Third Phase III trial of baricitinib shows superiority to methotrexate in rheumatoid arthritis- Eli Lilly + Incyte

Eli Lilly and Company and Incyte Corporation announced positive top-line results of RA-BEGIN, the third Phase III study evaluating the safety and efficacy of baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis (RA). The study met its primary objective of demonstrating non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment. Additionally, baricitinib was superior to methotrexate based on ACR20 response.

In RA-BEGIN, the incidence of treatment-emergent adverse events and serious adverse events, including serious infections, was similar across treatment groups. No cases of tuberculosis or gastrointestinal perforation were reported during the study. The most common adverse events observed were consistent with previous studies of baricitinib in RA.

Comment: 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 EULAR 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.