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

Russian Federation

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

Russian Federation

I. V. Vinogradova

Presidential Perinatal Center

Email: vinir1@rambler.ru

Shchelkovo

Russian Federation

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

Russian Federation

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

Russian Federation

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

Russian Federation

E. V. Nesterenko

City Clinical Perinatal Center

Email: nesterenkoelina@mail.ru

Omsk

Russian Federation

References

  1. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543–546. doi: 10.1001/archpedi.1986.02140200053026.
  2. Hall CB. Respiratory syncytial virus and parainfluenza virus. New Engl J Med. 2001;344(25):1917–1928. doi: 10.1056/NEJM200106213442507.
  3. Yanney M, Vyas H. The treatment of bronchiolitis. Arch Dis Child. 2008;93(9):793–798. doi: 10.1136/adc.2007.128736.
  4. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289(2):179–186. doi: 10.1001/jama.289.2.179.
  5. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095–2128. doi: 10.1016/S0140-6736(12)61728-0.
  6. Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010;375(9725):1545–1555. doi: 10.1016/S0140-6736(10)60206-1.
  7. Tatochenko V, Uchaikin V, Gorelov A, et al. Epidemiology of respiratory syncytial virus in children ≤2 years of age hospitalized with lower respiratory tract infections in the Russian Federation: a prospective, multicenter study. Clin Epidemiol. 2010;2:221–227. doi: 10.2147/CLEP.S12279.
  8. Law BJ, Carbonell-Estrany X, Simoes EA. An update on respiratory syncytial virus epidemiology: a developed country perspective. Respir Med. 2002;96(Suppl B):S1–S7. doi: 10.1053/rmed.2002.1294.
  9. Simoes EA. Respiratory syncytial virus infection. Lancet. 1999;354(9181):847–852. doi: 10.1016/S0140-6736(99)80040-3.
  10. Figueras-Aloy J, Carbonell-Estrany X, Quero J; IRIS Study Group. Case-control study of the risk factors linked to respiratory syncytial virus infection requiring hospitalization in premature infants born at a gestational age of 33–35 weeks in Spain. Pediatr Infect Dis J. 2004;23(9):815–820. doi: 10.1097/01.inf.0000136869.21397.6b.
  11. Law BJ, Langley JM, Allen U, et al. The Pediatric Investigators Collaborative Network on Infections in Canada study of predictors of hospitalization for respiratory syncytial virus infection for infants born at 33 through 35 completed weeks of gestation. Pediatr Infect Dis J. 2004;23(9):806–814.
  12. Цыбалова Л.М., Смородинцева Е.А., Карпова Л.С., и др. Значение РС-вирусной инфекции в эпидемиологии и этиологии ОРВИ у детей младшего возраста // Лечащий врач. — 2015. — №4 — C. 56. [Cybalova LM, Smorodintseva EA, Karpova LS, et al. The role of RSV disease in the epidemiology and etiology of acute respiratory viral infections in young children. Practitioner. 2015;(4):56. (In Russ).]
  13. Kamal-Bahl S, Doshi J, Campbell J. Economic analyses of respiratory syncytial virus immunoprophylaxis in high-risk infants: a systematic review. Arch Pediatr Adolesc Med. 2002;156(10):1034–1041. doi: 10.1001/archpedi.156.10.1034.
  14. Johnson S, Oliver C, Prince GA, et al. Development of a humanized monoclonal antibody (MEDI-493) with potent in vitro and in vivo activity against respiratory syncytial virus. J Infect Dis. 1997;176(5):1215–1224. doi: 10.1086/514115.
  15. Checchia PA, Nalysnyk L, Fernandes AW, et al. Mortality and morbidity among infants at high risk for severe respiratory syncytial virus infection receiving prophylaxis with palivizumab: a systematic literature review and meta-analysis. Pediatr Crit Care Med. 2011;12(5):580–588. doi: 10.1097/PCC.0b013e3182070990.
  16. Wegzyn C, Toh LK, Notario G, et al. Safety and effectiveness of palivizumab in children at high risk of serious disease due to respiratory syncytial virus infection: a systematic review. Infect Dis Ther. 2014;3(2):133–158. doi: 10.1007/s40121-014-0046-6.
  17. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3 Pt 1):531–537. doi: 10.1542/peds.102.3.531.
  18. Feltes TF, Cabalka AK, Meissner HC, et al. Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease. J Pediatr. 2003;143(4):532–540. doi: 10.1067/S0022-3476(03)00454-2.
  19. Pedersen O, Herskind AM, Kamper J, et al. Rehospitalization for respiratory syncytial virus infection in infants with extremely low gestational age or birthweight in Denmark. Acta Paediatr. 2003;92(2):240–242. doi: 10.1111/j.1651-2227.2003.tb00533.x.
  20. Simon A, Ammann RA, Wilkesmann A, et al. Respiratory syncytial virus infection in 406 hospitalized premature infants: results from a prospective German multicentre database. Eur J Pediatr. 2007;166(12):1273–1283. doi: 10.1007/s00431-007-0426-y.
  21. Lacaze-Masmonteil T, Roze JC, Fauroux B. Incidence of respiratory syncytial virus-related hospitalizations in high-risk children: follow-up of a national cohort of infants treated with Palivizumab as RSV prophylaxis. Pediatr Pulmonol. 2002;34(3):181–188. doi: 10.1002/ppul.10175.
  22. Frogel M, Nerwen C, Cohen A, et al. Prevention of hospitalization due to respiratory syncytial virus: results from the Palivizumab Outcomes Registry. J Perinatol. 2008;28(7):511–517. doi: 10.1038/jp.2008.28.
  23. Oh PI, Lanctôt KL, Yoon A, et al. Palivizumab prophylaxis for respiratory syncytial virus in Canada: utilization and outcomes. Pediatr Infect Dis J. 2002;21(6):512–518. doi: 10.1097/00006454-200206000-00007.
  24. Mitchell I, Paes B, Li A, Lanctоt KL; CARESS investigators. CARESS: the Canadian registry of palivizumab. Pediatr Infect Dis J. 2011;30(8):651–655. doi: 10.1097/INF.0b013e31821146f7.
  25. Намазова-Баранова Л.С., Турти Т.В., Кешишян Е.С., и др. Безопасность и эффективность применения паливизумаба у детей с высоким риском тяжелой респираторно-синцитиальной вирусной инфекции в Российской Федерации // Фарматека. — 2016. — №1 — C. 43–50. [Namazova-Baranova LS, Turti TV, Keshishyan ES, et al. Safety and efficacy of use of palivizumab in children with high risk of severe respiratory syncytial viral infection in the Russian Federation. Farmateka. 2016;(1):43–50. (In Russ).]
  26. Krilov LR, Masaquel AS, Weiner LB, et al. Partial palivizumab prophylaxis and increased risk of hospitalization due to respiratory syncytial in a Medicaid population: a retrospective cohort analysis. BMC Pediatr. 2014;14:261. doi: 10.1186/1471-2431-14-261.
  27. Stewart DL, Ryan KJ, Seare JG, et al. Association of RSV-related hospitalization and non-compliance with palivizumab among commercially insured infants: a retrospective claim analysis. BMC Infect Dis. 2013;13:334. doi: 10.1186/1471-2334-13-334.

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