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Benralizumab efficacy and safety in severe asthma: A randomized trial in Asia

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机构： [1]Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [2]Inner Mongolia People's Hospital, Hohhot, China. [3]Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China. [4]Healthlink Medical-Surgical-Dental Clinics and Diagnostic Center, Iloilo City, Philippines. [5]Ajou University School of Medicine, Ajou University Medical Center, Suwon, Republic of Korea. [6]Late-stage Respiratory & Immunology, AstraZeneca, Gothenburg, Sweden. [7]Late-stage Respiratory & Immunology, AstraZeneca, Gaithersburg, MD, USA. [8]BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA. [9]Respiratory & Immunology, R&D China, AstraZeneca, Shanghai, China. [10]Biometrics, R&D China, AstraZeneca, Shanghai, China. [11]Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [12]Manila Doctors Hospital, Metro Manila, Philippines. [13]Second Hospital of Shanxi Medical University, Shanxi, China. [14]The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. [15]Yinchuan First People's Hospital, Yinchuan, China. [16]Chengdu Fifth People's Hospital, Sichuan, China. [17]The Affiliated Hospital of Guangdong Medical University, Zhanjiang, China. [18]The General Hospital of Shenyang Military, Shenyang, China. [19]The Children's Hospital of Zhejiang University College of Medicine, Zhejiang, China. [20]Tri Service General Hospital, Taipei, Taiwan. [21]Asan Medical Center, Seoul, Republic of Korea. [22]The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China. [23]Central Hospital of Minhang District, Shanghai, China. [24]Nanjing First Hospital, Nanjing, China. [25]Qingdao Municipal Hospital, Qingdao, China. [26]Navy General Hospital, Beijing, China. [27]The Affiliated Hospital of Guizhou Medical University, Guizhou, China. [28]Beijing Chaoyang Hospital, Beijing, China. [29]Jiangsu Province Hospital, Jiangsu, China. [30]West Visayas State University Medical Center, Iloilo City, Philippines. [31]Konyang University Hospital, Daejeon, Republic of Korea. [32]Affiliated Hospital of Jining Medical College, Jining, China. [33]Xiangtan Central Hospital, Xiangtan, China. [34]Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, China. [35]Zhongshan Hospital of Fudan University, Shangha, China. [36]The First Affiliated Hospital of China Medical University, Chongqing, China. [37]The Catholic University of Korea, Seoul, Republic of Korea. [38]Yonsei University Wonju Severance Christian Hospital, Gangwon-do, Republic of Korea. [39]The Second Affiliated Hospital of Nanchang University, Nanchang, China. [40]National Taiwan University Hospital, Taipei, Taiwan. [41]First Affiliated Hospital of Ganzhou Medical University, Guangzhou, China. [42]The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [43]The First People's Hospital of Foshan, Foshan, China. [44]Xuzhou Central Hospital, Jiangsu, China. [45]The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China. [46]The First People's Hospital of Neijiang, Neijiang, China. [47]Beijing Hospital, Beijing, China. [48]Kangbuk Samsung Hospital, Seoul, Republic of Korea. [49]Children's Hospital, Capital Institute of Pediatrics, Beijing, China. [50]West China Hospital, Sichuan University, Sichuan, China. [51]The Fifth Affiliated Hospital Sun YAT-SEN University, China. [52]Beijing Friendship Hospital, Beijing, China. [53]Taizhou People's Hospital, Taizhou, China. [54]First Affiliated Hospital of Kunming Medical University, Kunming, China. [55]Xinxiang Central Hospital, Xinxiang, China. [56]Chongqing Three Gorges Central Hospital, Chongqing, China. [57]Korea University Guro Hospital, Seoul, Republic of Korea. [58]Heping Hospital Affiliated to Changzhi Medical College, Changzhi, China. [59]Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea. [60]Ajou University Hospital, Suwon-si, Republic of Korea. [61]Pusan National University Hospital, Busan, Republic of Korea. [62]Severance Hospital, Seoul, Republic of Korea. [63]Taipei Veterans General Hospital, Taipei, Taiwan. [64]Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [65]Lishui Central Hospital, Lishui, China. [66]Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan. [67]Peking University First Hospital, Beijing, China. [68]Hangzhou First People's Hospital, Hangzhou, China. [69]The First Affiliated Hospital Zhejiang University, Zhejiang, China. [70]The Second Affiliated Hospital of Army Medical University, PLA, China. [71]The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [72]Hainan General Hospital, Haikou, China. [73]Yanan Hospital, Kunming City, Yunnan, China. [74]Jiangxi Provincial People's Hospital, Jiangxi, China. [75]The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China. [76]Shanghai Pulmonary Hospital, Shanghai, China. [77]Northern Jiangsu People's Hospital, Jiangsu, China. [78]The First Affiliated Hospital of Baotou Medical College, Inner Mongolia, China. [79]Zhejiang Provincial People's Hospital, Zhejiang, China. [80]Changsha Central Hospital, Changsha, China. [81]Hanyang University Seoul Hospital, Seoul, Republic of Korea. [82]The Affiliated Hospital of Qingdao University, Qingdao, China. [83]General Hospital of Ningxia Medical University, Yinchuan, China. [84]The First People's Hospital of Zunyi, Zunyi, China. [85]The People's Hospital of Ganzhou, Ganzhou, China. [86]The First Affiliated Hospital of Nanchang University, Nanchang, China. [87]Tongji Hospital of Huazhong Science and Technology University, Wuhan, China. [88]Guangzhou First People's Hospital, Guangzhou, China. [89]Zhongda Hospital Southeast University, Nanjing, China. [90]The Third Hospital of Changsha, Changsha, China.

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关键词： Eosinophilic asthma exacerbations anti-interleukin-5 receptor biologics China

摘要：

Benralizumab is indicated as add-on therapy in patients with uncontrolled, severe eosinophilic asthma; it has not yet been evaluated in a large Asian population with asthma in a clinical trial.To evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia.MIRACLE (NCT03186209) was a randomized, Phase 3 study in China, South Korea, and the Philippines. Patients aged 12-75 years with severe asthma receiving medium-to-high-dose inhaled corticosteroid/long-acting β2-agonists, stratified (2:1) by baseline blood eosinophil count (bEOS) (≥300/μL; <300/μL), were randomized (1:1) to benralizumab 30 mg or placebo. Endpoints included annual asthma exacerbation rate (AAER; primary endpoint), change from baseline at Week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (pre-BD FEV1) and total asthma symptom score (TASS). Safety was evaluated ≤ Week 56.Of 695 patients randomized, 473 had baseline bEOS ≥300/μL (benralizumab n = 236; placebo n = 237). In this population, benralizumab significantly reduced AAER by 74% (rate ratio 0.26 [95% CI 0.19, 0.36], p < 0.0001) and significantly improved pre-BD FEV1 (least squares difference [LSD] 0.25 L [95% CI 0.17, 0.34], p < 0.0001) and TASS (LSD -0.25 [-0.45, -0.05], p = 0.0126) versus placebo. In patients with baseline bEOS <300/μL, there were numerical improvements in AAER, pre-BD FEV1, and TASS with benralizumab versus placebo. The frequency of adverse events was similar for benralizumab (76%) and placebo (80%) in the overall population.MIRACLE data reinforces the efficacy and safety of benralizumab for severe eosinophilic asthma in an Asian population, consistent with the global Phase 3 results.Copyright © 2024. Published by Elsevier Ltd.

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大类 | 3 区医学

小类 | 3 区心脏和心血管系统 3 区呼吸系统

第一作者：

第一作者机构： [1]Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

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Benralizumab efficacy and safety in severe asthma: A randomized trial in Asia

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