Sumsuzzman Dewan Md, Wang Zhen, Langley Joanne M, Moghadas Seyed M
Agent-Based Modelling Laboratory, York University, Toronto, ON, Canada.
Agent-Based Modelling Laboratory, York University, Toronto, ON, Canada; Center for Infectious Disease Modeling and Analysis, Yale School of Public Health, New Haven, CT, USA.
Lancet Child Adolesc Health. 2025 Jun;9(6):393-403. doi: 10.1016/S2352-4642(25)00093-8. Epub 2025 May 1.
Nirsevimab was approved in 2023, and implemented in all-infant immunisation programmes in several high-income countries to prevent lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV). Knowledge of real-world effectiveness of broad nirsevimab programmes is crucial to validate the benefits observed in clinical trials and guide immunisation policy. We assessed the real-world effectiveness of nirsevimab in populations where infant immunisation programmes were introduced.
For this systematic review and meta-analysis, we searched MEDLINE, Embase, Web of Science, Scopus, Global Health, and medRxiv from Jan 1, 2023, to Feb 25, 2025, to identify observational studies of immunisation programmes for infants aged 2 years or younger in routine clinical practice reporting original data for the real-world effectiveness of nirsevimab. The primary analysis focused on infants aged 12 months or younger. Pooled analyses were done with inverse-variance random-effects models for RSV-related hospital admissions, intensive care unit (ICU) admissions, and RSV-related LRTI incidence. For length of hospital stay, we used a restricted maximum likelihood random-effects model to estimate the weighted mean difference (WMD) in days between the nirsevimab and control groups. This study is registered with PROSPERO (CRD42024628782).
We identified and screened 1238 records, of which 32 cohort and case-control studies from five countries (France, Italy, Luxembourg, Spain, and the USA) were included in the systematic review and 27 of them were included in the meta-analysis. Nirsevimab was associated with a lower odds of RSV-related hospitalisation (odds ratio 0·17; 95% CI 0·12-0·23; I=85·8%), a lower odds of ICU admission (0·19; 0·12-0·29; 55·6%), and a lower odds of LRTI incidence (0·25; 0·19-0·33; 35·1%) in infants aged 0-12 months. However, length of hospital stay did not differ between the nirsevimab and control groups (WMD 0·01; 95% CI -0·63 to 0·65; I=62·3%).
Our findings indicate that the benefits of nirsevimab observed in clinical trials are also evident in real-world settings, effectively reducing the burden of RSV disease in infants and, consequently, health-care use.
Natural Sciences and Engineering Research Council of Canada and the Canadian Immunization Research Network.
尼塞维单抗于2023年获批，并在多个高收入国家的全婴儿免疫计划中实施，以预防呼吸道合胞病毒（RSV）引起的下呼吸道感染（LRTI）。了解广泛的尼塞维单抗计划在现实世界中的有效性对于验证临床试验中观察到的益处并指导免疫政策至关重要。我们评估了引入婴儿免疫计划的人群中尼塞维单抗的现实世界有效性。
对于这项系统评价和荟萃分析，我们检索了2023年1月1日至2025年2月25日期间的MEDLINE、Embase、Web of Science、Scopus、Global Health和medRxiv，以识别在常规临床实践中针对2岁及以下婴儿免疫计划的观察性研究，这些研究报告了尼塞维单抗现实世界有效性的原始数据。主要分析集中在12个月及以下的婴儿。对RSV相关的住院、重症监护病房（ICU）住院和RSV相关的LRTI发病率进行汇总分析时，使用了逆方差随机效应模型。对于住院时间，我们使用限制最大似然随机效应模型来估计尼塞维单抗组和对照组之间以天为单位的加权平均差（WMD）。本研究已在PROSPERO（CRD42024628782）注册。
我们识别并筛选了1238条记录，其中来自五个国家（法国、意大利、卢森堡、西班牙和美国）的32项队列研究和病例对照研究纳入了系统评价，其中27项纳入了荟萃分析。在0至12个月的婴儿中，尼塞维单抗与RSV相关住院的较低几率（优势比0·17；95% CI 0·12 - 0·23；I² = 85·8%）、ICU住院的较低几率（0·19；0·12 - 0·29；55·6%）以及LRTI发病率的较低几率（0·25；0·19 - 0·33；35·1%）相关。然而，尼塞维单抗组和对照组之间的住院时间没有差异（WMD 0·01；95% CI -0·63至0·65；I² = 62·3%）。
我们的研究结果表明，在临床试验中观察到的尼塞维单抗的益处在现实世界中也很明显，有效减轻了婴儿RSV疾病的负担，从而减少了医疗保健的使用。
加拿大自然科学与工程研究理事会和加拿大免疫研究网络。
