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, Kenneth Paris, Elie Haddad, Michael Borte, Nicholas Brodszki, Beáta Dérfalvi, Laszlo Maródi, Iftikhar Hussain, Amy Darter, Werner Engl, Heinz Leibl, Barbara McCoy, Leman Yel
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.
Trial registration: ClinicalTrials.gov NCT01218438 NCT01412385.
Keywords: Ig20Gly; immunodeficiencies; pediatric; tolerability.
Source: PubMed