 RHAPSODY met its prespecified primary and all major secondary efficacy endpoints, showing that rilonacept improved clinically meaningful outcomes associated with the unmet medical need in recurrent pericarditis, a painful and debilitating autoinflammatory disease. The U.S. Food and Drug Administration FDA granted Breakthrough Therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019, and Kiniksa expects to submit a Supplemental Biologics License Application sBLA later this year. 