority to placebo in preventing progressive radiographic structural joint damage. These treatment benefits were maintained through 52 weeks of therapy.

Lilly and Incyte previously announced top-line results from other Phase 3 studies for baricitinib, RA-BEACON, RA-BUILD and RA-BEGIN. The companies plan to submit detailed data from RA-BEAM and other Phase 3 studies for presentation at scientific meetings and journal publications in 2015 and 2016.

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