Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia

Vox Sanguinis
J BjörkanderHartmut J Ehrlich

Abstract

The aim of this study was to evaluate the pharmacokinetics, efficacy and safety of a newly developed 10% liquid immunoglobulin preparation in patients with primary immunodeficiency diseases. This new preparation for intravenous use includes three dedicated virus clearance steps in its manufacturing process to ensure a high margin of viral safety. This was a prospective, open-label, non-controlled, multicentre study. Twenty-two subjects with primary immunodeficiency were treated initially with three infusions of a licensed intravenous immunoglobulin to standardize the immunoglobulin G (IgG) replacement therapy of all subjects to the same intravenous product. A total of nine infusions of the new 10% liquid preparation were subsequently administered. The median terminal half-life of total IgG following administration of the new preparation was 30.1 days. Median terminal half-lives for IgG subclasses IgG(1), IgG(2), IgG(3) and IgG(4) were 28.3, 31.3, 20.9 and 24.2 days, respectively. The median total serum IgG steady-state trough level was 8.51 g/l. No severe infection episodes started after initiation of treatment with the new preparation. The median rate of mild or moderate infection episodes was 0.48 per month. A total of 194 in...Continue Reading

References

Sep 1, 1992·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M Henry-Amar
Feb 1, 1991·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M H BennettB Vaughan Hudson
Feb 1, 1994·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·F E van LeeuwenR Somers
Jan 1, 1995·European Journal of Pediatrics·P ImbachB Imholz
Jul 1, 1996·Transfusion Medicine Reviews·E R Stiehm
Dec 24, 1997·Australian Veterinary Journal·S Church, D J Middleton
Aug 15, 1998·The American Journal of the Medical Sciences·J N George, G E Raskob
May 25, 1999·Bone Marrow Transplantation·A Abdel-MageedH M Lazarus
Feb 17, 2000·Seminars in Hematology·R McMillan
Feb 27, 2001·Respiration; International Review of Thoracic Diseases·F ReichenbergerM Tamm
Oct 23, 2003·Transfusion Medicine Reviews·L Ross Pierce, Nisha Jain
Nov 18, 2003·Clinical and Experimental Immunology·M M GompelsUNKNOWN Associated Study Group
Jan 6, 2004·European Journal of Haematology·Véronique Le GuernLuc Mouthon
Apr 29, 2004·Journal of Clinical Immunology·Hans D OchsUNKNOWN Octagam Study Group

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Citations

Apr 28, 2010·Advances in Therapy·Steven Simoens
May 25, 2013·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Paul L McCormack
Sep 6, 2008·The Journal of Infectious Diseases·Jeffrey M JacobsonWilliam C Olson
Jul 3, 2013·Postgraduate Medicine·Randy BroylesMelvin Berger
Mar 1, 2011·Clinical Immunology : the Official Journal of the Clinical Immunology Society·Melvin BergerOthmar Zenker
Jun 6, 2009·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Richard L WassermanUNKNOWN IgPro10 in PID Study group
Oct 23, 2008·Immunology and Allergy Clinics of North America·Maria Garcia-LloretTalal A Chatila
May 20, 2011·Journal of Clinical Pharmacology·Josep DarbàTuy de Agustín
Jul 15, 2016·Expert Review of Clinical Immunology·Carlo AgostiniTorben Plesner
Oct 4, 2017·Pharmacology Research & Perspectives·Laia AlsinaUNKNOWN investigators of the Flebogamma DIF PASS Study Group
Sep 15, 2020·International Journal of Immunopathology and Pharmacology·Silvia RicciChiara Azzari
Jul 27, 2017·Nursing·Trevor J BarnumSheila Haas
Mar 20, 2021·International Journal of Hematology·Tomohiro MorioMikhail A Rojavin

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