Switch from adalimumab to baricitinib may benefit some RA patients
medwireNews: Analysis of data from the RA-BEAM and RA-BEYOND trials suggests that switching from adalimumab to baricitinib is associated with improvements in disease control and patient-reported outcomes in patients with rheumatoid arthritis (RA), with an acceptable safety profile.
The RA-BEAM analysis included 40 participants who had an inadequate response to the tumor necrosis factor (TNF) inhibitor adalimumab at week 16 or later of the phase III trial and were given open-label rescue therapy with the Janus kinase (JAK)1/2 inhibitor baricitinib 4 mg/day for the remainder of the 1-year study. The RA-BEYOND analysis included 238 participants treated with adalimumab who went on to receive baricitinib 4 mg/day without a washout period in the long-term extension study.
Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu, Japan) and co-investigators report in the Annals of the Rheumatic Diseases that patients who switched from adalimumab to baricitinib during RA-BEAM “showed sustained and clinically relevant improvements in efficacy.”
For example, average DAS28-ESR score improved significantly from the time of the switch to 4, 8, and 12 weeks later, with reductions of 1.38, 1.69, and 1.92 points, respectively, from an average score of 6.2 points at the time of switching. The corresponding improvements in CDAI score were 14.8, 17.8, and 20.2 points, from an average score of 36.4 points.
Participants switching from adalimumab to baricitinib in RA-BEAM also experienced significant improvements in SDAI, pain, and HAQ-DI scores from the time of switching to the 4-, 8-, and 12-week follow-up timepoints, as well as a significant reduction in the inflammatory markers C-reactive protein and erythrocyte sedimentation rate.
In accordance with these findings, patients who had an adequate response and received adalimumab throughout RA-BEAM and switched to baricitinib in the RA-BEYOND open-label extension study also experienced significant improvements in measures of disease activity, function, and pain from the time of switching to 4 weeks later, and these improvements were maintained until the 24-week follow-up.
Because the switch “occurred without a washout period, and adalimumab has a mean circulating half-life of approximately 14 days,” the investigators point out that participants “would therefore have received several weeks of dual TNF and JAK1/JAK2 inhibition after treatment change,” and thus “some of the initial benefit evident after switch might in fact be accounted for by the combination.”
The researchers report that safety findings in their study “were consistent with the known safety profile of baricitinib.” A total of 65.0% of patients switching from adalimumab to baricitinib during RA-BEAM experienced treatment-emergent adverse events (TEAEs) within 24 weeks of the switch, while 52.1% did so after switching to baricitinib in the long-term extension study. The most common TEAEs were infections and gastrointestinal disorders.
These safety data “suggest that a prompt transition from adalimumab to baricitinib can be executed with acceptable safety and tolerability,” say Tanaka et al.
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