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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.
Abstract:
A total of 27/28 (96%) immunocompromised Japanese children received ≥ 4 doses of palivizumab. No respiratory syncytial virus-associated hospitalizations occurred. Mean palivizumab trough concentrations were 59.0 and 91.8 μg/mL 30 days after the 1st and 4th doses, respectively. Of 28 subjects, 27 (96%) experienced ≥ 1 adverse event and 7 (25%) experienced ≥ 1 serious adverse event, none of which was considered related to palivizumab.
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