Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents
(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.
(Less)
- author
- publishing date
- 2019
- 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
- 2024-09-22 03:17:59
@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 & 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}}, }