マツモト　エツコ   MATSUMOTO Etsuko   松本　悦子    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Effectiveness of benralizumab in the Tokyo Asthma Study (TOAST): A real-world prospective interventional trial.
掲載誌名	正式名：Allergology international : official journal of the Japanese Society of Allergology 略　 称：Allergol Int ISSNコード：14401592/13238930
掲載区分	国内
巻・号・頁	74(2),pp.274-282
著者・共著者	Masaki Katsunori†, Suzukawa Maho, Sasano Hitoshi, Harada Norihiro, Miyazaki Yasunari, Katsura Hideki, Tagaya Etsuko, Terada Junko, Hojo Masayuki, Sugimoto Naoya, Nagase Hiroyuki, Kono Yuta, Hiranuma Hisato, Gon Yasuhiro, Takemura Ryo, Irie Misato, Nakamura Reina, Kabata Hiroki, Miyata Jun, Fukunaga Koichi
発行年月	2025/04
概要	BACKGROUND:Biologics are integral in the management of severe asthma. As the effectiveness of the anti-IL-5 receptor antibody benralizumab in Japan remains elusive, this study aimed to assess its real-world effectiveness in Japanese patients with severe asthma.METHODS:This prospective, interventional, single-arm clinical trial was conducted across ten facilities in Japan between September 2020 and July 2022. Adult patients with severe eosinophilic asthma (peripheral blood eosinophil count ≥150 cells/μl) were enrolled and treated with benralizumab. The primary endpoint was the change in ACQ-5 score from baseline to week 24.RESULTS:Of 103 patients, 98 (mean age: 62.1 years, women: 55.1 %, regular oral corticosteroids [OCS] treatment: 20.4 %) were included in the analysis. From baseline to week 24, benralizumab significantly improved ACQ-5 (-0.67, 95 % CI: -0.94 to -0.39) and AQLQ (0.71, 95 % CI: 0.46 to 0.96) scores with an increase in FEV1 (87 ml, 95 % CI: 15-159 ml). The maintenance OCS dose and the percentage of OCS users decreased from 13.9 mg/day to 6.0 mg/day and from 20.4 % to 9.2 %, respectively. Multivariable analysis identified baseline blood eosinophil count (≥400 cells/μl) and fractional exhaled nitric oxide (≥22 ppb) as independent predictors of therapeutic response to benralizumab. Benralizumab treatment was discontinued due to nonserious adverse events and patient choice in four and three patients, respectively.CONCLUSIONS:In a real-world setting in Japan, patients with severe eosinophilic asthma treated with benralizumab demonstrated substantial improvements in asthma control, quality of life, and respiratory function with reduced OCS usage.TRIAL REGISTRATION:Japan Registry of Clinical Trials (jRCTs031190237).
DOI	10.1016/j.alit.2024.10.009
PMID	39632158