Subcutaneous immune globulin 20% (Ig20Gly) is indicated in primary immunodeficiency disease (PID). We evaluated baseline medical history events, ongoing medical conditions, concomitant medication use, adverse events (AEs), tolerability, and infusion parameters by age in data pooled from 2 phase 2/3 studies of Ig20Gly in PID.
Data were pooled from North American (NCT01218438) and European (NCT01412385) Ig20Gly phase 2/3 studies in PID and assessed by age (advanced-age [≥60 years], adult [16–<60 years], and pediatric/adolescent [<16 years]).
Baseline medical history events were more common in advanced-age (n=19; 24.2 events/patient) versus adult (n=64; 12.8 events/patient) and pediatric/adolescent patients (n=39; 5.7 events/patient). Of these, ongoing medical conditions at baseline (comorbid events) were also higher in advanced-age (17.0 events/patient) versus adult (8.9 events/patient) and pediatric/adolescent patients (2.7 events/patient). All advanced-age patients needed concomitant medications to treat preexisting conditions (247 medications for 19 patients). Despite more comorbid conditions, median maximum infusion rates and infusion volumes/site were comparable in advanced-age (60.0 mL/h/site; 40.8 mL/site) and adult (55.0 mL/h/site; 36.3 mL/site) patients; as expected, lower infusion rates and volumes/site were reported in pediatric/adolescent patients (24.0 mL/h/site; 15.7 mL/site). Infusions were tolerated in patients of all ages and infusions associated with causally related AEs were low in advanced-age (local: 0.3%; systemic: 0.7%), adult (local: 1.8%; systemic: 3.4%), and pediatric/adolescent (local: 5.4%; systemic: 0.8%) patients.
Despite the higher prevalence of comorbidities in advanced-age patients, Ig20Gly was infused at relatively high rates and volumes. In this study, Ig20Gly was well tolerated in patients of all ages with PID.