Anakinra, added to standard care, did not improve days free from myocarditis complications in patients with acute myocarditis, the ARAMIS trial found.
The interleukin-1 receptor antagonist anakinra, added to standard of care, did not increase the number of days free from myocarditis complications in low-risk patients with acute myocarditis. However, the authors noted that larger trials are needed to evaluate anti-inflammatory strategies in high-risk patients.
The phase 2b ARAMIS trial randomly assigned 120 participants with acute myocarditis to standard of care plus anakinra (once-daily 100 mg, administered subcutaneously) or to standard of care plus placebo. The primary endpoint was the number of days alive and free from myocarditis complications at 28 days postdischarge. Mathieu Kerneis, MD, PhD, presented the results at ESC Congress 2023.
The participants were treated for a median of 2 days. The median number of days free from complications was 31 in the placebo group and 30 in the anakinra group (P=0.17). Although the cardiovascular event rate appeared to be higher in the placebo arm (16.7% vs 10.5%), the study was not powered for this endpoint. Finally, no particular safety issues emerged for the treatment with anakinra. Serious adverse events occurred in 12.1% of the participants in the anakinra arm and 10.2% in the placebo arm.
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