Study Shows New SCIG Drug Evogam Safe and Efficacious
- By BSTQ Staff
Researchers investigated the efficacy, safety and pharmacokinetics and quality of life impact of Evogam, a new chromatographically fractionated 16% subcutaneous immunoglobulin (SCIG). In the Phase III, open-label, multicenter study, 35 primary immunodeficiency patients previously treated with intravenous immunoglobulin received weekly Evogam over 36 weeks. Primary endpoints were rate of serious bacterial infections (SBIs) and steady-state serum immunoglobulin G (IgG) trough concentrations.
No SBIs were reported during the study, and Evogam produced significantly higher mean trough IgG concentrations with a 1:1 dose conversion compared with previous immunoglobulin treatment (8.94 versus 8.27 g/L, p=0.0063). The researchers concluded that Evogam is efficacious in the prevention of infections and maintenance of trough levels using a 1:1 dose conversion. It was well-tolerated with no withdrawals due to adverse events, and it was preferred to IVIG by the majority of patients.
References
- Empson MB, Tang MLK, Pearce LKC, Rozen L, Gold MS, et al. Efficacy, Safety and Pharmacokinetics of a Novel Subcutaneous Immunoglobulin, Evogam, in Primary Immunodeficiency. J Clin Immun, 2012 Oct; 32(1):897-906.
