IG20GLY TOLERABILITY AND INFUSION CHARACTERISTICS ACROSS AGE GROUPS IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES

Subcutaneous immune globulin 20%, Ig20Gly, was well tolerated in the phase 2/3 North American study in patients with primary immunodeficiency diseases (PIDD). Here we analyze the tolerability and onboarding experience with Ig20Gly infused at high rates and volumes in pediatric and advanced age patients (2–<16 y and ≥60 y). Patients aged ≥2 years with PIDD received weekly Ig20Gly infusions at volumes ≤60 mL/site and rates ≤60 mL/h/site for ∼1.3 years in the North American study (NCT01218438). Adverse events (AEs), tolerability, and infusion parameters were assessed in pediatric (n=21) and advanced age patients (n=14). Median maximum infusion rates and volumes/site were higher in advanced age patients (60 mL/h/site; 47.5 mL/site) versus pediatric patients (30 mL/h/site; 26.75 mL/site). Five (23.8%) pediatric patients and 9 (64.3%) advanced age patients used infusion rates ≥60 mL/h/site for ≥2 infusions. Maximum infusion rates were not tried in the majority of pediatric patients given the smaller dose volumes used in these patients. Percentages of infusions associated with causally related AEs were low among pediatric patients (all [2.8%], local [2.7%], systemic [0.4%]) and in advanced age patients (all [1.3 %], local [0.4%], systemic [0.9%]); none were serious or severe in either age group. Larger infusion volumes and faster infusion rates were not associated with an increase in causally related local AEs in either age group. Ig20Gly infused at relatively high rates and volumes was well tolerated in both pediatric and advanced age patients with PIDD.