Use of anakinra – an interleukin-1 receptor antagonist – in patients with acute myocarditis was found to be safe but did not reduce complications, according to findings from the ARAMIS trial presented at ESC Congress 2023.

The trial randomized 120 symptomatic patients hospitalized with increased cardiac troponin and acute myocarditis at six centers in France to either a daily subcutaneous dose of anakinra (100 mg) or placebo. The median age of participants was 28 years and nearly 90% were men.

Patients received anakinra or placebo within 72 hours of hospital admission and continued the treatment until discharge. Patients in both groups received standard of care treatments, including an ACE inhibitor for at least one month. The primary endpoint was the number of days free of myocarditis complications within 28 days post-discharge.

Overall, the rate of the composite endpoint of myocarditis complications occurred in 13.7% of patients. There was no difference in the number of days free of any myocarditis complications between the two arms, with a median of 30 days for anakinra compared with 31 days for placebo. The safety endpoint involving the number of serious adverse events within 28 days post-discharge occurred in seven patients (12.1%) in the anakinra group and six patients (10.2%) in the placebo group, with no significant difference between groups.

"A short course of anakinra did not increase the number of days free of myocarditis complications," said Mathieu Kerneis, MD, of Pitié Salpetrière APHP University Hospital in Paris, France. "There was no safety issue with anakinra administered during the acute phase of myocarditis diagnosed without endomyocardial biopsy, and therefore no proof of viral status. Further randomized controlled trials are needed to explore the potential benefit of an anti-inflammatory strategy in acute myocarditis patients at high risk of complications. In addition, larger studies are needed to evaluate prolonged anti-inflammatory strategies in acute myocarditis patients at low-to-moderate risk of complications."

Clinical Topics: Heart Failure and Cardiomyopathies

Keywords: ESC Congress, ESC23, ACC International, Myocarditis

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