Strauss Ronald, Leflein Hannah, Kolesar Anna, Hammel Jeffrey
Cleveland Allergy and Asthma Center and Case Western Reserve University School of Medicine, Cleveland, Ohio.
Case Western Reserve University, Cleveland Allergy and Asthma Center, Cleveland, Ohio.
J Allergy Clin Immunol Pract. 2023 Dec;11(12):3670-3679.e2. doi: 10.1016/j.jaip.2023.08.010. Epub 2023 Aug 10.
The major problem at the Cleveland Allergy and Asthma Center was the need for additional therapy for severe eosinophilic asthma patients who were steroid-dependent or required frequent bursts of prednisone.
The objectives of this study were to determine the efficacy of monthly mepolizumab (MP) injections up to 6½ years using Asthma Control Quesitonnaire-7 (ACQ-7), forced expiratory volume in 1 second (FEV), forced expiratory flow at 25% to 75% (FEF) overall and among super-responders, and to understand whether FEF is an effective parameter to evaluate MP efficacy.
We reviewed the charts of 67 patients with severe eosinophilic asthma and compared the results between 47 super-responders and the rest of the cohort regarding ACQ-6, ACQ-7, eosinophils, FEV, and FEF. The groups of super-responders and all other patients were described with respect to initial and current values of the study end points using medians and 25th and 75th percentiles. Changes from the initial to the current values in the study end points were measured using percent changes. The Wilcoxon signed rank test was used within each group to test the null hypothesis of 0 median percent change.
After 6½ years, there were no significant changes in FEV. The FEF, had a significant median percent increase of 40% among the super-responders (P < .001), which was substantially higher (P = .026) than the median percent increase of 13.8% observed among all other patients.
The use of MP up to 6½ years was safe and effective, with significant changes to ACQ-7 and FEF associated with MP treatment, but not the FEV. A higher magnitude of changes was observed among super-responders than the rest of the cohort. Changes in FEF were more meaningful than changes in FEV in evaluating pulmonary function responsiveness of severe eosinophilic asthma to MP.
克利夫兰过敏与哮喘中心的主要问题是，对于依赖类固醇或需要频繁使用泼尼松冲击治疗的重度嗜酸性粒细胞性哮喘患者，需要额外的治疗方法。
本研究的目的是使用哮喘控制问卷-7（ACQ-7）、第1秒用力呼气容积（FEV）、25%至75%用力呼气流量（FEF），总体及超反应者中评估长达6.5年每月注射美泊利单抗（MP）的疗效，并了解FEF是否为评估MP疗效的有效参数。
我们回顾了67例重度嗜酸性粒细胞性哮喘患者的病历，并比较了47例超反应者与队列中其他患者在ACQ-6、ACQ-7、嗜酸性粒细胞、FEV和FEF方面的结果。使用中位数以及第25和第75百分位数描述超反应者组和所有其他患者组的研究终点初始值和当前值。使用百分比变化来衡量研究终点从初始值到当前值的变化。在每组中使用Wilcoxon符号秩检验来检验中位数百分比变化为0的原假设。
6.5年后，FEV无显著变化。超反应者中FEF的中位数百分比显著增加了40%（P <.001），这显著高于（P =.026）所有其他患者中观察到的13.8%的中位数百分比增加。
长达6.5年使用MP是安全有效的，MP治疗与ACQ-7和FEF的显著变化相关，但与FEV无关。超反应者中的变化幅度高于队列中的其他患者。在评估重度嗜酸性粒细胞性哮喘对MP的肺功能反应性方面，FEF的变化比FEV的变化更有意义。
