依据血EOS计数判定奥马珠单抗治疗重度过敏性哮喘的有效性：STELLAIR 研究
2018/06/04
摘要
奥马珠单抗是一种用于治疗重度过敏性哮喘（severe allergic asthma，SAA）的抗IgE单克隆抗体。STELLAIR研究旨在判断治疗前血嗜酸性粒细胞计数（EOS）作为预测奥马珠单抗疗效指标的重要性。这是一项于2015年12月至2016年9月在法国进行的回顾性真实世界研究，收集了应用奥马珠单抗治疗的SAA患者的医疗记录。患者对奥马珠单抗的治疗反应通过以下3项标准来评估：（1）医师评估；（2）每年急性加重率减低≥40%；（3）两者结合。对奥马珠单抗的反应率是根据用药前一年所测得的血EOS计数来计算的。经78名医生诊治872名应用奥马珠单抗治疗的SAA患者，包括723名成人和149名年龄介于6-17岁的未成年人。其中52.1%的成人和73.8%的未成年人血EOS≥300/μl。经过医生评估发现，67.2%的成人和77.2%的未成年人对奥马珠单抗的治疗有效，71.1%的成人和78.5%的未成年人急性加重率下降≥40%。在血EOS≥300（n=377人）和血EOS<300（n=346人）的成人中，奥马珠单抗的反应率（两项标准结合评估）分别为58.4%（95% CI 53.2-63.4）和58.1% (95% CI 52.7-63.4)。这项研究表明在SAA的患者中，大部分患者血EOS≥300，且患者血EOS计数高或低对奥马珠单抗治疗的有效性是一致的。
Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study.
Abstract
Omalizumab is a monoclonal anti-immunoglobulin E antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count (EOS) as a predictive measure for response to omalizumab. This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate, and combination of both. Response rate was calculated according to blood EOS count measured in the year prior to omalizumab initiation. 872 SAA omalizumab-treated patients were included by 78 physicians (723 adults and 149 minors aged 6-17 years). EOS was ≥300/μl in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a 40% reduction in exacerbation rate. In adults, response rate for combined criteria was 58.4% (95% CI 53.2-63.4) in EOS ≥300 (n=377) and 58.1% (95% CI 52.7-63.4) in EOS <300 (n=346). This study shows that a large proportion of patients with SAA have EOS ≥300 and suggests that omalizumab effectiveness is similar in high and low EOS subgroups.
奥马珠单抗是一种用于治疗重度过敏性哮喘（severe allergic asthma，SAA）的抗IgE单克隆抗体。STELLAIR研究旨在判断治疗前血嗜酸性粒细胞计数（EOS）作为预测奥马珠单抗疗效指标的重要性。这是一项于2015年12月至2016年9月在法国进行的回顾性真实世界研究，收集了应用奥马珠单抗治疗的SAA患者的医疗记录。患者对奥马珠单抗的治疗反应通过以下3项标准来评估：（1）医师评估；（2）每年急性加重率减低≥40%；（3）两者结合。对奥马珠单抗的反应率是根据用药前一年所测得的血EOS计数来计算的。经78名医生诊治872名应用奥马珠单抗治疗的SAA患者，包括723名成人和149名年龄介于6-17岁的未成年人。其中52.1%的成人和73.8%的未成年人血EOS≥300/μl。经过医生评估发现，67.2%的成人和77.2%的未成年人对奥马珠单抗的治疗有效，71.1%的成人和78.5%的未成年人急性加重率下降≥40%。在血EOS≥300（n=377人）和血EOS<300（n=346人）的成人中，奥马珠单抗的反应率（两项标准结合评估）分别为58.4%（95% CI 53.2-63.4）和58.1% (95% CI 52.7-63.4)。这项研究表明在SAA的患者中，大部分患者血EOS≥300，且患者血EOS计数高或低对奥马珠单抗治疗的有效性是一致的。
(中国医科大学附属第一医院呼吸与危重症医学科 李文扬 摘译 杨冬 审校)
(Humbert M, et al. Eur Respir J. 2018 Mar 15 )
(Humbert M, et al. Eur Respir J. 2018 Mar 15 )
Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study.
Abstract
Omalizumab is a monoclonal anti-immunoglobulin E antibody used to treat severe allergic asthma (SAA). The aim of the STELLAIR study was to determine the importance of pre-treatment blood eosinophil count (EOS) as a predictive measure for response to omalizumab. This retrospective real-life study was conducted in France between December 2015 and September 2016 using medical records of SAA omalizumab-treated patients. Response to omalizumab was assessed by three criteria: physician evaluation, reduction of ≥40% in annual exacerbation rate, and combination of both. Response rate was calculated according to blood EOS count measured in the year prior to omalizumab initiation. 872 SAA omalizumab-treated patients were included by 78 physicians (723 adults and 149 minors aged 6-17 years). EOS was ≥300/μl in 52.1% of adults and 73.8% of minors. By physician evaluation, 67.2% of adults and 77.2% of minors were responders and 71.1% adults and 78.5% minors had a 40% reduction in exacerbation rate. In adults, response rate for combined criteria was 58.4% (95% CI 53.2-63.4) in EOS ≥300 (n=377) and 58.1% (95% CI 52.7-63.4) in EOS <300 (n=346). This study shows that a large proportion of patients with SAA have EOS ≥300 and suggests that omalizumab effectiveness is similar in high and low EOS subgroups.
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