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本瑞利珠单抗治疗基线外周血嗜酸性粒细胞计数≥150/μl重度哮喘患者的疗效:临床Ⅲ期MIRACLE研究亚组分析

Efficacy and clinical remission in patients with severe asthma and blood eosinophil counts ≥150 cells/μl treated with benralizumab: a sub-analysis of the Phase 3 MIRACLE study

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收录情况: ◇ 统计源期刊 ◇ 北大核心 ◇ CSCD-C ◇ 卓越:领军期刊 ◇ 中华系列

机构: [1]广州医科大学附属第一医院呼吸与危重症医学科国家呼吸医学中心国家呼吸系统疾病临床医学研究中心呼吸疾病国家重点实验室广州呼吸健康研究院,广州510120 [2]徐州市中心医院呼吸与危重症医学科,徐州221009 [3]昆明医科大学第一附属医院呼吸与危重症医学科,昆明650032 [4]内蒙古医科大学第一附属医院呼吸与危重症医学科,呼和浩特710061 [5]沈阳军区总医院呼吸内科,沈阳110016 [6]广州市第一人民医院呼吸与危重症医学科华南理工大学医学院,广州510180 [7]杭州市第一人民医院呼吸与危重症医学科西湖大学医学院,杭州310006 [8]四川大学华西医院呼吸与危重症医学科,成都610041 [9]阿斯利康BioPharmaceuticalsMedical,美国马里兰州盖瑟斯堡,20878 [10]阿斯利康Late‑stageRespiratory&Immunology,瑞典哥德堡,41255 [11]阿斯利康Late‑stageRespiratory&Immunology,美国马里兰州盖瑟斯堡,20878 [12]阿斯利康BioPharmaceuticalsMedical,英国剑桥,CB20AA [13]广州医科大学附属第一医院呼吸与危重症医学科呼吸疾病全国重点实验室,广州510120
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关键词: 哮喘  嗜酸性粒细胞  白细胞介素‑5受体  生物制剂  中国

摘要:
Objective: To evaluate the efficacy of benralizumab in patients with baseline bEOS ≥150 cells/μl using data from the MIRACLE study in Asia. Methods: MIRACLE was a phase Ⅲ clinical trial. From September 7, 2017 to January 30, 2023, patients aged 12-75 years with eosinophilic severe asthma receiving medium- to high-dosage inhaled corticosteroids and long-acting β2 agonists were enrolled from 79 centres in Asia. They were randomized (1∶1) to receive either benralizumab 30 mg or placebo for 48 weeks. The endpoints included annual asthma exacerbation rate (AAER), pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1), total asthma symptom score (TASS), St George's Respiratory Questionnaire (SGRQ) score, and the proportion of patients achieving clinical remission (defined as no asthma exacerbations, FEV1 improvement ≥100 ml, and 6-item Asthma Control Questionnaire [ACQ-6 score;≤0.75 or <1.5]; at Weeks 24 and 48) in patients with no baseline oral corticosteroid (OCS) use. Results: Of 695 patients randomized, 598 patients had baseline bEOS ≥150 cells/μl [benralizumab n=301, placebo n=297; age: (50.9±12.1) years; 61.2% were women]. In this population, benralizumab reduced the AAER by 67% [rate ratio (RR)=0.33, 95%CI: 0.25-0.44, P<0.001) and improved lung function [least squares (LS) mean difference vs. placebo: 0.21 L, 95%CI: 0.14-0.29, P<0.001]. Benralizumab achieved greater reductions in TASS (LS mean difference:-0.29, 95%CI:-0.46--0.11, P=0.002) and ACQ-6 scores (LS mean difference:-0.33, 95%CI:-0.46--0.19, P<0.001), and improved SGRQ scores (LS mean difference:-8.07, 95%CI:-11.35--4.79], P<0.001). Among patients with no baseline OCS use (benralizumab n=277; placebo n=264), a higher proportion of benralizumab-treated patients achieved clinical remission at Weeks 24 and 48 compared to the placebo-treated patients. Conclusion: These results reinforce that benralizumab can improve clinical outcomes in patients with severe, uncontrolled asthma with bEOS ≥150 cells/μl in Asia.

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第一作者机构: [1]广州医科大学附属第一医院呼吸与危重症医学科国家呼吸医学中心国家呼吸系统疾病临床医学研究中心呼吸疾病国家重点实验室广州呼吸健康研究院,广州510120
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