Content of review 1, reviewed on November 17, 2023

The authors investigated PK/PD and safety in the administration of benralizumab to children. The number of patients was limited to approximately 30, yet the findings were not significantly different from those of adults. I have identified specific points requiring your attention.

  1. Reason for Including Patients of Different Age Groups from Japan in PK Study: Kindly provide a brief explanation for the inclusion of patients from two different age groups in the PK study conducted in Japan.
  2. Discussion on Dosage Adjustment According to Age and Weight: How the dosage of benralizumab would be determined in real-world clinical practice based on the obtained results?
  3. Graphical Representation of Peripheral Blood Eosinophil Counts in ADA Cases: Include a graph illustrating the time course of peripheral blood eosinophil counts for the four cases with ADA. The graph should indicate when ADA was detected. A Supplemental Figure would be acceptable.

Source

    © 2023 the Reviewer.

References

    James, W. H., Takao, F., W., G. T., Masanori, I., Vinay, M., S., T. J., B., L. P., Sara, A., Tomasz, D., James, J., I., W. W., Mihir, S., Viktoria, W., L., J. M. 2024. Benralizumab in children with severe eosinophilic asthma: Pharmacokinetics and long-term safety (TATE study). Pediatric Allergy and Immunology.