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AZ Pediatría
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Vol. 25 - Num. 99

Debate

Evidentia praxis: Nirsevimab and bronchiolitis prevention in term-born infants

Carlos Ochoa Sangradora, Javier González de Diosb, Josep Albert Balaguer Santamaríac, Eduardo Ortega Páezd, Begoña Pérez-Moneo Agapitoe, Manuel Molina Ariasf, Paz González Rodríguezg

aServicio de Pediatría. Complejo Asistencial de Zamora. Zamora. España.
bServicio de Pediatría. Hospital General Universitario de Alicante. Departamento de Pediatría. Universidad Miguel Hernández. ISABIAL-Instituto de Investigación Sanitaria y Biomédica. Alicante. España.
cServicio de Pediatría. Hospital Universitari General de Catalunya. Universitat Internacional de Catalunya. Barcelona. España.
dPediatra. UGC Góngora. Distrito Granada-Metropolitano. Granada. España.
eServicio de Pediatría. Hospital Universitario Infanta Leonor. Universidad Complutense de Madrid. Madrid. España.
fServicio de Gastroenterología. Hospital Infantil Universitario La Paz. Universidad Autónoma de Madrid. Madrid. España.
gPediatra. CS Barrio del Pilar. Madrid. España.

Correspondence: C Ochoa. E-mail: cochoas2@gmail.com

Reference of this article: Ochoa Sangrador C, González de Dios J, Balaguer Santamaría JA, Ortega Páez E, Pérez-Moneo Agapito B, Molina Arias M, et al. Evidentia praxis: Nirsevimab and bronchiolitis prevention in term-born infants . Rev Pediatr Aten Primaria. 2023;25:301-8. https://doi.org/10.60147/cdf039a1

Published in Internet: 26-07-2023 - Visits: 4843

Abstract

We reviewed the published evidence on the efficacy and safety of nirsevimab, a monoclonal antibody, used to prevent respiratory syncytial virus (RSV) associated lower respiratory tract infections (LRTI) in term infants. We have found a randomized double-blind placebo-controlled clinical trial that included 3012 infants, born at term or late preterm, less than one year of age with a follow-up of at least 150 days. The quality of the evidence was classified as low for very severe LRTI and moderate for LRTI requiring medical care or admission. The evidence is based on a small number of events (only 29 cases for hospital admissions, 78 for IVRB with medical care), so any estimate must be considered imprecise. Efficacy, estimated as relative risk reduction (RRR) was 76.4% (95% confidence interval [95 CI]: 62.3 to 85.2) for RSV associated LRTI that required medical care and 76.8% (CI 95: 49.4 to 89.4%) for hospital admission. No differences were found in terms of safety. There are doubts about the clinical importance, due to the severity criteria used, and about its impact, with a number needed to treat of 63 to avoid a LRTI with hospital admission and of 24 to avoid LRTI requiring medical care. Based on the available information, it seems a safe intervention, from which we do not expect common adverse effects, but we cannot rule out low-frequency effects. We also expect to have more precise estimates of efficacy and safety soon.

Keywords

Humanized monoclonal antibodies Newborn infant Nirsevimab Premature infant Respiratory syncytial virus

Note:

Este artículo se publica simultáneamente con la revista electrónica Evidencias en Pediatría (www.evidenciasenpediatria.es).

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