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. Twentyseven 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.

Additional Metadata
Keywords common variable immune deficiency • CUVITRU • immunoglobulin • immunoglobulin replacement therapy (IgRT) • Ig20Gly • primary immunodeficiency • safety • subcutaneous • tolerability
Persistent URL dx.doi.org/10.2217/imt-2019-0057, hdl.handle.net/1765/122236
Journal Immunotherapy
Citation
Suez, D., Kriván, G, Jolles, S., Stein, M., Gupta, S, Paris, K., … Yel, L. (2019). Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents. Immunotherapy, 11(12), 1057–1065. doi:10.2217/imt-2019-0057