Two-year efficacy and safety of anti-interleukin-5/receptor therapy for eosinophilic granulomatosis with polyangiitis.

IF 20.6 1区医学 Q1 RHEUMATOLOGY

Annals of the Rheumatic Diseases Pub Date : 2025-08-07 DOI:10.1016/j.ard.2025.06.2131

Peter A Merkel, Parameswaran K Nair, Nader Khalidi, Benjamin Terrier, Bernhard Hellmich, Arnaud Bourdin, David R W Jayne, David J Jackson, Florence Roufosse, Christian Pagnoux, Ulrich Specks, Lena Börjesson Sjö, Calvin N Ho, Maria Jison, Christopher McCrae, Sofia Necander, Eva Rodríguez-Suárez, Anat Shavit, Claire Walton, Michael E Wechsler

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引用次数: 0

Abstract

Objectives: To summarise the efficacy and safety of 2 years of anti-interleukin-5/receptor (anti-IL-5/R) therapy in patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Methods: Patients were randomised 1:1 to receive benralizumab or mepolizumab every 4 weeks during the 52-week double-blind period of the MANDARA trial. Patients entered an open-label extension (OLE) in which they continued benralizumab (benralizumab/benralizumab) or switched from mepolizumab to benralizumab (mepolizumab/benralizumab). Remission (Birmingham Vasculitis Activity Score = 0 and oral glucocorticoid [OGC] dose ≤4 mg/d), OGC use, relapse, blood eosinophil count (bEOS), and safety up to year 2 (week 104) were reported.

Results: A total of 128 patients entered the OLE period (n = 66 benralizumab/benralizumab; n = 62 mepolizumab/benralizumab). At week 104, 41 (62.1%) benralizumab/benralizumab patients and 42 (67.7%) mepolizumab/benralizumab patients were in remission. During OLE year 1, 51 (77.3%) benralizumab/benralizumab patients and 42 (67.7%) mepolizumab/benralizumab patients had no relapses. By weeks 49 to 52, 27 (40.9%) benralizumab/benralizumab patients and 16 (25.8%) mepolizumab/benralizumab patients had withdrawn from OGCs, increasing to 29 (43.9%) and 27 (43.5%) at weeks 101 to 104, respectively; the median cumulative OGC dose was 950 mg and 791 mg during OLE year 1, respectively. The median bEOS among benralizumab/benralizumab-treated patients was 20 cells/µL (at weeks 52 and 100), and in mepolizumab/benralizumab-treated patients, it decreased from 70 cells/µL to 20 cells/µL 4 weeks after switching. Adverse events/serious adverse events were reported in 97.0%/22.7% of benralizumab/benralizumab and 100%/35.5% of mepolizumab/benralizumab patients.

Conclusions: In patients with EGPA, treatment for 2 years with anti-IL-5/R therapies is associated with durable rates of remission, discontinuation of OGCs, bEOS depletion, and low relapse rates. Switching from mepolizumab to benralizumab enhances bEOS depletion and OGC sparing.

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抗白细胞介素-5/受体治疗嗜酸性肉芽肿合并多血管炎的两年疗效和安全性

目的：总结抗白细胞介素5/受体（il -5/R）治疗嗜酸性肉芽肿病合并多血管炎（EGPA）患者2年的疗效和安全性。方法：在为期52周的MANDARA双盲试验期间，患者按1:1随机分组，每4周接受贝纳利珠单抗或美波利珠单抗治疗。患者进入开放标签扩展（OLE），其中他们继续使用benralizumab （benralizumab/benralizumab）或从mepolizumab切换到benralizumab （mepolizumab/benralizumab）。报告了缓解（伯明翰血管炎活动度评分= 0，口服糖皮质激素[OGC]剂量≤4mg /d）， OGC使用，复发，血嗜酸性粒细胞计数（bEOS）和2年（104周）的安全性。结果：共有128例患者进入OLE期(n = 66例benralizumab/benralizumab；N = 62 mepolizumab/benralizumab)。在第104周，41例（62.1%）benralizumab/benralizumab患者和42例（67.7%）mepolizumab/benralizumab患者缓解。在OLE第1年，51例（77.3%）benralizumab/benralizumab患者和42例（67.7%）mepolizumab/benralizumab患者没有复发。在第49至52周，27例（40.9%）benralizumab/benralizumab患者和16例（25.8%）mepolizumab/benralizumab患者退出OGCs，在第101至104周分别增加到29例（43.9%）和27例（43.5%）；OLE第1年的OGC累积剂量中位数分别为950 mg和791 mg。benralizumab/benralizumab治疗患者的中位bEOS为20个细胞/µL（第52周和第100周），而mepolizumab/benralizumab治疗患者的中位bEOS在转换后4周从70个细胞/µL降至20个细胞/µL。97.0%/22.7%的benralizumab/benralizumab患者和100%/35.5%的mepolizumab/benralizumab患者报告了不良事件/严重不良事件。结论：在EGPA患者中，抗il -5/R治疗2年与持久缓解率、OGCs停药率、bEOS耗竭率和低复发率相关。从mepolizumab切换到benralizumab可增强bEOS消耗和OGC节约。

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来源期刊

Annals of the Rheumatic Diseases 医学-风湿病学

CiteScore

35.00

自引率

9.90%

发文量

3728

审稿时长

1.4 months

期刊介绍： Annals of the Rheumatic Diseases (ARD) is an international peer-reviewed journal covering all aspects of rheumatology, which includes the full spectrum of musculoskeletal conditions, arthritic disease, and connective tissue disorders. ARD publishes basic, clinical, and translational scientific research, including the most important recommendations for the management of various conditions.