{"title":"用2型生物标志物预测杜必鲁单抗的疗效：一项关于严重哮喘的真实世界研究。","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","doi":"10.1016/j.alit.2024.08.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Treatment with dupilumab led to a reduction in exacerbations and enhancement in asthma control, FEV<sub>1</sub>, and CASA-Q scores. FEV<sub>1</sub> 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 FEV<sub>1</sub>. 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 FEV<sub>1</sub> improvement, with blood eosinophil counts also predicting sputum improvement in patients treated with dupilumab.</p><p><strong>Conclusions: </strong>Type-2 biomarkers may act as indicators of improvement in FEV<sub>1</sub> and sputum outcomes among patients with severe asthma undergoing dupilumab treatment in real-world settings.</p>","PeriodicalId":48861,"journal":{"name":"Allergology International","volume":" ","pages":""},"PeriodicalIF":6.2000,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Predicting dupilumab effectiveness with Type-2 biomarkers: A real-world study of severe asthma.\",\"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\",\"doi\":\"10.1016/j.alit.2024.08.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Treatment with dupilumab led to a reduction in exacerbations and enhancement in asthma control, FEV<sub>1</sub>, and CASA-Q scores. FEV<sub>1</sub> 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 FEV<sub>1</sub>. 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 FEV<sub>1</sub> improvement, with blood eosinophil counts also predicting sputum improvement in patients treated with dupilumab.</p><p><strong>Conclusions: </strong>Type-2 biomarkers may act as indicators of improvement in FEV<sub>1</sub> and sputum outcomes among patients with severe asthma undergoing dupilumab treatment in real-world settings.</p>\",\"PeriodicalId\":48861,\"journal\":{\"name\":\"Allergology International\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.2000,\"publicationDate\":\"2024-09-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergology International\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.alit.2024.08.005\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergology International","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.alit.2024.08.005","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
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 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.
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.
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