Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.
Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Vienna, Austria.
Pulm Pharmacol Ther. 2020 Oct;64:101946. doi: 10.1016/j.pupt.2020.101946. Epub 2020 Sep 17.
Mepolizumab was effective in several randomized clinical trials (RCTs) in patients with severe eosinophilic asthma, but evidence for symptom control in a real-world population is scarce.
To assess asthma symptom control, lung function, use of oral corticosteroids, and biomarkers after mepolizumab initiation in real-world clinical practice.
Thirty-five adult patients with severe eosinophilic asthma and inadequate asthma symptom control, including former smokers and patients with cardiac disease, were enrolled in a prospective single-arm real-world study. Asthma control tests (ACT), exacerbations, spirometry (pre-bronchodilator forced expiratory volume in 1 s [FEV1]), and oral corticosteroid doses were documented. Further assessments included peripheral blood eosinophil counts and adverse events.
After mepolizumab initiation asthma symptom control was significantly improved with the median ACT score of 12.5 at baseline (interquartile range [IQR ]10.5-19.5) rising to 19 (15-22.5) after 4 weeks. The improvement was maintained throughout the observation period of 20 weeks. Likewise, exacerbations were reduced. After 8 weeks of mepolizumab daily OCS doses were reduced from 6.25 mg daily (0-20) at baseline to 2.5 mg daily (0-11.9) at week 8 (P < 0.001). FEV1 remained generally unchanged during the course of the study. Eosinophil counts rapidly declined and remained at a low level during the observation period. No new safety signals were observed in this study.
Mepolizumab improved asthma symptom control and had a steroid-sparing effect. Efficacy in this real-world study was comparable to RCTs, despite a history of smoking and comorbidities in many of the patients included.
美泊利珠单抗在几项重度嗜酸性粒细胞性哮喘的随机临床试验（RCT）中有效，但在真实世界人群中关于症状控制的证据很少。
评估美泊利珠单抗在真实世界临床实践中的起始治疗后哮喘症状控制、肺功能、口服皮质类固醇的使用情况和生物标志物。
35 例重度嗜酸性粒细胞性哮喘且哮喘症状控制不佳的成年患者（包括曾经吸烟者和合并心脏病患者）纳入了一项前瞻性单臂真实世界研究。记录哮喘控制测试（ACT）、哮喘加重、肺活量测定（支气管扩张剂前用力呼气 1 秒量[FEV1]）和口服皮质类固醇剂量。进一步评估包括外周血嗜酸性粒细胞计数和不良事件。
起始美泊利珠单抗治疗后，哮喘症状控制明显改善，基线时的中位 ACT 评分为 12.5（四分位距[IQR]10.5-19.5），4 周后升至 19（15-22.5）。整个 20 周观察期间都保持了改善。同样，哮喘加重也减少了。起始美泊利珠单抗治疗 8 周后，每日口服皮质类固醇剂量从基线时的 6.25mg 每日（0-20）降至 8 周时的 2.5mg 每日（0-11.9）（P<0.001）。在研究过程中，FEV1 基本保持不变。嗜酸性粒细胞计数迅速下降，并在整个观察期间保持在较低水平。在本研究中未观察到新的安全性信号。
美泊利珠单抗改善了哮喘症状控制，并具有皮质类固醇节约作用。在本真实世界研究中，尽管纳入的许多患者有吸烟史和合并症，但疗效与 RCT 相当。
