Université Paris-Sud, Faculté de Médecine, Université Paris-Saclay, Le Kremlin-Bicêtre, France.
AP-HP, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
Eur Respir J. 2018 May 10;51(5). doi: 10.1183/13993003.02523-2017. Print 2018 May.
Omalizumab is a monoclonal anti-IgE 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 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 a combination of both. Response rate was calculated according to blood eosinophil count measured in the year prior to omalizumab initiation.872 SAA omalizumab-treated patients were included by 78 physicians (723 adults (age ≥18 years) and 149 minors (age 6-17 years)). Blood eosinophil count was ≥300 cells·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 the exacerbation rate. In adults, the response rate for combined criteria was 58.4% (95% CI 53.2-63.4%) for blood eosinophils ≥300 cells·µL (n=377) and 58.1% (95% CI 52.7-63.4%) for blood eosinophils <300 cells·µL (n=346).This study shows that a large proportion of patients with SAA have a blood eosinophil count ≥300 cells·µL, and suggests that omalizumab effectiveness is similar in "high" and "low" eosinophil subgroups.
奥马珠单抗是一种单克隆抗 IgE 抗体，用于治疗严重过敏性哮喘（SAA）。STELLAIR 研究的目的是确定治疗前血嗜酸性粒细胞计数作为预测奥马珠单抗治疗反应的重要性。本回顾性真实世界研究于 2015 年 12 月至 2016 年 9 月在法国进行，使用了接受奥马珠单抗治疗的 SAA 患者的病历。奥马珠单抗的治疗反应通过三个标准评估：医生评估、每年加重率降低≥40%以及两者的结合。根据奥马珠单抗治疗前一年测量的血嗜酸性粒细胞计数计算反应率。纳入了 78 名医生治疗的 872 名 SAA 奥马珠单抗治疗患者（723 名成人（年龄≥18 岁）和 149 名未成年人（年龄 6-17 岁））。52.1%的成年患者和 73.8%的未成年患者的血嗜酸性粒细胞计数≥300 个细胞·μL。根据医生评估，67.2%的成年患者和 77.2%的未成年患者为应答者，71.1%的成年患者和 78.5%的未成年患者的加重率降低≥40%。在成年患者中，血嗜酸性粒细胞计数≥300 个细胞·μL（n=377）和<300 个细胞·μL（n=346）的患者联合标准的反应率分别为 58.4%（95%CI 53.2-63.4%）和 58.1%（95%CI 52.7-63.4%）。本研究表明，很大一部分 SAA 患者的血嗜酸性粒细胞计数≥300 个细胞·μL，并表明奥马珠单抗在“高”和“低”嗜酸性粒细胞亚组中的有效性相似。
