Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies

Kenneth Paris, Elie Haddad, Michael Borte, Nicholas Brodszki, Beáta Dérfalvi, Laszlo Maródi, Iftikhar Hussain, Amy Darter, Werner Engl, Heinz Leibl, Barbara McCoy, Leman Yel

Research output: Contribution to journalArticle

Abstract

Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies. Patients & methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. Results: Of 2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low. Conclusion: Ig20Gly infused at relatively high rates and volumes was well tolerated in children.

Original languageEnglish
Pages (from-to)397-406
Number of pages10
JournalImmunotherapy
Volume11
Issue number5
DOIs
Publication statusPublished - Apr 2019

Keywords

  • Ig20Gly
  • immunodeficiencies
  • pediatric
  • tolerability

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Oncology

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    Paris, K., Haddad, E., Borte, M., Brodszki, N., Dérfalvi, B., Maródi, L., Hussain, I., Darter, A., Engl, W., Leibl, H., McCoy, B., & Yel, L. (2019). Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies. Immunotherapy, 11(5), 397-406. https://doi.org/10.2217/imt-2018-0088