Palivizumab use in Japanese infants and children with immunocompromised conditions

Masaaki Mori1, Masafumi Onodera, Akira Morimoto

  • 1From the *Department of Pediatrics, Yokohama City University Medical Center, Yokohama; †Department of Human Genetics, National Center for Child Health and Development, Tokyo; ‡Department of Pediatrics, Jichi Medical University School of Medicine, Shimotsuke; §Department of Hematology and Oncology, Hyogo Prefectural Kobe Children's Hospital, Kobe; ¶Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences, Tokyo; ‖Virology; **Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL; and ††Department of Pediatrics, Toho University Medical Center Omori Hospital, Tokyo, Japan.

Insights

Palivizumab effectively prevented respiratory syncytial virus hospitalizations in immunocompromised Japanese children. High palivizumab doses were well-tolerated, with no drug-related serious adverse events observed.

Area of Science:

  • Pediatrics
  • Immunology
  • Infectious Diseases

Background:

  • Respiratory syncytial virus (RSV) poses a significant threat to immunocompromised children.
  • Palivizumab is an antibody used for RSV prophylaxis.

Purpose of the Study:

  • To evaluate the efficacy and safety of palivizumab in immunocompromised Japanese children.
  • To assess palivizumab trough concentrations in this population.

Main Methods:

  • A cohort of 28 immunocompromised Japanese children received palivizumab.
  • RSV-associated hospitalizations and adverse events were monitored.
  • Palivizumab trough concentrations were measured after the 1st and 4th doses.

Main Results:

  • 96% of children received at least 4 doses of palivizumab.
  • No RSV-associated hospitalizations were reported.
  • Mean palivizumab trough concentrations were 59.0 μg/mL (after 1st dose) and 91.8 μg/mL (after 4th dose).
  • 25% of children experienced serious adverse events, none linked to palivizumab.

Conclusions:

  • Palivizumab prophylaxis was effective in preventing RSV hospitalizations in this cohort.
  • Palivizumab demonstrated a favorable safety profile in immunocompromised Japanese children.
  • Achieved palivizumab concentrations suggest adequate therapeutic levels.

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