Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and meta-analysis of randomized clinical trials

<i>Objective</i>: We aimed to perform a meta-analysis evaluating the efficacy and safety of dupilumab in patients with uncontrolled asthma. <i>Data source</i>: A search of electronic databases was performed using PubMed, Cochrane library and Embase. <i>Study selection</i>: The literature search was conducted independently by two reviewers. Only randomized controlled trials (RCTs) that compared between placebo and dupilumab in patients with uncontrolled asthma were included in this analysis. Pooled risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs) were calculated for dichotomous and continuous data, respectively. <i>Results</i>: A total of four RCTs representing 2,992 patients were included. Pooled analysis showed significant reductions of the annualized rate of severe asthma exacerbation in the dupilumab group compared with placebo (RR 0.44; 95% CI 0.35–0.055; P Conclusion: Among patients with uncontrolled asthma, the addition of dupilumab was associated with a reduced risk of severe asthma exacerbations and improvement in FEV1 without an increased risk of adverse events apart from injection site reactions with dupilumab.

### 研究目标
我们旨在开展一项荟萃分析，评估度普利尤单抗（dupilumab）在未控制哮喘患者中的疗效与安全性。
### 数据来源
通过PubMed、Cochrane图书馆与Embase电子数据库进行文献检索。
### 研究筛选
由两名研究者独立完成文献筛选流程。本分析仅纳入对比安慰剂与度普利尤单抗治疗未控制哮喘患者的随机对照试验（randomized controlled trials, RCTs）。分别针对二分类数据与连续性数据，计算合并风险比（risk ratios, RRs）及其对应95%置信区间（confidence intervals, CIs）、均数差（mean differences, MDs）。
### 研究结果
最终共纳入4项随机对照试验，涉及2992名患者。合并分析结果显示，相较于安慰剂组，度普利尤单抗组的重度哮喘急性发作年发生率显著降低（RR=0.44；95%CI 0.35~0.55；P<0.001）。度普利尤单抗组患者的第一秒用力呼气容积（forced expiratory volume in one second, FEV1）亦得到显著改善。
### 结论
在未控制哮喘患者中，加用度普利尤单抗可降低重度哮喘急性发作风险并改善第一秒用力呼气容积，且除注射部位反应外，未增加其他不良事件的发生风险。