Article written by Bruce Sylvester.
Rilonacept, an FDA approved drug for other inflammatory diseases, shows high efficacy for treating acute pericarditis, an inflammation of tissue around the heart.
The findings were published on Nov. 17, 2020 in the NEJM/New England Journal of Medicine and presented at the American Heart Association’s 2020 Scientific Sessions.
“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.”
The investigators conducted a phase 3, multicenter, double-blind, event-driven, randomized-withdrawal trial of rilonacept in patients with acute symptoms of recurrent pericarditis and systemic inflammation (as indicated by an elevated C-reactive protein [CRP] level).
Patients suffering recurring pericarditis while being treated with standard therapy were enrolled in a 12-week run-in period, in which rilonacept treatment began for all patients and background treatment ended.
Eighty-six patients with pericarditis pain and an elevated CRP level participated in the run-in. During the run-in, median time-to-resolution or near-resolution of pain was 5 days. Median time to CRP normalization was 7 days.
Patients who achieved a clinical response were randomized (1:1 ratio) to continued once-weekly rilonacept monotherapy or placebo. The investigators randomized 61 subjects.
After 16 weeks of further treatment, 81% of patients on once-weekly rilonacept achieved no or minimal pericarditis symptoms compared to 25% in the placebo-treated group, a significant difference (P<0.001).
Rilonacept treatment decreased recurrences by 96%.
Of 25 reported safety events, 23 occurred in the placebo group and two occurred in the rilonacept group.
‘Among patients with recurrent pericarditis, rilonacept led to rapid resolution of recurrent pericarditis episodes and to a significantly lower risk of pericarditis recurrence than placebo,” the authors concluded.
The study was sponsored by Kiniksa Pharmaceuticals, Ltd., the maker of rilonacept. All analyses were independently confirmed by the Cleveland Clinic Center for Clinical Research.