846:
Onboarding Experience of Pediatric Patients With Primary Immunodeficiency Diseases With Subcutaneous Human Immune Globulin 20% (Ig20Gly)
Monday, March 5, 2018
South Hall A2 (Convention Center)
Kenneth Paris, Iftikhar Hussain, Sudhir Gupta, Ping Wang, Barbara McCoy, Christopher J. Rabbat, Leman Yel
RATIONALE: The safety and efficacy of subcutaneous immune globulin 20%, Ig20Gly, was demonstrated in a phase 2/3 North American study (NCT01218438) in patients with primary immunodeficiency diseases (PIDD). This post hoc analysis assessed the onboarding experience with Ig20Gly in pediatric patients.

METHODS: Patients aged ≥2 years received weekly Ig20Gly infusions at volumes of ≤60 mL/site and rates of ≤60 mL/h/site for ~1.3 years. To evaluate the Ig20Gly onboarding experience, adverse events (AEs), tolerability, and infusion parameters were assessed in patients aged 2 to <16 years.

RESULTS: Most infusions (97.3%; 1134/1166) were not associated with a causally related local AE; 66.7% (14/21) of patients did not experience a causally related local AE. Five patients (23.8%) reached the maximum infusion rate of 60 mL/h/site for ≥2 infusions. A total of 54.3% and 95.2% of infusions were completed in <1 and <2 hours, respectively. Of 1165 infusions, 404 infusions (34.7%) were administered using 1 site and 728 infusions (62.5%) required 2 sites (median [range] infusion sites, 2[1–3]). For dose volumes of 0–59 mL, 41.3% (364/881) of infusions were administered using 1infusion site. For dose volumes of 60–119 mL, 85% (242/284) of infusions were administered using 2 sites. No association was observed between increasing infusion rates or volumes per site and rates of causally related local AEs per infusion.

CONCLUSIONS: Ig20Gly infusions were well tolerated at high infusion rates and volumes/site in pediatric patients with PIDD; no increases in local AEs were observed with increasing infusion volumes per site and infusion rates.