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Three monthly doses of palivizumab are not adequate for 5-month protection: a population pharmacokinetic analysis.

Abstract
Recent guidelines in British Columbia, Canada have suggested that the use of a maximum of 3 monthly doses of palivizumab 15 mg/kg intramuscularly for RSV immunoprophylaxis of high risk infants born prior to the RSV season is adequate to provide protection against severe RSV disease for a 5-month RSV season. Efficacy was established, however, with 2 large, randomized controlled clinical studies using 5 monthly doses of immunoprophylaxis. To evaluate the differences in expected palivizumab exposures between the 2 dosing regimens (3 vs 5 monthly doses across a 5-month period), we used a population pharmacokinetic (PK) model that was developed using palivizumab PK data collected from 22 clinical studies with a total of 1800 subjects. This model adequately described observed palivizumab concentrations from the different pediatric studies and was subsequently used to simulate expected palivizumab serum concentrations for 3 monthly doses compared with 5 monthly doses in children younger than 24 months with chronic lung disease of prematurity and infants younger than 6 months postnatal age who were born at ≤ 35 weeks gestational age. Results from the population PK model indicated lower serum concentrations of palivizumab during the fourth and fifth months, after an abbreviated 3-monthly-dose regimen when compared with the mean trough concentrations seen with the 5-monthly-dose regimen studied in the pivotal clinical trials in premature infants. Specifically, during the fourth and fifth months, 52% and 85%, respectively, would have levels below the lowest concentration (fifth percentile) in those receiving the 5-monthly-dose regimen. Simulations using this model did not support a 3-monthly-dose regimen to protect against severe RSV disease during the typical 5-month season.
AuthorsWilliam V La Via, Gerard F Notario, Xiang-Qing Yu, Shringi Sharma, Peter A Noertersheuser, Gabriel J Robbie
JournalPulmonary pharmacology & therapeutics (Pulm Pharmacol Ther) Vol. 26 Issue 6 Pg. 666-71 (Dec 2013) ISSN: 1522-9629 [Electronic] England
PMID23523663 (Publication Type: Journal Article)
CopyrightCopyright © 2013 Elsevier Ltd. All rights reserved.
Chemical References
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Palivizumab
Topics
  • Age Factors
  • Antibodies, Monoclonal, Humanized (administration & dosage, pharmacokinetics)
  • Antiviral Agents (administration & dosage, pharmacokinetics)
  • British Columbia
  • Clinical Trials as Topic
  • Drug Administration Schedule
  • Humans
  • Infant
  • Injections, Intramuscular
  • Models, Biological
  • Palivizumab
  • Practice Guidelines as Topic
  • Respiratory Syncytial Virus Infections (prevention & control)
  • Risk Factors
  • Time Factors

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