Rilonacept benefits patients with recurrent pericarditis
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In patients with recurrent pericarditis, compared with placebo, rilonacept better resolved recurrent episodes and lowered risk for future episodes, according to data presented at the virtual American Heart Association Scientific Sessions.
For the RHAPSODY trial, researchers randomly assigned patients with acute symptoms of recurrent pericarditis and elevated C-reactive protein levels to rilonacept (Kiniksa Pharmaceuticals), an interleukin (IL)-1-alpha and IL-1-beta cytokine trap, or placebo. The results were simultaneously published in The New England Journal of Medicine.
Rilonacept is FDA-approved to treat cryopyrin-associated periodic syndromes and is marketed for that purpose by Regeneron under the brand name Arcalyst. Kiniksa licensed the drug from Regeneron for evaluation in diseases mediated by IL-1-alpha and IL-1-beta, including recurrent pericarditis, and an FDA application for a recurrent pericarditis indication is pending, according to Kiniksa’s website.
“Recurrent pericarditis is a debilitating disease with no FDA-approved therapies,” Allan L. Klein, MD, director of CV imaging research, director of the Center for the Diagnosis and Treatment of Pericardial Diseases and a staff cardiologist in the section of CV imaging, the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, at the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic, said during a presentation. “Typically, the disease is managed with a combination of NSAIDs, colchicine and steroids. Long-term steroid use and the associated morbidity are concerns in patients with recurrent disease. IL-1 has been implicated as a mediator of recurrent pericarditis.”
The researchers enrolled 86 patients (mean age, 45 years; 57% women) into a run-in period to assess for response to rilonacept, and 61 patients responded sufficiently and underwent randomization, Klein said.
The primary endpoint was time to pericarditis recurrence, but the median time to first pericarditis recurrence in the rilonacept group could not be calculated because there were so few recurrent events, Klein said. The median time to first pericarditis recurrence was 8.6 weeks (HR = 0.04; 95% CI, 0.01-0.18; log-rank P < .0001).
During the study period, 6.7% of patients in the rilonacept group had a pericarditis recurrence compared with 74.2% of those in the placebo group, Klein said.
There were no deaths or drug-related serious adverse events in the rilonacept group, he said.
“These data represent a robust treatment response to rilonacept,” Klein said. “These data could represent a paradigm shift, in that rilonacept not only provided a steroid-sparing option to half of the study population who were on steroids at study entry, but potentially obviated the need for initiation of steroids in patients experiencing recurrence despite colchicine.”
In a discussion following the presentation, Brendan M. Everett, MD, MPH, FACC, associate professor of medicine at Brigham and Woman’s Hospital and Harvard Medical School, said, “It appears that rilonacept is remarkably beneficial for those patients who can tolerate it, and one wonders whether or not it’s best-suited to replace corticosteroids as second-line therapy in the management of pericarditis.”
Reference:
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Klein AL, et al. LBS.07: Randomized trials – Brain, kidney and heart. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).
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