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Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies

Paris, Kenneth ; Haddad, Elie ; Borte, Michael ; Brodszki, Nicholas LU ; Dérfalvi, Beáta ; Maródi, Laszlo ; Hussain, Iftikhar ; Darter, Amy ; Engl, Werner and Leibl, Heinz , et al. (2019) In Immunotherapy 11(5). p.397-406
Abstract

Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies. Patients & methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. Results: Of 2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low.... (More)

Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies. Patients & methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. Results: Of 2624 Ig20Gly infusions, >99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low. Conclusion: Ig20Gly infused at relatively high rates and volumes was well tolerated in children.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Ig20Gly, immunodeficiencies, pediatric, tolerability
in
Immunotherapy
volume
11
issue
5
pages
10 pages
publisher
Future Medicine Ltd.
external identifiers
  • scopus:85061973800
  • pmid:30626238
ISSN
1750-743X
DOI
10.2217/imt-2018-0088
language
English
LU publication?
no
id
a3c75a71-8f11-4bed-a7ef-b6f8bbd66160
date added to LUP
2019-03-05 14:49:41
date last changed
2024-07-09 07:21:54
@article{a3c75a71-8f11-4bed-a7ef-b6f8bbd66160,
  abstract     = {{<p>Aim: To assess Ig20Gly tolerability in pediatric patients with primary immunodeficiencies. Patients &amp; methods: Infusion parameters and tolerability were analyzed in pediatric patients (aged 2-5 years [n = 6], 6-11 years [n = 22] and 12-17 years [n = 22]) receiving Ig20Gly in two Phase II/III trials. Results: Of 2624 Ig20Gly infusions, &gt;99% did not require any rate reduction, interruption or discontinuation due to adverse events (AEs). Median maximum infusion rates and volumes/site were higher in patients 12-17 years of age (30 ml/h/site; 30 ml/site) versus 6-11 years (20 ml/h/site; 15 ml/site) and 2-5 years (18 ml/h/site; 14 ml/site). Rates of causally related systemic and local AEs (0.009 and 0.063 AEs/infusion) were low. Conclusion: Ig20Gly infused at relatively high rates and volumes was well tolerated in children.</p>}},
  author       = {{Paris, Kenneth and Haddad, Elie and Borte, Michael and Brodszki, Nicholas and Dérfalvi, Beáta and Maródi, Laszlo and Hussain, Iftikhar and Darter, Amy and Engl, Werner and Leibl, Heinz and McCoy, Barbara and Yel, Leman}},
  issn         = {{1750-743X}},
  keywords     = {{Ig20Gly; immunodeficiencies; pediatric; tolerability}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{397--406}},
  publisher    = {{Future Medicine Ltd.}},
  series       = {{Immunotherapy}},
  title        = {{Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies}},
  url          = {{http://dx.doi.org/10.2217/imt-2018-0088}},
  doi          = {{10.2217/imt-2018-0088}},
  volume       = {{11}},
  year         = {{2019}},
}