EMBARGOED UNTIL 8:34 P.M. ET, Monday, November 16, 2020, Cleveland: Cleveland Clinic researchers leading a global clinical trial have found that rilonacept, an FDA approved drug for other inflammatory diseases, resolved acute pericarditis episodes and reduced risk of pericarditis recurrence. The study was published today in the New England Journal of Medicine and presented at the American Heart Association’s Scientific Sessions.

Pericarditis is an inflammation of the pericardium, which is two thin layers of tissue that surround the heart and help it function. A common symptom is severe sharp chest pain, which is caused by the inflamed layers rubbing against the heart. Pericarditis can be acute, recurrent or chronic, and often occurs after a viral infection or cardiac surgery. Recurrent pericarditis usually occurs 4-6 weeks after the first episode of acute pericarditis and often causes debilitating chest pain, physical limitations, hospitalizations and decreased quality of life.

Currently, there are no FDA approved therapies for pericarditis. Anti-inflammatories and steroids- often with harsh side effects- are used to treat the condition. The Rhapsody global Phase 3 clinical trial studied 61 patients with recurrent pericarditis, who were randomized to rilonacept or placebo. After 16 weeks of treatment, 81% of patients on once-weekly rilonacept, reported no or minimal pericarditis symptoms versus 25% on the placebo. The drug not only resolved active episodes after the first dose, but it also decreased recurrences by 96%.

All patients involved who had been taking corticosteroids tapered and successfully transitioned to rilonacept.

«Recurring pericarditis is painful and can be debilitating to those who suffer from it,» said Allan Klein M.D., director of the Center for the Diagnosis and Treatment of Pericardial Diseases at Cleveland Clinic, co-principal investigator of the study, and a paid member of Kiniksa Pharmaceuticals’ scientific advisory board. «The Rhapsody trial was highly successful, essentially stopping this disease, and provides a new hope for these patients.»

Of the 25 safety events in the study, 23 occurred in the placebo group, while only two occurred in the rilonacept group.

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The study was sponsored by Kiniksa Pharmaceuticals, Ltd., the maker of Rilonacept, however all analyses were independently confirmed by the Cleveland Clinic Center for Clinical Research.

About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual «America’s Best Hospitals» survey. Among Cleveland Clinic’s 67,554 employees worldwide are more than 4,520 salaried physicians and researchers, and 17,000 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,026-bed health system that includes a 165-acre main campus near downtown Cleveland, 18 hospitals, more than 220 outpatient facilities, and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2019, there were 9.8 million total outpatient visits, 309,000 hospital admissions and observations, and 255,000 surgical cases throughout Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries. Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

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