尼塞韦单抗预防婴儿呼吸道合胞病毒相关住院治疗的有效性。

Nirsevimab Effectiveness at Preventing RSV-Related Hospitalization in Infants.

作者信息

Jabagi Marie Joelle, Cohen Jérémie, Bertrand Marion, Chalumeau Martin, Zureik Mahmoud

机构信息

EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, French National Agency for the Safety of Medicines and Health Products (ANSM), French National Fund for Health Insurance (CNAM), Saint-Denis, France.

Department of General Pediatrics and Pediatric Infectious Diseases, Necker-Enfants Malades University Hospital, AP-HP, Paris Cité University.

出版信息

NEJM Evid. 2025 Mar;4(3):EVIDoa2400275. doi: 10.1056/EVIDoa2400275. Epub 2025 Feb 25.

DOI:10.1056/EVIDoa2400275

PMID:39998305

Abstract

BACKGROUND

In pivotal trials, nirsevimab showed promising efficacy in reducing hospitalizations for respiratory syncytial virus-associated lower respiratory tract infections (RSV-LRTIs). Nirsevimab's real-world effectiveness needs to be assessed.

METHODS

This population-based study used the French National Health Data System. All infants born between February 6 and September 15, 2023 were eligible. Each day during the study period (September 15, 2023, to January 31, 2024), all infants newly passively immunized with nirsevimab were matched to unimmunized controls in a 1:1 ratio according to sex, birth month, gestational age, department of residence, and the French Social Deprivation Index (Fdep). Study outcomes included RSV-LRTI-related hospitalization, RSV-LRTI necessitating admission to a pediatric intensive care unit (PICU) or high dependency unit (HDU), and RSV-LRTI requiring ventilation support or oxygen therapy. We estimated nirsevimab effectiveness using propensity score-weighted conditional Cox models.

RESULTS

The study included 82,474 infants (41,237 in each group) with a median follow-up of 118 days (interquartile range, 76 to 125). The population included predominantly male infants (52.5%) born at term (94.6%), mostly between April and July 2023 (64.0%), and from more advantaged municipalities (FDep first quintile: 29.8%). In total, 342 infants (0.8%) in the nirsevimab group and 992 (2.4%) in the unimmunized group were hospitalized for RSV-LRTI. Nirsevimab's effectiveness was 65% (95% confidence interval [CI], 61 to 69) for RSV-LRTI hospitalizations; 74% (95% CI, 56 to 85) for RSV-LRTI PICU admissions; 64% (95% CI, 55 to 71) for RSV-LRTI HDU admissions; 66% (95% CI, 51 to 76) for RSV-LRTI hospitalization requiring ventilation support; and 67% (95% CI, 57 to 75) for RSV-LRTI hospitalization requiring oxygen therapy. Subgroup and sensitivity analyses yielded consistent effectiveness estimates.

CONCLUSIONS

This study in a nationwide monoclonal antibody infusion setting suggests that a single injection of nirsevimab was associated with substantial protection of infants against hospitalization for RSV-LRTI.

摘要

背景

在关键试验中，尼塞韦单抗在降低呼吸道合胞病毒相关下呼吸道感染（RSV-LRTI）住院率方面显示出有前景的疗效。尼塞韦单抗在现实世界中的有效性需要评估。

方法

这项基于人群的研究使用了法国国家卫生数据系统。所有在2023年2月6日至9月15日之间出生的婴儿均符合条件。在研究期间（2023年9月15日至2024年1月31日）的每一天，所有新接受尼塞韦单抗被动免疫的婴儿均按照性别、出生月份、胎龄、居住省份和法国社会剥夺指数（Fdep）以1:1的比例与未免疫的对照进行匹配。研究结局包括与RSV-LRTI相关的住院、因RSV-LRTI需要入住儿科重症监护病房（PICU）或高依赖病房（HDU），以及因RSV-LRTI需要通气支持或氧疗。我们使用倾向评分加权条件Cox模型估计尼塞韦单抗的有效性。

结果

该研究纳入了82474名婴儿（每组41237名），中位随访时间为118天（四分位间距，76至125天）。人群主要包括足月出生的男婴（52.5%），大多出生于2023年4月至7月之间（64.0%），且来自更具优势的城市（FDep第一五分位数：29.8%）。尼塞韦单抗组共有342名婴儿（0.8%）因RSV-LRTI住院，未免疫组有992名（2.4%）。尼塞韦单抗对RSV-LRTI住院的有效性为65%（95%置信区间[CI]，61至69）；对RSV-LRTI入住PICU的有效性为74%（95%CI，56至85）；对RSV-LRTI入住HDU的有效性为64%（95%CI，55至71）；对需要通气支持的RSV-LRTI住院的有效性为66%（95%CI，51至76）；对需要氧疗的RSV-LRTI住院的有效性为67%（95%CI，57至75）。亚组分析和敏感性分析得出了一致的有效性估计值。