Reynold A. Panettieri Jr., Monica Kraft, Mario Castro, Magdalena Bober, Andrew W. Lindsley, Max Shelkrot, Christopher S. Ambrose
{"title":"生物制剂在减少中度或重度未控制哮喘患者需要住院或急诊就诊的恶化中的疗效","authors":"Reynold A. Panettieri Jr., Monica Kraft, Mario Castro, Magdalena Bober, Andrew W. Lindsley, Max Shelkrot, Christopher S. Ambrose","doi":"10.1007/s12325-025-03184-w","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Patients with moderate or severe, uncontrolled asthma are often prescribed biologic therapies to improve disease control and reduce asthma exacerbations. The efficacy of different biologics in reducing asthma exacerbations associated with hospitalization or an emergency department (ED) visit has varied across randomized controlled trials (RCTs). This study summarizes published US Food and Drug Administration-approved biologic efficacy data for exacerbations that required hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.</p><h3>Methods</h3><p>A PubMed literature search (24 May 2024) identified phase 2b/3 RCTs of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab. Annualized asthma exacerbation rate (AAER) ratios for exacerbations that required hospitalization or an ED visit, or hospitalization regardless of an ED visit, were extracted. A pooled efficacy estimate of the AAER ratio for exacerbations that required hospitalization or an ED visit across the RCTs was assessed using a meta-analysis based on a random effects model. The percentage of total variation across all included RCTs that was due to heterogeneity was calculated (<i>I</i><sup>2</sup>).</p><h3>Results</h3><p>Among 308 articles identified, nine publications describing 10 RCTs reported relevant AAER ratio data. No suitable omalizumab data were identified. In all trials, biologic treatment showed a reduction versus placebo in the AAER for exacerbations that required hospitalization or an ED visit, except in one of two benralizumab studies and both reslizumab studies. The pooled efficacy estimate showed a 56% reduction (95% CI 37–69) in the AAER for exacerbations requiring hospitalization or an ED visit (<i>I</i><sup>2</sup>, 59.93%; <i>p</i> = 0.0075). One of three mepolizumab trials and both tezepelumab trials showed a reduction versus placebo in the AAER for exacerbations that required hospitalization regardless of an ED visit.</p><h3>Conclusion</h3><p>These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 6","pages":"2679 - 2689"},"PeriodicalIF":3.4000,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03184-w.pdf","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma\",\"authors\":\"Reynold A. Panettieri Jr., Monica Kraft, Mario Castro, Magdalena Bober, Andrew W. Lindsley, Max Shelkrot, Christopher S. Ambrose\",\"doi\":\"10.1007/s12325-025-03184-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Patients with moderate or severe, uncontrolled asthma are often prescribed biologic therapies to improve disease control and reduce asthma exacerbations. The efficacy of different biologics in reducing asthma exacerbations associated with hospitalization or an emergency department (ED) visit has varied across randomized controlled trials (RCTs). This study summarizes published US Food and Drug Administration-approved biologic efficacy data for exacerbations that required hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.</p><h3>Methods</h3><p>A PubMed literature search (24 May 2024) identified phase 2b/3 RCTs of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab. Annualized asthma exacerbation rate (AAER) ratios for exacerbations that required hospitalization or an ED visit, or hospitalization regardless of an ED visit, were extracted. A pooled efficacy estimate of the AAER ratio for exacerbations that required hospitalization or an ED visit across the RCTs was assessed using a meta-analysis based on a random effects model. The percentage of total variation across all included RCTs that was due to heterogeneity was calculated (<i>I</i><sup>2</sup>).</p><h3>Results</h3><p>Among 308 articles identified, nine publications describing 10 RCTs reported relevant AAER ratio data. No suitable omalizumab data were identified. In all trials, biologic treatment showed a reduction versus placebo in the AAER for exacerbations that required hospitalization or an ED visit, except in one of two benralizumab studies and both reslizumab studies. The pooled efficacy estimate showed a 56% reduction (95% CI 37–69) in the AAER for exacerbations requiring hospitalization or an ED visit (<i>I</i><sup>2</sup>, 59.93%; <i>p</i> = 0.0075). One of three mepolizumab trials and both tezepelumab trials showed a reduction versus placebo in the AAER for exacerbations that required hospitalization regardless of an ED visit.</p><h3>Conclusion</h3><p>These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.</p></div>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\"42 6\",\"pages\":\"2679 - 2689\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-04-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://link.springer.com/content/pdf/10.1007/s12325-025-03184-w.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12325-025-03184-w\",\"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/s12325-025-03184-w","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma
Introduction
Patients with moderate or severe, uncontrolled asthma are often prescribed biologic therapies to improve disease control and reduce asthma exacerbations. The efficacy of different biologics in reducing asthma exacerbations associated with hospitalization or an emergency department (ED) visit has varied across randomized controlled trials (RCTs). This study summarizes published US Food and Drug Administration-approved biologic efficacy data for exacerbations that required hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.
Methods
A PubMed literature search (24 May 2024) identified phase 2b/3 RCTs of omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tezepelumab. Annualized asthma exacerbation rate (AAER) ratios for exacerbations that required hospitalization or an ED visit, or hospitalization regardless of an ED visit, were extracted. A pooled efficacy estimate of the AAER ratio for exacerbations that required hospitalization or an ED visit across the RCTs was assessed using a meta-analysis based on a random effects model. The percentage of total variation across all included RCTs that was due to heterogeneity was calculated (I2).
Results
Among 308 articles identified, nine publications describing 10 RCTs reported relevant AAER ratio data. No suitable omalizumab data were identified. In all trials, biologic treatment showed a reduction versus placebo in the AAER for exacerbations that required hospitalization or an ED visit, except in one of two benralizumab studies and both reslizumab studies. The pooled efficacy estimate showed a 56% reduction (95% CI 37–69) in the AAER for exacerbations requiring hospitalization or an ED visit (I2, 59.93%; p = 0.0075). One of three mepolizumab trials and both tezepelumab trials showed a reduction versus placebo in the AAER for exacerbations that required hospitalization regardless of an ED visit.
Conclusion
These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma.
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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