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特泽布尔单抗与安慰剂在成人重症未控制哮喘患者中的安全性和有效性:系统评价和荟萃分析。

Safety and efficacy of tezepelumab vs. placebo in adult patients with severe uncontrolled asthma: a systematic review and meta-analysis.

机构信息

Faculty of Medicine, Ain-Shams University, Cairo, Egypt.

Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt.

出版信息

Sci Rep. 2022 Dec 3;12(1):20905. doi: 10.1038/s41598-022-24763-9.

Abstract

Patients with severe uncontrolled asthma still experience acute asthma symptoms and exacerbations, particularly those with non-eosinophilic inflammation who take the maximum amount of standard drug therapy. Tezepelumab, a human monoclonal antibody, can improve lung function and enhance control of asthma symptoms in those patients, regardless of the disease's baseline characteristics. This study aims to investigate the safety and efficacy of using tezepelumab in controlling severe symptoms of uncontrolled asthma. We performed a comprehensive literature search in several databases, including PubMed, Scopus, Web of Science, Cochrane Library, and clinicaltrial.gov, using a well-established search strategy to include all relevant publications. According to our inclusion criteria, we searched for randomized controlled trials comparing tezepelumab versus placebo in patients with severe, uncontrolled asthma. We analyzed the data using The Revman 5.4 program software. The search identified 589 potential articles. After excluding studies inconsistent with selection criteria, four studies were included and analyzed qualitatively and quantitatively. The pooled effect demonstrated the better performance of tezepelumab over the placebo regarding the decrease in annualized asthma exacerbation rate (MD = - 0.74, (95% CI [- 1.04, - 0.44], p < 0.00001)), asthma control questionnaire-6 (ACQ-6) Score MD = - 0.32, (95% CI [- 0.43, - 0.21], p < 0.00001)), blood eosinophil count (MD = - 139.38 cells/mcL, (95% CI [- 150.37, - 128.39], p < 0.00001)), feNO (MD = - 10 ppb, (95% CI [- 15.81, - 4.18], p = 0.0008)) and serum total IgE (MD = - 123.51 UI/ml, (95% CI [- 206.52, - 40.50], p = 0.004)). All tezepelumab groups had higher pre-bronchodilator forced expiratory volume in 1 s than the placebo group (MD = 0.16, (95% CI [0.10, 0.21], p < 0.00001)). Higher efficacy and safety profile was detected for tezepelumab to control the exacerbations of severe uncontrolled adult asthmatics.

摘要

患者患有严重的未控制哮喘,仍会出现急性哮喘症状和加重,尤其是那些接受最大剂量标准药物治疗的非嗜酸性粒细胞性炎症患者。特泽单抗是一种人单克隆抗体,可改善这些患者的肺功能并增强对哮喘症状的控制,无论疾病的基线特征如何。本研究旨在探讨特泽单抗在控制严重未控制哮喘症状方面的安全性和有效性。我们在几个数据库中进行了全面的文献检索,包括 PubMed、Scopus、Web of Science、Cochrane Library 和 clinicaltrial.gov,使用了经过验证的搜索策略来纳入所有相关出版物。根据我们的纳入标准,我们搜索了比较特泽单抗与安慰剂在严重未控制哮喘患者中的疗效的随机对照试验。我们使用 The Revman 5.4 程序软件分析数据。搜索确定了 589 篇潜在文章。排除了不符合选择标准的研究后,纳入了 4 项研究进行定性和定量分析。汇总效应表明,特泽单抗在降低年化哮喘加重率(MD=-0.74,(95%CI[-1.04,-0.44],p<0.00001))、哮喘控制问卷-6(ACQ-6)评分 MD=-0.32,(95%CI[-0.43,-0.21],p<0.00001))、血嗜酸性粒细胞计数(MD=-139.38 个/μL,(95%CI[-150.37,-128.39],p<0.00001))、呼出气一氧化氮(MD=-10 ppb,(95%CI[-15.81,-4.18],p=0.0008))和血清总 IgE(MD=-123.51 UI/ml,(95%CI[-206.52,-40.50],p=0.004))方面均优于安慰剂组。所有特泽单抗组的支气管扩张前用力呼气量(FEV1)均高于安慰剂组(MD=0.16,(95%CI[0.10,0.21],p<0.00001))。特泽单抗在控制严重未控制成人哮喘患者的加重方面具有更高的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d83/9719466/ad96fe6cf79d/41598_2022_24763_Fig1_HTML.jpg

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