title: Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease.
abstract: A multi-center, prospective, open-label study was conducted in primary immunodeficiency disease patients to determine the tolerability and pharmacokinetics of a 10% liquid IgG preparation administered subcutaneously. Forty-nine subjects (3-77 years old) were enrolled. Pharmacokinetic equivalence of subcutaneous treatment was achieved at a median dose of 137% of the intravenous dose, with a mean trough IgG level of 1,202 mg/dL at the end of the assessment period. The overall infection rate during subcutaneous treatment was 4.1 per subject-year. Three acute serious bacterial infections were reported, resulting in a rate of 0.067 per subject-year. A low overall rate of temporally associated adverse events (8%), and a very low rate of infusion site adverse events (2.8%), was seen at volumes up to 30 mL/site and rates ≤ 30 mL/h/site. Thus, subcutaneous replacement therapy with a 10% IgG preparation proved effective, safe and well-tolerated in our study population of subjects with primary immunodeficiency disease.
authors.affiliation: Pediatrics Allergy/Immunology Assoc., PA, Dallas, TX 75230, USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wasserman
authors.forename: Isaac
authors.initials: I
authors.lastname: Melamed
authors.forename: Lisa
authors.initials: L
authors.lastname: Kobrynski
authors.forename: Steven D
authors.initials: SD
authors.lastname: Strausbaugh
authors.forename: Mark R
authors.initials: MR
authors.lastname: Stein
authors.forename: Marlies
authors.initials: M
authors.lastname: Sharkhawy
authors.forename: Werner
authors.initials: W
authors.lastname: Engl
authors.forename: Heinz
authors.initials: H
authors.lastname: Leibl
authors.forename: Luba
authors.initials: L
authors.lastname: Sobolevsky
authors.forename: David
authors.initials: D
authors.lastname: Gelmont
authors.forename: Richard I
authors.initials: RI
authors.lastname: Schiff
authors.forename: William J
authors.initials: WJ
authors.lastname: Grossman
mesh_terms: D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology / Q000473:pathology; D000368:Aged; D001419:Bacteria / Q000254:growth & development; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D017074:Common Variable Immunodeficiency / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D040181:Genetic Diseases, X-Linked / Q000150:complications / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology / Q000473:pathology; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012996:Solutions; D016896:Treatment Outcome; D014481:United States
chemical_list: D007074:Immunoglobulin G; D012996:Solutions