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雷索芦单抗对比贝那利珠单抗治疗嗜酸性粒细胞性哮喘患者的疗效:系统文献回顾和网络荟萃分析。

Reslizumab Compared with Benralizumab in Patients with Eosinophilic Asthma: A Systematic Literature Review and Network Meta-Analysis.

机构信息

Division of Allergy and Immunology, University of South Florida, Tampa, Fla.

Amaris, Paris, France.

出版信息

J Allergy Clin Immunol Pract. 2019 Jan;7(1):122-130.e1. doi: 10.1016/j.jaip.2018.08.036. Epub 2018 Sep 11.

Abstract

BACKGROUND

The interaction of IL-5 with its receptor on eosinophils increases the activation and maintenance of eosinophils; blocking this interaction reduces asthma symptoms in patients with the eosinophilic phenotype. Reslizumab, which binds to IL-5, and benralizumab, which targets the IL-5 receptor α subunit, have not been compared in head-to-head trials.

OBJECTIVE

To indirectly compare reslizumab with benralizumab in similar patient populations using a network meta-analysis.

METHODS

A systematic literature review was conducted and a network meta-analysis was performed on eligible studies using the Markov Chain Monte-Carlo simulation method and a Bayesian statistical framework.

RESULTS

Eleven studies were identified, 4 of which evaluated clinically relevant doses and had outcomes at similar time points. To control for population differences, subgroups were selected for the base-case efficacy analysis: a benralizumab subgroup with blood eosinophil levels of greater than or equal to 300 cells/μL (n = 1537) and a reslizumab subgroup in Global Initiative for Asthma step 4/5 with 2 or more previous exacerbations and greater than or equal to 400 eosinophils/μL (n = 318). Safety was analyzed in the full population (N = 3462). Reslizumab significantly improved Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) scores compared with benralizumab once every 4 weeks and there were reasonably high posterior probabilities that reslizumab is superior to benralizumab once every 4 weeks and once every 8 weeks for ACQ score, AQLQ score, FEV, and clinical asthma exacerbations.

CONCLUSIONS

This indirect comparison suggests that reslizumab may be more efficacious than benralizumab in patients with eosinophilic asthma in Global Initiative for Asthma step 4/5 with elevated blood eosinophil levels (benralizumab, ≥300/μL; reslizumab, ≥400/μL) and 2 or more exacerbations in the previous year.

摘要

背景

白细胞介素 5(IL-5)与其在嗜酸性粒细胞上的受体相互作用可增强嗜酸性粒细胞的激活和维持;阻断这种相互作用可减少嗜酸性粒细胞表型患者的哮喘症状。与 IL-5 结合的雷那珠单抗和针对 IL-5 受体α亚基的贝那利珠单抗尚未在头对头试验中进行比较。

目的

通过网络荟萃分析,在相似的患者人群中,间接比较雷那珠单抗和贝那利珠单抗。

方法

进行了系统的文献回顾,并对符合条件的研究使用马尔可夫链蒙特卡罗模拟方法和贝叶斯统计框架进行了网络荟萃分析。

结果

确定了 11 项研究,其中 4 项评估了临床相关剂量,并在相似的时间点获得了结果。为了控制人群差异,选择了亚组进行基本疗效分析:贝那利珠单抗亚组血液嗜酸性粒细胞水平≥300 个/μL(n=1537),雷那珠单抗亚组在全球哮喘倡议(GINA)第 4/5 步,2 次或以上既往加重且嗜酸性粒细胞≥400 个/μL(n=318)。在全人群(n=3462)中分析了安全性。与贝那利珠单抗相比,雷那珠单抗每 4 周一次治疗可显著改善哮喘控制问卷(ACQ)和哮喘生活质量问卷(AQLQ)评分,且雷那珠单抗每 4 周和每 8 周一次治疗的后验概率都相当高,表明其在 ACQ 评分、AQLQ 评分、FEV 和临床哮喘加重方面优于贝那利珠单抗。

结论

本间接比较表明,雷那珠单抗可能比贝那利珠单抗在 GINA 第 4/5 步且血液嗜酸性粒细胞水平升高(贝那利珠单抗≥300/μL;雷那珠单抗≥400/μL)和前 1 年有 2 次或以上加重的患者中更有效。

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