title: Safety, efficacy and pharmacokinetics of a new 10% liquid intravenous immunoglobulin (IVIG) in patients with primary immunodeficiency.
abstract: BACKGROUND
  An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.
  
  
  METHODS
  Patients were treated every 3 or 4 weeks with 254-1029 mg/kg/infusion of IVIG.
  
  
  RESULTS
  Overall, Biotest-IVIG infusions were well tolerated. The proportion of infusions that were associated with adverse events during infusion, and up to 72 h after infusion, including those unrelated to study product, was 27.7% with an upper 95% confidence limit ≤30.6%. Two serious bacterial infections (SBIs) were observed resulting in a serious bacterial infection rate of 0.035 per person per year and an upper one-sided 99% confidence limit of ≤0.136 SBI/patient/year. The number of days of work or school missed due to infection were relatively low at 2.28 days/patient/year. Two patients were hospitalized for infection producing a rate of 0.21 hospitalization days/patient/year. The IgG half-life was approximately 30 days with variation among individuals.
  
  
  CONCLUSIONS
  Pharmacokinetic parameters of specific antibody activities were essentially the same as those of total IgG. Biotest-IVIG is safe and effective in the treatment of PID.
authors.affiliation: Pediatric Allergy/Immunology Associates, 777 Forest Lane, Suite B-332, Dallas, TX 75230, USA. drrichwasserman@gmail.com
authors.forename: Richard L
authors.initials: RL
authors.lastname: Wasserman
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Church
authors.forename: Mark
authors.initials: M
authors.lastname: Stein
authors.forename: James
authors.initials: J
authors.lastname: Moy
authors.forename: Martha
authors.initials: M
authors.lastname: White
authors.forename: Steven
authors.initials: S
authors.lastname: Strausbaugh
authors.forename: Harry
authors.initials: H
authors.lastname: Schroeder
authors.forename: Mark
authors.initials: M
authors.lastname: Ballow
authors.forename: James
authors.initials: J
authors.lastname: Harris
authors.forename: Isaac
authors.initials: I
authors.lastname: Melamed
authors.forename: David
authors.initials: D
authors.lastname: Elkayam
authors.forename: William
authors.initials: W
authors.lastname: Lumry
authors.forename: Daniel
authors.initials: D
authors.lastname: Suez
authors.forename: Syed M
authors.initials: SM
authors.lastname: Rehman
mesh_terms: D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000628:therapy*; D000368:Aged; D001424:Bacterial Infections / Q000276:immunology / Q000517:prevention & control; D002648:Child; D017074:Common Variable Immunodeficiency / Q000628:therapy*; D005260:Female; D040181:Genetic Diseases, X-Linked / Q000628:therapy*; D006801:Humans; D017099:IgG Deficiency / Q000235:genetics / Q000628:therapy*; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D016756:Immunoglobulins, Intravenous