Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis.

The New England Journal of Medicine
Allan L KleinRHAPSODY Investigators

Abstract

Interleukin-1 has been implicated as a mediator of recurrent pericarditis. The efficacy and safety of rilonacept, an interleukin-1α and interleukin-1β cytokine trap, were studied previously in a phase 2 trial involving patients with recurrent pericarditis. We conducted a phase 3 multicenter, double-blind, event-driven, randomized-withdrawal trial of rilonacept in patients with acute symptoms of recurrent pericarditis (as assessed on a patient-reported scale) and systemic inflammation (as shown by an elevated C-reactive protein [CRP] level). Patients presenting with pericarditis recurrence while receiving standard therapy were enrolled in a 12-week run-in period, during which rilonacept was initiated and background medications were discontinued. Patients who had a clinical response (i.e., met prespecified response criteria) were randomly assigned in a 1:1 ratio to receive continued rilonacept monotherapy or placebo, administered subcutaneously once weekly. The primary efficacy end point, assessed with a Cox proportional-hazards model, was the time to the first pericarditis recurrence. Safety was also assessed. A total of 86 patients with pericarditis pain and an elevated CRP level were enrolled in the run-in period. During the r...Continue Reading

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Citations

Jan 28, 2021·Expert Review of Cardiovascular Therapy·Yasser Al-KhadraM Chadi Alraies
Dec 3, 2020·Nature Reviews. Cardiology·Irene Fernández-Ruiz
Dec 29, 2020·European Heart Journal. Cardiovascular Pharmacotherapy·Gianluigi Savarese
Mar 6, 2021·JACC. Basic to Translational Science·Adolfo G MauroStefano Toldo
Mar 11, 2021·JACC. Basic to Translational Science·Jean-Sébastien Silvestre
Mar 19, 2021·Internal and Emergency Medicine·George LazarosKonstantinos Tsioufis
Apr 8, 2021·European Heart Journal·Giovanna Liuzzo, Carlo Patrono
Apr 10, 2021·Frontiers in Immunology·Giacomo De LucaMarco Matucci-Cerinic
Apr 13, 2021·Advances in Therapy·Aileen KearneyIan B A Menown
Apr 15, 2021·The New England Journal of Medicine·Allan L KleinJohn F Paolini
Apr 15, 2021·The New England Journal of Medicine·Edward Tabor
May 20, 2021·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Manasvi GuptaRaktim K Ghosh
Apr 15, 2021·The New England Journal of Medicine·George LazarosDimitrios Vassilopoulos
Jul 9, 2021·Zeitschrift für Rheumatologie·Gerd-Rüdiger BurmesterThomas Rose
Jul 22, 2021·Journal of the American Heart Association·Allan KleinMatthew Magestro
Jul 29, 2021·Current Cardiology Reports·Emanuele BizziAntonio Brucato
Aug 6, 2021·European Heart Journal·Aldo Bonaventura
Aug 18, 2021·JACC. Case Reports·Ashwin K KumarAllan L Klein
Aug 28, 2021·Current Cardiology Reports·Jelani K Grant, Nishant P Shah
Aug 31, 2021·The Annals of Pharmacotherapy·Nicholas C Schwier
Sep 17, 2021·European Heart Journal·Massimo ImazioAllan Klein
Oct 3, 2021·Current Cardiology Reports·Alessandra VecchiéAldo Bonaventura
Oct 9, 2021·Current Cardiology Reports·Ria GargMichael Chetrit
Oct 12, 2021·Current Cardiology Reports·Massimo Imazio
May 30, 2021·European Journal of Clinical Investigation·Emilia LazarouCharalambos Vlachopoulos
Dec 19, 2020·Panminerva Medica·Aldo BonaventuraAntonio Abbate
Jan 27, 2021·Panminerva Medica·Aldo Bonaventura
Feb 24, 2021·Panminerva Medica·Alessandra VecchièAntonio Abbate
Mar 10, 2021·Panminerva Medica·Lisa SeratiAntonio Brucato
Nov 11, 2021·Expert Opinion on Biological Therapy·Agostina M FavaAllan L Klein

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