ARAMIS: Can anakinra alleviate acute myocarditis?

The IL-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.

“Experimental studies and case reports suggest that IL-1β inhibition could be effective in acute myocarditis,” said Prof. Mathieu Kerneis (Sorbonne University, France) [1]. The ARAMIS trial (NCT03018834) randomised 120 participants with acute myocarditis to standard-of-care plus anakinra (once daily 100 mg, subcutaneously administered) or to standard-of-care plus placebo. The primary endpoint was the number of days alive and free from myocarditis complications at 28 days post-discharge.

The participants were treated for a median of 2 days. The median 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.

Discussant Dr Enrico Ammirati (Niguarda Hospital, Italy) emphasised that the ARAMIS trial reflects the situation in the real world. “Most patients with acute myocarditis are at low risk of events. However, other randomised-controlled trials are needed to assess anakinra or other immunosuppressive drugs in high-risk patients with acute myocarditis.”

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   1. Kerneis M, et al. The ARAMIS trial: anakinra versus placebo, a double blind randomized controlled trial, for the treatment of acute myocarditis. Hot Line Session 7, ESC Congress 2023, 25–28 August, Amsterdam, the Netherlands.

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Posted on 30 October 202330 October 2023