Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma

Background: The therapeutic effectiveness of dupilumab for severe asthma in real-world settings is yet to be prospectively investigated across multiple institutions, and uncertainties persist regarding predictive factors for its effectiveness. We aimed to assess the effectiveness of dupilumab and id...

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Main Authors: Kenji Mizumura, Yasuhiro Gon, Norihiro Harada, Shiho Yamada, Asami Fukuda, Ryosuke Ozoe, Shuichiro Maruoka, Sumiko Abe, Kazuhisa Takahashi, Akihiko Tanaka, Hironori Sagara, Taisuke Akamatsu, Toshihiro Shirai, Katsunori Masaki, Koichi Fukunaga, Konomi Kobayashi, Hiroyuki Nagase, Nobuaki Miyahara, Arihiko Kanehiro, Noboru Kitamura, Naruhiko Sugihara, Fumio Kumasawa, Junko Terada-Hirashima, Masayuki Hojo, Kazuyuki Chibana, Etsuko Tagaya
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Allergology International
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Online Access:http://www.sciencedirect.com/science/article/pii/S132389302400087X
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author Kenji Mizumura
Yasuhiro Gon
Norihiro Harada
Shiho Yamada
Asami Fukuda
Ryosuke Ozoe
Shuichiro Maruoka
Sumiko Abe
Kazuhisa Takahashi
Akihiko Tanaka
Hironori Sagara
Taisuke Akamatsu
Toshihiro Shirai
Katsunori Masaki
Koichi Fukunaga
Konomi Kobayashi
Hiroyuki Nagase
Nobuaki Miyahara
Arihiko Kanehiro
Noboru Kitamura
Naruhiko Sugihara
Fumio Kumasawa
Junko Terada-Hirashima
Masayuki Hojo
Kazuyuki Chibana
Etsuko Tagaya
author_facet Kenji Mizumura
Yasuhiro Gon
Norihiro Harada
Shiho Yamada
Asami Fukuda
Ryosuke Ozoe
Shuichiro Maruoka
Sumiko Abe
Kazuhisa Takahashi
Akihiko Tanaka
Hironori Sagara
Taisuke Akamatsu
Toshihiro Shirai
Katsunori Masaki
Koichi Fukunaga
Konomi Kobayashi
Hiroyuki Nagase
Nobuaki Miyahara
Arihiko Kanehiro
Noboru Kitamura
Naruhiko Sugihara
Fumio Kumasawa
Junko Terada-Hirashima
Masayuki Hojo
Kazuyuki Chibana
Etsuko Tagaya
author_sort Kenji Mizumura
collection DOAJ
description Background: The therapeutic effectiveness of dupilumab for severe asthma in real-world settings is yet to be prospectively investigated across multiple institutions, and uncertainties persist regarding predictive factors for its effectiveness. We aimed to assess the effectiveness of dupilumab and identify predictors of its effectiveness in real-world settings using two type-2 biomarkers: FeNO concentration and blood eosinophil count. Methods: This prospective multicenter study included 103 patients with severe asthma. Exacerbations and respiratory functions were monitored for 24 weeks. Asthma control was evaluated using the Asthma Control Questionnaire-5. Clinical symptoms and their impact on cough and sputum were assessed using the Cough and Sputum Assessment Questionnaire (CASA-Q). Subgroup analyses of type-2 biomarkers were conducted based on FeNO levels and blood eosinophil counts at baseline. Results: Treatment with dupilumab led to a reduction in exacerbations and enhancement in asthma control, FEV1, and CASA-Q scores. FEV1 improvement was correlated with enhancement in the sputum domain of the CASA-Q. Patients exhibiting elevated FeNO levels and blood eosinophil counts demonstrated more significant enhancements in FEV1. CASA-Q sputum domain scores were significantly higher in the group with elevated eosinophil counts. Regression analysis revealed that FeNO levels and blood eosinophil counts are significant predictors of FEV1 improvement, with blood eosinophil counts also predicting sputum improvement in patients treated with dupilumab. Conclusions: Type-2 biomarkers may act as indicators of improvement in FEV1 and sputum outcomes among patients with severe asthma undergoing dupilumab treatment in real-world settings.
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spelling doaj-art-6a9277efefff408fae7a6dc9171cca7d2025-01-04T04:56:06ZengElsevierAllergology International1323-89302025-01-01741144155Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthmaKenji Mizumura0Yasuhiro Gon1Norihiro Harada2Shiho Yamada3Asami Fukuda4Ryosuke Ozoe5Shuichiro Maruoka6Sumiko Abe7Kazuhisa Takahashi8Akihiko Tanaka9Hironori Sagara10Taisuke Akamatsu11Toshihiro Shirai12Katsunori Masaki13Koichi Fukunaga14Konomi Kobayashi15Hiroyuki Nagase16Nobuaki Miyahara17Arihiko Kanehiro18Noboru Kitamura19Naruhiko Sugihara20Fumio Kumasawa21Junko Terada-Hirashima22Masayuki Hojo23Kazuyuki Chibana24Etsuko Tagaya25Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan; Corresponding author. Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kami-cho, Itabashi-ku, Tokyo 173-8610, Japan.Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanDepartment of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Juntendo University, Tokyo, JapanDivision of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanDivision of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanDivision of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanDivision of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, JapanDepartment of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Juntendo University, Tokyo, JapanDepartment of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Juntendo University, Tokyo, JapanDivision of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, JapanDivision of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, JapanDepartment of Respiratory Medicine, Shizuoka General Hospital, Shizuoka, JapanDepartment of Respiratory Medicine, Shizuoka General Hospital, Shizuoka, JapanDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo, JapanDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, Tokyo, JapanDivision of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, JapanDivision of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, JapanDepartment of Medical Technology, Okayama University Academic Field of Health Sciences, Okayama, JapanSocial Medical Corporation Foundation of St. Francis Himeji St. Mary's Hospital, Hyogo, JapanJinyu Clinic, Tokyo, JapanJinyu Clinic, Tokyo, JapanDivision of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan; Division of Respiratory Medicine, Akabane Central General Hospital, Tokyo, JapanDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, JapanDepartment of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, JapanDepartment of Pulmonary Medicine and Clinical Immunology, Dokkyo Medical University School of Medicine, Tochigi, JapanDepartment of Respiratory Medicine, Tokyo Women's Medical University, Tokyo, JapanBackground: The therapeutic effectiveness of dupilumab for severe asthma in real-world settings is yet to be prospectively investigated across multiple institutions, and uncertainties persist regarding predictive factors for its effectiveness. We aimed to assess the effectiveness of dupilumab and identify predictors of its effectiveness in real-world settings using two type-2 biomarkers: FeNO concentration and blood eosinophil count. Methods: This prospective multicenter study included 103 patients with severe asthma. Exacerbations and respiratory functions were monitored for 24 weeks. Asthma control was evaluated using the Asthma Control Questionnaire-5. Clinical symptoms and their impact on cough and sputum were assessed using the Cough and Sputum Assessment Questionnaire (CASA-Q). Subgroup analyses of type-2 biomarkers were conducted based on FeNO levels and blood eosinophil counts at baseline. Results: Treatment with dupilumab led to a reduction in exacerbations and enhancement in asthma control, FEV1, and CASA-Q scores. FEV1 improvement was correlated with enhancement in the sputum domain of the CASA-Q. Patients exhibiting elevated FeNO levels and blood eosinophil counts demonstrated more significant enhancements in FEV1. CASA-Q sputum domain scores were significantly higher in the group with elevated eosinophil counts. Regression analysis revealed that FeNO levels and blood eosinophil counts are significant predictors of FEV1 improvement, with blood eosinophil counts also predicting sputum improvement in patients treated with dupilumab. Conclusions: Type-2 biomarkers may act as indicators of improvement in FEV1 and sputum outcomes among patients with severe asthma undergoing dupilumab treatment in real-world settings.http://www.sciencedirect.com/science/article/pii/S132389302400087XAsthmaDupilumabEosinophilFractional exhaled nitric oxideSputum
spellingShingle Kenji Mizumura
Yasuhiro Gon
Norihiro Harada
Shiho Yamada
Asami Fukuda
Ryosuke Ozoe
Shuichiro Maruoka
Sumiko Abe
Kazuhisa Takahashi
Akihiko Tanaka
Hironori Sagara
Taisuke Akamatsu
Toshihiro Shirai
Katsunori Masaki
Koichi Fukunaga
Konomi Kobayashi
Hiroyuki Nagase
Nobuaki Miyahara
Arihiko Kanehiro
Noboru Kitamura
Naruhiko Sugihara
Fumio Kumasawa
Junko Terada-Hirashima
Masayuki Hojo
Kazuyuki Chibana
Etsuko Tagaya
Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
Allergology International
Asthma
Dupilumab
Eosinophil
Fractional exhaled nitric oxide
Sputum
title Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
title_full Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
title_fullStr Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
title_full_unstemmed Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
title_short Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma
title_sort predicting dupilumab effectiveness with type 2 biomarkers a real world study of severe asthma
topic Asthma
Dupilumab
Eosinophil
Fractional exhaled nitric oxide
Sputum
url http://www.sciencedirect.com/science/article/pii/S132389302400087X
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