TY - JOUR
T1 - Benralizumab efficacy and safety in severe asthma
T2 - A randomized trial in Asia
AU - the MIRACLE Study Investigators, Principle investigators
AU - Other investigators
AU - AstraZenenca
AU - ClinChoice
AU - Lai, Kefang
AU - Sun, Dejun
AU - Dai, Ranran
AU - Samoro, Ronnie
AU - Park, Hae Sim
AU - Åstrand, Annika
AU - Cohen, David
AU - Jison, Maria
AU - Shih, Vivian H.
AU - Werkström, Viktoria
AU - Yao, Yuhui
AU - Zhang, Yajuan
AU - Zheng, Wenying
AU - Zhong, Nanshan
AU - Albay, Albert
AU - Bo, Jianping
AU - Chen, Bi
AU - Chen, Lijun
AU - Chen, Mei
AU - Chen, Min
AU - Chen, Ping
AU - Chen, Zhimin
AU - Chian, Chih Feng
AU - Cho, You Sook
AU - Fu, Xiuhua
AU - Gao, Xiwen
AU - Gu, Wei
AU - Han, Wei
AU - Han, Zhihai
AU - Hu, Xi Wei
AU - Huang, Kewu
AU - Huang, Mao
AU - Isidro, Marie Grace Dawn
AU - Jeong, Inbeom
AU - Jiang, Luning
AU - Jiang, Mingyan
AU - Jiang, Shanping
AU - Jin, Meiling
AU - Kang, Jian
AU - Kim, Jin Woo
AU - Kim, Sang Ha
AU - Kuang, Jiulong
AU - Kuo, Ping Hung
AU - Li, Jie
AU - Li, Manxiang
AU - Li, Minjing
AU - Li, Ruoran
AU - Li, Wen
AU - Kim, Sei Won
AU - Yeo, Chang Dong
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024/8
Y1 - 2024/8
N2 - 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.
AB - 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.
KW - Anti-interleukin-5 receptor
KW - Biologics
KW - China
KW - Eosinophilic asthma
KW - Exacerbations
UR - https://www.scopus.com/pages/publications/85195377573
U2 - 10.1016/j.rmed.2024.107611
DO - 10.1016/j.rmed.2024.107611
M3 - Article
C2 - 38570145
AN - SCOPUS:85195377573
SN - 0954-6111
VL - 229
JO - Respiratory Medicine
JF - Respiratory Medicine
M1 - 107611
ER -