FDA approves rilonacept for recurrent pericarditis in adults, children
The FDA announced it approved rilonacept injection to treat and reduce risk for recurrent pericarditis in adults and children 12 years and older.
The efficacy and safety of rilonacept (Arcalyst, Kiniksa Pharmaceuticals) was evaluated in the double-blind, randomized RHAPSODY trial presented at the virtual American Heart Association Scientific Sessions. For this trial that enrolled 86 patients with symptomatic pericarditis recurrence, participants received rilonacept for 12 weeks, at which point half continued weekly rilonacept 160 mg and the other half received placebo.
As Healio previously reported, rilonacept better resolved recurrent episodes of symptomatic pericarditis, which often include sharp chest pain, and reduced risk for future episodes (rilonacept group, 6.7%; placebo group, 74.2%).
According to the FDA release, serious, life-threatening infections have been reported among patients using rilonacept. Patients with active or chronic infections should not take rilonacept and should also avoid live vaccines.