title: Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency.
abstract: Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.
authors.affiliation: Division of Allergic Diseases, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905, USA. hagan.john@mayo.edu
authors.forename: John B
authors.initials: JB
authors.lastname: Hagan
authors.forename: Mary B
authors.initials: MB
authors.lastname: Fasano
authors.forename: Sheldon
authors.initials: S
authors.lastname: Spector
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wasserman
authors.forename: Isaac
authors.initials: I
authors.lastname: Melamed
authors.forename: Mikhail A
authors.initials: MA
authors.lastname: Rojavin
authors.forename: Othmar
authors.initials: O
authors.lastname: Zenker
authors.forename: Jordan S
authors.initials: JS
authors.lastname: Orange
mesh_terms: D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D000368:Aged; D001424:Bacterial Infections / Q000517:prevention & control; D002648:Child; D017074:Common Variable Immunodeficiency / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D005260:Female; D040181:Genetic Diseases, X-Linked / Q000097:blood / Q000188:drug therapy / Q000276:immunology / Q000503:physiopathology; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055550:Protein Stability
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors
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