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We report final results from a study of IGSC 20% in patients aged ≥2 years with PIDD in North America.
Methods:
Epoch 1 (13 weeks): immunoglobulin G 10% was administered intravenously (IGIV) at prestudy doses every 3-4 weeks (Q3W/Q4W). Epochs 2-4: IGSC 20% administered weekly (Epoch 2 [~12-16 weeks], 145% of the weekly equivalent Epoch 1 dose; Epoch 3 [12 weeks], dose adjusted per AUC assessments in Epochs 1-2; Epoch 4 [40 weeks], dose adapted individually per Epoch 3 IgG trough levels). Primary endpoint=validated acute serious bacterial infection (VASBI) rate.
Results:
Seventy-four patients aged 3-83 years received IGSC 20% and 67 completed; no patient discontinued IGSC 20% due to a serious adverse event (SAE) or adverse reaction (AR). During IGSC 20% treatment (n=74), 1 VASBI (rate=0.012/year; P<0.0001) was reported; the all-infection rate/patient-year was 2.41. Local ARs occurred in 23/74 patients (rate=0.022/infusion); all were mild (92.5%) and moderate (7.5%). In 4327 IGSC 20% infusions, median infusion rate was 60 mL/hr/site, resulting in a <1h-median infusion time. A 30-59-mL volume/site was used in 67.4% of infusions, and 7.4% infusions employed a ≥60mL/site volume without tolerability issues. Overall, 84.9% of infusions were administered using ≤2 infusion sites; 99.8% were completed without slowing the rate or interrupting/stopping administration. Ratio of geometric means of AUC/week for IgG with individualized IGSC 20% treatment over IGIV 10% Q3W/Q4W was 109% (90% CI=1.0394-1.1336).
Conclusions:
In patients treated with IGSC 20%, VASBI and infection rates were low, and infusions—most administered using ≤2 sites—were well-tolerated at relatively high infusion rates.