Pretreatment Frequency of Circulating Th17 Cells and FeNO Levels Predicted the Real-World Response after 1 Year of Benralizumab Treatment in Patients with Severe Asthma.

Benralizumab treatment reduces exacerbations and improves symptom control and quality of life in patients with severe eosinophilic asthma. However, the determination of biomarkers that predict therapeutic effectiveness is required for precision medicine. Herein, we elucidated the dynamics of various parameters before and after treatment as well as patient characteristics predictive of clinical effectiveness after 1 year of benralizumab treatment in severe asthma in a real-world setting. Thirty-six patients with severe asthma were treated with benralizumab for 1 year. Lymphocyte subsets in peripheral blood samples were analyzed using flow cytometry. Treatment effectiveness was determined based on the ACT score, forced expiratory volume in 1 s (FEV1), and the number of exacerbations. Benralizumab provided symptomatic improvement in severe asthma. Benralizumab significantly decreased peripheral blood eosinophil and basophil counts and the frequencies of regulatory T cells (Tregs), and increased the frequencies of Th2 cells. To our knowledge, this is the first study to show benralizumab treatment increasing circulating Th2 cells and decreasing circulating Tregs. Finally, the ROC curve to discriminate patients who achieved clinical effectiveness of benralizumab treatment revealed that the frequency of circulating Th17 cells and FeNO levels might be used as parameters for predicting the real-world response of benralizumab treatment in patients with severe asthma.

Déclaration de conflit d'intérêts

N.H. reports personal fees from AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi and grants from AstraZeneca, Daikin, Kao, Kyorin, SRL Medisearch, and TOSOH, outside the submitted work. K.I. reports grants from Shino-test Co., Ltd. during the conduct of the study and grants from AstraZeneca, outside the submitted work. In addition, K.I. has patents licensed in Japan and the United States managed by Shino-test Co., Ltd., Saga University, and Kurume University. S.M. reports personal fees from Amgen, Asahi Kasei, Astellas, Biogen, Bristol-Myers, Chugai, Eisai, and Ono and grants from Bristol-Myers and Pfizer, outside the submitted work. In addition, S.M. has a patent (JP 6730708) on a method for evaluating selective IL-4 production by Juntendo University in Japan. K.T. reports grants and personal fees from Boehringer Ingelheim, Chugai, Eli Lilly, Kyorin, Novartis, Ono, Pfizer, Taiho, and Takeda; grants from Asahi Kasei, Astellas, Bayer Yakuhin, Daiichi Sankyo, Kyowa Kirin, Nipro pharma, Nipro Kayaku, Nippon Shinyaku, Sanofi, Shionogi, Teijin, and Tsumura; personal fees from Abbott, AstraZeneca, Bristol-Myers, Eisai, Janssen, Meiji Seika, Merck, MSD, Sumitomo Dainippon, Thermo Fisher Scientific, and Viatris outside the submitted work. In addition, K.T. has a patent (P6840330) on a method for detecting cells managed by Juntendo University in Japan. The rest of the authors have no competing interests to declare.