Nirsevimab immunization's real‐world effectiveness in preventing severe bronchiolitis: A test‐negative case

Nirsevimab immunization's real‐world effectiveness in preventing severe bronchiolitis: A test‐negative case–control study

Published:2024-06 Issue:6 Volume:35 Page:
ISSN:0905-6157
Container-title:Pediatric Allergy and Immunology
language:en
Short-container-title:Pediatric Allergy Immunology

Author:

Agüera Marta¹^ORCID,Soler‐Garcia Aleix¹²³^ORCID,Alejandre Carme⁴,Moussalam‐Merino Sara¹,Sala‐Castellví Pere⁴⁵^ORCID,Pons Gemma¹^ORCID,Penela‐Sánchez Daniel²⁶^ORCID,González‐Grado Carla¹⁷,Alsina‐Rossell Judit¹,Climent Carme⁴⁵,Esteva Cristina²⁸^ORCID,Fortuny Clàudia²³,de‐Sevilla Mariona‐F¹²³⁸^ORCID,García‐García Juan‐José¹²³⁸^ORCID,Brotons Pedro²⁴⁸^ORCID,Balaguer Albert⁴^ORCID,Estrada Josep⁷,Jordan Iolanda²³⁶⁸^ORCID,Muñoz‐Almagro Carmen²⁴⁸⁹^ORCID,Launes Cristian¹²³⁸^ORCID

Affiliation:

1. Pediatrics Department Hospital Sant Joan de Déu Barcelona Spain

2. Pediatric Infectious Diseases and Microbiome Research Group Institut de Recerca Sant Joan de Déu Spain

3. Departament de Cirurgia i Especialitats Medicoquirúrgiques, Facultat de Medicina i Ciències de la Salut Universitat de Barcelona Barcelona Spain

4. Department of Medicine, School of Medicine Universitat Internacional de Catalunya Barcelona Spain

5. Pediatrics Department Hospital General de Catalunya Barcelona Spain

6. Pediatric Intensive Care Unit Department Hospital Sant Joan de Déu Barcelona Spain

7. Pediatrics and Neonatology Department Hospital Nostra Senyora de Meritxell Escaldes‐Engordany Andorra

8. CIBER Epidemiology and Public Health (CIBERESP) Madrid Spain

9. RDI Microbiology Department Hospital Sant Joan de Déu Barcelona Spain

Abstract

AbstractBackgroundSeveral clinical trials have shown that nirsevimab, an antibody targeting the respiratory syncytial virus (RSV), reduces RSV bronchiolitis requiring admission. In 2023–2024, Catalonia and Andorra adopted immunization strategies for children <6 months and those born during the epidemic season. This study evaluates the effectiveness of nirsevimab in preventing hospitalizations from RSV bronchiolitis.MethodsIn the epidemic season of 2023–2024, a test‐negative case–control study was conducted in three hospitals from Catalonia and Andorra. Patients <12 months old admitted with bronchiolitis and tested for RSV using molecular microbiology tests were included.The effectiveness in preventing RSV bronchiolitis hospitalization and severe disease was estimated using multivariate models. Comparisons between immunized, non‐immunized, and non‐eligible patients were made in prospectively collected epidemiological, clinical, and microbiological variables.ResultsTwo hundred thirty‐four patients were included. RSV was detected in 141/234 (60.2%), being less common in the immunized group (37% vs 75%, p < .001). The rate of immunized patients among those eligible was 59.7%. The estimated effectiveness for RSV‐associated lower respiratory tract infection was 81.0% (95% confidence interval: 60.9–90.7), and for preventing severe disease (the need for NIV/CMV), 85.6% (41.7–96.4%). No significant differences by immunization status were observed in patients with RSV concerning viral coinfections, the need for NIV/CMV or length of hospital stay.ConclusionsThis study provides real‐world evidence of the effectiveness of nirsevimab in preventing RSV‐lower respiratory tract infection hospitalization and severe disease in infants during their first RSV season following a systematic immunization program. Immunized patients did not exhibit a higher rate of viral coinfections nor differences in clinical severity once admitted.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/pai.14175

Reference30 articles.

1. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis

2. Respiratory syncytial virus hospitalization and mortality: Systematic review and meta‐analysis

3. Respiratory Syncytial Virus Is the Leading Cause of United States Infant Hospitalizations, 2009–2019: A Study of the National (Nationwide) Inpatient Sample

4. The burden of non‐SARS‐CoV2 viral lower respiratory tract infections in hospitalized children in Barcelona (Spain): A long‐term, clinical, epidemiologic and economic study

5. Clinical and economic hospital burden of acute respiratory infection (BARI) due to respiratory syncytial virus in Spanish children, 2015–2018