Safety and tolerability of subcutaneous immunoglobulin 20% in primary immunodeficiency diseases from two continents

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.

Trial registration: ClinicalTrials.gov NCT01412385 NCT01218438.

Keywords: CUVITRU; Ig20Gly; common variable immune deficiency; immunoglobulin; immunoglobulin replacement therapy (IgRT); primary immunodeficiency; safety; subcutaneous; tolerability.