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

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...

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Autores: Agüera M, Soler-Garcia A, Alejandre C, Moussalam-Merino S, Sala-Castellví P, Pons G, Penela-Sánchez D, González-Grado C, Alsina-Rosell J, Climent C, Esteva C, Fortuny C, de-Sevilla MF, García-García JJ, Brotons P, Balaguer A, Estrada J, Jordan I, Muñoz-Almagro C, Launes C
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Fundació Sant Joan de Déu
Repositorio:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p26438
Acceso en línea:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=26438
Access Level:acceso abierto
Palabra clave:bronchiolitis
effectiveness
immunization
nirsevimab
pediatrics
severity
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spelling Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control studyAgüera MSoler-Garcia AAlejandre CMoussalam-Merino SSala-Castellví PPons GPenela-Sánchez DGonzález-Grado CAlsina-Rosell JCliment CEsteva CFortuny Cde-Sevilla MFGarcía-García JJBrotons PBalaguer AEstrada JJordan IMuñoz-Almagro CLaunes CbronchiolitiseffectivenessimmunizationnirsevimabpediatricsseverityBackground: 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.WILEY-BLACKWELL PUBLISHING, INC2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=26438PEDIATRIC ALLERGY AND IMMUNOLOGYISSN: 09056157ISSNe: 13993038reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déuinstname:Fundació Sant Joan de DéuInglésinfo:eu-repo/semantics/openAccessoai:fsjd.fundanetsuite.com:p264382026-05-27T12:37:41Z
dc.title.none.fl_str_mv Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
title Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
spellingShingle Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
Agüera M
bronchiolitis
effectiveness
immunization
nirsevimab
pediatrics
severity
title_short Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
title_full Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
title_fullStr Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
title_full_unstemmed Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
title_sort Nirsevimab immunization's real-world effectiveness in preventing severe bronchiolitis: A test-negative case-control study
dc.creator.none.fl_str_mv Agüera M
Soler-Garcia A
Alejandre C
Moussalam-Merino S
Sala-Castellví P
Pons G
Penela-Sánchez D
González-Grado C
Alsina-Rosell J
Climent C
Esteva C
Fortuny C
de-Sevilla MF
García-García JJ
Brotons P
Balaguer A
Estrada J
Jordan I
Muñoz-Almagro C
Launes C
author Agüera M
author_facet Agüera M
Soler-Garcia A
Alejandre C
Moussalam-Merino S
Sala-Castellví P
Pons G
Penela-Sánchez D
González-Grado C
Alsina-Rosell J
Climent C
Esteva C
Fortuny C
de-Sevilla MF
García-García JJ
Brotons P
Balaguer A
Estrada J
Jordan I
Muñoz-Almagro C
Launes C
author_role author
author2 Soler-Garcia A
Alejandre C
Moussalam-Merino S
Sala-Castellví P
Pons G
Penela-Sánchez D
González-Grado C
Alsina-Rosell J
Climent C
Esteva C
Fortuny C
de-Sevilla MF
García-García JJ
Brotons P
Balaguer A
Estrada J
Jordan I
Muñoz-Almagro C
Launes C
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv bronchiolitis
effectiveness
immunization
nirsevimab
pediatrics
severity
topic bronchiolitis
effectiveness
immunization
nirsevimab
pediatrics
severity
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=26438
url https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=26438
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY-BLACKWELL PUBLISHING, INC
publisher.none.fl_str_mv WILEY-BLACKWELL PUBLISHING, INC
dc.source.none.fl_str_mv PEDIATRIC ALLERGY AND IMMUNOLOGY
ISSN: 09056157
ISSNe: 13993038
reponame:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
instname:Fundació Sant Joan de Déu
instname_str Fundació Sant Joan de Déu
reponame_str r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
collection r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
repository.name.fl_str_mv
repository.mail.fl_str_mv
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