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Late-Stage Study Finds Lilly’s Investigational RA Medicine Effective
Top-line results of the RA-BEGIN study evaluating the safety and efficacy of baricitinib (Lilly/Incyte) for patients with moderate-to-severe active rheumatoid arthritis (RA) found the treatment to be superior to methotrexate.
The study examined approximately 600 patients to test the oral medication. In addition to improved efficacy findings over methotrexate based on the ACR20 response (an American College of Rheumatology 20% improvement), there were no differences in safety between the two drugs.
Baricitinib is a once-daily, oral, selective JAK1 and JAK2 inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3, and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK3 in kinase assays.
Lilly and Incyte announced top-line results in December 2014 for the first phase III trial of baricitinib, RA-BEACON, and in February 2015 for the second, RA-BUILD. Data from these studies were presented at the European League Against Rheumatism annual scientific congress in June 2015. The companies plan to submit additional detailed data from all three of these studies for presentation in scientific meetings and publication in peer-reviewed journals in 2015 and 2016. Top-line results of the fourth phase III study, RA-BEAM, are expected later this year.
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
Sources: Eli Lilly; September 29, 2015; The Washington Times, September 29, 2015.