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
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