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Anakinra is safe but does not reduce complications of acute myocarditis

ARAMIS trial presented in a Hot Line session today at ESC Congress 2023

Acute Cardiac Care
Acute Coronary Syndromes

Amsterdam, Netherlands – 28 Aug 2023: The largest randomised controlled trial of patients with acute myocarditis has found that anakinra is safe but does not reduce complications. The late breaking research presented in a Hot Line session today at ESC Congress 2023.1

Acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias and death. The disease can occur in individuals of all ages, but is most frequent in the young.2 There are no specific therapies, and patients are generally treated with beta-blockers, ACE inhibitors and sometimes steroids, in accordance with an ESC expert consensus.2 Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. While anakinra is effective in pericarditis,3,4 there are only case reports of successfully treated acute myocarditis.5,6

ARAMIS was the largest randomised controlled trial of acute myocarditis and the first to evaluate inhibition of the interleukin-1β innate immune pathway in these patients. The trial enrolled hospitalised, symptomatic patients with increased cardiac troponin and acute myocarditis diagnosed using cardiac magnetic resonance (CMR) imaging. Patients were randomly allocated in a 1:1 ratio within 72 hours of hospital admission to a daily subcutaneous dose of anakinra 100 mg or placebo until hospital 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 (heart failure requiring hospitalisation, chest pain requiring medication, left ventricular ejection fraction <50%, and ventricular arrythmias) within 28 days post-discharge.

The study included 120 patients from six academic centres in France. A total of 117 patients were included in the intention-to-treat analysis. Consistent with prior data, the median age of participants was 28 years and nearly 90% were men. 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 (quartile 1, quartile 3) of 30 days (30, 32) for anakinra versus 31 days (30, 32) for placebo, for a difference of 0.0 (95% confidence interval -1.0 to 0.0, p=0.168).

The safety endpoint was the number of serious adverse events within 28 days post-discharge. This endpoint occurred in 7 patients (12.1%) in the anakinra arm and 6 patients (10.2%) in the placebo arm, with no significant difference between groups. Cases of severe infection within 28 days post-discharge were reported in both arms.

Principal investigator Dr. Mathieu Kerneis of Pitié Salpetrière APHP University Hospital, Paris, France said: “ARAMIS enrolled an all-comer acute myocarditis population diagnosed with CMR, who were mostly at a low risk of complications. A short course of anakinra did not increase the number of days free of myocarditis complications. 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 randomised 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.”




Notes to editor

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This press release accompanies both a presentation and an ESC press conference at ESC Congress 2023. It does not necessarily reflect the opinion of the European Society of Cardiology.


Funding: The study was a pure academic trial, and was funded by the French Ministry of Health and coordinated by the ACTION Group, an academic research organisation, based at the Pitié Salpetrière Hospital in Paris.


Disclosures: Dr. Kerneis has no direct conflict of interest in relation to the study (no funding or consulting fees/lectures fees from SOBI, the pharmaceutical company that licensed anakinra). He has received consulting fees from Kiniksa, Sanofi, Bayer over the past three years, for an amount less than €5,000/year.


References and notes

1ARAMIS will be discussed during Hot Line 7 on Monday 28 August at 11:15 to 12:15 CEST in room Amsterdam.

2Caforio ALP, Pankuweit S, Arbustini E, et al. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013;34:2636-2648.

3Brucato A, Imazio M, Gattorno M, et al. Effect of anakinra on recurrent pericarditis among patients with colchicine resistance and corticosteroid dependence: The AIRTRIP randomized clinical trial. JAMA. 2016;316:1906-1912.

4Cheema AH, Chaludiya K, Khalid M, et al. Efficacy of anakinra in pericarditis: A systematic review. Cureus. 2022;14:e29862.

5Maunier L, Charbel R, Lambert V, et al. Anakinra in pediatric acute fulminant myocarditis. Ann Intensive Care. 2022;12:80.

6Parisi F, Paglionico A, Varriano V, et al. Refractory adult-onset Still disease complicated by macrophage activation syndrome and acute myocarditis: A case report treated with high doses (8 mg/kg/d) of anakinra. Medicine (Baltimore). 2017;96:e6656.


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