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

Bjorkander, J ; Nikoskelainen, J ; Leibl, H ; Lanbeck, Peter LU ; Wallvik, J ; Lumio, JT ; Braconier, Jean Henrik LU ; Pavlova, BG ; Birthistle, K and Engl, W , et al. (2006) In Vox Sanguinis 90(4). p.286-293
Abstract
Background and Objectives 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. Materials and Methods 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... (More)
Background and Objectives 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. Materials and Methods 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. Results 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 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0.41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences. Conclusion The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
pharmacokinetics, immunoglobulin, IVIG, primary immunodeficiency
in
Vox Sanguinis
volume
90
issue
4
pages
286 - 293
publisher
Wiley-Blackwell
external identifiers
  • pmid:16635071
  • wos:000237065400006
  • scopus:33646079375
ISSN
1423-0410
DOI
10.1111/j.1423-0410.2006.00764.x
language
English
LU publication?
yes
additional info
The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Division of Infection Medicine (SUS) (013008000), Infectious Diseases Research Unit (013242010)
id
7e417c16-5fcf-424a-8193-dd4e32c722db (old id 410580)
date added to LUP
2016-04-01 15:35:33
date last changed
2020-06-24 03:33:33
@article{7e417c16-5fcf-424a-8193-dd4e32c722db,
  abstract     = {Background and Objectives 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. Materials and Methods 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. Results 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 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0.41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences. Conclusion The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals.},
  author       = {Bjorkander, J and Nikoskelainen, J and Leibl, H and Lanbeck, Peter and Wallvik, J and Lumio, JT and Braconier, Jean Henrik and Pavlova, BG and Birthistle, K and Engl, W and Walter, S and Ehrlich, HJ},
  issn         = {1423-0410},
  language     = {eng},
  number       = {4},
  pages        = {286--293},
  publisher    = {Wiley-Blackwell},
  series       = {Vox Sanguinis},
  title        = {Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia},
  url          = {http://dx.doi.org/10.1111/j.1423-0410.2006.00764.x},
  doi          = {10.1111/j.1423-0410.2006.00764.x},
  volume       = {90},
  year         = {2006},
}