Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension.

Publication Title

CJC Open

Authors

Antonio Brucato
Lucia Trotta
Michael Arad
Paul C Cremer
Antonella Insalaco
Marc Klutstein
Martin LeWinter
David Lin
Sushil A Luis
Yishay Wasserstrum
JoAnn Clair
Sheldon Wang
Allan L Klein
Massimo Imazio
John F Paolini
RHAPSODY Investigators
John Petersen, Swedish Medical Center Seattle, Washington, USA.Follow

Document Type

Article

Publication Date

6-1-2024

Keywords

washington; swedish; covid-19

Abstract

BACKGROUND: Rilonacept inhibits the interleukin-1 pathway, and extended treatment in patients with recurrent pericarditis (RP) reduced recurrence risk by 98% in the phase 3 trial, RHAPSODY long-term extension (LTE). Severe acute respiratory syndrome (SARS)-CoV-2 vaccination and/or infection may trigger pericarditis recurrence, and in clinical practice, it is unknown whether to continue rilonacept during SARS-CoV-2 infection. This post-hoc analysis of the RHAPSODY LTE aimed to inform rilonacept management in RP patients vaccinated against SARS-CoV-2 or who contract COVID-19.

METHODS: Analysis was conducted from May 2020 to June 2022. The LTE portion of RHAPSODY LTE enabled up to 24 months of additional open-label rilonacept treatment beyond the pivotal study. Rilonacept efficacy data in preventing pericarditis recurrence were assessed, and concomitant SARS-CoV-2 vaccination and COVID-19 adverse event data were evaluated.

RESULTS: No pericarditis recurrences were temporally associated with vaccination. Sixteen COVID-19 cases were reported; 10 in 30 unvaccinated or partially vaccinated patients (33%) vs 6 of 44 fully vaccinated patients (14%;

CONCLUSIONS: Full vaccination effectively reduced COVID-19 events in patients treated with rilonacept. Vaccination or COVID-19 during rilonacept treatment did not increase pericarditis recurrence. Continued rilonacept treatment in patients contracting COVID-19 did not worsen disease severity, whereas rilonacept interruption increased pericarditis recurrence, supporting a recommendation for continued rilonacept treatment for RP during vaccination or COVID-19.

CLINICALTRIALSGOV IDENTIFIER: NCT03737110.

Clinical Institute

Cardiovascular (Heart)

Specialty/Research Institute

Infectious Diseases

Specialty/Research Institute

Cardiology