Effectiveness of nirsevimab immunoprophylaxis against respiratory syncytial virus-related outcomes in hospital and primary care settings: a retrospective cohort study in infants in Catalonia (Spain)

Arch Dis Child. 2024 Aug 16;109(9):736-741. doi: 10.1136/archdischild-2024-327153.

Abstract

Background: In Catalonia, infants under 6 months old were eligible to receive nirsevimab, a novel monoclonal antibody against respiratory syncytial virus (RSV). We aimed to analyse nirsevimab's effectiveness across primary and hospital care outcomes.

Methods: Retrospective cohort study from 1 October 2023 to 31 January 2024, including all infants born between April and September 2023. We established two cohorts based on nirsevimab administration (immunised and non-immunised). We followed individuals until the earliest moment of an outcome-RSV infection, primary care attended bronchiolitis and pneumonia, hospital emergency visits due to bronchiolitis, hospital admission or intensive care unit (ICU) admission due to RSV bronchiolitis-death or the end of the study. We used the Kaplan-Meier estimator and fitted Cox regression models using a calendar time scale to estimate HRs and their 95% CIs.

Results: Among 26 525 infants, a dose of nirsevimab led to an adjusted HR for hospital admission due to RSV bronchiolitis of 0.124 (95% CI: 0.086 to 0.179) and an adjusted HR for ICU admission of 0.099 (95% CI: 0.041 to 0.237). Additionally, the adjusted HRs observed for emergency visits were 0.446 (95% CI: 0.385 to 0.516) and 0.393 (95% CI: 0.203 to 0.758) for viral pneumonia, 0.519 (95% CI: 0.467 to 0.576) for bronchiolitis attended in primary care and 0.311 (95% CI: 0.200 to 0.483) for RSV infection.

Conclusion: We demonstrated nirsevimab's effectiveness with reductions of 87.6% and 90.1% in hospital and ICU admissions, respectively. These findings offer crucial guidance for public health authorities in implementing RSV immunisation campaigns.

Keywords: Child Health; Immunisation; Infectious Disease Medicine; Respiratory Medicine.

MeSH terms

  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use
  • Bronchiolitis / drug therapy
  • Bronchiolitis / prevention & control
  • Bronchiolitis / virology
  • Female
  • Hospitalization* / statistics & numerical data
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Primary Health Care*
  • Respiratory Syncytial Virus Infections* / prevention & control
  • Retrospective Studies
  • Spain / epidemiology
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents