Effectiveness of nirsevimab against RSV-bronchiolitis in paediatric ambulatory care: a test-negative case-control study.
Bronchiolitis
Nirsevimab
Outpatient
Paediatric ambulatory care
RSV
Journal
The Lancet regional health. Europe
ISSN: 2666-7762
Titre abrégé: Lancet Reg Health Eur
Pays: England
ID NLM: 101777707
Informations de publication
Date de publication:
Sep 2024
Sep 2024
Historique:
received:
24
04
2024
revised:
02
07
2024
accepted:
08
07
2024
medline:
14
8
2024
pubmed:
14
8
2024
entrez:
14
8
2024
Statut:
epublish
Résumé
Respiratory syncytial virus (RSV) is the leading cause of lower-respiratory-tract infection in children. Nirsevimab, a monoclonal antibody against RSV, was implemented in a few countries in September 2023. However, its post-license effectiveness in ambulatory care settings is unknown. We aimed to assess the effectiveness of nirsevimab against RSV-bronchiolitis in outpatients aged <12 months. We conducted a test-negative case-control study based on a national ambulatory surveillance system. We included all infants aged <12 months who had bronchiolitis and results of an RSV rapid antigen test performed, visiting a network of 107 ambulatory paediatricians from September 15, 2023, to February 1, 2024. Case patients were infants with bronchiolitis and a rapid antigen test positive for RSV. Control patients were infants with bronchiolitis and a rapid antigen test negative for RSV. Effectiveness was assessed by a logistic regression model adjusted for potential confounders. A range of sensitivity analyses were conducted to assess the robustness of the findings. We included 883 outpatients who had bronchiolitis and results of an RSV rapid antigen test (453 were case patients, and 430 were control patients). Overall, 62/453 (13.7%) case patients and 177/430 (41.2%) control patients had been previously immunised for nirsevimab. The adjusted effectiveness of nirsevimab against RSV-bronchiolitis was 79.7% (95% CI 67.7-87.3). Sensitivity analyses gave similar results. This post-license study indicates that nirsevimab was effective in preventing RSV-bronchiolitis in ambulatory care settings. The study was supported by Association Clinique et Thérapeutique Infantile du Val de Marne (ACTIV), French Pediatrician Ambulatory Association (AFPA) and unrestricted grants from GSK, MSD, Pfizer and Sanofi.
Sections du résumé
Background
UNASSIGNED
Respiratory syncytial virus (RSV) is the leading cause of lower-respiratory-tract infection in children. Nirsevimab, a monoclonal antibody against RSV, was implemented in a few countries in September 2023. However, its post-license effectiveness in ambulatory care settings is unknown. We aimed to assess the effectiveness of nirsevimab against RSV-bronchiolitis in outpatients aged <12 months.
Methods
UNASSIGNED
We conducted a test-negative case-control study based on a national ambulatory surveillance system. We included all infants aged <12 months who had bronchiolitis and results of an RSV rapid antigen test performed, visiting a network of 107 ambulatory paediatricians from September 15, 2023, to February 1, 2024. Case patients were infants with bronchiolitis and a rapid antigen test positive for RSV. Control patients were infants with bronchiolitis and a rapid antigen test negative for RSV. Effectiveness was assessed by a logistic regression model adjusted for potential confounders. A range of sensitivity analyses were conducted to assess the robustness of the findings.
Findings
UNASSIGNED
We included 883 outpatients who had bronchiolitis and results of an RSV rapid antigen test (453 were case patients, and 430 were control patients). Overall, 62/453 (13.7%) case patients and 177/430 (41.2%) control patients had been previously immunised for nirsevimab. The adjusted effectiveness of nirsevimab against RSV-bronchiolitis was 79.7% (95% CI 67.7-87.3). Sensitivity analyses gave similar results.
Interpretation
UNASSIGNED
This post-license study indicates that nirsevimab was effective in preventing RSV-bronchiolitis in ambulatory care settings.
Funding
UNASSIGNED
The study was supported by Association Clinique et Thérapeutique Infantile du Val de Marne (ACTIV), French Pediatrician Ambulatory Association (AFPA) and unrestricted grants from GSK, MSD, Pfizer and Sanofi.
Identifiants
pubmed: 39139197
doi: 10.1016/j.lanepe.2024.101007
pii: S2666-7762(24)00174-1
pmc: PMC11321316
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101007Informations de copyright
© 2024 The Authors.
Déclaration de conflit d'intérêts
YL has no conflicts of interest to disclose. RB declares receiving fees from Sanofi and MSD for medical conferences or scientific meetings. CL declares receiving travel grants from MSD, Pfizer and fees from MSD and Pfizer for scientific meetings and expert board participation. AW declares receiving fees from Sanofi, GSK and MSD for medical conferences or scientific meetings. FCS declares receiving fees from Sanofi for expert board participation. CB declares receiving fees from Sanofi, GSK and MSD for medical conferences or scientific meetings. RC reports personal fees and non-financial support from Pfizer and personal fees from GSK, Merck, Pfizer, Sanofi, Viatris outside the submitted work. NO declares receiving travel grants from MSD, Pfizer, Sanofi, and GSK.