Details

Autor(en) / Beteiligte

• Viallard, J.-F.
• Brion, J.-P.
• Malphettes, M.
• Durieu, I.
• Gardembas, M.
• Schleinitz, N.
• Hoarau, C.
• Lazaro, E.
• Puget, S.

Titel

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)

Ist Teil von

• La revue de medecine interne, 2017-09, Vol.38 (9), p.578-584

Ort / Verlag

France: Elsevier SAS

Erscheinungsjahr

2017

Quelle

MEDLINE

Beschreibungen/Notizen

• 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®. 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. Bioequivalence was established with a mean average total IgG trough level at steady state being 8.05g/L with TEGELINE® and 9.17g/L with ClairYg® (i.e. geometric mean for the difference between ClairYg® and TEGELINE® was 1.136; [90% CI: 1.092–1.181] P<0.001), within the pre-specified margin to establish bioequivalence (0.80–1.25). Total IgG trough levels remained clinically adequate (>4–6g/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 (>8.16g/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®. ClairYg® is safe and effective in the treatment of adult PID.