3 research outputs found
Sustained Pericarditis Recurrence Risk Reduction With LongâTerm Rilonacept
Background Rilonacept, a onceâweekly interleukinâ1 alpha and beta cytokine trap, reduced pericarditis recurrence in the phase 3 study, RHAPSODY (Rilonacept Inhibition of Interleukinâ1 Alpha and Beta for Recurrent Pericarditis: A Pivotal Symptomatology and Outcomes Study). The RHAPSODY longâterm extension further explored recurrent pericarditis natural history and treatment duration decisionâmaking during 24 additional months of openâlabel rilonacept treatment. Methods and Results Seventyâfour patients commenced the longâterm extension, with a median (maximum) total rilonacept duration of 22 (35) months. Individually, 18âmonths after the most proximal pericarditis recurrence, investigators decided to continue rilonacept on study, suspend rilonacept for offâtreatment observation (rescue allowed), or discontinue the study. The annualized incidence of pericarditis recurrence on rilonacept up to the 18âmonth decision milestone was 0.04 events/patientâyear versus 4.4 events/patientâyear prestudy while on oral therapies. At the 18âmonth decision milestone, 64% (33/52) continued rilonacept, 15% (8/52) suspended rilonacept for observation, and 21% (11/52) discontinued the study. Among the 33 patients (1/33; 3.0%) continuing rilonacept (median time to recurrence could not be estimated due to too few events), a single recurrence occurred 4âweeks after a treatment interruption. Among patients suspending rilonacept, 75% (6/8) experienced recurrence (median time to recurrence, 11.8âweeks [95% CI, 3.7âweeks to not estimable]). There was a 98% reduction in risk of pericarditis recurrence among patients continuing rilonacept treatment after the 18âmonth decision milestone versus those suspending treatment for observation (hazard ratio, 0.02; P<0.0001). Conclusions In the RHAPSODY longâterm extension, continued rilonacept treatment resulted in continued response; treatment suspension at the 18âmonth decision milestone was associated with pericarditis recurrence. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03737110