Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today additional detailed results from RA-BEAM - a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - were published in the New England Journal of Medicine.
The New England Journal of Medicine publication includes supplementary data, which show that starting as early as week 8, and sustained through week 52, a higher proportion of patients taking baricitinib achieved ACR50 and ACR70 response - composite scores that represent at least 50 percent and 70 percent improvement, respectively, in multiple components of RA disease activity - compared to adalimumab (Humira®*). These improvements were statistically significant compared to adalimumab at weeks 12, 20, 28, 32 and 40. At week 52, both ACR50 and ACR70 rates were higher in the baricitinib group compared to adalimumab, although only ACR 50 was statistically significant.
A significantly higher proportion of patients taking baricitinib had low disease activity, assessed by the 28-joint Disease Activity Score (using high-sensitivity C reactive protein [DAS28-CRP]), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) scores, compared to adalimumab at weeks 12 and 52.
Lilly and Incyte previously announced positive topline results of RA-BEAM, stating that 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 percent improvement in RA disease activity.
"This is an exciting time for rheumatology, with potential new treatments for rheumatoid arthritis on the horizon. The RA-BEAM study of baricitinib is the first phase 3 trial showing that a once-daily, oral treatment significantly improved clinical outcomes compared with a current standard of care, injectable adalimumab used with background methotrexate therapy," said Peter Taylor, M.A., Ph.D., F.R.C.P., study author and Norman Collisson chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. "These data demonstrate that baricitinib could provide another treatment option for people with rheumatoid arthritis."
The 52-week RA-BEAM study included more than 1,300 patients with inadequate response to methotrexate, all of whom continued to receive methotrexate through the study period. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). At week 24, patients taking placebo were crossed over to the baricitinib treatment group. The design of the head-to-head study and statistical analysis plan included prespecified and controlled for multiple testing for both non-inferiority and superiority of baricitinib compared with adalimumab.
Detailed safety results from the trial show that the percentage of patients stopping therapy due to adverse events through week 24 were 3 percent in placebo, 5 percent in baricitinib and 2 percent in the adalimumab group. Serious adverse event rates through 24 weeks were similar with placebo and baricitinib (5 percent each) and lower with adalimumab (2 percent).
Through the 52-week period, serious adverse event rates were 8 percent for baricitinib and 4 percent for adalimumab. Patients stopping therapy due to adverse events from baseline through week 52 were 7 percent for baricitinib and 4 percent for adalimumab. Major adverse cardiovascular events (MACE) were reported in less than 1 percent of patients in both the baricitinib and adalimumab groups (baseline through 52 weeks). A total of 5 deaths were reported in the study (1 placebo, 2 baricitinib, 1 adalimumab and 1 placebo rescued to baricitinib).
Baricitinib, an investigational medicine for the treatment of moderate-to-severe RA, is in the late stages of regulatory review in the United States and Japan. In February 2017, the European Commission granted marketing authorization for baricitinib for the treatment of moderate-to-severe RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
About Baricitinib
Baricitinib is a once-daily oral selective JAK1 and...
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