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

作者：Kefang Lai, Dejun Sun, Ranran Dai, Ronnie Samoro, Hae‐Sim Park, Annika Åstrand, David Cohen, Maria Jison, Vivian H. Shih, Viktoría Werkström, Yuhui Yao, Yajuan Zhang, Wenying Zheng, Nanshan Zhong · 发表于：Respiratory Medicine · 年份：2024 · DOI：10.1016/j.rmed.2024.107611 · 被引用次数：14 · 研究领域：Asthma and respiratory diseases、Delphi Technique in Research、Chronic Obstructive Pulmonary Disease (COPD) Research

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 β 2 -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 FEV 1 ) 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 FEV 1 (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 FEV 1 , and TASS with benralizumab versus placebo. The frequency of adverse e...