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Nirsevimab and Hospitalization for RSV Bronchiolitis.
Assad, Zein; Romain, Anne-Sophie; Aupiais, Camille; Shum, Mickaël; Schrimpf, Cécile; Lorrot, Mathie; Corvol, Harriet; Prevost, Blandine; Ferrandiz, Charlène; Giolito, Anna; Valtuille, Zaba; Bendavid, Matthieu; Cohen, Jérémie F; Toubiana, Julie; de Pontual, Loïc; Delande, Camille F; Levy, Michael; See, Perrine; Cohen, Robert; Levy, Corinne; Angoulvant, François; Lenglart, Léa; Gits-Muselli, Maud; Biran, Valérie; Diallo, Kadiatou; Alemede, Oluwafunmilola; El Hebil, Mohamed M; Durrmeyer, Xavier; Labouret, Géraldine; Casanovas, Natacha; Hallak, Benjamin; Maréchal, Olympe; Jung, Camille; Bréhin, Camille; Ouldali, Naïm.
Afiliación
  • Assad Z; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Romain AS; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Aupiais C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Shum M; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Schrimpf C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Lorrot M; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Corvol H; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Prevost B; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Ferrandiz C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Giolito A; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Valtuille Z; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Bendavid M; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Cohen JF; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Toubiana J; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • de Pontual L; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Delande CF; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Levy M; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • See P; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Cohen R; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Levy C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Angoulvant F; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Lenglart L; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Gits-Muselli M; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Biran V; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Diallo K; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Alemede O; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • El Hebil MM; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Durrmeyer X; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Labouret G; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Casanovas N; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Hallak B; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Maréchal O; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Jung C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Bréhin C; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
  • Ouldali N; From the Department of General Pediatrics, Pediatric Infectious Disease, and Internal Medicine (Z.A., A.G., N.O.), Centre d'Investigations Cliniques, INSERM Unité 1426 (Z.V.), the Pediatric Intensive Care Unit (M. Levy, P.S.), the Pediatric Emergency Department (L.L.), the Department of Microbiology
N Engl J Med ; 391(2): 144-154, 2024 Jul 11.
Article en En | MEDLINE | ID: mdl-38986058
ABSTRACT

BACKGROUND:

Respiratory syncytial virus (RSV) is the leading cause of bronchiolitis, resulting in 3 million hospitalizations each year worldwide. Nirsevimab is a monoclonal antibody against RSV that has an extended half-life. Its postlicensure real-world effectiveness against RSV-associated bronchiolitis is unclear.

METHODS:

We conducted a prospective, multicenter, matched case-control study to analyze the effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis in infants younger than 12 months of age. Case patients were infants younger than 12 months of age who were hospitalized for RSV-associated bronchiolitis between October 15 and December 10, 2023. Control patients were infants with clinical visits to the same hospitals for conditions unrelated to RSV infection. Case patients were matched to control patients in a 21 ratio on the basis of age, date of hospital visit, and study center. We calculated the effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis (primary outcome) by means of a multivariate conditional logistic-regression model with adjustment for confounders. Several sensitivity analyses were performed.

RESULTS:

The study included 1035 infants, of whom 690 were case patients (median age, 3.1 months; interquartile range, 1.8 to 5.3) and 345 were matched control patients (median age, 3.4 months; interquartile range, 1.6 to 5.6). Overall, 60 case patients (8.7%) and 97 control patients (28.1%) had received nirsevimab previously. The estimated adjusted effectiveness of nirsevimab therapy against hospitalization for RSV-associated bronchiolitis was 83.0% (95% confidence interval [CI], 73.4 to 89.2). Sensitivity analyses gave results similar to those of the primary analysis. The effectiveness of nirsevimab therapy against RSV-associated bronchiolitis resulting in critical care was 69.6% (95% CI, 42.9 to 83.8) (27 of 193 case patients [14.0%] vs. 47 of 146 matched control patients [32.2%]) and against RSV-associated bronchiolitis resulting in ventilatory support was 67.2% (95% CI, 38.6 to 82.5) (27 of 189 case patients [14.3%] vs. 46 of 151 matched control patients [30.5%]).

CONCLUSIONS:

In a real-world setting, nirsevimab therapy was effective in reducing the risk of hospitalized RSV-associated bronchiolitis. (Funded by the National Agency for AIDS Research-Emerging Infectious Disease and others; ENVIE ClinicalTrials.gov number, NCT06030505.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Bronquiolitis Viral / Infecciones por Virus Sincitial Respiratorio / Anticuerpos Monoclonales Humanizados Límite: Female / Humans / Infant / Male / Newborn Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Bronquiolitis Viral / Infecciones por Virus Sincitial Respiratorio / Anticuerpos Monoclonales Humanizados Límite: Female / Humans / Infant / Male / Newborn Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos