The New England Journal of Medicine published supplementary data, which show that people with moderate-to-severe rheumatoid arthritis (RA) who took the oral Janus kinase inhibitor baricitinib had better outcomes through 52 weeks compared to adalimumab (Humira).
“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.
In the RA-BEAM study, researchers studies more than 1,300 people who did not have an adequate response to methotrexate, but continued the use of methotrexate throughout the duration of the study. Participants were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). At the 24th week, participants taking placebo 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.
A higher proportion of participants 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. This was observed as early as week 8 and continued through week 52.
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 ACR50 was statistically significant.
Serious adverse events were observed in 8% for baricitinib and 4% for Adalimumab. Major adverse cardiovascular events (MACE) were reported in less than 1% 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).
“These data demonstrate that baricitinib could provide another treatment option for people with rheumatoid arthritis,” Taylor added.