Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents
Year: 2019
Type: article
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.
Source: Immunotherapy
Institutions: Unified Szent István and Szent László Hospital, University Hospital of Wales, Allergy Associates of the Palm Beaches, University of California, Irvine, Children's Hospital of New Orleans, Louisiana State University Health Sciences Center New Orleans, Erasmus MC, Skåne University Hospital, Takeda (Austria), Takeda (United States)
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: bronze
Funder: Baxalta
OpenAlex ID: W2953941249