Importance: Anakinra, an interleukin 1beta 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 patients were followed up for 12 months. Median follow-up was 14 (range,

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial / Brucato, A; Imazio, M; Gattorno, M; Lazaros, G; Maestroni, S; Carraro, M; Finetti, M; Cumetti, D; Carobbio, A; Ruperto, N; Marcolongo, R; Lorini, M; Rimini, A; Valenti, A; Erre, Gl; Sormani, Mp; Belli, R; Gaita, F; Martini, A. - In: JOURNAL OF ADVANCED MATHEMATICS AND APPLICATIONS, 2156-7557. - ISSN 2156-7557. - 316:18(2016), pp. 1906-1912. [10.1001/jama.2016.15826]

Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial

Carobbio A;
2016

Abstract

Importance: Anakinra, an interleukin 1beta 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 patients were followed up for 12 months. Median follow-up was 14 (range,
2016
316
18
1906
1912
Effect of Anakinra on Recurrent Pericarditis Among Patients With Colchicine Resistance and Corticosteroid Dependence: The AIRTRIP Randomized Clinical Trial / Brucato, A; Imazio, M; Gattorno, M; Lazaros, G; Maestroni, S; Carraro, M; Finetti, M; Cumetti, D; Carobbio, A; Ruperto, N; Marcolongo, R; Lorini, M; Rimini, A; Valenti, A; Erre, Gl; Sormani, Mp; Belli, R; Gaita, F; Martini, A. - In: JOURNAL OF ADVANCED MATHEMATICS AND APPLICATIONS, 2156-7557. - ISSN 2156-7557. - 316:18(2016), pp. 1906-1912. [10.1001/jama.2016.15826]
Brucato, A; Imazio, M; Gattorno, M; Lazaros, G; Maestroni, S; Carraro, M; Finetti, M; Cumetti, D; Carobbio, A; Ruperto, N; Marcolongo, R; Lorini, M; Rimini, A; Valenti, A; Erre, Gl; Sormani, Mp; Belli, R; Gaita, F; Martini, A
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