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抗 IL-5/抗 IL-5 受体治疗 2 年后对口服皮质类固醇的节省作用。

Oral corticosteroid sparing effects of anti-IL5/ anti-IL5 receptor treatment after 2 years of treatment.

机构信息

Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Denmark.

Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Denmark.

出版信息

Respir Med. 2021 Jan;176:106260. doi: 10.1016/j.rmed.2020.106260. Epub 2020 Nov 27.

Abstract

INTRODUCTION

Clinical trials have shown oral corticosteroid (OCS) sparing effects of anti-IL5/anti-IL5-receptor treatments. The generalisability of these clinical trials may be limited, due to the rigid inclusion and exclusion criteria, and the short tapering duration. Real-world evidence is needed to bridge the gap between the clinical trials and the clinical practice. With this study we present real-life data on the OCS sparing effects of anti-IL5/anti-IL5-receptor treatments after 12 and 24 months of treatment.

METHODS

Severe, eosinophilic asthma patients treated with mepolizumab, reslizumab or benralizumab for 24 months were included in this observational study. Data on OCS-dose, FEV1, ACT/ACQ score and blood eosinophils were obtained from the patients records before anti-IL5/anti-IL5-receptor treatment, and after 12 and 24 months of treatment.

RESULTS

At baseline 75% of patients were on daily OCS. This number was reduced to 50% after one year of treatment, p < 0.001, and 28% after two years of treatment, p < 0.001. Within the group on daily OCS the median daily dose was reduced from 10 mg of Prednisolone at baseline (IQR 5-20) to 3.75 mg Prednisolone (IQR 0-10) after 12 months, and 0 mg Prednisolone (IQR 0-7.5) after 24 months, p < 0.001.

CONCLUSIONS

The findings in this study add to the generalisability of the clinical studies, showing significant OCS sparing effects of anti-IL5/anti-IL5-receptor treatment in a real-life setting. Furthermore, these findings add to the understanding of the long-term effects of anti-IL5/anti-IL5-receptor treatment, showing an even further and persistent OCS reduction after two years of treatment.

摘要

简介

临床试验表明,抗白细胞介素 5/抗白细胞介素 5 受体治疗具有减少口服皮质类固醇(OCS)的作用。由于严格的纳入和排除标准以及较短的减量时间,这些临床试验的普遍性可能受到限制。需要真实世界的证据来弥合临床试验与临床实践之间的差距。通过这项研究,我们提供了抗白细胞介素 5/抗白细胞介素 5 受体治疗 12 个月和 24 个月后减少 OCS 作用的真实数据。

方法

纳入接受美泊利珠单抗、瑞利珠单抗或贝那利珠单抗治疗 24 个月的重度嗜酸性粒细胞性哮喘患者进行这项观察性研究。在接受抗白细胞介素 5/抗白细胞介素 5 受体治疗之前以及治疗 12 个月和 24 个月后,从患者记录中获取 OCS 剂量、FEV1、ACQ/ACT 评分和血液嗜酸性粒细胞的数据。

结果

基线时,75%的患者每天服用 OCS。治疗 1 年后,这一数字减少到 50%,p<0.001,治疗 2 年后减少到 28%,p<0.001。在每天服用 OCS 的患者中,中位每日剂量从基线时的 10mg 泼尼松龙(IQR 5-20)减少到 12 个月时的 3.75mg 泼尼松龙(IQR 0-10),24 个月时为 0mg 泼尼松龙(IQR 0-7.5),p<0.001。

结论

本研究的发现增加了临床试验的普遍性,表明抗白细胞介素 5/抗白细胞介素 5 受体治疗在真实环境中具有显著的减少 OCS 的作用。此外,这些发现增加了对抗白细胞介素 5/抗白细胞介素 5 受体治疗长期效果的认识,表明治疗 2 年后 OCS 进一步持续减少。

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