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


Por: Agüera M, Soler-García a, Alejandre-Galobardes C, Moussalam-Merino S, Sala-Castellví P, Pons G, Penela-Sánchez D, González-Grado C, Alsina-Rosell J, Climent C, Esteva-Afonso C, Fortuny-Guasch C, Fernández de Sevilla-Estrach M, García-García JJ, Brotons-de los Reyes P, Balaguer A, Estrada J, Jordán-García I, Munoz-Almagro C and Launes-Montana C

Publicada: 20 jun 2024
Resumen:
Background: Several 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. Methods: In 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. Results: Two 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. Conclusions: This 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.

Filiaciones:
:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

Soler-García a:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

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

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

Alejandre-Galobardes C:
 Department of Medicine, School of Medicine, Universitat Internacional de Catalunya, Barcelona, Spain

Moussalam-Merino S:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

Sala-Castellví P:
 Department of Medicine, School of Medicine, Universitat Internacional de Catalunya, Barcelona, Spain

 Pediatrics Department, Hospital General de Catalunya, Barcelona, Spain

:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

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

González-Grado C:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

 Pediatrics and Neonatology Department, Hospital Nostra Senyora de Meritxell, Escaldes-Engordany, Andorra

Alsina-Rosell J:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

Climent C:
 Department of Medicine, School of Medicine, Universitat Internacional de Catalunya, Barcelona, Spain

 Pediatrics Department, Hospital General de Catalunya, Barcelona, Spain

Esteva-Afonso C:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

Fortuny-Guasch C:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

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

Fernández de Sevilla-Estrach M:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

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

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

García-García JJ:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

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

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

Brotons-de los Reyes P:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

Balaguer A:
 Department of Medicine, School of Medicine, Universitat Internacional de Catalunya, Barcelona, Spain

Estrada J:
 Pediatrics and Neonatology Department, Hospital Nostra Senyora de Meritxell, Escaldes-Engordany, Andorra

Jordán-García I:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

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

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

Munoz-Almagro C:
 Pediatric Infectious Diseases and Microbiome Research Group, Institut de Recerca Sant Joan de Déu, Spain

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain

 RDI Microbiology Department, Hospital Sant Joan de Deu, Barcelona, Spain

Launes-Montana C:
 Pediatrics Department, Hospital Sant Joan de Deu, Barcelona, Spain

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

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

 CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain
ISSN: 09056157





PEDIATRIC ALLERGY AND IMMUNOLOGY
Editorial
WILEY, 111 RIVER ST, HOBOKEN 07030-5774, NJ, Dinamarca
Tipo de documento: Article
Volumen: 35 Número: 6
Páginas:
WOS Id: 001251047900001
ID de PubMed: 38899631
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