Tolerability of subcutaneous immunoglobulin 20%, Ig20Gly, in pediatric patients with primary immunodeficiencies
(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.
(Less)
- author
- publishing date
- 2019
- 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
-
- pmid:30626238
- scopus:85061973800
- 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 & 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.</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}}, }