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, Engl, Werner, Leibl, Heinz, McCoy, Barbara and Yel, Leman 2019. Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents. Immunotherapy 11 (12) , pp. 1057-1065. 10.2217/imt-2019-0057

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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 or rate and causally related local AEs. Conclusion: Ig20Gly was well tolerated in a broad population of patients with primary immunodeficiency diseases.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Publisher:	Future Medicine
ISSN:	1750-743X
Funders:	N/A
Date of Acceptance:	18 June 2019
Last Modified:	30 Oct 2019 10:45
URI:	https://orca.cardiff.ac.uk/id/eprint/126389

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