Article
作者: Jin, Zhang ; Park, Hae-Sim ; Xiuhua, Fu ; Mao, Huang ; Min, Chen ; Min, Zhang ; Canmao, Xie ; Åstrand, Annika ; Jie, Li ; Kewu, Huang ; Wei, Gu ; Hye-Kyung, Park ; Longju, Zhang ; Liangping, Mao ; Shih, Vivian H ; Cohen, David ; Woo, Kim Jin ; Lijun, Chen ; Ruoran, Li ; Meiling, Jin ; Zheng, Wenying ; Limin, Wang ; Minjing, Li ; Huiyu, Lu ; Sang-Ha, Kim ; Jison, Maria ; Xiaoxia, Liu ; Haihong, Wu ; Zuke, Xiao ; Yi, Xiao ; Ping, Chen ; Xiyuan, Xu ; Mei, Chen ; Zhimin, Chen ; Yanming, Li ; Sim, Park Hae ; Diahn-Warng, Perng ; Grace Dawn, Isidro Marie ; Jianping, Yan ; Xianhua, Li ; Chun-Hua, Wang ; Joo, Yoon Ho ; Shengxi, Ma ; Chuntao, Liu ; Hongzhong, Yang ; Jianping, Zhao ; Debin, Sun ; Yingqun, Zhu ; Jianping, Bo ; Wei, Han ; Guangfa, Wang ; Jiulong, Kuang ; Hoon, Min Kyung ; Sun, Dejun ; Ziwen, Zhao ; Mingyan, Jiang ; Zhong, Nanshan ; Yao, Yuhui ; Luning, Jiang ; Chuanhe, Liu ; Chih-Feng, Chian ; Dejun, Sun ; Yong, Lim Seong ; Bi, Chen ; Xiwen, Gao ; Wei, Zhang ; Jian, Kang ; Ronnie, Samoro ; Sook, Cho You ; Liping, Wei ; Zhang, Yajuan ; Zhuang, Luo ; Xingxiang, Xu ; Samoro, Ronnie ; Guochao, Shi ; Werkström, Viktoria ; Jin-Fu, Xu ; Lai, Kefang ; Jung-Won, Park ; Choon-Sik, Park ; Shanping, Jiang ; Xiaoli, Zhu ; Wen, Li ; Inbeom, Jeong ; Zhihai, Han ; Xuefen, Wang ; Wei, Hu Xi ; Wencheng, Yu ; Ping-Hung, Kuo ; Lin, Mu ; Dai, Ranran ; Albert, Albay ; Yan, Wang ; Manxiang, Li ; Jing, Liu
BACKGROUNDBenralizumab 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.OBJECTIVETo evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia.METHODSMIRACLE (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.RESULTSOf 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.CONCLUSIONSMIRACLE data reinforces the efficacy and safety of benralizumab for severe eosinophilic asthma in an Asian population, consistent with the global Phase 3 results.