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tezepelumab治疗重度哮喘的真实世界证据:一项回顾性多中心队列研究

Real-world evidence of tezepelumab for severe asthma: a retrospective multicentre cohort.

作者信息

Khateeb Jasmin, Kramer Mordechai R, Freund Ophir, Mhameed Reem, Naamany Eviatar, Kupershmidt Aviv, Elkayam Gal, Breslavsky Anna, Rosengarten Dror, Dotan Yaniv, Wand Ori, Bar-Shai Amir

机构信息

Pulmonary Institute, Rambam Health Care Campus, Haifa, Israel.

Ruth & Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.

出版信息

ERJ Open Res. 2025 Sep 1;11(5). doi: 10.1183/23120541.00314-2025. eCollection 2025 Sep.

Abstract

BACKGROUND

Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, has demonstrated efficacy for severe asthma in clinical trials, but real-world evidence remains limited. We aimed to evaluate the characteristics and outcomes of patients initiating tezepelumab in a real-world setting.

METHODS

We conducted a retrospective, multicentre cohort study across four tertiary care centres to evaluate the real-world effectiveness of tezepelumab in patients with severe asthma. Eligible patients were adults with a confirmed diagnosis of severe asthma, treated with tezepelumab. Data on exacerbation rates, pulmonary function and corticosteroid use were collected and analysed at baseline and 1-year follow-up.

RESULTS

The study included 103 patients treated with tezepelumab with a median (interquartile range) duration of 323 (267-359) days. Overall, 39% had prior biologic therapy and 32% had an eosinophil count <300 cells·μL. At follow-up, there was a 66.7% relative reduction in annual exacerbations. The most pronounced reduction was observed in biologic-naïve patients with peripheral eosinophil counts ≥300 cells·μL (78% reduction). A 62% relative reduction was found among patients with eosinophil counts <150 cells·μL. There were significant improvements in forced expiratory volume in 1 s, with 51% of patients demonstrating a ≥10% relative increase. Of patients using maintenance oral corticosteroid (mOCS), 45% discontinued mOCS and 23% reduced their dose by more than 50%.

CONCLUSIONS

In this real-world cohort, treatment with tezepelumab for a median of 46 weeks was associated with improved asthma control, reductions in exacerbations, mOCS and inhaled corticosteroid doses, and a low symptom burden. These findings were consistent in biologic-experienced or low-eosinophil patients.

摘要

背景

tezepelumab是一种靶向胸腺基质淋巴细胞生成素的单克隆抗体,在临床试验中已证明对重度哮喘有效,但真实世界证据仍然有限。我们旨在评估在真实世界环境中开始使用tezepelumab的患者的特征和结局。

方法

我们在四个三级医疗中心进行了一项回顾性多中心队列研究,以评估tezepelumab在重度哮喘患者中的真实世界有效性。符合条件的患者为确诊为重度哮喘且接受tezepelumab治疗的成年人。在基线和1年随访时收集并分析关于加重率、肺功能和皮质类固醇使用的数据。

结果

该研究纳入了103例接受tezepelumab治疗的患者,中位(四分位间距)治疗持续时间为323(267 - 359)天。总体而言,39%的患者曾接受过生物治疗,32%的患者嗜酸性粒细胞计数<300个细胞·μL。在随访时,年加重次数相对减少了66.7%。在未接受过生物治疗且外周嗜酸性粒细胞计数≥300个细胞·μL的患者中观察到最显著的减少(减少78%)。在嗜酸性粒细胞计数<150个细胞·μL的患者中相对减少了62%。1秒用力呼气量有显著改善,51%的患者相对增加≥10%。在使用维持性口服皮质类固醇(mOCS)的患者中,45%停止使用mOCS,23%将剂量减少了超过50%。

结论

在这个真实世界队列中,tezepelumab中位治疗46周与哮喘控制改善、加重次数减少、mOCS和吸入性皮质类固醇剂量减少以及低症状负担相关。这些发现在有生物治疗经验或嗜酸性粒细胞水平低的患者中是一致的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e6d/12400181/6a164c314497/00314-2025.01.jpg

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