Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Table 6 Pharmacokinetic parameters for the IGSC 20 % and IGIV 10 % treatments

Treatment Period^a (IP)	Period 1 (IGIV 10 %)				Period 2 (IGSC 20 %, 145 % of IGIV 10 %)		Period 4 (IGSC 20 %, individualized)
Dosing interval	3 weeks (n = 16)		4 weeks (n = 38)		1 week (n = 18)		1 week (n = 60)
Parameter [unit]	Geom. mean	95 % CI	Geom. mean	95 % CI	Geom. mean	95 % CI	Geom. mean	95 % CI
AUC (g/days/l)	352.05	319.74–387.63	410.40	381.24–441.79	108.33	97.60–120.24	115.21	109.23–121.52
AUC / (Dose/Weight) [(g/days/l)/(g/kg)]	606.99	495.29–743.87	796.30	715.36–886.40	472.50	411.07–543.10	536.05	495.58–579.82
Clearance^b [ml/kg/days]	1.65	1.34–2.02	1.26	1.13–1.40	2.12	1.84–2.43	1.87	1.72–2.02
Cmax (g/l)	27.09	24.30–30.19	24.85	23.18–26.64	17.31	15.11–19.82	19.31	18.13–20.57
Tmax (h)	6.94	3.96–12.17	5.84	3.62–9.40	54.19	36.28–80.92	78.68	65.37–94.70
Cmin (g/l)	12.03	10.64–13.60	10.37	9.50–11.33	13.85	12.61–15.21	14.00	13.14–14.91

95 %CI 95 % confidence interval
^aPeriod 1 and period 2 data includes patients aged 12 years and older; period 4 data includes patients aged 2 years and older.
^bApparent clearance for SC administration