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英夫利昔单抗治疗心肌结节病的有效性和安全性。

Effectiveness and safety of infliximab in cardiac Sarcoidosis.

机构信息

Department of Cardiology, St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.

Department of Cardiology, St. Antonius Hospital, Nieuwegein, Utrecht, the Netherlands.

出版信息

Int J Cardiol. 2021 May 1;330:179-185. doi: 10.1016/j.ijcard.2021.02.022. Epub 2021 Feb 12.

DOI:10.1016/j.ijcard.2021.02.022
PMID:33582196
Abstract

BACKGROUND

Immunosuppressive therapy in active cardiac sarcoidosis (CS) might prevent potential life-threatening complications. Infliximab (IFX) is a tumor necrosis factor alpha monoclonal antibody proven to be effective in refractory extracardiac sarcoidosis. It is sparsely used in CS, because of its association with worsening heart failure in prior studies. The goal of this study is to assess the effectiveness and safety of IFX in CS.

METHODS AND RESULTS

A retrospective, single center cohort study was performed in sarcoidosis patients treated with IFX based on a cardiac indication between January 2016 and March 2019. Patients received IFX intravenously at a dose of 5 mg/kg at week 0, 2, and subsequently every 4 weeks. After every six months, treatment response was evaluated within the multidisciplinary team using FDG-PET/CT, transthoracic echocardiography, biomarkers and device interrogation reports. Responder analysis definitions were based on; dosage of immunosuppressive drugs, improvement in functional class, left ventricular ejection fraction (LVEF) and SUVmax. Twenty-two patients were included (mean age 51.0 SD10.0 years, male 68.2%) with a mean follow-up of 18.9 months (6 to 44 months) of whom 18 (82%) were classified as responders. Median SUVmax on FDG-PET/CT decreased from SUVmax 5.2 [3.7-8.4] to 2.3 [1.4-2.3], p = 0.015. The target-to-background ratio decreased from 3.2 [2.1-5.1] to 1.0 [0.7-2.4], p = 0.002. The median left ventricular (LV) ejection fraction increased from 45.0% [34.0-60.0] to 55.0% [41.0-60.0], p = 0.02. The majority of patients (73%) experienced no side effects and no patients had worsening of heart failure.

CONCLUSION

In this pilot study, patients with refractory CS treated with infliximab, on top of standard of care, had a reduction in inflammation on FDG-PET/CT and an improvement in LV function, without serious adverse events.

摘要

背景

在活动期心肌结节病(CS)中进行免疫抑制治疗可能预防潜在的危及生命的并发症。英夫利昔单抗(IFX)是一种肿瘤坏死因子-α单克隆抗体,已被证明对难治性心脏外结节病有效。由于先前的研究表明其与心力衰竭恶化有关,因此在 CS 中很少使用。本研究的目的是评估 IFX 在 CS 中的疗效和安全性。

方法和结果

对 2016 年 1 月至 2019 年 3 月期间因心脏指征接受 IFX 治疗的结节病患者进行了回顾性、单中心队列研究。患者每周接受 5mg/kg 的 IFX 静脉注射,第 0、2 周,随后每 4 周一次。此后每 6 个月,多学科团队使用 FDG-PET/CT、经胸超声心动图、生物标志物和设备检测报告评估治疗反应。应答分析定义基于:免疫抑制剂药物剂量、功能分级改善、左心室射血分数(LVEF)和 SUVmax。共纳入 22 例患者(平均年龄 51.0±10.0 岁,男性 68.2%),平均随访 18.9 个月(6-44 个月),其中 18 例(82%)患者为应答者。FDG-PET/CT 上的 SUVmax 中位数从 5.2[3.7-8.4]降至 2.3[1.4-2.3],p=0.015。靶/背景比从 3.2[2.1-5.1]降至 1.0[0.7-2.4],p=0.002。左心室(LV)射血分数中位数从 45.0%[34.0-60.0]增加至 55.0%[41.0-60.0],p=0.02。大多数患者(73%)无副作用,无心力衰竭恶化。

结论

在这项初步研究中,在标准治疗的基础上加用英夫利昔单抗治疗难治性 CS 的患者,其 FDG-PET/CT 上的炎症减轻,左心室功能改善,且无严重不良事件。

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