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
Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
Clinical Research Center, National Hospital Organization Tokyo National Hospital, Tokyo, Japan.
Allergol Int. 2025 Apr;74(2):274-282. doi: 10.1016/j.alit.2024.10.009. Epub 2024 Dec 3.
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.
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.
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.
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.
Japan Registry of Clinical Trials (jRCTs031190237).
生物制剂在重度哮喘的治疗中不可或缺。由于抗白细胞介素-5受体抗体贝那利珠单抗在日本的有效性尚不明确，本研究旨在评估其在日本重度哮喘患者中的真实世界有效性。
本前瞻性、干预性、单臂临床试验于2020年9月至2022年7月在日本的10家医疗机构开展。纳入重度嗜酸性粒细胞性哮喘成年患者（外周血嗜酸性粒细胞计数≥150个/μl），并给予贝那利珠单抗治疗。主要终点为第24周时自基线起的哮喘控制问卷（ACQ-5）评分变化。
103例患者中，98例（平均年龄：62.1岁，女性：55.1%，规律口服糖皮质激素[OCS]治疗：20.4%）纳入分析。从基线至第24周，贝那利珠单抗显著改善了ACQ-5评分（-0.67，95%置信区间：-0.94至-0.39）和哮喘生活质量问卷（AQLQ）评分（0.71，95%置信区间：0.46至0.96），第一秒用力呼气容积（FEV1）增加（87 ml，95%置信区间：15至159 ml）。维持性OCS剂量和OCS使用者比例分别从13.9 mg/天降至6.0 mg/天和从20.4%降至9.2%。多变量分析确定基线血嗜酸性粒细胞计数（≥400个/μl）和呼出一氧化氮分数（≥22 ppb）为贝那利珠单抗治疗反应的独立预测因素。分别有4例和3例患者因非严重不良事件和患者选择而停用贝那利珠单抗治疗。
在日本的真实世界环境中，接受贝那利珠单抗治疗的重度嗜酸性粒细胞性哮喘患者在哮喘控制、生活质量和呼吸功能方面有显著改善，且OCS使用减少。
日本临床试验注册中心（jRCTs031190237）
