Background and aims: Intragam® 10 NF is the next generation 10% intravenous immunoglobulin with three pathogen reduction steps and a noncarbohydrate stabiliser. This open label, cross-over study in patients with primary immunodeficiency was designed to evaluate whether Intragam 10 NF differed in its pharmacokinetics (PK) compared with Intragam P and to assess Intragam 10 NF safety and tolerability. Methods: Nineteen primary immunodeficiency patients were administered one cycle of their existing Intragam P dose (0.2-0.8g/kg 3-4 weekly), followed by seven cycles of Intragam 10 NF administered at the same dosing schedule as Intragam P. The primary objective was to compare serum immunoglobulin G (IgG) trough levels. Secondary endpoints were PK variables, safety and tolerability. Results: There was no significant within-patient difference in the average trough immunoglobulin G concentration between Intragam P and Intragam 10 NF (8.76g/L, 8.55g/L respectively) (geometrical mean ratio 1.034; 95% confidence interval 0.996-1.073; P=0.079). Mean PK parameters for both products were similar, with all 95% confidence interval encompassing 1.0 except for time to maximum concentration. Time to maximum concentration occurred earlier with Intragam 10 NF compared with Intragam P, with a shorter infusion time (mean 1.75h vs 2.52h respectively; P<0.05). Headache was the most frequent treatment-related event following both products. There were no study withdrawals, deaths, or notable changes in laboratory values or vital signs. Conclusion: Intragam 10 NF was well tolerated and exhibited similar PK to Intragam P, with the advantage of a 45min shorter infusion time.
- Antibody deficiency syndrome
- Intragam 10 NF