Benralizumab efficacy and safety in severe asthma: A randomized trial in Asia.
Journal
Respiratory medicine
Journal Volume
229
Start Page
107611
ISSN
1532-3064
Date Issued
2024-04-01
Author(s)
Lai, Kefang
Sun, Dejun
Dai, Ranran
Samoro, Ronnie
Park, Hae-Sim
Åstrand, Annika
Cohen, David
Jison, Maria
Shih, Vivian H
Werkström, Viktoria
Yao, Yuhui
Zhang, Yajuan
Zheng, Wenying
Zhong, Nanshan
Albert, Albay
Jianping, Bo
Bi, Chen
Lijun, Chen
Mei, Chen
Min, Chen
Ping, Chen
Zhimin, Chen
Chih-Feng, Chian
Sook, Cho You
Xiuhua, Fu
Xiwen, Gao
Wei, Gu
Wei, Han
Zhihai, Han
Wei, Hu Xi
Kewu, Huang
Mao, Huang
Grace Dawn, Isidro Marie
Inbeom, Jeong
Luning, Jiang
Mingyan, Jiang
Shanping, Jiang
Meiling, Jin
Jian, Kang
Woo, Kim Jin
Sang-Ha, Kim
Jiulong, Kuang
Jie, Li
Manxiang, Li
Minjing, Li
Ruoran, Li
Wen, Li
Xianhua, Li
Yanming, Li
Yong, Lim Seong
Chuanhe, Liu
Chuntao, Liu
Jing, Liu
Xiaoxia, Liu
Huiyu, Lu
Zhuang, Luo
Shengxi, Ma
Liangping, Mao
Hoon, Min Kyung
Lin, Mu
Choon-Sik, Park
Sim, Park Hae
Hye-Kyung, Park
Jung-Won, Park
Diahn-Warng, Perng
Ronnie, Samoro
Guochao, Shi
Debin, Sun
Dejun, Sun
Chun-Hua, Wang
Guangfa, Wang
Limin, Wang
Xuefen, Wang
Yan, Wang
Liping, Wei
Haihong, Wu
Yi, Xiao
Zuke, Xiao
Canmao, Xie
Jin-Fu, Xu
Xingxiang, Xu
Xiyuan, Xu
Jianping, Yan
Hongzhong, Yang
Joo, Yoon Ho
Wencheng, Yu
Jin, Zhang
Longju, Zhang
Min, Zhang
Wei, Zhang
Jianping, Zhao
Ziwen, Zhao
Xiaoli, Zhu
Yingqun, Zhu
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 s (FEV1 is being defined, not BD, which has already been defined) 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.
Subjects
Anti-Interleukin-5 receptor
Biologics
China
Eosinophilic asthma
Exacerbations
SDGs
Type
journal article