Eli Lilly and Company and Incyte Corporation announced Tuesday positive top-line results from the Phase 3 study RA-BEGIN which evaluated baricitinib against methotrexate, a common treatment for rheumatoid arthritis.
Based on the results, RA-BEGIN met its primary objective to show that baricitinib is not inferior to methotrexate when addressing moderately to severely active rheumatoid arthritis. However, more than just not being inferior, baricitinib was found to be superior to methotrexate, making it a viable treatment option for those with the disease.
A lot of people with rheumatoid arthritis who are treated with methotrexate are not getting the results they desire, which causes disability and impedes productivity. If people with rheumatoid arthritis can adequately control their disease, they can be more active in their communities, careers and families, allowing them to enjoy a better quality of life.
RA-BEGIN involved patients who have no prior or limited experience with being treated with methotrexate and have not been exposed to other biologic or conventional disease-modifying antirheumatic drugs (DMARDs). This Phase 3 study is part of a larger program with over 3,000 patients at different points of treatment for rheumatoid arthritis, enrolling almost 600 patients who were randomized to receive a daily 4mg dose of oral baricitinib, a weekly dose of oral methotrexate, or a daily 4mg dose of oral baricitinib with a weekly dose of oral methotrexate.
According to Rich Levy, M.D., chief drug development officer for Incyte, baricitinib superiority adds to data showing the investigational drug's positive effects on patients with rheumatoid arthritis but have experienced poor response to traditional DMARDs and biological therapies.
RA-BEGIN is the third Phase 3 study carried out by Lilly and Incyte for baricitinib. Results for the first Phase 3 study, RA-BEACON, were announced in December 2014, followed by RA-BUILD's in February of this year. Data from the Phase 3 studies were presented in June at the EULAR annual scientific congress, but Lilly and Incyte are keen on submitting additional data from the studies to peer-reviewed journals and more scientific meet this year and the next. Results from RA-BEAM, the fourth Phase 3 study, are expected later in 2015.
Rheumatoid arthritis is classified as an autoimmune disease featuring inflammation and progressive damage to joints. Around the world, it is estimated that over 23 million are living with the disease. Current treatment options include non-steroidal anti-inflammatory drugs, injectable biological response modifiers and oral DMARDs.
Photo: Steven Depolo | Flickr
