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; 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

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, 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

Research output: Contribution to journal › Article

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.

Original language	Undefined/Unknown
Journal	Articles, Abstracts, and Reports
State	Published - Jun 1 2024

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http://digitalcommons.providence.org/publications/9074

Cite this

Brucato, A., Trotta, L., Arad, M., Cremer, P. C., Insalaco, A., Klutstein, M., LeWinter, M., Lin, D., Luis, S. A., Wasserstrum, Y., Clair, J., Wang, S., Klein, A. L., Imazio, M., Paolini, J. F., Investigators, RHAPSODY., & Petersen, J. (2024). Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension. Articles, Abstracts, and Reports. http://digitalcommons.providence.org/publications/9074

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

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.",

author = "Antonio Brucato and Lucia Trotta and Michael Arad and Cremer, {Paul C} and Antonella Insalaco and Marc Klutstein and Martin LeWinter and David Lin and Luis, {Sushil A} and Yishay Wasserstrum and JoAnn Clair and Sheldon Wang and Klein, {Allan L} and Massimo Imazio and Paolini, {John F} and RHAPSODY Investigators and John Petersen",

year = "2024",

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day = "1",

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journal = "Articles, Abstracts, and Reports",

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Brucato, A, Trotta, L, Arad, M, Cremer, PC, Insalaco, A, Klutstein, M, LeWinter, M, Lin, D, Luis, SA, Wasserstrum, Y, Clair, J, Wang, S, Klein, AL, Imazio, M, Paolini, JF, Investigators, RHAPSODY & Petersen, J 2024, 'Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension.', Articles, Abstracts, and Reports. <http://digitalcommons.providence.org/publications/9074>

TY - JOUR

T1 - Absence of Pericarditis Recurrence in Rilonacept-Treated Patients With COVID-19 and SARS-CoV-2 Vaccination: Results From the RHAPSODY Long-term Extension.

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, JoAnn

AU - Wang, Sheldon

AU - Klein, Allan L

AU - Imazio, Massimo

AU - Paolini, John F

AU - Investigators, RHAPSODY

AU - Petersen, John

PY - 2024/6/1

Y1 - 2024/6/1

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%; 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.

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%; 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.

M3 - Article

JO - Articles, Abstracts, and Reports

JF - Articles, Abstracts, and Reports

ER -