Effect of nirsevimab on hospitalisations for respiratory syncytial virus bronchiolitis in France, 2023–24: a modelling study

IF 19.9 1区 医学 Q1 PEDIATRICS
Antoine Brault PhD , Isabelle Pontais PhD , Vincent Enouf PhD , Christine Debeuret PharmD , Emma Bloch MSc , Juliette Paireau PhD , Prof Marie-Anne Rameix-Welti PhD , Michael White PhD , Gaëlle Baudemont MsC , Prof Bruno Lina PhD , Isabelle Parent du Châtelet MD , Jean-Sébastien Casalegno MD , Sophie Vaux PharmD , Prof Simon Cauchemez PhD
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引用次数: 0

Abstract

Background

Respiratory syncytial virus (RSV) is a major cause of hospitalisations and deaths among infants worldwide. France was one of the first countries to implement a national programme (beginning on Sept 15, 2023) for administration of nirsevimab, a single-dose long-acting monoclonal antibody treatment, to infants born on or after Feb 6, 2023, to prevent lower respiratory tract infection caused by RSV. We aimed to estimate the effectiveness of nirsevimab and the number of hospitalisations averted in children younger than 24 months in real-world settings.

Methods

In this modelling study, we developed an age-structured deterministic model characterising RSV transmission as well as plausible scenarios for the administration of nirsevimab doses based on maternity ward and community pharmacy supply data. We retrospectively estimated nirsevimab effectiveness in infants younger than 24 months during the 2023–24 RSV season in France (excluding overseas territories) and the number of averted hospitalisations for RSV bronchiolitis occurring after emergency department visits, by calibrating the model to hospital and virological surveillance data from Aug 21, 2017, to Feb 4, 2024, alongside serological data from a previous cross-sectional study. To assess the robustness of our estimates, we conducted sensitivity analyses in which we modified our assumptions about the number of doses administered, the reconstruction of the number of RSV-associated hospitalisations for bronchiolitis, the duration of maternal and post-infection immunity to RSV, and the number of contacts in children aged 0–2 months.

Findings

We estimated that nirsevimab administration prevented 5800 (95% credible interval 3700–7800) RSV-associated hospitalisations for bronchiolitis after emergency department visits among children younger than 24 months, including 4200 (2900–5600) hospitalisations among those aged 0–2 months, between Sept 15, 2023 (the date nirsevimab was introduced), and Feb 4, 2024—a 23% (16–30) reduction in the total number of hospitalisations and a 35% (25–44) reduction in the 0–2 months age group, compared with the scenario without administration. In our baseline scenario, in which we estimated that 215 000 doses of nirsevimab were administered by Jan 31, 2024, the estimated effectiveness against RSV-associated hospitalisations for bronchiolitis was 73% (61–84), corresponding to one hospitalisation averted for every 39 (26–54) doses administered. In sensitivity analyses, nirsevimab remained effective against RSV-associated hospitalisations for bronchiolitis after emergency department attendance.

Interpretation

Our findings show that nirsevimab administration campaigns could effectively reduce the RSV-related hospital burden of bronchiolitis in children younger than 24 months.

Funding

European Commission, Laboratoire d'Excellence Integrative Biology of Emerging Infectious Diseases programme, and INCEPTION project.

尼舍单抗对 2023-24 年法国呼吸道合胞病毒支气管炎住院人数的影响:一项模型研究。
背景:呼吸道合胞病毒(RSV)是全球婴儿住院和死亡的主要原因。法国是首批实施国家计划(从 2023 年 9 月 15 日开始)的国家之一,该计划旨在为 2023 年 2 月 6 日或之后出生的婴儿提供单剂量长效单克隆抗体治疗药物 nirsevimab,以预防 RSV 引起的下呼吸道感染。我们的目的是估算尼舍单抗的疗效以及在实际环境中为 24 个月以下儿童避免的住院次数:在这项建模研究中,我们根据产科病房和社区药房的供应数据,建立了一个年龄结构确定性模型,该模型描述了 RSV 传播的特点以及使用尼尔舍维单抗剂量的合理方案。我们根据 2017 年 8 月 21 日至 2024 年 2 月 4 日的医院和病毒学监测数据以及之前一项横断面研究的血清学数据对模型进行了校准,从而回顾性地估算了 2023-24 年 RSV 流行季节期间法国(不包括海外领地)24 个月以下婴儿使用 nirsevimab 的有效性,以及急诊科就诊后因 RSV 支气管炎而避免住院的人数。为了评估估算结果的稳健性,我们进行了敏感性分析,在分析中我们修改了以下假设:给药剂量、RSV相关的支气管炎住院人数重建、母体和感染后对RSV的免疫持续时间以及0-2个月儿童的接触人数:我们估计,在 24 个月以下的儿童中,使用 nirsevimab 可预防 5800 例(95% 可信区间为 3700-7800 例)急诊就诊后因支气管炎导致的 RSV 相关住院病例,其中包括 4200 例(2900-5600 例)0-2 个月儿童的住院病例、在 2023 年 9 月 15 日(引入尼舍单抗的日期)至 2024 年 2 月 4 日期间,与不使用尼舍单抗的方案相比,住院总人数减少了 23%(16-30),0-2 个月年龄组的住院人数减少了 35%(25-44)。在基线方案中,我们估计到 2024 年 1 月 31 日将使用 215,000 剂 nirsevimab,估计对 RSV 相关性支气管炎住院治疗的有效率为 73% (61-84),相当于每使用 39 (26-54) 剂 nirsevimab 就能避免一次住院治疗。在敏感性分析中,在急诊科就诊后,nirsevimab对RSV相关的支气管炎住院治疗仍然有效:我们的研究结果表明,在 24 个月以下的儿童中,通过开展 nirsevimab 施用活动可有效减少与 RSV 相关的支气管炎住院负担:经费来源:欧盟委员会、新发传染病综合生物学卓越实验室计划和 INCEPTION 项目。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Lancet Child & Adolescent Health
Lancet Child & Adolescent Health Psychology-Developmental and Educational Psychology
CiteScore
40.90
自引率
0.80%
发文量
381
期刊介绍: The Lancet Child & Adolescent Health, an independent journal with a global perspective and strong clinical focus, presents influential original research, authoritative reviews, and insightful opinion pieces to promote the health of children from fetal development through young adulthood. This journal invite submissions that will directly impact clinical practice or child health across the disciplines of general paediatrics, adolescent medicine, or child development, and across all paediatric subspecialties including (but not limited to) allergy and immunology, cardiology, critical care, endocrinology, fetal and neonatal medicine, gastroenterology, haematology, hepatology and nutrition, infectious diseases, neurology, oncology, psychiatry, respiratory medicine, and surgery. Content includes articles, reviews, viewpoints, clinical pictures, comments, and correspondence, along with series and commissions aimed at driving positive change in clinical practice and health policy in child and adolescent health.
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