title: Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies.
abstract: OBJECTIVE
  The present study was designed to evaluate the efficacy and safety of a novel, 10% liquid formulation of intravenous immunoglobulin, stabilized with 250 mmol/L L-proline (Privigen), in patients with primary immunodeficiency disease.
  
  
  METHODS
  Eighty adults and children diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen infusions (200-888 mg/kg) at 3- or 4-week intervals over a 12-month period, according to their previously established maintenance dose. The primary endpoint was the annual rate of acute serious bacterial infections.
  
  
  RESULTS
  There were six episodes of acute serious bacterial infections, corresponding to an annual rate of 0.08; the annual rate for all infections was 3.55. Mean serum IgG trough levels were between 8.84 and 10.27 g/L. A total of 1,038 infusions were administered, most of them at the maximum rate permitted (8.0 mg kg(-1) min(-1)). Temporally associated adverse events, possibly or probably related to study drug, occurred in 9% of infusions, either during or within 72 h after infusion end.
  
  
  CONCLUSIONS
  Privigen is well tolerated and effective for the treatment of primary immunodeficiency.
authors.affiliation: Allergy Associates of the Palm Beaches, 840 US Highway 1, Suite 235, North Palm Beach, FL 33408, USA. latallergy@aol.com
authors.forename: Mark R
authors.initials: MR
authors.lastname: Stein
authors.forename: Robert P
authors.initials: RP
authors.lastname: Nelson
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Church
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wasserman
authors.forename: Michael
authors.initials: M
authors.lastname: Borte
authors.forename: Christiane
authors.initials: C
authors.lastname: Vermylen
authors.forename: Johann
authors.initials: J
authors.lastname: Bichler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000009:adverse effects; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous