Qionghua Xiao, Yuanming Huang, Bingyu Xue, Minghang Wang
{"title":"生物制剂对严重哮喘患者的疗效和安全性：系统评价和荟萃分析的综合综述。","authors":"Qionghua Xiao, Yuanming Huang, Bingyu Xue, Minghang Wang","doi":"10.3389/fmed.2025.1573596","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Many systematic reviews and meta-analyses (SR/MAs) have evaluated the efficacy of biologic therapy for severe asthma. However, the quality of these SR/MAs is unclear, which may influence the selection of biologics and lead to misleading clinical decisions. Therefore, this umbrella review aims to objectively evaluate the quality of these SR/MAs and reassess the efficacy of biologic therapy for severe asthma.</p><p><strong>Methods: </strong>A systematic search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and MEDLINE databases. Literature screening and data extraction were conducted according to inclusion and exclusion criteria. Then, we evaluated the methodological quality of these SR/MAs using A MeaSurement Tool to Assess Reviews 2 (AMSTAR 2). In addition, the re-meta-analysis of study outcomes was performed applying R 4.3.3 software.</p><p><strong>Results: </strong>The umbrella review included 23 SR/MAs. In the evaluation of methodological quality, five SR/MAs were rated as high quality, one was rated as moderate, and 17 were rated as low or critically low. In terms of efficacy evaluation, biologics were associated with a 45% reduction in AER (RR: 0.55; <i>P</i> < 0.0001), a 57% reduction of asthma-related hospitalizations (RR: 0.43; <i>P</i> < 0.0001), an increase in the forced expiratory volume in 1 s (FEV1) of 0.13 L (<i>P</i> < 0.0001), a reduction in asthma control questionnaire (ACQ) scores by 0.33 points (<i>P</i> < 0.0001), an increase in asthma quality of life questionnaire (AQLQ) scores by 0.26 points (<i>P</i> < 0.0001), and a reduction in fractional exhaled nitric oxide (FeNO) levels by 22.52 ppb (<i>P</i> < 0.0001). In terms of safety evaluation, overall, biologics demonstrated favorable safety.</p><p><strong>Conclusion: </strong>This umbrella review has demonstrated that biologics have good efficacy and acceptable safety in the treatment of severe asthma. However, the methodological quality of included SR/MAs was mostly low or critically low, suggesting that we need to be cautious when interpreting the results of this study. Therefore, more high-quality SR/MAs are needed to provide robust clinical evidence.</p><p><strong>Systematic review registration: </strong>https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024607393.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1573596"},"PeriodicalIF":3.1000,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12162592/pdf/","citationCount":"0","resultStr":"{\"title\":\"The efficacy and safety of biologics for patients with severe asthma: an umbrella review of systematic reviews and meta-analyses.\",\"authors\":\"Qionghua Xiao, Yuanming Huang, Bingyu Xue, Minghang Wang\",\"doi\":\"10.3389/fmed.2025.1573596\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Many systematic reviews and meta-analyses (SR/MAs) have evaluated the efficacy of biologic therapy for severe asthma. However, the quality of these SR/MAs is unclear, which may influence the selection of biologics and lead to misleading clinical decisions. Therefore, this umbrella review aims to objectively evaluate the quality of these SR/MAs and reassess the efficacy of biologic therapy for severe asthma.</p><p><strong>Methods: </strong>A systematic search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and MEDLINE databases. Literature screening and data extraction were conducted according to inclusion and exclusion criteria. Then, we evaluated the methodological quality of these SR/MAs using A MeaSurement Tool to Assess Reviews 2 (AMSTAR 2). In addition, the re-meta-analysis of study outcomes was performed applying R 4.3.3 software.</p><p><strong>Results: </strong>The umbrella review included 23 SR/MAs. In the evaluation of methodological quality, five SR/MAs were rated as high quality, one was rated as moderate, and 17 were rated as low or critically low. In terms of efficacy evaluation, biologics were associated with a 45% reduction in AER (RR: 0.55; <i>P</i> < 0.0001), a 57% reduction of asthma-related hospitalizations (RR: 0.43; <i>P</i> < 0.0001), an increase in the forced expiratory volume in 1 s (FEV1) of 0.13 L (<i>P</i> < 0.0001), a reduction in asthma control questionnaire (ACQ) scores by 0.33 points (<i>P</i> < 0.0001), an increase in asthma quality of life questionnaire (AQLQ) scores by 0.26 points (<i>P</i> < 0.0001), and a reduction in fractional exhaled nitric oxide (FeNO) levels by 22.52 ppb (<i>P</i> < 0.0001). In terms of safety evaluation, overall, biologics demonstrated favorable safety.</p><p><strong>Conclusion: </strong>This umbrella review has demonstrated that biologics have good efficacy and acceptable safety in the treatment of severe asthma. 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The efficacy and safety of biologics for patients with severe asthma: an umbrella review of systematic reviews and meta-analyses.
Introduction: Many systematic reviews and meta-analyses (SR/MAs) have evaluated the efficacy of biologic therapy for severe asthma. However, the quality of these SR/MAs is unclear, which may influence the selection of biologics and lead to misleading clinical decisions. Therefore, this umbrella review aims to objectively evaluate the quality of these SR/MAs and reassess the efficacy of biologic therapy for severe asthma.
Methods: A systematic search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and MEDLINE databases. Literature screening and data extraction were conducted according to inclusion and exclusion criteria. Then, we evaluated the methodological quality of these SR/MAs using A MeaSurement Tool to Assess Reviews 2 (AMSTAR 2). In addition, the re-meta-analysis of study outcomes was performed applying R 4.3.3 software.
Results: The umbrella review included 23 SR/MAs. In the evaluation of methodological quality, five SR/MAs were rated as high quality, one was rated as moderate, and 17 were rated as low or critically low. In terms of efficacy evaluation, biologics were associated with a 45% reduction in AER (RR: 0.55; P < 0.0001), a 57% reduction of asthma-related hospitalizations (RR: 0.43; P < 0.0001), an increase in the forced expiratory volume in 1 s (FEV1) of 0.13 L (P < 0.0001), a reduction in asthma control questionnaire (ACQ) scores by 0.33 points (P < 0.0001), an increase in asthma quality of life questionnaire (AQLQ) scores by 0.26 points (P < 0.0001), and a reduction in fractional exhaled nitric oxide (FeNO) levels by 22.52 ppb (P < 0.0001). In terms of safety evaluation, overall, biologics demonstrated favorable safety.
Conclusion: This umbrella review has demonstrated that biologics have good efficacy and acceptable safety in the treatment of severe asthma. However, the methodological quality of included SR/MAs was mostly low or critically low, suggesting that we need to be cautious when interpreting the results of this study. Therefore, more high-quality SR/MAs are needed to provide robust clinical evidence.
期刊介绍：
Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate
- the use of patient-reported outcomes under real world conditions
- the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines
- the scientific bases for guidelines and decisions from regulatory authorities
- access to medicinal products and medical devices worldwide
- addressing the grand health challenges around the world
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