title: An open, prospective trial investigating the pharmacokinetics and safety, and the tolerability of escalating infusion rates of a 10% human normal immunoglobulin for intravenous infusion (IVIg), BT090, in patients with primary immunodeficiency disease.
abstract: OBJECTIVE
  Pharmacokinetics, safety and tolerability of escalating infusion rates of BT090, a 10% intravenous immunoglobulin (IVIg), were studied in patients with primary immunodeficiency disease.
  
  
  METHODS
  In Part A, patients (n = 30) received 3 infusions of BT090 at their pretrial dose and dosing interval; the infusion rate of BT090 was increased from 0·3 to 1·4 to 2·0 ml/kg/h for each infusion in each patient initially at 30-min intervals. Pharmacokinetics was evaluated at the 3rd infusion (n = 24). At the 4th infusion, infusion rates were to be gradually escalated from 0·3 to 1·4 to 4·0 to a maximum of 8·0 ml/kg/h initially at 30-min intervals to establish the maximum tolerated infusion rate per patient.
  
  
  RESULTS
  The pharmacokinetic characteristics and safety profile of BT090 were comparable with those of other IVIgs, including Intratect(®) . Escalation of infusion rates was well tolerated, allowing identification of individual patient's maximum tolerated infusion rate. At subsequent infusions, all patients tolerated their individually defined maximum infusion rate: 17 patients (68·0%) tolerated infusion rates of 6·0 or 8·0 ml/kg/h and four patients (16%) had maximum tolerated infusion rates of <4·0 ml/kg/h at subsequent infusions. Escalation of infusion rates shortened infusion time from a median of around 2·5 h to around 1·6 h. SAEs were reported in three patients, but none was related to BT090 treatment.
  
  
  CONCLUSIONS
  Shortening infusion time may reduce overall healthcare spending, for example nursing time needed, and also minimize disruption of patients' daily routine, especially for those patients in work or school settings.
authors.affiliation: Department of Paediatric Haematology and Stem Cell Transplantation, United St. Istvan and St. László Hospital, Budapest, Hungary.
authors.forename: G
authors.initials: G
authors.lastname: Kriván
authors.affiliation: Department of Paediatrics, Stem Cell Transplantation and Immunology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
authors.forename: Ch
authors.initials: Ch
authors.lastname: Königs
authors.affiliation: Department of Immunology, Children's Memorial Health Institute, Warsaw, Poland.
authors.forename: E
authors.initials: E
authors.lastname: Bernatowska
authors.affiliation: Institute for Transfusion Medicine, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Salama
authors.affiliation: Biotest AG, Dreieich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Wartenberg-Demand
authors.affiliation: Biotest AG, Dreieich, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Sonnenburg
authors.affiliation: Department of Paediatrics, Stem Cell Transplantation and Immunology, University Hospital Frankfurt, Goethe University, Frankfurt am Main, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Linde
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006207:Half-Life; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage* / Q000493:pharmacokinetics; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous
keywords: infusion rates; intravenous immunoglobulin; primary immunodeficiency disease