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. 2024 Apr 1:107611.
doi: 10.1016/j.rmed.2024.107611. Online ahead of print.

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

Kefang Lai  1 , Dejun Sun  2 , Ranran Dai  3 , Ronnie Samoro  4 , Hae-Sim Park  5 , Annika Åstrand  6 , David Cohen  7 , Maria Jison  7 , Vivian H Shih  8 , Viktoria Werkström  6 , Yuhui Yao  9 , Yajuan Zhang  9 , Wenying Zheng  10 , Nanshan Zhong  11 ; MIRACLE Study Investigators; Principle investigators; Albay Albert Jr  12 , Bo Jianping  13 , Chen Bi  14 , Chen Lijun  15 , Chen Mei  16 , Chen Min  17 , Chen Ping  18 , Chen Zhimin  19 , Chian Chih-Feng  20 , Cho You Sook  21 , Fu Xiuhua  22 , Gao Xiwen  23 , Gu Wei  24 , Han Wei  25 , Han Zhihai  26 , Hu Xi Wei  27 , Huang Kewu  28 , Huang Mao  29 , Isidro Marie Grace Dawn  30 , Jeong Inbeom  31 , Jiang Luning  32 , Jiang Mingyan  33 , Jiang Shanping  34 , Jin Meiling  35 , Kang Jian  36 , Kim Jin Woo  37 , Kim Sang-Ha  38 , Kuang Jiulong  39 , Kuo Ping-Hung  40 , Li Jie  41 , Li Manxiang  42 , Li Minjing  43 , Li Ruoran  44 , Li Wen  45 , Li Xianhua  46 , Li Yanming  47 , Lim Seong Yong  48 , Liu Chuanhe  49 , Liu Chuntao  50 , Liu Jing  51 , Liu Xiaoxia  52 , Lu Huiyu  53 , Luo Zhuang  54 , Ma Shengxi  55 , Mao Liangping  56 , Min Kyung Hoon  57 , Mu Lin  58 , Park Choon-Sik  59 , Park Hae Sim  60 , Park Hye-Kyung  61 , Park Jung-Won  62 , Perng Diahn-Warng  63 , Samoro Ronnie  4 , Shi Guochao  64 , Sun Debin  65 , Sun Dejun  2 , Wang Chun-Hua  66 , Wang Guangfa  67 , Wang Limin  68 , Wang Xuefen  69 , Wang Yan  70 , Wei Liping  71 , Wu Haihong  72 , Xiao Yi  73 , Xiao Zuke  74 , Xie Canmao  75 , Xu Jin-Fu  76 , Xu Xingxiang  77 , Xu Xiyuan  78 , Yan Jianping  79 , Yang Hongzhong  80 , Yoon Ho Joo  81 , Yu Wencheng  82 , Zhang Jin  83 , Zhang Longju  84 , Zhang Min  85 , Zhang Wei  86 , Zhao Jianping  87 , Zhao Ziwen  88 , Zhu Xiaoli  89 , Zhu Yingqun  90 ; Other investigators; AstraZenenca; ClinChoice
Collaborators, Affiliations
Free article

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

Kefang Lai et al. Respir Med. .
Free article

Abstract

Background: 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.

Objective: To evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia.

Methods: 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.

Results: 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.

Conclusions: MIRACLE data reinforces the efficacy and safety of benralizumab for severe eosinophilic asthma in an Asian population, consistent with the global Phase 3 results.

Keywords: Anti-Interleukin-5 receptor; Biologics; China; Eosinophilic asthma; Exacerbations.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Nanshan Zhong reports financial support was provided by AstraZeneca. Kefang Lai reports financial support was provided by AstraZeneca. Dejun Sun reports financial support was provided by AstraZeneca. Ranran Dai reports financial support was provided by AstraZeneca. Ronnie Samoro reports financial support was provided by AstraZeneca. Hae-Sim Park reports financial support was provided by AstraZeneca. Annika Astrand reports a relationship with AstraZeneca that includes: employment and equity or stocks. David Cohen reports a relationship with AstraZeneca that includes: employment and equity or stocks. Maria Jison reports a relationship with AstraZeneca that includes: employment and equity or stocks. Vivian H Shih reports a relationship with AstraZeneca that includes: employment and equity or stocks. Viktoria Werkstrom reports a relationship with AstraZeneca that includes: employment and equity or stocks. Yuhui Yao reports a relationship with AstraZeneca that includes: employment and equity or stocks. Yajuan Zhang reports a relationship with AstraZeneca that includes: employment and equity or stocks. Wenying Zheng reports a relationship with AstraZeneca that includes: employment and equity or stocks. Tanya Jandu and Helen Brereton of inScience Communications, Springer Healthcare Ltd, UK, provided medical writing support, which was funded by AstraZeneca. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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