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.

中文翻译：

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治疗 2 年后抗 IL5/抗 IL5 受体治疗的口服皮质类固醇保留效果

介绍

临床试验表明，抗 IL5/抗 IL5 受体治疗具有口服皮质类固醇 (OCS) 保留作用。由于严格的纳入和排除标准以及较短的减量持续时间，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和临床实践之间的差距。通过这项研究，我们展示了抗 IL5/抗 IL5 受体治疗 12 个月和 24 个月后 OCS 保留效果的真实数据。

方法

这项观察性研究包括接受美泊利单抗、瑞利珠单抗或贝那利珠单抗治疗 24 个月的严重嗜酸性粒细胞哮喘患者。OCS 剂量、FEV1、ACT/ACQ 评分和血液嗜酸性粒细胞的数据是从抗 IL5/抗 IL5 受体治疗前以及治疗 12 和 24 个月后的患者记录中获得的。

结果

在基线时，75% 的患者每天接受 OCS。这个数字在治疗一年后减少到 50%，p < 0.001，在治疗两年后减少到 28%，p < 0.001。在每日 OCS 组内，中位日剂量从基线时的 10 mg 泼尼松龙 (IQR 5-20) 减少至 12 个月后的 3.75 mg 泼尼松龙 (IQR 0-10)，以及 0 mg 泼尼松龙 (IQR 0-7.5) 24 个月，p < 0.001。

结论

本研究中的发现增加了临床研究的普遍性，显示了在现实生活环境中抗 IL5/抗 IL5 受体治疗的显着 OCS 保留效应。此外，这些发现增加了对抗 IL5/抗 IL5 受体治疗长期影响的理解，表明治疗两年后 OCS 进一步和持续减少。