Effectiveness of nirsevimab against hospitalisation for RSV-bronchiolitis during high RSV-B circulation in the second year of nationwide implementation in France: a test-negative case-control study

Apolline Furgier; Camille Brehin; Corinne Levy; Romain Basmaci; Elise Launay; Camille Jung; Zein Assad; Léa Lenglart; Jérome Naudin; Anne-Lise Mary; Camille Aupiais; Loïc de Pontual; Valérie Biran; Béatrice Boutillier; Isabelle Hau; Mickael Shum; Sandra Biscardi; Céline Delestrain; Julie Toubiana; Jérémie F. Cohen; Amélie Lambert-Hoffert; Mathie Lorrot; Anne-Sophie Romain; Marion Ashman; Jee-Seon Yang; Blandine Prevost; Harriet Corvol; Clément Basse; François Dubos; Marie Cotillon; Constance Bridonneau; Lise-Martin Perceval; Etienne Bizot; Inès Fafi; Aurélie Portefaix; Léa Domitien; Carine Jaillet; Antoine Ouziel; Luigi Titomanlio; Stephane Bechet; Vincent Gajdos; Christèle Gras-Le Guen; Yves Gillet; Robert Cohen; Eric Jeziorski; Naim Ouldali; Lola Alemende; François Angoulvant; Marta Bendavides; Aurélie Bourmaud; Stéphane Bonacorsi; Natacha Casanovas; Stéphane Dauger; Camille Delande; Claire Delcourt; Kadiatou Diallo; Anne Drouard; Xavier Durrmeyer; Benjamin Hallak; Mohamed M. El Hebil; Charlène Ferrandiz; Anna Giolito; Maud Gits; Géraldine Labouret; Olympe Marechal; Elodie Miha Nantenaina; Cecile Schrimpf; Perrine See; Zaba Valtuille; Sebastien Walser; French Paediatric OVNI Network

doi:10.1016/j.lanepe.2025.101443

Retour

Effectiveness of nirsevimab against hospitalisation for RSV-bronchiolitis during high RSV-B circulation in the second year of nationwide implementation in France: a test-negative case-control study

Article de revue

Avec comité de lecture

Effectiveness of nirsevimab against hospitalisation for RSV-bronchiolitis during high RSV-B circulation in the second year of nationwide implementation in France: a test-negative case-control study

Apolline Furgier, Camille Brehin, Corinne Levy, Romain Basmaci, Elise Launay, Camille Jung, Zein Assad, Léa Lenglart, Jérome Naudin, Anne-Lise Mary, …

The Lancet regional health. Europe, Vol.58, pp.101443-101443

01/11/2025

DOI: https://doi.org/10.1016/j.lanepe.2025.101443

PMID: 41220615

Résumé

Effectiveness

Nirsevimab

Paediatrics

RSV-bronchiolitis

Test-negative study

Nirsevimab was first introduced in September 2023, showing strong real-world effectiveness in preventing hospitalised RSV-bronchiolitis. RSV-A circulation predominated during 2023–2024, whereas RSV-B was frequent in 2024–2025. Recent reports indicated resistance to nirsevimab in RSV-B strains in France. We aimed to assess the effectiveness of large-scale nirsevimab implementation against hospitalised RSV-bronchiolitis during high RSV-B circulation. A test-negative case-control study was conducted using a national hospital-based surveillance system. All children <12 months hospitalised for bronchiolitis and tested for RSV in 12 French hospitals from October 10, 2024 to March 15, 2025, were included. Cases were RSV-positive bronchiolitis; controls were RSV-negative bronchiolitis. Effectiveness was assessed by a multivariable logistic regression model adjusted for confounders (sex, gestational age at birth, birth weight, risk factors for severe bronchiolitis, month of diagnosis, and medical centre). A range of sensitivity analyses was conducted. 1270 patients were included; among which 830 (65.3%) were RSV-positive and 440 (34.7%) were RSV-negative bronchiolitis. The male-to-female sex ratio was 1.35, and the median age was 3 months (IQR: 1.5–5.6). Among cases, 182 (22.0%) received nirsevimab, compared to 282 (64.1%) for controls. Adjusted effectiveness against RSV-bronchiolitis was 84.9% (95% CI, 80.0–88.6). Subgroup analyses by age and severity (intensive care unit admission, respiratory support) showed consistent results, along with sensitivity analyses. Despite high RSV-B circulation, which has recently been identified to carry mutations potentially inducing resistance to nirsevimab, the effectiveness of the second national nirsevimab campaign against hospitalisation for RSV-bronchiolitis remained high. The study received financial support from Sanofi, AstraZeneca, and the 2023 ATIP-Avenir grant from the National Institute of Health and Medical Research (Inserm).

Indicateurs

1 Consultations de la notice

Détails

Titre: Effectiveness of nirsevimab against hospitalisation for RSV-bronchiolitis during high RSV-B circulation in the second year of nationwide implementation in France: a test-negative case-control study
Créateurs - sans rôle: Apolline Furgier - University of Paris Cite, Paris, France
Camille Brehin - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Corinne Levy - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Romain Basmaci - Infection, Antimicrobials, Modelling, Evolution (IAME), INSERM UMR 1137, Paris Cité University, 75018, Paris, France
Elise Launay - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Camille Jung - Délégation de Recherche en Santé et Innovation University Paris Est Créteil, Créteil, France
Zein Assad - AP–HP, Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine, Robert Debre Hospital, Paris, France
Léa Lenglart - Infection, Antimicrobials, Modelling, Evolution (IAME), INSERM UMR 1137, Paris Cité University, 75018, Paris, France
Jérome Naudin - Paediatric Intensive Care Unit, Robert-Debré University Hospital, AP-HP, Paris, France
Anne-Lise Mary - Paediatric Intensive Care Unit, Robert-Debré University Hospital, AP-HP, Paris, France
Camille Aupiais - Sorbonne Paris Nord University, Assistance Publique-Hôpitaux de Paris, Paediatric Emergency Department and Department of General Paediatrics, Jean Verdier University Hospital, Bondy, France
Loïc de Pontual - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Valérie Biran - Assistance Publique – Hôpitaux de Paris
Béatrice Boutillier - Neonatal Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, Robert Debre Hospital, Paris, France
Isabelle Hau - General Pediatrics Department, Centre Hospitalier Intercommunal de Créteil, Créteil, France
Mickael Shum - General Pediatrics Department, Centre Hospitalier Intercommunal de Créteil, Créteil, France
Sandra Biscardi - Hôpital Intercommunal de Créteil
Céline Delestrain - General Pediatrics Department, Centre Hospitalier Intercommunal de Créteil, Créteil, France
Julie Toubiana - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Jérémie F. Cohen - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Amélie Lambert-Hoffert - Necker Hospital for Sick Children, General Pediatrics and Pediatric Infectious Diseases, University of Paris Cité, Paris, France
Mathie Lorrot - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Anne-Sophie Romain - Department of General Pediatrics, Hôpital Armand-Trousseau, APHP, Université Paris Sorbonne, Paris, France
Marion Ashman - Department of General Pediatrics, Hôpital Armand-Trousseau, APHP, Université Paris Sorbonne, Paris, France
Jee-Seon Yang - Department of General Pediatrics, Hôpital Armand-Trousseau, APHP, Université Paris Sorbonne, Paris, France
Blandine Prevost - Department of General Pediatrics, Hôpital Armand-Trousseau, APHP, Université Paris Sorbonne, Paris, France
Harriet Corvol - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Clément Basse - Paediatric Emergency Unit and Infectious Diseases, Centre Hospitalier Universitaire Lille, Université de Lille, Lille, France
François Dubos - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Marie Cotillon - Paediatric Emergency Department and General Pediatrics Department, Louis Mourier University Hospital, Assistance Publique-Hôpitaux de Paris, Paris Cité Université, Colombes, France
Constance Bridonneau - Paediatric Emergency Department and General Pediatrics Department Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 5, Nantes, 44000, France
Lise-Martin Perceval - Paediatric Emergency Department and General Pediatrics Department Nantes Université, CHU Nantes, Pôle Hospitalo-Universitaire 5, Nantes, 44000, France
Etienne Bizot - Paediatric Emergency Department and Department of General Paediatrics, Antoine-Béclère Hospital-Assistance Publique-Hôpitaux de Paris, Paris Saclay University, Clamart, France
Inès Fafi - Infection, Antimicrobials, Modelling, Evolution (IAME), INSERM UMR 1137, Paris Cité University, 75018, Paris, France
Aurélie Portefaix - Department of General Pediatrics, Infectiology, and Clinical Immunology, Department of Emergency, Post-Emergency Department, University Hospital of Montpellier, Montpellier, France
Léa Domitien - Department of General Pediatrics, Infectiology, and Clinical Immunology, Department of Emergency, Post-Emergency Department, University Hospital of Montpellier, Montpellier, France
Carine Jaillet - Department of General Pediatrics, Infectiology, and Clinical Immunology, Department of Emergency, Post-Emergency Department, University Hospital of Montpellier, Montpellier, France
Antoine Ouziel - Department of General Pediatrics, Infectiology, and Clinical Immunology, Department of Emergency, Post-Emergency Department, University Hospital of Montpellier, Montpellier, France
Luigi Titomanlio - Paediatric Emergency Department, Robert Debré University Hospital, Assistance Publique-Hôpitaux de Paris, Paris Cité University, Paris, France
Stephane Bechet - Association Clinique et Therapeutique Infantile du Val-de-Marne France (ACTIV), France
Vincent Gajdos - Assistance Publique – Hôpitaux de Paris
Christèle Gras-Le Guen - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Yves Gillet - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Robert Cohen - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Eric Jeziorski - French Paediatric Infectious Disease Group (GPIP), Nice, 06200, France
Naim Ouldali - University of Paris Cite, Paris, France
Lola Alemende
François Angoulvant
Marta Bendavides
Aurélie Bourmaud
Stéphane Bonacorsi
Natacha Casanovas
Stéphane Dauger
Camille Delande
Claire Delcourt
Kadiatou Diallo
Anne Drouard
Xavier Durrmeyer
Benjamin Hallak
Mohamed M. El Hebil
Charlène Ferrandiz
Anna Giolito
Maud Gits
Géraldine Labouret
Olympe Marechal
Elodie Miha Nantenaina
Cecile Schrimpf
Perrine See
Zaba Valtuille
Sebastien Walser
French Paediatric OVNI Network
Détails de publication: The Lancet regional health. Europe, Vol.58, pp.101443-101443
Éditeur: Elsevier Ltd
Note de subvention: National Institute of Health and Medical Research (Inserm) (https://doi.org/10.13039/501100001677) Sanofi (https://doi.org/10.13039/100031283) AstraZeneca (https://doi.org/10.13039/501100014088)
Identifiants: 99148748809311
Unité académique: Pathogenesis and Control of Chronic and Emerging Infections - PCCEI
Langue: English
Type de ressource: Journal article