Nirsevimab Prophylaxis for Reduction of Respiratory Syncytial Virus Complications in Hospitalised Infants: The Multi-Centre Study During the 2023-2024 Season in Andalusia, Spain (NIRSEGRAND)

Background: Nirsevimab was indicated in a population level for all infants < 6 months during the 2023-2024 season in Andalusia (southern Spain). Our aim was to analyse the effect of nirsevimab in the reduction in complications in infants hospitalised for RSV bronchiolitis.

Methods: A retrospective observational cohort study was conducted in nine relevant hospitals from all provinces of Andalusia, a region with over 9 million inhabitants. The study sample included 222 children, divided into two groups: infants administered with nirsevimab for passive immunisation (exposure) and infants not administered with nirsevimab. Clinical outcomes were analysed, including the use of respiratory support, the need for admission to paediatric intensive care unit (PICU), and duration of hospitalisation. Bivariate analyses were performed, and multivariable logistic regression models were designed to calculate adjusted odds ratios (ORa), and Cox regression models to calculate adjusted hazard ratios (HRa).

Results: Bivariate analysis showed an association between passive immunisation with nirsevimab and a lower frequency of numerous outcomes. After adjustment for relevant covariates, multivariable models showed that the exposure (nirsevimab) reduced nasal cannula use by 64% (13-85%), invasive or non-invasive mechanical ventilation by 48% (1-73%), PICU admission by 54% (14-75%), length of hospitalisation by 30% (8-47%), and length of nasal cannula by 31% (7-49%). A higher risk of co-infection was observed in those immunised (aOR = 3.42, 95%CI: 1.52-7.68).

Conclusions: Passive immunisation with nirsevimab may decrease the severity of RSV bronchiolitis in infants requiring hospitalisation, thus contributing tertiary prevention that extends beyond the prevention of RSV infection.

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