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Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents

Suez, Daniel ; Kriván, Gergely ; Jolles, Stephen ; Stein, Mark ; Gupta, Sudhir ; Paris, Kenneth ; van Hagen, P Martin ; Brodszki, Nicholas LU ; Engl, Werner and Leibl, Heinz , et al. (2019) In Immunotherapy 11(12). p.1057-1065
Abstract

Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients & materials/methods: Patients received Ig20Gly (volumes, ≤60 ml/site; rates, ≤60 ml/h/site). Adverse events (AEs), tolerability and infusion parameters were assessed. Results: Patients (2-83 years; N = 122) received 6676 Ig20Gly infusions. No causally related serious or severe AEs were reported. Thirty-five patients (28.7%) reported 232 causally related local AEs. Twenty-seven patients (22.1%) reported 165 causally related systemic AEs. There was no association between the infusion volume... (More)

Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients & materials/methods: Patients received Ig20Gly (volumes, ≤60 ml/site; rates, ≤60 ml/h/site). Adverse events (AEs), tolerability and infusion parameters were assessed. Results: Patients (2-83 years; N = 122) received 6676 Ig20Gly infusions. No causally related serious or severe AEs were reported. Thirty-five patients (28.7%) reported 232 causally related local AEs. Twenty-seven patients (22.1%) reported 165 causally related systemic AEs. There was no association between the infusion volume or rate and causally related local AEs. Conclusion: Ig20Gly was well tolerated in a broad population of patients with primary immunodeficiency diseases.

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publishing date
type
Contribution to journal
publication status
published
keywords
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Drug-Related Side Effects and Adverse Reactions/epidemiology, Europe, Female, Humans, Immunoglobulin G/therapeutic use, Injections, Subcutaneous, Male, Middle Aged, North America, Primary Immunodeficiency Diseases/drug therapy, Prospective Studies, Young Adult
in
Immunotherapy
volume
11
issue
12
pages
1057 - 1065
publisher
Future Medicine Ltd.
external identifiers
  • pmid:31268374
  • scopus:85071642650
ISSN
1750-743X
DOI
10.2217/imt-2019-0057
language
English
LU publication?
no
id
b665e59d-2ed1-472c-94ac-063a3107c14b
date added to LUP
2021-10-11 14:33:23
date last changed
2024-06-16 21:00:53
@article{b665e59d-2ed1-472c-94ac-063a3107c14b,
  abstract     = {{<p>Aim: This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two Phase II/III studies conducted in North America and Europe. Patients &amp; materials/methods: Patients received Ig20Gly (volumes, ≤60 ml/site; rates, ≤60 ml/h/site). Adverse events (AEs), tolerability and infusion parameters were assessed. Results: Patients (2-83 years; N = 122) received 6676 Ig20Gly infusions. No causally related serious or severe AEs were reported. Thirty-five patients (28.7%) reported 232 causally related local AEs. Twenty-seven patients (22.1%) reported 165 causally related systemic AEs. There was no association between the infusion volume or rate and causally related local AEs. Conclusion: Ig20Gly was well tolerated in a broad population of patients with primary immunodeficiency diseases.</p>}},
  author       = {{Suez, Daniel and Kriván, Gergely and Jolles, Stephen and Stein, Mark and Gupta, Sudhir and Paris, Kenneth and van Hagen, P Martin and Brodszki, Nicholas and Engl, Werner and Leibl, Heinz and McCoy, Barbara and Yel, Leman}},
  issn         = {{1750-743X}},
  keywords     = {{Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Drug-Related Side Effects and Adverse Reactions/epidemiology; Europe; Female; Humans; Immunoglobulin G/therapeutic use; Injections, Subcutaneous; Male; Middle Aged; North America; Primary Immunodeficiency Diseases/drug therapy; Prospective Studies; Young Adult}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{1057--1065}},
  publisher    = {{Future Medicine Ltd.}},
  series       = {{Immunotherapy}},
  title        = {{Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents}},
  url          = {{http://dx.doi.org/10.2217/imt-2019-0057}},
  doi          = {{10.2217/imt-2019-0057}},
  volume       = {{11}},
  year         = {{2019}},
}