Lilly: Baricitinib Superior To Placebo In Reducing Rheumatoid Arthritis Activity

(RTTNews) - Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) announced that the investigational medicine baricitinib showed a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis or RA. The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug or cDMARD. The study achieved its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.

According to the company, part of an extensive Phase 3 program testing baricitinib in over 3,000 patients at different stages along the RA treatment continuum, the RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug or bDMARD. Patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy.

In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment, including serious infections, was similar to placebo.

Lilly and Incyte reported top-line results from the first Phase 3 trial of baricitinib, RA-BEACON, which also met its primary endpoint, in December 2014 and plan to present detailed data from both RA-BEACON and RA-BUILD at scientific meetings in 2015.