美泊利珠单抗的真实世界研究：它兑现了承诺吗？
2020/04/07
摘要
背景：严重嗜酸性粒细胞哮喘患者群体中进行的随机对照试验表明，美泊利珠单抗（一种抗IL-5治疗）能够减少哮喘急性加重和口服糖皮质激素维持剂量，在一些研究中，能够改善哮喘控制和肺功能。
目的：本研究的目的是证实在116例严重嗜酸性粒细胞哮喘患者中，应用美泊利珠单抗治疗后，他们每月在哮喘门诊随访至少18个月，在现实生活中的随机对照试验结果。
方法：对重度哮喘患者进行FeNO、肺功能、哮喘控制及生活质量问卷调查、痰液诱导、基线、6个月后及每年一次血样测定。
结果：6个月后，我们发现病情恶化率显著降低了85%（P<0.0001），并且随着时间的推移而保持。我们还发现口服皮质类固醇的剂量显著且持续减少50%（P<0.001）。6个月时，患者的ACT（+5.31分，P<0.0001）ACQ（-1.13分，P<0.0001）和AQLQ评分（+1.24分，P<0.0001）均得到改善，并在随访期间得到维持。只有37%达到哮喘控制（ACQ<1.5，ACT>20）。我们观察到使用支气管扩张剂后测定的FEV1逐渐增加并在18个月后达到显著性差异（190ml或11%，P<0.01）。FEV1改善的患者比不改善者有更高的基线痰嗜酸性粒细胞。研究发现6个月后痰嗜酸性粒细胞计数显著减少60%（P<0.01），血液嗜酸性粒细胞计数持续减少98%（P<0.0001）。
结论：在我们的真实世界研究中，我们证实了RCT研究中公布的结果，研究显示急性发作和口服皮质类固醇剂量明显减少，哮喘控制和生活质量得到改善。
Real-word experience with Mepolizumab: Does it deliver what it has promised?
Schleich F, Graff S, Nekoee H, Moermans C, Henket M, Sanchez C, Paulus V, Guissard F, Donneau AF, Louis R.
Abstract
BACKGROUND: Randomized control trials performed in selected populations of severe eosinophilic asthmatics have shown that mepolizumab, an anti-IL5 therapy, was able to reduce exacerbations and OCS maintenance dose and in some studies, to improve asthma control and lung function.
OBJECTIVE: The aim of this study was to confirm the results of the RCTs in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months.
METHODS: Severe asthmatics underwent FENO, lung function, asthma control and quality of life questionnaires, sputum induction and gave a blood sample at baseline, after 6 months and then every year.
RESULTS: We found a significant reduction in exacerbations by 85% after 6 months (P < .0001), which was maintained over time. We also found a significant and maintained reduction by 50% in the dose of oral corticosteroids (P < .001). Patients improved their ACT (+5.31pts, P < .0001) ACQ (-1.13pts, P < .0001) and their AQLQ score (+1.24, P < .0001) at 6 months and this was maintained during follow-up. Only 37% reached asthma control (ACQ < 1.5, ACT > 20). We observed a progressive increase in post-BD FEV1 that reached significance after 18 months (190ml or 11%, P < .01). Patients improving their FEV1 had higher baseline sputum eosinophils than those not improving airway caliber. We found a significant reduction in sputum eosinophil counts by 60% after 6 months (P < .01) and a maintained reduction in blood eosinophil counts by 98% (P < .0001).
CONCLUSION: In our real-life study, we confirm the results published in the RCTs showing a sharp reduction in exacerbation and oral corticosteroids dose and an improvement in asthma control and quality of life.
背景：严重嗜酸性粒细胞哮喘患者群体中进行的随机对照试验表明，美泊利珠单抗（一种抗IL-5治疗）能够减少哮喘急性加重和口服糖皮质激素维持剂量，在一些研究中，能够改善哮喘控制和肺功能。
目的：本研究的目的是证实在116例严重嗜酸性粒细胞哮喘患者中，应用美泊利珠单抗治疗后，他们每月在哮喘门诊随访至少18个月，在现实生活中的随机对照试验结果。
方法：对重度哮喘患者进行FeNO、肺功能、哮喘控制及生活质量问卷调查、痰液诱导、基线、6个月后及每年一次血样测定。
结果：6个月后，我们发现病情恶化率显著降低了85%（P<0.0001），并且随着时间的推移而保持。我们还发现口服皮质类固醇的剂量显著且持续减少50%（P<0.001）。6个月时，患者的ACT（+5.31分，P<0.0001）ACQ（-1.13分，P<0.0001）和AQLQ评分（+1.24分，P<0.0001）均得到改善，并在随访期间得到维持。只有37%达到哮喘控制（ACQ<1.5，ACT>20）。我们观察到使用支气管扩张剂后测定的FEV1逐渐增加并在18个月后达到显著性差异（190ml或11%，P<0.01）。FEV1改善的患者比不改善者有更高的基线痰嗜酸性粒细胞。研究发现6个月后痰嗜酸性粒细胞计数显著减少60%（P<0.01），血液嗜酸性粒细胞计数持续减少98%（P<0.0001）。
结论：在我们的真实世界研究中，我们证实了RCT研究中公布的结果，研究显示急性发作和口服皮质类固醇剂量明显减少，哮喘控制和生活质量得到改善。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(Clin Exp Allergy. 2020 Mar 21. doi: 10.1111/cea.13601.)
(Clin Exp Allergy. 2020 Mar 21. doi: 10.1111/cea.13601.)
Real-word experience with Mepolizumab: Does it deliver what it has promised?
Schleich F, Graff S, Nekoee H, Moermans C, Henket M, Sanchez C, Paulus V, Guissard F, Donneau AF, Louis R.
Abstract
BACKGROUND: Randomized control trials performed in selected populations of severe eosinophilic asthmatics have shown that mepolizumab, an anti-IL5 therapy, was able to reduce exacerbations and OCS maintenance dose and in some studies, to improve asthma control and lung function.
OBJECTIVE: The aim of this study was to confirm the results of the RCTs in real-life in a population of 116 severe eosinophilic asthmatics treated with mepolizumab and who were followed up at the asthma clinic every month for at least 18 months.
METHODS: Severe asthmatics underwent FENO, lung function, asthma control and quality of life questionnaires, sputum induction and gave a blood sample at baseline, after 6 months and then every year.
RESULTS: We found a significant reduction in exacerbations by 85% after 6 months (P < .0001), which was maintained over time. We also found a significant and maintained reduction by 50% in the dose of oral corticosteroids (P < .001). Patients improved their ACT (+5.31pts, P < .0001) ACQ (-1.13pts, P < .0001) and their AQLQ score (+1.24, P < .0001) at 6 months and this was maintained during follow-up. Only 37% reached asthma control (ACQ < 1.5, ACT > 20). We observed a progressive increase in post-BD FEV1 that reached significance after 18 months (190ml or 11%, P < .01). Patients improving their FEV1 had higher baseline sputum eosinophils than those not improving airway caliber. We found a significant reduction in sputum eosinophil counts by 60% after 6 months (P < .01) and a maintained reduction in blood eosinophil counts by 98% (P < .0001).
CONCLUSION: In our real-life study, we confirm the results published in the RCTs showing a sharp reduction in exacerbation and oral corticosteroids dose and an improvement in asthma control and quality of life.
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法国、德国、意大利和英国的哮喘患者口服皮质类固醇处方模式
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固定剂量皮下注射reslizumab对重度非控制性哮喘患者哮喘急性发作和口服激素依赖性哮喘患者皮质类固醇剂量的影响：来自
