美泊利单抗治疗重度嗜酸粒细胞性哮喘的有效性：奥地利真实世界数据
2020/10/14
摘要
背景：美波利单抗在患有重度嗜酸性粒细胞性哮喘患者的多项随机临床试验（RCTs）中有效，但在现实世界的人口中缺乏控制症状的证据。
目的：在实际临床实践中评估美泊利单抗作用后的哮喘症状控制，肺功能，口服糖皮质激素的使用以及生物标志物。
方法：将35例患有重度嗜酸性粒细胞性哮喘且哮喘症状控制不理想的成人患者（包括之前有过吸烟史的患者和心脏病患者）纳入一项前瞻性单臂真实世界研究。包括哮喘控制测试（ACT），病情加重，肺活量测定（支气管扩张剂在1 s内呼气前体积[FEV1]）以及口服皮质类固醇剂量均得到记录。进一步的评估包括外周血嗜酸性粒细胞计数和不良事件。
结果：在用美泊利单抗治疗后，哮喘患者的症状控制得到了显著改善，ACT评分中位数在基线（四分位距[IQR] 10.5-19.5]）时为12.5，在4周后升至19（15-22.5）。在整个20周的观察期内，这种改善一直保持。同样，病情加重程度有所减轻。在使用美泊珠单抗8周后，每天的OCS剂量从基线时的每天6.25 mg（0–20）减少到第8周时的每天2.5 mg（0–11.9）（P <0.001）。在整个研究过程中，FEV1基本上保持不变。嗜酸性粒细胞计数迅速下降，并在观察期间保持在较低水平。在这项研究中没有观察到新的安全性问题。
结论：美泊利单抗可改善哮喘症状控制并具有类固醇样效应。尽管入组患者其中许多有吸烟史以及有合并症，但该真实世界研究的疗效与RCT相当。
Effectiveness of mepolizumab therapy in patients with severe eosinophilic asthma: Austrian real-life data
Renner, K. Marth, K. Patocka, M. Idzko, W. Pohl.
Abstract
BACKGROUND: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.
OBJECTIVE: To assess asthma symptom control, lung function, use of oral corticosteroids, and biomarkers after mepolizumab initiation in real-world clinical practice.
METHODS: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 1s [FEV1]), and oral corticosteroid doses were documented. Further assessments included peripheral blood eosinophil counts and adverse events.
RESULTS: 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.
CONCLUSION: 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.
背景：美波利单抗在患有重度嗜酸性粒细胞性哮喘患者的多项随机临床试验（RCTs）中有效，但在现实世界的人口中缺乏控制症状的证据。
目的：在实际临床实践中评估美泊利单抗作用后的哮喘症状控制，肺功能，口服糖皮质激素的使用以及生物标志物。
方法：将35例患有重度嗜酸性粒细胞性哮喘且哮喘症状控制不理想的成人患者（包括之前有过吸烟史的患者和心脏病患者）纳入一项前瞻性单臂真实世界研究。包括哮喘控制测试（ACT），病情加重，肺活量测定（支气管扩张剂在1 s内呼气前体积[FEV1]）以及口服皮质类固醇剂量均得到记录。进一步的评估包括外周血嗜酸性粒细胞计数和不良事件。
结果：在用美泊利单抗治疗后，哮喘患者的症状控制得到了显著改善，ACT评分中位数在基线（四分位距[IQR] 10.5-19.5]）时为12.5，在4周后升至19（15-22.5）。在整个20周的观察期内，这种改善一直保持。同样，病情加重程度有所减轻。在使用美泊珠单抗8周后，每天的OCS剂量从基线时的每天6.25 mg（0–20）减少到第8周时的每天2.5 mg（0–11.9）（P <0.001）。在整个研究过程中，FEV1基本上保持不变。嗜酸性粒细胞计数迅速下降，并在观察期间保持在较低水平。在这项研究中没有观察到新的安全性问题。
结论：美泊利单抗可改善哮喘症状控制并具有类固醇样效应。尽管入组患者其中许多有吸烟史以及有合并症，但该真实世界研究的疗效与RCT相当。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（Pulm Pharmacol Ther, 2020, 64: 101946）
（Pulm Pharmacol Ther, 2020, 64: 101946）
Effectiveness of mepolizumab therapy in patients with severe eosinophilic asthma: Austrian real-life data
Renner, K. Marth, K. Patocka, M. Idzko, W. Pohl.
Abstract
BACKGROUND: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.
OBJECTIVE: To assess asthma symptom control, lung function, use of oral corticosteroids, and biomarkers after mepolizumab initiation in real-world clinical practice.
METHODS: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 1s [FEV1]), and oral corticosteroid doses were documented. Further assessments included peripheral blood eosinophil counts and adverse events.
RESULTS: 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.
CONCLUSION: 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.
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ICS + LABA与ICS + LABA + LAMA在哮喘-COPD重叠（ACO）治疗中的一项随机非劣性试验：ACO
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Dupilumab在不可控制的中度至重度过敏性哮喘患者的疗效研究
