title: Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam®, in primary immunodeficiency.
abstract: This phase III, open-label, multi-centre study investigated the efficacy, safety, pharmacokinetics and quality of life impact of Evogam(®), a new chromatographically fractionated 16% subcutaneous immunoglobulin, utilising a 1:1 dose transition ratio from previous immunoglobulin therapy. Thirty-five previously treated patients with primary immunodeficiency 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. Evogam produced significantly higher mean trough IgG concentrations with 1:1 dose conversion compared to previous immunoglobulin treatment (8.94 versus 8.27 g/L, p = 0.0063). Evogam was 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 was preferred to IVIg by the majority of patients.
authors.affiliation: Auckland City Hospital, 2 Park Road, Grafton, Auckland, 1023, New Zealand. mbempson@ihug.co.nz
authors.forename: Marianne B
authors.initials: MB
authors.lastname: Empson
authors.forename: Mimi L K
authors.initials: ML
authors.lastname: Tang
authors.forename: Lisa K C
authors.initials: LK
authors.lastname: Pearce
authors.forename: Leon
authors.initials: L
authors.lastname: Rozen
authors.forename: Michael S
authors.initials: MS
authors.lastname: Gold
authors.forename: Constance H
authors.initials: CH
authors.lastname: Katelaris
authors.forename: David
authors.initials: D
authors.lastname: Langton
authors.forename: Joanne
authors.initials: J
authors.lastname: Smart
authors.forename: William B
authors.initials: WB
authors.lastname: Smith
authors.forename: Richard H
authors.initials: RH
authors.lastname: Steele
authors.forename: John B
authors.initials: JB
authors.lastname: Ziegler
authors.forename: Darryl
authors.initials: D
authors.lastname: Maher
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000097:blood / Q000494:pharmacology; D007153:Immunologic Deficiency Syndromes / Q000097:blood / Q000188:drug therapy*; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000097:blood / Q000494:pharmacology; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D055815:Young Adult
chemical_list: D007074:Immunoglobulin G; D007155:Immunologic Factors