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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)

17 Pages Posted: 7 Mar 2024

See all articles by Ermengol Coma

Ermengol Coma

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP)

Montse Martinez-Marcos

Generalitat de Catalunya - Department of Health

Eduardo Hermosilla

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP)

Jacobo Mendioroz Peña

Generalitat de Catalunya

Anna Reñé

Institut Català de la Salut

Francesc Fina-Aviles

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP)

Aida Perramon

Universitat Politècnica de Catalunya (UPC Barcelona Tech) - Department of Physics

Clara Prats

Polytechnic University of Catalonia (UPC) - Computational Biology and Complex Systems (BIOCOM-SC)

Gloria Cereza

Generalitat de Catalunya

Pilar Ciruela

Generalitat de Catalunya

Valentí Pineda

Autonomous University of Barcelona - Hospital Universitari Parc Taulí

Andrés Antón

Hospital Vall d’Hebron

Gemma Ricós-Furió

Institut Català de la Salut

Antoni Soriano-Arandes

Autonomous University of Barcelona - Paediatric Infectious Diseases and Immunodeficiencies Unit

Carmen Cabezas

Generalitat de Catalunya - Department of Health

More...

Abstract

Background: Respiratory syncytial virus (RSV) is a major cause of bronchiolitis and hospitalisations in children under two years. In Catalonia, infants under six months old were eligible to receive nirsevimab, a novel monoclonal antibody against RSV. Our aim here is to analyse nirsevimab's effectiveness across primary- and hospital care outcomes.

Methods: Retrospective cohort study from October 1, 2023, to January 31, 2024, including all infants born between April and September 2023, were eligible for nirsevimab immunisation. 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 - or the end of the study. We used the Kaplan-Meier estimator and fitted Cox regression models using a calendar time-scale to estimate hazard ratios (HR) and their 95% confidence intervals, adjusting by confounders. Effectiveness of nirsevimab was calculated as (1-HR)*100.

Findings: Among 26,525 infants, a dose of nirsevimab led to an adjusted HR for hospital admission due to RSV bronchiolitis of 0·124 (0·086 to 0·179) and an adjusted HR for ICU admission of 0·099 (0·041 to 0·237). Additionally, the adjusted HR observed for emergency visits was 0·446 (95% CI: 0·385 to 0·516), 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. Sensitivity and negative control outcome analyses supported these findings.

Interpretation: Our analysis demonstrated nirsevimab's effectiveness, with reductions of 87·6% and 90·1% in hospital and ICU admissions for bronchiolitis due to RSV, respectively. Moreover, we observed substantial decreases in less severe outcomes, including primary care attended bronchiolitis (48·1%), RSV infections (68·9%), viral pneumonia (60·7%), and hospital emergency visits for bronchiolitis (55·4%). These findings offer crucial guidance for public health authorities in implementing RSV immunisation campaigns for infants under six months old.

Funding: None.

Declaration of Interest: ASA has received an honorarium for attending scientific meetings from Sanofi, MSD and Pfizer. VP has received an honorarium for attending scientific meetings from Sanofi andf Pfizer. AA has received sponsorship from Sanofi to attend scientific meetings.

Ethical Approval: The study was approved by the Clinical Research Ethics Committee of the IDIAP Jordi Gol with reference number 24/015-EOm.

Keywords: Respiratory syncytial virus, infants, nirsevimab, immunisation, public health

Suggested Citation

Coma, Ermengol and Martinez-Marcos, Montse and Hermosilla, Eduardo and Mendioroz Peña, Jacobo and Reñé, Anna and Fina-Aviles, Francesc and Perramon, Aida and Prats, Clara and Cereza, Gloria and Ciruela, Pilar and Pineda, Valentí and Antón, Andrés and Ricós-Furió, Gemma and Soriano-Arandes, Antoni and Cabezas, Carmen, 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). Available at SSRN: https://ssrn.com/abstract=4749763 or http://dx.doi.org/10.2139/ssrn.4749763

Ermengol Coma

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP) ( email )

Barcelona
Spain

Montse Martinez-Marcos (Contact Author)

Generalitat de Catalunya - Department of Health ( email )

Barcelona
Spain

Eduardo Hermosilla

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP) ( email )

Barcelona
Spain

Jacobo Mendioroz Peña

Generalitat de Catalunya ( email )

Anna Reñé

Institut Català de la Salut ( email )

Girona
Spain

Francesc Fina-Aviles

Institut Català de la Salut - Sistemes d’Informació dels Serveis d’Atenció Primària (SISAP) ( email )

Barcelona
Spain

Aida Perramon

Universitat Politècnica de Catalunya (UPC Barcelona Tech) - Department of Physics ( email )

Clara Prats

Polytechnic University of Catalonia (UPC) - Computational Biology and Complex Systems (BIOCOM-SC) ( email )

Castelldefels
Spain

Gloria Cereza

Generalitat de Catalunya ( email )

Pilar Ciruela

Generalitat de Catalunya ( email )

Valentí Pineda

Autonomous University of Barcelona - Hospital Universitari Parc Taulí ( email )

Andrés Antón

Hospital Vall d’Hebron ( email )

Gemma Ricós-Furió

Institut Català de la Salut ( email )

Girona
Spain

Antoni Soriano-Arandes

Autonomous University of Barcelona - Paediatric Infectious Diseases and Immunodeficiencies Unit ( email )

Barcelona
Spain
+34639712438 (Phone)

Carmen Cabezas

Generalitat de Catalunya - Department of Health ( email )

Barcelona
Spain

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