Dr. Mathieu Kerneis, MD, PhD, was the Principal Investigator of the recently completed ARAMIS Study. (Anakinra versus Placebo for the Treatment of Acute Myocarditis).
Whereas acute myocarditis can resolve spontaneously, an abnormal immune response can lead to impaired left ventricular contractility and clinical progression to chronic heart failure.
The ARAMIS Study was a national multicenter randomized parallel-group double blind study of 120 symptomatic patients with elevated Troponin and Cardiac MRI proven acute myocarditis.
Although it was a small sample group, it was the largest randomized trial for treatment of acute myocarditis in many years.
Patients were given Anakinra 100 mg or a placebo until hospital discharge. A short course of Anakinra did not increase the number of days free of myocarditis complications. There were no safety issues with Anakinra administered during the acute phase of myocarditis. Further randomized controlled trials are needed to explore the potential benefit of an anti-inflammatory strategy in acute myocarditis patients at high risk of complication.
While the outcome of the trial was neutral/negative, it established a network of enthusiastic clinicians that can be used to study the next promising therapies.