Imazio Massimo, Andreis Alessandro, Piroli Francesco, Lazaros George, Gattorno Marco, Lewinter Martin, Klein Allan L, Brucato Antonio
University Cardiology, Cardiovascular and Thoracic Department, AOU Città della Salute e della Scienza di Torino, Torino, Italy
Department of Public Health and Pediatrics, University of Turin, Torino, Italy.
Heart. 2021 Jul 12;107(15):1240-1245. doi: 10.1136/heartjnl-2020-318869.
Corticosteroid-dependent and colchicine-resistant recurrent pericarditis (RP) is a challenging management problem, in which conventional anti-inflammatory therapy (nonsteroidal anti-inflammatory drugs, colchicine, corticosteroids) is unable to control the disease. Recent data suggest a potential role for anti-interleukin-1 (IL-1) agents for this condition. This study was designed to assess the safety and efficacy of anti-IL-1 agents in this setting.
We performed a systematic review and meta-analysis of randomised controlled trials and observational studies assessing pericarditis recurrences and drug-related adverse events in patients receiving anti-IL-1 drugs for pericarditis.
The meta-analysis assessed 7 studies including 397 pooled patients with RP. The median age was 42 years, 60% were women and the aetiology was idiopathic in 87%. After a median follow-up of 14 months (IQR,12-39), patients receiving anti-IL-1 agents (anakinra or rilonacept) had a significantly reduction in pericarditis recurrences (incidence rate ratio 0.06, 95% CI 0.03 to 0.14), compared with placebo and/or standard medical therapy. Anti-IL-1 agents were associated with increased risk of adverse events compared with placebo (risk ratio (RR) 5.38, 95% CI 2.08 to 13.92): injection-site reactions occurred in 15/41 (36.6%) vs none (RR 14.98, 95% CI 2.09 to 107.09), infections occurred in 13/51 (25.5%) vs 3/41 (7.3%; RR 3.65, 95% CI 1.23 to 10.85). Anti-IL-1 agents were not associated with increased risk of severe adverse events.
In patients with RP, anti-IL-1 agents (anakinra and rilonacept) are efficacious for prevention of recurrences, without severe adverse events.
依赖皮质类固醇且对秋水仙碱耐药的复发性心包炎(RP)是一个具有挑战性的管理问题,传统抗炎疗法(非甾体抗炎药、秋水仙碱、皮质类固醇)无法控制该病。近期数据表明抗白细胞介素 -1(IL-1)药物在这种情况下可能发挥作用。本研究旨在评估抗IL-1药物在此情况下的安全性和疗效。
我们对评估接受抗IL-1药物治疗心包炎患者的心包炎复发情况及药物相关不良事件的随机对照试验和观察性研究进行了系统评价和荟萃分析。
荟萃分析评估了7项研究,共纳入397例RP患者。中位年龄为42岁,60%为女性,87%的病因是特发性的。中位随访14个月(四分位间距,12 - 39个月)后,与安慰剂和/或标准药物治疗相比,接受抗IL-1药物(阿那白滞素或利洛纳塞)治疗的患者心包炎复发显著减少(发病率比0.06,95%置信区间0.03至0.14)。与安慰剂相比,抗IL-1药物与不良事件风险增加相关(风险比(RR)5.38,95%置信区间2.08至13.92):注射部位反应发生率为15/41(36.6%),而安慰剂组无发生(RR 14.98,95%置信区间2.09至107.09);感染发生率为13/51(25.5%),安慰剂组为3/41(7.3%;RR 3.65,95%置信区间1.23至10.85)。抗IL-1药物与严重不良事件风险增加无关。
在RP患者中,抗IL-1药物(阿那白滞素和利洛纳塞)对预防复发有效,且无严重不良事件。