贝那珠单抗对混合型气流阻塞及重症难控制性嗜酸性粒细胞型哮喘患者的疗效
2020/06/11
摘要
背景：混合型气流阻塞（FAO）与重症嗜酸性粒细胞型哮喘有关。贝那珠单抗是一种针对白细胞介素5受体、α-定向的溶细胞单克隆抗体，用于治疗重症难控制性嗜酸性粒细胞型哮喘患者。
目的：我们评估混合型气流阻塞对贝那利珠单抗的治疗反应。
方法：我们对重度难控制性哮喘患者，并且基线外周血嗜酸性粒细胞计数在300细胞/μL以上，每8周给予贝那珠单抗30 mg或安慰剂治疗，并对III期SIROCCO（NCT01928771）和CALIMA（NCT01914757）数据进行事后分析。 根据混合型气流阻塞的状况评估人口统计学，基线临床特征及治疗反应。 FAO +和FAO-定义为基线时支气管扩张剂后FEV1/FVC小于70％、及大于等于70％。
结果：FAO +患病率为63％（935/1493）。与安慰剂相比，使用贝那利珠单抗，FAO +和FAO-患者的年哮喘急性发作率（AER）降低幅度相似（95％ CI分别为0.56 [0.44-0.71]和0.58 [0.41-0.83]）），但是与急诊就诊或住院相关的年急性发作次数减少程度更强（95％CI= 0.55 [0.33-0.91]和0.70 [0.33-1.48]）。与安慰剂组相比，接受贝那利珠单抗治疗的FAO +与FAO-患者，舒张试验前FEV1（95％CI）较基线水平明显升高（0.159 L [0.082-0.236] vs 0.103 L [-0.008至0.215]）。FAO +患者与FAO-患者之间，其他肺功能指标、患者报告结局和症状改善程度在数值上也明显改善。
结论：贝那珠单抗通过多种途径改善重症难控制性嗜酸性粒细胞型哮喘患者的控制水平及和气流阻塞程度。
Benralizumab Efficacy for Patients With Fixed Airflow Obstruction and Severe, Uncontrolled Eosinophilic Asthma
Bradley E Chipps, Ian Hirsch, Frank Trudo, Marianna Alacqua, James G Zangrilli.
Abstract
Background:Fixed airflow obstruction (FAO) is associated with severe eosinophilic asthma. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody for patients with severe, uncontrolled eosinophilic asthma.
Objective:We evaluated FAO influence on benralizumab treatment response.
Methods:We performed a post hoc analysis of pooled phase III SIROCCO (NCT01928771) and CALIMA (NCT01914757) data for patients with severe, uncontrolled asthma with baseline blood eosinophil counts of 300 or more cells/μL who received benralizumab 30 mg every 8 weeks or placebo. Demographics, baseline clinical characteristics, and treatment responses were evaluated by FAO status. FAO+ and FAO- were defined as ratios of postbronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity of less than 70% and 70% or more, respectively, at baseline.
Results:FAO+ prevalence was 63% (935/1493). With benralizumab, similar annual asthma exacerbation rate (AER) reductions vs placebo were achieved for FAO+ and FAO- patients (rate ratio [95% confidence interval (CI)] = 0.56 [0.44-0.71] and 0.58 [0.41-0.83], respectively), whereas annual AER reductions associated with emergency department visits or hospitalizations were greater for FAO+ vs FAO- patients (rate ratio [95% CI] = 0.55 [0.33-0.91] and 0.70 [0.33-1.48], respectively). Prebronchodilator FEV1 (95% CI) increase from baseline to end of treatment was greater for FAO+ vs FAO- patients receiving benralizumab compared with placebo (0.159 L [0.082-0.236] vs 0.103 L [-0.008 to 0.215]). Other lung function measures, patient-reported outcomes, and symptom improvements were also numerically greater for FAO+ vs FAO- patients.
Conclusion:Benralizumab improved asthma control across several measures for patients with severe, uncontrolled eosinophilic asthma and FAO.
背景：混合型气流阻塞（FAO）与重症嗜酸性粒细胞型哮喘有关。贝那珠单抗是一种针对白细胞介素5受体、α-定向的溶细胞单克隆抗体，用于治疗重症难控制性嗜酸性粒细胞型哮喘患者。
目的：我们评估混合型气流阻塞对贝那利珠单抗的治疗反应。
方法：我们对重度难控制性哮喘患者，并且基线外周血嗜酸性粒细胞计数在300细胞/μL以上，每8周给予贝那珠单抗30 mg或安慰剂治疗，并对III期SIROCCO（NCT01928771）和CALIMA（NCT01914757）数据进行事后分析。 根据混合型气流阻塞的状况评估人口统计学，基线临床特征及治疗反应。 FAO +和FAO-定义为基线时支气管扩张剂后FEV1/FVC小于70％、及大于等于70％。
结果：FAO +患病率为63％（935/1493）。与安慰剂相比，使用贝那利珠单抗，FAO +和FAO-患者的年哮喘急性发作率（AER）降低幅度相似（95％ CI分别为0.56 [0.44-0.71]和0.58 [0.41-0.83]）），但是与急诊就诊或住院相关的年急性发作次数减少程度更强（95％CI= 0.55 [0.33-0.91]和0.70 [0.33-1.48]）。与安慰剂组相比，接受贝那利珠单抗治疗的FAO +与FAO-患者，舒张试验前FEV1（95％CI）较基线水平明显升高（0.159 L [0.082-0.236] vs 0.103 L [-0.008至0.215]）。FAO +患者与FAO-患者之间，其他肺功能指标、患者报告结局和症状改善程度在数值上也明显改善。
结论：贝那珠单抗通过多种途径改善重症难控制性嗜酸性粒细胞型哮喘患者的控制水平及和气流阻塞程度。
（中日友好医院呼吸与危重症医学科 张鑫 摘译 林江涛 审校）
（Clinical Trial Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.）
（Clinical Trial Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.）
Benralizumab Efficacy for Patients With Fixed Airflow Obstruction and Severe, Uncontrolled Eosinophilic Asthma
Bradley E Chipps, Ian Hirsch, Frank Trudo, Marianna Alacqua, James G Zangrilli.
Abstract
Background:Fixed airflow obstruction (FAO) is associated with severe eosinophilic asthma. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody for patients with severe, uncontrolled eosinophilic asthma.
Objective:We evaluated FAO influence on benralizumab treatment response.
Methods:We performed a post hoc analysis of pooled phase III SIROCCO (NCT01928771) and CALIMA (NCT01914757) data for patients with severe, uncontrolled asthma with baseline blood eosinophil counts of 300 or more cells/μL who received benralizumab 30 mg every 8 weeks or placebo. Demographics, baseline clinical characteristics, and treatment responses were evaluated by FAO status. FAO+ and FAO- were defined as ratios of postbronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity of less than 70% and 70% or more, respectively, at baseline.
Results:FAO+ prevalence was 63% (935/1493). With benralizumab, similar annual asthma exacerbation rate (AER) reductions vs placebo were achieved for FAO+ and FAO- patients (rate ratio [95% confidence interval (CI)] = 0.56 [0.44-0.71] and 0.58 [0.41-0.83], respectively), whereas annual AER reductions associated with emergency department visits or hospitalizations were greater for FAO+ vs FAO- patients (rate ratio [95% CI] = 0.55 [0.33-0.91] and 0.70 [0.33-1.48], respectively). Prebronchodilator FEV1 (95% CI) increase from baseline to end of treatment was greater for FAO+ vs FAO- patients receiving benralizumab compared with placebo (0.159 L [0.082-0.236] vs 0.103 L [-0.008 to 0.215]). Other lung function measures, patient-reported outcomes, and symptom improvements were also numerically greater for FAO+ vs FAO- patients.
Conclusion:Benralizumab improved asthma control across several measures for patients with severe, uncontrolled eosinophilic asthma and FAO.
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