Successful Phase III RA-BUILD study for baricitinib in rheumatoid arthritis- Eli Lilly

Eli Lilly and Company and Incyte Corporation announced that the investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive Phase III trial in rheumatoid arthritis (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 (cDMARD). The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment. Part of an extensive Phase III program testing baricitinib in more than 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 (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. There were no opportunistic infections or gastrointestinal perforations in the study.

Lilly and Incyte announced top-line results from the first Phase III 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.

Comment:Unlike the injected TNF blockers baricitinib is an oral JAK inhibitor designed to block inflammatory signaling and treat the underlying cause of immune diseases including RA, all without the need for needles and is in the same class as Xeljanz (tofacitinib citrate) from Pfizer which was approved in the US with a risk evaluation and mitigation strategy plan.