Njira L. Lugogo, Xavier Soler, Yasuhiro Gon, Andréanne Côté, Ole Hilberg, Changming Xia, Yi Zhang, Lucía de Prado Gómez, Paul J. Rowe, Amr Radwan, Juby A. Jacob-Nara, Yamo Deniz, Anju T. Peters
{"title":"真实世界中杜匹单抗治疗的哮喘患者的基线特征：RAPID 全球注册","authors":"Njira L. Lugogo, Xavier Soler, Yasuhiro Gon, Andréanne Côté, Ole Hilberg, Changming Xia, Yi Zhang, Lucía de Prado Gómez, Paul J. Rowe, Amr Radwan, Juby A. Jacob-Nara, Yamo Deniz, Anju T. Peters","doi":"10.1007/s12325-024-03051-0","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Patients with uncontrolled, moderate-to-severe asthma have a higher risk for exacerbations, negatively impacting lung function and quality of life. Dupilumab, a fully human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. Dupilumab has been effective in the treatment of certain types of moderate-to-severe asthma across several clinical trials. We describe the characteristics of patients enrolled in RAPID, a global prospective registry, who initiated dupilumab (primary indication: asthma) in a real-world clinical setting.</p><h3>Methods</h3><p>A total of 205 patients (aged ≥ 12 years) were enrolled between March 2020 and October 2021 and are included in this analysis. Data are shown as mean (SD) unless stated otherwise.</p><h3>Results</h3><p>Patients were aged 50.1 (17.4) years and were mostly female (65.4%) and white (74.1%). At enrollment, 24.4% reported being current/former smokers and 86.8% had moderate-to-severe asthma (Global Initiative for Asthma steps 3–5). A mean (SD) of 4.4 (6.4) severe asthma exacerbations were reported in the year before enrolling in the registry in 78 of 152 patients with available data. Patients had reduced lung function [pre-bronchodilator forced expiratory volume in 1 s (FEV<sub>1</sub>): 2.3 (1.1) L; pre-bronchodilator percent predicted FEV<sub>1</sub>: 70.3 (20.3) %] and poor asthma control [6-item Asthma Control Questionnaire: 2.4 (1.2); Asthma Quality of Life Questionnaire: 4.1 (1.3)]. The median (Q1–Q3) blood eosinophil count was 305 (200–695) cells/µL and the mean (SD) fractional exhaled nitric oxide levels were 42 (35) ppb (range: 4–186 ppb).</p><h3>Conclusion</h3><p>Our findings suggest that most patients who enrolled in RAPID and initiated dupilumab in real-world clinical settings had a high disease burden, despite receiving current standard-of-care treatment at enrollment.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 2","pages":"849 - 862"},"PeriodicalIF":3.4000,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-024-03051-0.pdf","citationCount":"0","resultStr":"{\"title\":\"Baseline Characteristics of Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry\",\"authors\":\"Njira L. Lugogo, Xavier Soler, Yasuhiro Gon, Andréanne Côté, Ole Hilberg, Changming Xia, Yi Zhang, Lucía de Prado Gómez, Paul J. Rowe, Amr Radwan, Juby A. Jacob-Nara, Yamo Deniz, Anju T. Peters\",\"doi\":\"10.1007/s12325-024-03051-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Patients with uncontrolled, moderate-to-severe asthma have a higher risk for exacerbations, negatively impacting lung function and quality of life. Dupilumab, a fully human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. Dupilumab has been effective in the treatment of certain types of moderate-to-severe asthma across several clinical trials. We describe the characteristics of patients enrolled in RAPID, a global prospective registry, who initiated dupilumab (primary indication: asthma) in a real-world clinical setting.</p><h3>Methods</h3><p>A total of 205 patients (aged ≥ 12 years) were enrolled between March 2020 and October 2021 and are included in this analysis. Data are shown as mean (SD) unless stated otherwise.</p><h3>Results</h3><p>Patients were aged 50.1 (17.4) years and were mostly female (65.4%) and white (74.1%). At enrollment, 24.4% reported being current/former smokers and 86.8% had moderate-to-severe asthma (Global Initiative for Asthma steps 3–5). A mean (SD) of 4.4 (6.4) severe asthma exacerbations were reported in the year before enrolling in the registry in 78 of 152 patients with available data. Patients had reduced lung function [pre-bronchodilator forced expiratory volume in 1 s (FEV<sub>1</sub>): 2.3 (1.1) L; pre-bronchodilator percent predicted FEV<sub>1</sub>: 70.3 (20.3) %] and poor asthma control [6-item Asthma Control Questionnaire: 2.4 (1.2); Asthma Quality of Life Questionnaire: 4.1 (1.3)]. The median (Q1–Q3) blood eosinophil count was 305 (200–695) cells/µL and the mean (SD) fractional exhaled nitric oxide levels were 42 (35) ppb (range: 4–186 ppb).</p><h3>Conclusion</h3><p>Our findings suggest that most patients who enrolled in RAPID and initiated dupilumab in real-world clinical settings had a high disease burden, despite receiving current standard-of-care treatment at enrollment.</p></div>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\"42 2\",\"pages\":\"849 - 862\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-12-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://link.springer.com/content/pdf/10.1007/s12325-024-03051-0.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12325-024-03051-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12325-024-03051-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Baseline Characteristics of Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry
Introduction
Patients with uncontrolled, moderate-to-severe asthma have a higher risk for exacerbations, negatively impacting lung function and quality of life. Dupilumab, a fully human monoclonal antibody, blocks interleukins 4 and 13, key and central drivers of type 2 inflammation. Dupilumab has been effective in the treatment of certain types of moderate-to-severe asthma across several clinical trials. We describe the characteristics of patients enrolled in RAPID, a global prospective registry, who initiated dupilumab (primary indication: asthma) in a real-world clinical setting.
Methods
A total of 205 patients (aged ≥ 12 years) were enrolled between March 2020 and October 2021 and are included in this analysis. Data are shown as mean (SD) unless stated otherwise.
Results
Patients were aged 50.1 (17.4) years and were mostly female (65.4%) and white (74.1%). At enrollment, 24.4% reported being current/former smokers and 86.8% had moderate-to-severe asthma (Global Initiative for Asthma steps 3–5). A mean (SD) of 4.4 (6.4) severe asthma exacerbations were reported in the year before enrolling in the registry in 78 of 152 patients with available data. Patients had reduced lung function [pre-bronchodilator forced expiratory volume in 1 s (FEV1): 2.3 (1.1) L; pre-bronchodilator percent predicted FEV1: 70.3 (20.3) %] and poor asthma control [6-item Asthma Control Questionnaire: 2.4 (1.2); Asthma Quality of Life Questionnaire: 4.1 (1.3)]. The median (Q1–Q3) blood eosinophil count was 305 (200–695) cells/µL and the mean (SD) fractional exhaled nitric oxide levels were 42 (35) ppb (range: 4–186 ppb).
Conclusion
Our findings suggest that most patients who enrolled in RAPID and initiated dupilumab in real-world clinical settings had a high disease burden, despite receiving current standard-of-care treatment at enrollment.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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