Real-World Effectiveness of Universal Nirsevimab on Bronchiolitis Incidence: A Regional Hub-Spoke Surveillance Analysis in Liguria, Italy.

IF 2.3 3区医学 Q1 PEDIATRICS

Pediatric Pulmonology Pub Date : 2026-05-01 DOI:10.1002/ppul.71653

Marcello Mariani, Giacomo Brisca, Marina Francesca Strati, Silvia Buratti, Marta Ferretti, Alberto Gaiero, Valeria Musso, Andrea Gazzolo, Francesca Ginocchio, Katiuscia Zerbini, Diego Minghetti, Maria Franca Corona, Laura De Hoffer, Daniela Pirlo, Emanuela Piccotti, Luca Antonio Ramenghi, Marisa Alberti, Raffaele Spiazzi, Elio Castagnola, Andrea Moscatelli

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引用次数: 0

Abstract

Background: Bronchiolitis represents a major cause of infant hospitalization, predominantly due to respiratory syncytial virus (RSV). Nirsevimab, a long-acting monoclonal antibody targeting the prefusion RSV F protein, has recently been introduced to provide season-long protection against RSV-related lower respiratory tract infection.

Methods: We conducted a multicenter, retrospective, population-based study across the Liguria Region (Northwest Italy) to assess the impact and effectiveness of the 2024-2025 nirsevimab immunization campaign. All infants under 2 years of age hospitalized with acute bronchiolitis between October 2023 and March 2025 were identified through the regional pediatric Hub-and-Spoke network. Data were compared between the pre-nirsevimab (2023-2024) and post-nirsevimab (2024-2025) seasons. Nirsevimab effectiveness (VE) against RSV-positive hospitalization was estimated using a test-negative design.

Results: A total of 858 infants were hospitalized with bronchiolitis across the two seasons. Following the introduction of nirsevimab, bronchiolitis hospitalizations decreased from 41.7 to 17.3 per 1000 admissions (Incidence Rate Ratio 0.4; 95% CI: 0.4-0.5; p < 0.001), corresponding to a 60% reduction. Estimated nirsevimab effectiveness was 65.0% (95% CI: 39.2%-79.8%) against RSV-positive hospitalization. No high-risk infants-those previously eligible for palivizumab-developed severe RSV infection requiring PICU admission. Breakthrough infections occurred in a minority of immunized infants but showed a similar clinical course to non-immunized cases.

Conclusions: The introduction of universal nirsevimab immunization in Liguria was associated with a marked reduction in RSV-related hospitalizations, confirming its strong real-world epidemiological impact. These findings support nirsevimab as an effective and feasible public health intervention to substantially reduce the burden of RSV bronchiolitis in infants.

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通用Nirsevimab对毛细支气管炎发病率的实际有效性：意大利利古里亚地区中心-辐状监测分析。

背景：毛细支气管炎是婴儿住院的主要原因，主要是由于呼吸道合胞病毒（RSV）。Nirsevimab是一种靶向RSV预融合F蛋白的长效单克隆抗体，最近被引入以提供针对RSV相关下呼吸道感染的季节性保护。方法：我们在利古利亚地区（意大利西北部）开展了一项多中心、回顾性、基于人群的研究，以评估2024-2025年nirsevimab免疫运动的影响和有效性。所有在2023年10月至2025年3月期间因急性细支气管炎住院的2岁以下婴儿都是通过区域儿科中心辐射型网络确定的。比较了尼罗伐前（2023-2024）和尼罗伐后（2024-2025）季节的数据。采用阴性试验设计估计抗rsv阳性住院的尼瑟维单抗有效性（VE）。结果：两个季节共有858名婴儿因毛细支气管炎住院。引入尼瑟维单抗后，毛细支气管炎住院率从每1000例入院41.7例下降到17.3例（发病率比0.4;95% CI: 0.4-0.5; p）结论：利古利亚省普遍引入尼瑟维单抗免疫接种与rsv相关住院率显著降低相关，证实了其强大的现实流行病学影响。这些发现支持nirseimab作为一种有效和可行的公共卫生干预措施，可以大大减轻婴儿RSV细支气管炎的负担。

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

Pediatric Pulmonology 医学-呼吸系统

CiteScore

6.00

自引率

12.90%

发文量

468

审稿时长

3-8 weeks

期刊介绍： Pediatric Pulmonology (PPUL) is the foremost global journal studying the respiratory system in disease and in health as it develops from intrauterine life though adolescence to adulthood. Combining explicit and informative analysis of clinical as well as basic scientific research, PPUL provides a look at the many facets of respiratory system disorders in infants and children, ranging from pathological anatomy, developmental issues, and pathophysiology to infectious disease, asthma, cystic fibrosis, and airborne toxins. Focused attention is given to the reporting of diagnostic and therapeutic methods for neonates, preschool children, and adolescents, the enduring effects of childhood respiratory diseases, and newly described infectious diseases. PPUL concentrates on subject matters of crucial interest to specialists preparing for the Pediatric Subspecialty Examinations in the United States and other countries. With its attentive coverage and extensive clinical data, this journal is a principle source for pediatricians in practice and in training and a must have for all pediatric pulmonologists.