Study of Hizentra meets primary endpoint in primary immunodeficiency .- CSL Behring

CSL Behring announced that a clinical study examining faster infusion rates and higher volumes than currently approved for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) (SCIg) in patients with primary immunodeficiency (PI) met its primary endpoint. The study also evaluated the feasibility of manual push administration with Hizentra, a new method that would eliminate the need for an infusion pump to administer the SCIg. Pump-assisted cohort results: Responder rates for the pump-assisted volume cohort were 86.7% (25 mL) and 73.3% (40 and 50 mL), while responder rates for the pump-assisted flow rate cohort were 77.8% (25 and 50 mL/hour), 66.7% (75 mL/hour) and 61.1% (100 mL/hour). Dose and volume adherence rates were at least 90% in all patients of the volume cohort, and 83.3% in patients in the flow rate cohort (<90% in three patients). mean serum immunoglobulin g (igg) trough levels (g l) were similar between day 1 and end of the study for the volume cohort and the flow rate cohort. manual push administration cohort results: responder rates were 100% (0.5 and 1 ml minute) and 87.5% (2 ml minute), with 98.5-100% of infusions completed per the planned schedule. compliance rates were at least 90% in all patients but one. mean serum igg trough levels were similar between day 1 and the end of the study. the final analysis examined the rate of treatment-emergent adverse event (teae) frequency, type, intensity or duration across all three cohorts. low rates of teaes infusion were observed across all cohorts, with mild to moderate infusion site reaction being the most common. specifically, teae rates infusion were 0.145, 0.228 and 0.085 in the pump-assisted volume cohort, pump-assisted flow rate cohort and manual push administration flow rate cohort, respectively. there was no clinically meaningful difference in teae frequency, type, intensity or duration among the three cohorts and rates of teaes infusion did not increase with expanded infusion parameters.>