A multicentre, prospective, non-randomized, sequential, open-label trial to demonstrate the bioequivalence between intravenous immunoglobulin new generation (IGNG) and standard IV immunoglobulin (IVIG) in adult patients with primary immunodeficiency (PID)

Abstract Objectives To demonstrate the bioequivalence between 2 intravenous immunoglobulin (IVIG) preparations, TEGELINE ® and ClairYg ® , a ready-to-use 5% IVIG, in primary immunodeficiency (PID). Secondary objectives were to assess the efficacy, safety and pharmacokinetics of ClairYg ® . Methods Twenty-two adult PID patients receiving stable doses of TEGELINE ® (5% lyophilized IVIG) were switched to ClairYg ® for 6 months. ClairYg ® was administered under the same conditions as TEGELINE ® , either every 3 or 4 weeks. The primary endpoint was mean average total IgG trough level at steady state with ClairYg ® versus TEGELINE ® . Clinical efficacy was also assessed in terms of infections and associated events. Results Bioequivalence was established with a mean average total IgG trough level at steady state being 8.05 g/L with TEGELINE ® and 9.17 g/L with ClairYg ® (i.e. geometric mean for the difference between ClairYg ® and TEGELINE ® was 1.136; [90% CI: 1.092–1.181] P  4–6 g/L) throughout the study. No patient was hospitalized for infection or had serious bacterial infections while receiving ClairYg ® . The median annualized infections rate per patient was similar for both products: 4.35 [0; 21.8] for TEGELINE ® and 4.30 [0; 15.1] for ClairYg ® . Infections were less common with higher IgG trough levels (> 8.16 g/L). ClairYg ® showed good safety, in particular good hepatic and renal tolerance, and did not induce hemolysis. ClairYg ® pharmacokinetics profile was comparable to that of TEGELINE ® . Conclusion ClairYg ® is safe and effective in the treatment of adult PID.