Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence

作者：Antonio Luca Brucato, Massimo Imazio, Marco Gattorno, George A. Lazaros, Silvia Maestroni, Mara Carraro, Martina Finetti, Davide Cumetti, Alessandra Carobbio, Nicolino Ruperto, R Marcolongo, Monia Lorini, Alessandro Rimini, Anna Chiara Valenti, Gian Luca Erre, Maria Pia Sormani, Riccardo Belli, Fiorenzo Gaïta, Alberto Martini · 发表于：JAMA · 年份：2016 · DOI：10.1001/jama.2016.15826 · 被引用次数：397 · 研究领域：Pericarditis and Cardiac Tamponade、Inflammasome and immune disorders、Intraperitoneal and Appendiceal Malignancies

Importance: Anakinra, an interleukin 1β recombinant receptor antagonist, may have potential to treat colchicine-resistant and corticosteroid-dependent recurrent pericarditis. Objective: To determine the efficacy of anakinra for colchicine-resistant and corticosteroid-dependent recurrent pericarditis. Design, Setting, and Participants: The Anakinra-Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP) double-blind, placebo-controlled, randomized withdrawal trial (open label with anakinra followed by a double-blind withdrawal step with anakinra or placebo until recurrent pericarditis occurred) conducted among 21 consecutive patients enrolled at 3 Italian referral centers between June and November 2014 (end of follow-up, October 2015). Included patients had recurrent pericarditis (with ≥3 previous recurrences), elevation of C-reactive protein, colchicine resistance, and corticosteroid dependence. Interventions: Anakinra was administered at 2 mg/kg per day, up to 100 mg, for 2 months, then patients who responded with resolution of pericarditis were randomized to continue anakinra (n = 11) or switch to placebo (n = 10) for 6 months or until a pericarditis recurrence. Main Outcomes and Measures: The primary outcomes were recurrent pericarditis and time to recurrence after randomization. Results: Eleven patients (7 female) randomized to anakinra had a mean age of 46.5 (SD, 16.3) years; 10 patients (7 female) randomized to placebo had a mean age of 44 (SD, 12.5) years. All patient...