Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia
(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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https://lup.lub.lu.se/record/410580
- author
- organization
- publishing date
- 2006
- 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
- 2022-04-22 08:25:31
@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}},
keywords = {{pharmacokinetics; immunoglobulin; IVIG; primary immunodeficiency}},
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}},
}