In a pivotal Phase 3 clinical trial, Olumiant (baricitinib) improved patients’ outcomes in the treatment of moderate-to-severe rheumatoid arthritis (RA), in comparison to Humira (adalimumab) and placebo, according to a recent article published in the New England Journal of Medicine.
“Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis” presented the results of RA-BEAM (NCT01710358), the pivotal Phase 3 study evaluating the effectiveness and safety of Olumiant in patients with moderate-to-severe active RA, who have had an inadequate response to methotrexate therapy.
Olumiant, developed by Eli Lilly and Company and Incyte Corporation, is the first Janus kinase (JAK) inhibitor to receive marketing authorization in the European Union for the treatment of moderate-to-severe active RA, either as monotherapy or in combination with methotrexate.
In the United States and Japan, baricitinib is in the late stages of regulatory review.
The RA-BEAM study included more than 1,300 randomized patients (488 on placebo, 488 on Olumiant, and 330 on Humira) with inadequate response to methotrexate, all of whom continued to receive it through the entire trial period.
Findings from this 52-week trial showed that from week eight to week 52, more patients taking Olumiant achieved ACR50 and ACR70 response, as compared to Humira.
ACR score is a standard clinical measure developed by the American College of Rheumatology (ACR) that represents, in this case, a 50% and 70% improvement in RA disease activity, respectively.
More people receiving Olumiant also showed lower levels of disease activity, in comparison to people receiving Humira, at weeks 12 and 52.
Further details on the drug’s safety demonstrated that the percentage of patients who were forced to stop treatment due to adverse events through week 24 were: 3% for placebo, 5% for Olumiant, and 2% for Humira. The severity of these adverse events was similar in the placebo and Olumiant groups, and lower in the Humira group.
“This is an exciting time for rheumatology, with potential new treatments for rheumatoid arthritis on the horizon,” Peter Taylor, MA, PhD, FRCP, author of the study, said in a press release. Taylor is Normal Collisson chair of Musculoskeletal Sciences at the University of Oxford.
“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. These data demonstrate that baricitinib could provide another treatment option for people with rheumatoid arthritis,” Taylor concluded.