EFFECTIVENESS OF PALIVIZUMAB IN PREVENTING RSV HOSPITALIZATION IN HIGH-RISK CHILDREN: A PROSPECTIVE OBSERVATIONAL MULTICENTER STUDY

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Abstract

Background: Palivizumab is indicated for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.

Aims: The purpose of the study was to assess the real-world effectiveness and safety of palivizumab in children at high risk for serious RSV disease during the 2014−2015 RSV season in the Russian Federation.

Methods: A prospective, observational, multicentre, cohort study was conducted in a population of infants at high-risk for serious RSV illness: infants born ≤35 weeks of gestation and infants ≤24 months with bronchopulmonary dysplasia (BDP) or congenital heart disease (CHD), who were administered palivizumab immunoprophylaxis in routine clinical settings. The study was conducted at 16 investigational sites of European Russia and Western Siberia.

Results: A total of 359 infants were enrolled (180 boys and 179 girls). Of them, 148 (41.2%) infants had BDP, 45 (12.5%) infants had hemodynamically significant CHD, and 166 (46.2%) children of prematurity were at the risk of RSV. The majority of infants (86.9%) received three or more injections during the course of study. Of the 359 participants enrolled, 11 (3.1%; 95% CI 1.5−5.4) patients were hospitalized for lower respiratory tract infection. A RSV diagnostic test was performed in 9 infants, and RSV was detected in one patient giving an overall incidence of RSV hospitalization as 0.3% (95% CI 0.0−1.5).

Conclusions: This study showed that immunoprophylaxis with palivizumab was associated with a low rate of RSV hospitalization. Overall, therapy with palivizumab was well-tolerated and showed a favourable benefit-risk profile.

About the authors

A. I. Chubarova

Children’s’ City Clinical Hospital № 13 named after N.F. Filatov; Russian National Research Medical University named after N.I. Pirogov

Email: ach-12@yandex.ru

Moscow

Россия

I. V. Davydova

National Scientific and Practical Center of Children Health

Author for correspondence.
Email: davydova@nczd.ru
ORCID iD: 0000-0002-7780-6737

Moscow

Россия

I. V. Vinogradova

Presidential Perinatal Center

Email: vinir1@rambler.ru

Shchelkovo

Россия

E. A. Degtiareva

Russian National Research Medical University named after N.I. Pirogov; Pediatric Infectious Clinical Hospital № 6

Email: dib6@yandex.ru
ORCID iD: 0000-0003-4865-732X

Moscow

Россия

E. S. Keshishyan

Science Research Clinical Institute of Pediatrics named after U.E. Veltishev

Email: ekeshishian@list.ru
ORCID iD: 0000-0001-6268-7782

Moscow

Россия

A. I. Safina

Kazan State Medical Academy

Email: safina_asia@mail.ru
ORCID iD: 0000-0002-3261-1143

Доктор медицинских наук, профессор, заведующая кафедрой педиатрии и неонатологии.

420034, Казань, ул. Муштари, д. 11, тел.: +7 (843) 562-52-66

Россия

E. V. Nesterenko

City Clinical Perinatal Center

Email: nesterenkoelina@mail.ru

Omsk

Россия

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