Eli Lilly and Company and Incyte Corporation have announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis (RA).
Lilly says that 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.
“Too many people with rheumatoid arthritis who are treated with methotrexate – commonly used across the disease continuum for 25 years – do not achieve adequate disease control, which can cause disability and impede productivity,” said David Ricks, Lilly senior vice president, and president of Lilly Bio-Medicines.
“People living with RA who achieve adequate disease control can be more active with their families, in their careers and in their communities – emphasizing the importance of effective treatment options.”
Lilly explains that the RA-BEGIN study included patients who had limited or no prior treatment with methotrexate, and were naïve to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs). Part of a larger Phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEGIN enrolled nearly 600 patients who were randomized to one of the following treatment groups:
Once-weekly oral methotrexate monotherapy
4 mg once-daily oral baricitinib monotherapy
4 mg once-daily oral baricitinib in combination with once-weekly oral methotrexate
“The superiority of baricitinib over methotrexate in the treatment of patients with early RA adds to the positive data already seen for baricitinib in RA patients with inadequate responses to traditional DMARDs (RA-BUILD) and biological therapies (RA-BEACON),” said Rich Levy, M.D., chief drug development officer of Incyte. “The sum of these results further illustrates the therapeutic profile of baricitinib. If approved, we believe that baricitinib has the potential to be used across multiple lines of therapy in rheumatoid arthritis.”
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. Discontinuations due to adverse events were more common in patients receiving the combination of baricitinib plus methotrexate. A large majority of patients completing RA-BEGIN opted to participate in a long-term extension study.
Lilly and Incyte announced top-line results in December 2014 for the first Phase 3 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. Toplineresults of the fourth Phase 3 study, RA-BEAM, are expected later this year.