Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial.

IF 4.3 2区医学 Q2 ALLERGY

Allergy, Asthma & Immunology Research Pub Date : 2025-07-01 DOI:10.4168/aair.2025.17.4.473

Ruchong Chen, Yuanrong Dai, Danrong Yang, Chuntao Liu, Wei Han, Wei Gu, Jie Cao, Qiong Zhou, Peter Howarth, Stephen Weng, Cui Xiong, Jie Huang, Peiwen Liang, Nanshan Zhong

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Abstract

Purpose: Clinical remission (CR), an emerging treatment goal in asthma, was assessed by a post hoc analysis of a phase 3 study of mepolizumab in severe asthma with an eosinophilic phenotype (SA-EP).

Methods: Asthmatic patients aged ≥ 12 years, with a blood eosinophil count of ≥ 150 cells/µL at screening (or ≥ 300 cells/µL in the previous year), receiving fluticasone propionate ≥ 500 µg/day or equivalent plus ≥ 1 controller medication, and experiencing ≥ 2 exacerbations in the previous year were randomised to receive add-on mepolizumab or placebo every 4 weeks for 52 weeks. CR was assessed using both 3- and 4-component definitions (at 1 year, no maintenance oral corticosteroids, no clinically significant exacerbations, and asthma control questionnaire-5 [ACQ-5] score ≤ 1.5 for both, plus change from baseline in pre-bronchodilator forced expiratory volume in 1 second ≥ 0 mL for 4-component definition).

Results: At week 52, 41.6% (62/149) of mepolizumab-treated patients and 21.2% (32/151) of placebo-treated patients met the 4-component definition (odds ratio [OR], 2.65; 95% confidence interval [CI], 1.59-4.41; P < 0.001), with a difference of 20.4% (95% CI, 9.1%-31.2%), and 54.4% (81/149) of mepolizumab-treated patients and 32.5% (49/151) of placebo-treated patients met the 3-component definition (OR, 2.48; 95% CI, 1.55-3.96; P < 0.001), with a difference of 21.9% (95% CI, 10.5%-32.7%). Baseline characteristics potentially associated with CR in the mepolizumab group were lower ACQ-5 score and lower St George's Respiratory Questionnaire scores.

Conclusions: A higher proportion of Chinese SA-EP patients treated with mepolizumab achieved CR compared to those receiving placebo. Certain baseline characteristics are potentially predictive of CR.

Trial registration: ClinicalTrials.gov Identifier: NCT03562195.

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中国嗜酸性粒细胞表型重度哮喘患者接受Mepolizumab治疗的临床缓解结果：一项随机、双盲、安慰剂对照试验的3期事后分析

目的：临床缓解（CR）是哮喘的一个新兴治疗目标，通过对mepolizumab治疗嗜酸性粒细胞表型（SA-EP）的严重哮喘的3期研究的事后分析进行了评估。方法：年龄≥12岁，筛查时血嗜酸性粒细胞计数≥150个细胞/µL（或上一年度≥300个细胞/µL），接受丙酸氟替卡松≥500µg/天或同等剂量加上≥1种对照药物，且上一年度发作≥2次的哮喘患者随机分组，每4周加用美polizumab或安慰剂，共52周。采用3组分和4组分定义评估CR（1年时，无维持性口服皮质类固醇，无临床显著恶化，哮喘控制问卷-5 [ACQ-5]评分均≤1.5，加上4组分定义支气管扩张前1秒用力呼气量≥0 mL与基线相比的变化）。结果：在第52周，41.6%（62/149）的mepolizumab治疗患者和21.2%（32/151）的安慰剂治疗患者符合4组分定义(优势比[OR]， 2.65；95%置信区间[CI]， 1.59-4.41；P < 0.001)，差异为20.4% (95% CI, 9.1%-31.2%), 54.4%（81/149）的mepolizumab治疗患者和32.5%（49/151）的安慰剂治疗患者符合3组分定义(OR, 2.48；95% ci, 1.55-3.96；P < 0.001)，差异为21.9% （95% CI, 10.5%-32.7%）。mepolizumab组与CR潜在相关的基线特征是较低的ACQ-5评分和较低的圣乔治呼吸问卷评分。结论：与接受安慰剂的患者相比，mepolizumab治疗的中国SA-EP患者达到CR的比例更高。试验注册：ClinicalTrials.gov标识符：NCT03562195。

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来源期刊

Allergy, Asthma & Immunology Research ALLERGY-IMMUNOLOGY

CiteScore

6.10

自引率

6.80%

发文量

审稿时长

>12 weeks

期刊介绍： The journal features cutting-edge original research, brief communications, and state-of-the-art reviews in the specialties of allergy, asthma, and immunology, including clinical and experimental studies and instructive case reports. Contemporary reviews summarize information on topics for researchers and physicians in the fields of allergy and immunology. As of January 2017, AAIR do not accept case reports. However, if it is a clinically important case, authors can submit it in the form of letter to the Editor. Editorials and letters to the Editor explore controversial issues and encourage further discussion among physicians dealing with allergy, immunology, pediatric respirology, and related medical fields. AAIR also features topics in practice and management and recent advances in equipment and techniques for clinicians concerned with clinical manifestations of allergies and pediatric respiratory diseases.