The pharmacokinetic (PK) properties of IgPro10 (Privigen®, CSL Behring, King of Prussia, PA, USA), a 10% liquid intravenous immunoglobulin (IVIG), are well-established in non-Japanese patients with primary immunodeficiency (PID). This study evaluated PK parameters of IgPro10 in Japanese patients with PID.
This was a prospective, Phase 3, open-label, single-arm study of IgPro10 in Japanese patients with PID. IgPro10 (138–554 mg/kg body weight, as per patient’s last steady-state dose) was administered in 3- or 4-weekly dosing regimens for up to 4 months. Serum samples for PK analysis were collected during the last IgPro10 dosing cycle (beginning from Week 13). PK parameters including area under the concentration-time curve from time point zero to the last quantifiable time point (AUC0–last), dose-adjusted AUC0–last (dAUC), lowest/highest observed immunoglobulin G levels (Cmin/Cmax), time to reach Cmax (Tmax), and total clearance (CL) were analyzed for both dosing regimens.
Ten patients were included in this analysis (3-weekly/4-weekly: n=2/n=8); the small number of patients in the 3-weekly regimen limits the interpretation. Cmax was observed approximately 1 h after the start of the infusion in both treatment groups. Mean (SD [not applicable for 3-weekly infusion parameters]) PK parameters were: Cmax, 16.60 and 14.20 (5.53) g/L; Cmin, 10.60 and 8.53 (3.89) g/L; AUC0–last, 5971 and 6591 (2633) g*h/L; dAUC, 0.41 and 0.46 (0.19) g*h/L; CL, 2.53 and 2.53 (0.99) mL/h and median Tmax was 1.19 and 1.14 h, for 3-weekly/4-weekly dosing regimens, respectively.
PK parameters of IgPro10 in Japanese patients were similar between 3- and 4-weekly dosing regimens.