FDA Approves Rilonacept to Treat Recurrent Pericarditis and to Curb Recurrences

The US Food and Drug Administration has approved rilonacept (Arcalyst; Kiniksa Pharmaceuticals), an interleukin-1 inhibitor, for the treatment of recurrent pericarditis and to reduce the risk of recurrence in adults and children over the age of 12.

The agent is the first to be approved for this disease and comes on the heels of the small RHAPSODY trial, released at the virtual American Heart Association Scientific Sessions in 2020. That small, randomized trial, undertaken in patients showing symptoms of pericarditis recurrence despite first- and second-line therapies, demonstrated that rilonacept agent produced rapid resolution of pericarditis and fewer recurrent pericarditis episodes.

Allan Klein, MD (Cleveland Clinic, OH), who presented the trial results last year, estimated that there are 40,000 patients with pericarditis in the United States, many of them young women in midlife who develop it after a viral illness or surgery. Up to 30% have a recurrent episode.

The FDA announcement includes a warning that serious, life-threatening infections have been reported in patients taking rilonacept and that patients with active or chronic infections should not take the drug and, if taking it, should avoid live vaccines. Rilonacept is already approved in a number of other clinical settings such as cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in patients 12 years and older, a press release notes.