Pericarditis is a cardiovascular condition characterized by the inflammation of the pericardium, resulting in sharp chest pain. Interleukin-1 is a mediator of recurrent pericarditis, but its efficacy and safety are not well studies. This study aims to investigate the safety and efficacy of rilonacept, an interleukin-1α and interleukin-1β cytokine trap, for recurrent pericarditis.

This multicenter, phase 3, event-driven, randomized-withdrawal, double-blind trial including a total of 61 patients with acute symptoms of recurrent pericarditis and systematic inflammation. The eligible patients were assigned in a 1:1 ratio to receive rilonacept monotherapy or placebo. The primary outcome of the study was the time to the first pericarditis recurrence as assessed with a Cox proportional-hazards model.

During the study period, the recurrence events in the rilonacept group were too few to allow for the median time to the first adjudicated recurrence. The median time to the first adjudicated recurrence in the placebo group was 8.6 weeks. A total of 2 patients (7%) in the rilonacept group and 23 patients (74%) in the placebo group had a pericarditis recurrence.

The research concluded that in patients with recurrent pericarditis, rilonacept was associated with a reduced incidence of pericarditis recurrence when compared with placebo.