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雷西珠单抗治疗嗜酸性肉芽肿性多血管炎的疗效和安全性。

Efficacy and safety of reslizumab in the treatment of eosinophilic granulomatosis with polyangiitis.

机构信息

Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, Denver, Colorado; The Cohen Family Asthma Institute, National Jewish Health, Denver, Colorado.

Division of Pulmonary Diseases, Critical Care & Environmental Medicine, Tulane University, New Orleans, Louisiana.

出版信息

Ann Allergy Asthma Immunol. 2021 Jun;126(6):696-701.e1. doi: 10.1016/j.anai.2021.01.035. Epub 2021 Feb 4.

Abstract

BACKGROUND

Eosinophilic granulomatosis with polyangiitis (EGPA), a rare vasculitis with substantial morbidity, is characterized by asthma, eosinophilia, sinusitis, pulmonary infiltrates, neuropathy, positivity for antineutrophil cytoplasmic antibody, and multiorgan vasculitis. Although treatment options previously included corticosteroids and immunosuppressants, anti-interleukin 5 therapies have gained interest in EGPA treatment. Mepolizumab was approved for and recently benralizumab was found to have safety and efficacy in EGPA.

OBJECTIVE

To determine the safety and efficacy of reslizumab in EGPA.

METHODS

In this open-label, pilot study, we evaluated the safety and efficacy of intravenous reslizumab (3 mg/kg) in EGPA in 10 subjects. Oral corticosteroid dose, adverse events, exacerbations, symptom control, disease activity, blood markers, and lung function were evaluated before, during, and after 7 monthly reslizumab treatments.

RESULTS

Reslizumab was tolerated and resulted in a significant reduction in daily oral corticosteroid (P < .05). Of the 10 subjects, 3 experienced an EGPA exacerbation during the treatment. One had a severe adverse event, requiring removal from the study.

CONCLUSION

Yielding similar results to other anti-interleukin 5 biologic medications, reslizumab is generally a safe and effective treatment for EGPA that warrants further study.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02947945.

摘要

背景

嗜酸性肉芽肿伴多血管炎(EGPA)是一种罕见的血管炎,发病率较高,其特征是哮喘、嗜酸性粒细胞增多、鼻窦炎、肺部浸润、神经病、抗中性粒细胞胞浆抗体阳性和多器官血管炎。尽管以前的治疗选择包括皮质类固醇和免疫抑制剂,但抗白细胞介素 5 治疗在 EGPA 治疗中引起了兴趣。美泊利珠单抗已获得批准,最近贝那利珠单抗也被发现对 EGPA 安全有效。

目的

确定雷帕珠单抗在 EGPA 中的安全性和疗效。

方法

在这项开放标签的初步研究中,我们评估了 10 名 EGPA 患者静脉注射雷帕珠单抗(3mg/kg)的安全性和疗效。在 7 次每月雷帕珠单抗治疗前后评估口服皮质类固醇剂量、不良事件、加重、症状控制、疾病活动、血液标志物和肺功能。

结果

雷帕珠单抗耐受性良好,导致每日口服皮质类固醇显著减少(P<.05)。在 10 名受试者中,3 名在治疗期间发生 EGPA 加重。1 名发生严重不良事件,需要退出研究。

结论

雷帕珠单抗与其他抗白细胞介素 5 生物药物产生相似的结果,是 EGPA 的一种安全有效的治疗方法,值得进一步研究。

试验注册

ClinicalTrials.gov 标识符:NCT02947945。

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