Monoclonal Antibodies for the Prevention of Respiratory Syncytial Virus in Infants and Children: An Updated Systematic Review and Network Meta-analysis.

IF 14.7 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2026-10-15 DOI:10.1007/s40265-026-02395-x

Jing Xiong, Chunyang Bai, Mingyao Sun, Janne Estill, Caixia An, Long Ge

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Abstract

Background and objective: Motivated by the emergence of a long-acting monoclonal antibody (clesrovimab), the availability of data from the complete MELODY trial cohort, and results from a large randomized trial (HARMONIE), we updated our prior network meta-analysis to evaluate the efficacy and safety of monoclonal antibodies for preventing severe respiratory syncytial virus (RSV) infection in infants.

Methods: We searched for randomized controlled trials that examined the efficacy and safety of RSV infection prophylaxis with clesrovimab, motavizumab, nirsevimab, palivizumab, and suptavumab versus one another or placebo or no prophylaxis in infants. We performed a frequentist framework random-effects network meta-analysis and used the Grading of Recommendations, Assessments, Developments and Evaluation (GRADE) approach to assess the certainty of evidence.

Results: Eighteen trials enrolling 33,283 infants were included. Clesrovimab (odds ratio [OR] 0.08, 95% confidence interval [CI] 0.02-0.37, moderate certainty), motavizumab (OR 0.12; 95% CI 0.07-0.19, moderate certainty), and nirsevimab (OR 0.20, 95% CI 0.11-0.34; moderate certainty) were associated with reductions in the rate of severe respiratory syncytial virus infection. Nirsevimab, motavizumab, clesrovimab, and intramuscular palivizumab were associated with reductions in RSV infection, and several agents were also associated with reduced hospitalization. Motavizumab and nirsevimab, and clesrovimab were associated with reductions in broader lower respiratory tract infection-related outcomes. Motavizumab reduced both mechanical ventilation use and intensive care unit admission. No significant differences were found in all-cause mortality and drug-related or serious adverse events.

Conclusions: This updated network meta-analysis confirmed that the effectiveness and safety of clesrovimab were comparable to those of established monoclonal antibodies. Motavizumab, nirsevimab, and clesrovimab showed benefits for broader lower respiratory tract infection-related outcomes.

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单克隆抗体预防婴幼儿呼吸道合胞病毒：最新的系统综述和网络荟萃分析

背景和目的：受长效单克隆抗体（clesrovimab）的出现、MELODY完整试验队列数据的可用性以及大型随机试验（HARMONIE）结果的激励，我们更新了先前的网络荟萃分析，以评估单克隆抗体预防婴儿严重呼吸道合胞病毒（RSV）感染的有效性和安全性。方法：我们检索了随机对照试验，这些试验检查了在婴儿中使用clesrovimab、motavizumab、nirsevimab、palvizumab和suptavumab预防RSV感染的有效性和安全性，与安慰剂或无预防相比。我们进行了频率框架随机效应网络荟萃分析，并使用推荐、评估、发展和评估分级（GRADE）方法来评估证据的确定性。结果：18项试验纳入33,283名婴儿。Clesrovimab（比值比[OR] 0.08, 95%可信区间[CI] 0.02-0.37，中等确定性）、motavizumab（比值比0.12,95% CI 0.07-0.19，中等确定性）和nirsevimab（比值比0.20,95% CI 0.11-0.34，中等确定性）与严重呼吸道合胞病毒感染率的降低相关。尼塞维单抗、莫他维单抗、clesrovimab和肌注帕利维单抗与RSV感染的减少有关，一些药物也与住院率的减少有关。Motavizumab和nirseimab以及clesrovimab与更广泛的下呼吸道感染相关结果的降低相关。Motavizumab减少了机械通气的使用和重症监护病房的入住。在全因死亡率和药物相关或严重不良事件方面没有发现显著差异。结论：这项最新的网络荟萃分析证实，clesrovimab的有效性和安全性与已建立的单克隆抗体相当。Motavizumab， nirseimab和clesrovimab显示出对更广泛的下呼吸道感染相关结果的益处。

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.