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

Abstract

Introduction 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 safety, tolerability, and infusion parameters by age groups. Methods 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 74 patients (2- Results Overall, 71.6% (53/74) of patients achieved a maximum infusion rate ≥60 mL/h/site. Median maximum infusion rates and volumes/site were higher in adults (16–[60 mL/h/site; 45.3 mL/site]; ≥65 y [60 mL/h/site; 39 mL/site]) and adolescents aged 12–5–Percentages of infusions associated with causally related AEs were low among all pediatric age groups (0% [2–[5–12–3.1% [16–; there were no serious or severe causally related AEs. Ig20Gly infusions were well tolerated by all age groups; >99% of infusions were administered without an infusion rate reduction, interruption, or discontinuation due to AEs. Conclusions Ig20Gly infused at relatively high rates and volumes was well tolerated in patients of all ages with PIDD.