Sustained Pericarditis Recurrence Risk Reduction With Long-Term Rilonacept.

Area of Science:

• Cardiology
• Immunology
• Pharmacology

Background:

• Recurrent pericarditis poses a significant clinical challenge.
• Rilonacept, an interleukin-1 trap, demonstrated efficacy in reducing pericarditis recurrence in the phase 3 RHAPSODY study.
• The RHAPSODY long-term extension investigated sustained treatment and its impact on disease natural history.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of rilonacept in patients with recurrent pericarditis.
• To explore treatment duration decision-making and its association with pericarditis recurrence.
• To assess the impact of continued rilonacept treatment versus suspension on recurrence rates.

Main Methods:

• Seventy-four patients from the RHAPSODY study entered the long-term extension.
• Patients received open-label rilonacept for up to 24 additional months.
• Treatment decisions (continue, suspend, or discontinue rilonacept) were made at an 18-month milestone post-recurrence.

Main Results:

• The annualized recurrence rate on rilonacept was significantly lower (0.04 events/patient-year) compared to prestudy rates (4.4 events/patient-year).
• At the 18-month milestone, 64% of patients continued rilonacept, 15% suspended it, and 21% discontinued.
• Patients continuing rilonacept had a 98% lower risk of recurrence compared to those who suspended treatment (HR=0.02, P<0.0001).

Conclusions:

• Continued rilonacept treatment is associated with sustained response and low recurrence rates in recurrent pericarditis.
• Treatment suspension at the 18-month decision point was linked to a higher incidence of pericarditis recurrence.
• Sustained interleukin-1 inhibition with rilonacept is crucial for managing recurrent pericarditis.