Phase III study of LY 3009104 (baricitinib) meets primary objective in rheumatoid arthritis- Eli Lilly/Incyte Corp

Eli Lilly and Incyte Corporation announced positive topline results of RA-BEAM, the fourth successful Phase III study of LY 3009104 (baricitinib), an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis. The study met its primary objective of demonstrating superiority compared 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 objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment. Following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. These treatment benefits with baricitinib observed at 12 and 24 weeks were maintained through 52 weeks of therapy.

Compared to placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. Rates of treatment-emergent adverse events, including infections, were higher for baricitinib and adalimumab compared to placebo. The companies plan to submit detailed data from RA-BEAM and other Phase III studies for presentation at scientific meetings and publication in peer-reviewed journals in 2015 and 2016.

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 without the need for needles, and is in the same class as Xeljanz (tofacitinib citrate). Xeljanz was approved in the US with a risk evaluation and mitigation strategy plan, but its marketing authorisation application was refused in the EU based on the benefit/risk balance.