medwireNews: Results of the RA-BEAM trial suggest that baricitinib may improve clinical outcomes relative to placebo or adalimumab among patients with active rheumatoid arthritis (RA) who have an inadequate response to methotrexate.
As reported in The New England Journal of Medicine, 70% of 487 patients receiving baricitinib treatment achieved the primary endpoint of a 20% improvement according to the criteria of the American College of Rheumatology (ACR20 response) at 12 weeks. By comparison, 40% of 488 patients receiving placebo had an ACR20 response at week 12, a significant difference.
The study participants were randomly assigned to receive one of three treatment regimens: placebo, 4 mg baricitinib once daily, or 40 mg of adalimumab every other week.
Participants received the study drug in addition to background treatment with methotrexate, “a context in which adalimumab has proved to be most efficacious,” report researcher Peter Taylor (University of Oxford, UK) and colleagues.
The team observed significant improvements in disease activity as measured by the Health Assessment Questionnaire–Disability Index and the Disease Activity Score for 28 joints based on C-reactive protein levels at 12 weeks with baricitinib versus placebo, and more patients receiving baricitinib were in remission according to the Simplified Disease Activity Index.
Participants in the baricitinib group also experienced a significant reduction in radiographic progression of structural joint damage at week 24 compared with those receiving placebo.
Furthermore, the week 12 ACR20 response rate was significantly higher among baricitinib-treated patients compared with 330 participants receiving adalimumab (70 vs 61%), suggesting that the Janus kinase 1 and 2 inhibitor is associated with “significant clinical improvements” compared with placebo and “a current standard-of-care treatment in this patient population,” says the team.
A total of 71% of participants in the baricitinib group experienced an adverse event from baseline to week 24, compared with 68% of patients receiving adalimumab and 60% receiving placebo.
Rates of serious adverse events were 5%, 2%, and 5%, respectively, “with no particular type of event contributing to the lower rate observed with adalimumab,” observe Taylor and colleagues.
Infections occurred more frequently among patients receiving baricitinib or adalimumab compared with placebo, with corresponding rates of 36%, 33%, and 27%, and “similar” rates of adverse events, including infections, were observed up to 52 weeks of follow-up.
Although baricitinib improved outcomes relative to placebo and adalimumab, the researchers note that only 15 to 18% of patients in each group were receiving other disease-modifying antirheumatic drugs (DMARDs).
“Thus, the study has a limited capacity to assess the effectiveness of baricitinib when used in combination with conventional synthetic DMARDs other than methotrexate,” they caution.
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