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

Antonio Brucato,Amin Karim,John F Paolini,Sean Collins,Marc Klutstein,Sheldon Wang,Majdi Halabi,Robert Siegel,Antonella Insalaco,Michael Stokes,David Colquhoun,Shmuel Fuchs,Paul Sutej,Eliyazar Gaddam,David Leibowitz,Paul C Cremer,Samuel Wittekind,Girish Dwivedi,David Lin,Valentin Witzling,Joann Clair,Asif Akhtar,Apostolos Kontzias,Elad Schiff,John Petersen,Antonio Abbate,David Harris,Martin Lewinter,Robert Kornberg,Philip Roberts-Thomson,Paul Cremer,Shaul Atar,Kirk Knowlton,Pey Wen Lou,Sushil A Luis,Karan Bhalla,Massimo Imazio,Allan Klein,Marco Gattorno,Wael Abo-Auda,Eli Gelfand,Bipul Baibhav,Allan L Klein,Nahum Freedberg,David Cross,Alon Eisen,Michael Portman,Paul Grena,Robert Zukermann,Stephen Nicholls,S Allen Luis,Michael Arad,Antonio Brucato,Yishay Wasserstrum,Faisal Latif,Lucia Trotta

doi:10.1016/j.cjco.2024.02.002

Abstract

BackgroundRilonacept 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. MethodsAnalysis 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. ResultsNo 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%; P = 0.04). Twelve of 16 patients (75%) were receiving rilonacept at the time of infection, and none experienced pericarditis recurrence. One pericarditis recurrence occurred in the peri-COVID-19 period in 1 of 4 patients who had stopped rilonacept treatment > 4.5 months prior. COVID-19 severity was mild in 13 patients, moderate in 2, and severe in 1. ConclusionsFull 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. ClinicalTrials.gov identifierNCT03737110

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