TY - JOUR
T1 - Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination
T2 - Results From the RHAPSODY Long-term Extension
AU - RHAPSODY Investigators
AU - Brucato, Antonio
AU - Trotta, Lucia
AU - Arad, Michael
AU - Cremer, Paul C.
AU - Insalaco, Antonella
AU - Klutstein, Marc
AU - LeWinter, Martin
AU - Lin, David
AU - Luis, Sushil A.
AU - Wasserstrum, Yishay
AU - Clair, Jo Ann
AU - Wang, Sheldon
AU - Klein, Allan L.
AU - Imazio, Massimo
AU - Paolini, John F.
AU - Abbate, Antonio
AU - Abo-Auda, Wael
AU - Akhtar, Asif
AU - Atar, Shaul
AU - Baibhav, Bipul
AU - Collins, Sean
AU - Colquhoun, David
AU - Cremer, Paul
AU - Cross, David
AU - Dwivedi, Girish
AU - Eisen, Alon
AU - Freedberg, Nahum
AU - Fuchs, Shmuel
AU - Gaddam, Eliyazar
AU - Gattorno, Marco
AU - Gelfand, Eli
AU - Grena, Paul
AU - Halabi, Majdi
AU - Harris, David
AU - Karim, Amin
AU - Klein, Allan
AU - Knowlton, Kirk
AU - Kontzias, Apostolos
AU - Kornberg, Robert
AU - Latif, Faisal
AU - Leibowitz, David
AU - Lou, Pey Wen
AU - Luis, S. Allen
AU - Nicholls, Stephen
AU - Petersen, John
AU - Portman, Michael
AU - Roberts-Thomson, Philip
AU - Schiff, Elad
AU - Siegel, Robert
AU - Stokes, Michael
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/6
Y1 - 2024/6
N2 - 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%; 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. 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. ClinicalTrials.gov
AB - 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%; 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. 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. ClinicalTrials.gov
UR - http://www.scopus.com/inward/record.url?scp=85194072142&partnerID=8YFLogxK
U2 - 10.1016/j.cjco.2024.02.002
DO - 10.1016/j.cjco.2024.02.002
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C2 - 39022168
AN - SCOPUS:85194072142
SN - 2589-790X
VL - 6
SP - 805
EP - 810
JO - CJC Open
JF - CJC Open
IS - 6
ER -