Treatment of hereditary angioedema with nanofiltered C1-esterase inhibitor concentrate (Cetor®): Multi-center phase II and III studies to assess pharmacokinetics, clinical efficacy and safety

Abstract From 1997, plasma-derived C1-inhibitor concentrate (Cetor®) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pha...

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Published in:Clinical immunology (Orlando, Fla.) Fla.), 2012-03, Vol.142 (3), p.280-290
Main Authors: Hofstra, J.J, Budde, I. Kleine, van Twuyver, E, Choi, G, Levi, M, Leebeek, F.W.G, de Monchy, J.G.R, Ypma, P.F, Keizer, R.J, Huitema, A.D.R, Strengers, P.F.W
Format: Article
Language:English
Subjects:
Adult
Allergic diseases
Allergy and Immunology
Angioedema
Angioedemas, Hereditary - drug therapy
Angioedemas, Hereditary - prevention & control
Biological and medical sciences
Complement C1 Inhibitor Protein - adverse effects
Complement C1 Inhibitor Protein - pharmacokinetics
Complement C1 Inhibitor Protein - therapeutic use
Female
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Humans
Immunopathology
Male
Medical sciences
Middle Aged
Nanofiltration
Plasma-derived C1-inhibitor
Skin allergic diseases. Stinging insect allergies
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Summary:Abstract From 1997, plasma-derived C1-inhibitor concentrate (Cetor®) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pharmacokinetics (PK) of nanofiltered (C1-INH-NF) with conventional C1-inhibitor (C1-INH). Efficacy and safety were investigated in an open-label, on-demand and a prophylactic study. No differences in pharmacokinetic parameters between C1-INH and C1-INH-NF were found (13 non-symptomatic HAE patients). Both C1-inhibitor products equally increased plasma C4 levels. In the on-demand study, 14 acute angioedema attacks in 8 patients were analyzed. In the prophylactic study, 1 AAE and 5 HAE patients experienced in total 31 attacks during 748 observation days. In total 180,000 units of C1-INH-NF were administered. No product-related adverse events occurred, and no anti-C1-antibodies were induced. Nanofiltration in the production process of C1-inhibitor did not affect the pharmacokinetics, efficacy, and safety.
ISSN:1521-6616
1521-7035
DOI:10.1016/j.clim.2011.11.005