SAFETY AND EFFICACY OF USE OF PALIVIZUMAB IN CHILDREN WITH HIGH RISK OF SEVERE RESPIRATORY SYNCYTIAL VIRAL INFECTION IN THE RUSSIAN FEDERATION


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Purpose: Palivizumab, a humanized, respiratory syncytial virus (RSV)-specific monoclonal antibody, is safe and effective in reducing RSV-associated hospitalizations of infants and children at high risk for RSV disease. The purpose of this study was to assess the safety and efficacy of palivizumab in subjects in the Russian Federation who participated in three studies. Patients and Methods: Infants and children with risk factors for serious RSV disease (prematurity [gestational age <35 weeks], bronchopulmonary dysplasia, congenital heart disease) were administered up to 5 monthly doses ( 15 mg/kg) of palivizumab during the RSV season. RSV-associated hospitalizations and adverse events (AEs) among Russian participants in the 3 studies were pooled and assessed. Results: Of the subjects in the combined trials (n=176), there were 7 discontinuations (4.0%). Most subjects (78.4%) received 5 doses of palivizumab. No RSV-associated hospitalizations occurred. Ninety-three subjects (52.8%) experienced an AE. Most AEs were mild or moderate in severity. AEs considered at least possibly related to study drug occurred in five subjects (2.8%). Serious AEs occurred in 29 subjects (16.5%). One subject died due to an AE not considered related to study drug. Conclusion: The safety and efficacy of palivizumab in children in the Russian Federation at high risk for severe RSV disease appear similar to that demonstrated in other studies conducted with palivizumab elsewhere.

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Sobre autores

L. Namazova-Baranova

FSBI «Scientific Center of Children's Health» of RMPH

T. Turti

FSBI «Scientific Center of Children's Health» of RMPH

E. Keshishyan

Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery of Rosmedtechnology

I. Davydova

FSBI «Scientific Center of Children's Health» of RMPH

A. Galustyan

Saint Petersburg State Pediatric Medical University

Brian Harris

MedImmune

E. Demskaya

LLC «AbbVie «

Email: elena.demskaya@abbvie.com
MD

Gerard Notario

AbbVie Inc

Greg Schulz

AbbVie Inc

Natalia Kan-Dobrosky

AbbVie GmbH & Co. KG

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