Scholarlink

Background <p>Severe eosinophilic asthma is associated with frequent exacerbations, decline in lung function, and impaired quality of life, posing significant challenges in clinical management. Benralizumab is a monoclonal antibody targeting the interleukin-5 receptor alpha subunit that rapidly depletes eosinophils via antibody-dependent cellular cytotoxicity. However, a systematic evaluation of its efficacy differences among patients with varying baseline characteristics and different dosing intervals, based on large-scale randomized controlled trials, is lacking. This study aimed to comprehensively assess the efficacy and safety of benralizumab in patients with severe eosinophilic asthma through a meta-analysis and to perform stratified analyses based on baseline blood eosinophil count and dosing regimen, thereby providing high-quality evidence for clinical individualized treatment and precise dosing.</p> Methods <p>Randomized controlled trials (RCTs) were systematically searched in PubMed, Embase, and the Cochrane Library from inception to November 5, 2025. RCTs comparing benralizumab with placebo or standard therapy were included. Data on asthma exacerbations, hospitalizations, lung function (forced expiratory volume in 1&#xa0;s, FEV<sub>1</sub>), symptom control (Asthma Control Questionnaire-6, ACQ-6), daily symptom burden (Asthma Symptom Score, ASS), quality of life (Asthma Quality of Life Questionnaire, AQLQ; St. George's Respiratory Questionnaire, SGRQ), and safety were extracted. Study quality was assessed using the Cochrane Risk of Bias tool. Dichotomous variables were expressed as risk ratios (RR) with 95% confidence intervals (CI), and continuous variables as weighted mean differences (WMD) with 95% CI. Data were pooled using fixed- or random-effects models based on heterogeneity (I<sup>2</sup>). Prespecified subgroup and sensitivity analyses were conducted. Publication bias was evaluated using funnel plots, Egger’s test, and Begg’s test.</p> Results <p>A total of 14 RCTs involving 13,166 patients were included. Meta-analysis showed that, compared with the control group, benralizumab significantly reduced the risk of asthma exacerbations by 39% (RR = 0.61, 95% CI 0.57–0.66) and the risk of asthma-related hospitalization by 46% (RR = 0.54, 95% CI 0.43–0.67). Subgroup analysis indicated that patients with a baseline eosinophil count ≥ 300&#xa0;cells/μL derived more significant benefit (exacerbation RR = 0.56; FEV<sub>1</sub> improvement WMD = 0.10&#xa0;L), whereas those with &lt; 300 cells/μL showed limited improvement (exacerbation RR = 0.71; FEV₁ WMD = 0.02&#xa0;L). Dosing every 8&#xa0;weeks and every 4&#xa0;weeks showed similar efficacy in reducing exacerbation risk (RR = 0.60 and 0.64, respectively). Benralizumab also significantly improved asthma control (ACQ-6 WMD =  − 0.20), alleviated daily symptoms (ASS WMD =  − 0.18), and enhanced quality of life (AQLQ WMD = 0.15), with the reduction in SGRQ score exceeding the minimal clinically important difference (WMD =  − 9.37). Regarding safety, benralizumab did not increase the risk of overall adverse events (RR = 0.97), pneumonia, or all-cause mortality, and significantly reduced the risk of serious adverse events (RR = 0.77, 95% CI 0.69–0.87).</p> Conclusion <p>Benralizumab significantly reduces the risk of exacerbations and hospitalizations, improves lung function (FEV₁), symptom control (ACQ-6), and quality of life (AQLQ) in patients with severe eosinophilic asthma, with an overall favorable safety profile. A baseline blood eosinophil count ≥ 300 cells/μL is a key biomarker predicting better treatment response. The every-8-week dosing regimen maintains efficacy while offering greater patient convenience, supporting its priority as a clinical dosing strategy. This study provides systematic, updated, and clinically oriented high-level evidence for precision treatment and individualized dosing in severe eosinophilic asthma.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Clinical profile of benralizumab in severe eosinophilic asthma: a subgroup-driven meta-analysis

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月10日

查看全文
  • Yubing Li,
  • Hongxia Yang,
  • Jun Li,
  • Yong Zhang

摘要

Background

Severe eosinophilic asthma is associated with frequent exacerbations, decline in lung function, and impaired quality of life, posing significant challenges in clinical management. Benralizumab is a monoclonal antibody targeting the interleukin-5 receptor alpha subunit that rapidly depletes eosinophils via antibody-dependent cellular cytotoxicity. However, a systematic evaluation of its efficacy differences among patients with varying baseline characteristics and different dosing intervals, based on large-scale randomized controlled trials, is lacking. This study aimed to comprehensively assess the efficacy and safety of benralizumab in patients with severe eosinophilic asthma through a meta-analysis and to perform stratified analyses based on baseline blood eosinophil count and dosing regimen, thereby providing high-quality evidence for clinical individualized treatment and precise dosing.

Methods

Randomized controlled trials (RCTs) were systematically searched in PubMed, Embase, and the Cochrane Library from inception to November 5, 2025. RCTs comparing benralizumab with placebo or standard therapy were included. Data on asthma exacerbations, hospitalizations, lung function (forced expiratory volume in 1 s, FEV1), symptom control (Asthma Control Questionnaire-6, ACQ-6), daily symptom burden (Asthma Symptom Score, ASS), quality of life (Asthma Quality of Life Questionnaire, AQLQ; St. George's Respiratory Questionnaire, SGRQ), and safety were extracted. Study quality was assessed using the Cochrane Risk of Bias tool. Dichotomous variables were expressed as risk ratios (RR) with 95% confidence intervals (CI), and continuous variables as weighted mean differences (WMD) with 95% CI. Data were pooled using fixed- or random-effects models based on heterogeneity (I2). Prespecified subgroup and sensitivity analyses were conducted. Publication bias was evaluated using funnel plots, Egger’s test, and Begg’s test.

Results

A total of 14 RCTs involving 13,166 patients were included. Meta-analysis showed that, compared with the control group, benralizumab significantly reduced the risk of asthma exacerbations by 39% (RR = 0.61, 95% CI 0.57–0.66) and the risk of asthma-related hospitalization by 46% (RR = 0.54, 95% CI 0.43–0.67). Subgroup analysis indicated that patients with a baseline eosinophil count ≥ 300 cells/μL derived more significant benefit (exacerbation RR = 0.56; FEV1 improvement WMD = 0.10 L), whereas those with < 300 cells/μL showed limited improvement (exacerbation RR = 0.71; FEV₁ WMD = 0.02 L). Dosing every 8 weeks and every 4 weeks showed similar efficacy in reducing exacerbation risk (RR = 0.60 and 0.64, respectively). Benralizumab also significantly improved asthma control (ACQ-6 WMD =  − 0.20), alleviated daily symptoms (ASS WMD =  − 0.18), and enhanced quality of life (AQLQ WMD = 0.15), with the reduction in SGRQ score exceeding the minimal clinically important difference (WMD =  − 9.37). Regarding safety, benralizumab did not increase the risk of overall adverse events (RR = 0.97), pneumonia, or all-cause mortality, and significantly reduced the risk of serious adverse events (RR = 0.77, 95% CI 0.69–0.87).

Conclusion

Benralizumab significantly reduces the risk of exacerbations and hospitalizations, improves lung function (FEV₁), symptom control (ACQ-6), and quality of life (AQLQ) in patients with severe eosinophilic asthma, with an overall favorable safety profile. A baseline blood eosinophil count ≥ 300 cells/μL is a key biomarker predicting better treatment response. The every-8-week dosing regimen maintains efficacy while offering greater patient convenience, supporting its priority as a clinical dosing strategy. This study provides systematic, updated, and clinically oriented high-level evidence for precision treatment and individualized dosing in severe eosinophilic asthma.