Effectiveness of benralizumab in the Tokyo Asthma Study (TOAST): A real-world prospective interventional trial.

IF 6.2 2区医学 Q1 ALLERGY

Allergology International Pub Date : 2024-12-03 DOI:10.1016/j.alit.2024.10.009

Katsunori Masaki, Maho Suzukawa, Hitoshi Sasano, Norihiro Harada, Yasunari Miyazaki, Hideki Katsura, Etsuko Tagaya, Junko Terada, Masayuki Hojo, Naoya Sugimoto, Hiroyuki Nagase, Yuta Kono, Hisato Hiranuma, Yasuhiro Gon, Ryo Takemura, Misato Irie, Reina Nakamura, Hiroki Kabata, Jun Miyata, Koichi Fukunaga

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引用次数: 0

Abstract

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).

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来源期刊

Allergology International ALLERGY-IMMUNOLOGY

CiteScore

12.60

自引率

5.90%

发文量

审稿时长

29 weeks

期刊介绍： Allergology International is the official journal of the Japanese Society of Allergology and publishes original papers dealing with the etiology, diagnosis and treatment of allergic and related diseases. Papers may include the study of methods of controlling allergic reactions, human and animal models of hypersensitivity and other aspects of basic and applied clinical allergy in its broadest sense. The Journal aims to encourage the international exchange of results and encourages authors from all countries to submit papers in the following three categories: Original Articles, Review Articles, and Letters to the Editor.