Recurrent pericarditis (RP) is a painful autoinflammatory cardiovascular disease.
Inhibitor of interleukin-1α (IL-1α) and interleukin-1β (IL-1β), cytokines that have been shown to play a key role in inflammatory diseases.
Health plan claims analysis (cross-validated with published estimates) supports that there are approximately 40,000 patients with RP in the United States receiving medical treatment.
Reported data suggest that IL-1α and IL-1β may play roles in RP and other autoinflammatory diseases. We have completed an open-label Phase 2 clinical trial of rilonacept in different RP populations. Interim data from all symptomatic RP and postpericardiotomy syndrome (PPS) subjects showed reductions in both C-reactive protein (CRP) and reported pain as well as improvement in quality-of-life scores. Additionally, CRP and reported pain remained low for all asymptomatic RP and PPS subjects.
RHAPSODY is a double-blind, placebo-controlled, randomized-withdrawal (RW) design study with open-label extension in subjects with symptomatic RP. After a run-in period with stabilization and tapering of background medications to rilonacept, clinical responders will be randomized to continued rilonacept or placebo injected subcutaneously weekly during the 24-week RW period. The primary efficacy endpoint is time to first adjudicated pericarditis recurrence in the RW period. Topline data are expected in the second half of 2020.
We are not aware of any current therapies approved by the FDA for the treatment of RP.