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贝那利珠单抗治疗嗜酸性肉芽肿性多血管炎的长期疗效

Long-Term Effectiveness of Benralizumab in Eosinophilic Granulomatosis With Polyangiitis.

作者信息

Nanzer Alexandra M, Maynard-Paquette Anne-Catherine, Alam Vardah, Green Linda, Thomson Louise, Lam Jodie, Fernandes Mariana, Roxas Cris, d'Ancona Grainne, Hearn Andrew, Gates Jessica, Agarwal Sangita, Kent Brian D, Fernando Michelle, D'Cruz David P, Hopkins Claire, Ismail Tevfik F, Dhariwal Jaideep, Jackson David J

机构信息

Guy's Severe Asthma Centre, Guy's and St Thomas' NHS Trust, London, United Kingdom; School of Immunology & Microbial Sciences, King's College London, London, United Kingdom.

Guy's Severe Asthma Centre, Guy's and St Thomas' NHS Trust, London, United Kingdom.

出版信息

J Allergy Clin Immunol Pract. 2024 Mar;12(3):724-732. doi: 10.1016/j.jaip.2024.01.006. Epub 2024 Jan 9.

Abstract

BACKGROUND

Eosinophilic granulomatosis with polyangiitis (EGPA) is a multisystemic disease characterized by eosinophilic tissue inflammation. Benralizumab, an anti-IL-5 receptor (anti-IL-5R) monoclonal antibody, induces rapid depletion of eosinophils; its longer-term effect in EGPA is unknown.

OBJECTIVE

To assess the real-world effectiveness and clinical remission rates of anti-IL-5R therapy in EGPA.

METHODS

We performed a retrospective cohort analysis of patients with EGPA, who commenced treatment with benralizumab. Clinical remission, assessed at 1 year and 2 years after the initiation of benralizumab, was defined as an absence of active vasculitis (Birmingham Vasculitis Activity Score of 0) and an oral corticosteroid (OCS) dose of ≤4 mg/d of prednisolone. "Super-responders" were defined as patients in remission and free of any significant relapses (asthma or extrapulmonary) over the preceding 12 months. The corticosteroid-sparing capacity of benralizumab, patient-reported outcome measures, and characteristics associated with clinical remission and super-responder status were also analyzed.

RESULTS

A total of 70 patients completed at least 1 year of treatment with benralizumab, of whom 53 completed 2 years. Of 70 patients, 47 (67.1%) met the definition for clinical remission at 1 year, with a similar proportion in remission at 2 years. Excluding asthma-related relapses, 61 of 70 (87.1%) patients were relapse free at 1 year, and of the 53 who completed 2 years, 45 (84.9%) were relapse free. A total of 67.9% of patients no longer needed any OCS for disease control. No significant difference was seen between antineutrophilic cytoplasmic antibody (ANCA)-positive and ANCA-negative subgroups.

CONCLUSIONS

In this real-world setting of patients with EGPA, treatment with benralizumab was well tolerated and resulted in corticosteroid-free clinical remission for the majority of patients.

摘要

背景

嗜酸性肉芽肿性多血管炎(EGPA)是一种以嗜酸性粒细胞组织炎症为特征的多系统疾病。贝那利珠单抗是一种抗白细胞介素-5受体(抗IL-5R)单克隆抗体,可诱导嗜酸性粒细胞快速耗竭;其在EGPA中的长期疗效尚不清楚。

目的

评估抗IL-5R疗法在EGPA中的实际疗效和临床缓解率。

方法

我们对开始使用贝那利珠单抗治疗的EGPA患者进行了一项回顾性队列分析。在开始使用贝那利珠单抗后1年和2年评估的临床缓解定义为无活动性血管炎(伯明翰血管炎活动评分为0)且口服糖皮质激素(OCS)剂量≤4mg/d泼尼松龙。“超级反应者”定义为在过去12个月内处于缓解状态且无任何显著复发(哮喘或肺外复发)的患者。还分析了贝那利珠单抗的糖皮质激素节省能力、患者报告的结局指标以及与临床缓解和超级反应者状态相关的特征。

结果

共有70例患者完成了至少1年的贝那利珠单抗治疗,其中53例完成了2年治疗。在70例患者中,47例(67.1%)在1年时达到临床缓解定义,2年时缓解比例相似。排除与哮喘相关的复发,70例患者中有61例(87.1%)在1年时无复发,在完成2年治疗的53例患者中,45例(84.9%)无复发。共有67.9%的患者不再需要任何OCS来控制疾病。抗中性粒细胞胞浆抗体(ANCA)阳性和ANCA阴性亚组之间未见显著差异。

结论

在这一EGPA患者的实际临床环境中,贝那利珠单抗治疗耐受性良好,大多数患者实现了无糖皮质激素的临床缓解。

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