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.
2012-02-27
Eng.
Department of Internal Medicine, Academic Medical Centre, Amsterdam, The Netherlands.
Clin Immunol. 2012 Mar;142(3):280-90
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