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Nemes, L. et al.

Evaluation of pharmacokinetics, efficacy and safety of Immunate((R)) solvent detergent in previously treated patients with severe haemophilia A.

Immunate((R)) Solvent Detergent (S/D) is a plasma derived, purified, human factor VIII (FVIII) - von Willebrand factor (VWF) complex subjected to two virus inactivation/removal processes: S/D and vapor heat treatment. This prospective, multicentre, three-part clinical study evaluated the pharmacokinetics (in comparison to the predecessor product Immunate((R))), efficacy and safety of Immunate((R)) S/D in 56 previously treated patients with severe haemophilia A. Subjects received Immunate((R)) S/D on-demand, as a prophylactic regimen or both. The results of the pharmacokinetic population demonstrate that Immunate((R)) and Immunate((R)) S/D were equivalent with respect to the FVIII - and to the retrospectively VWF - parameters assessed. A total of 623 bleeding episodes were reported in 47/56 subjects. The duration of prophylaxis ranged from 0.1--5.2 months with a total of 175.6 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0--10). Ninety-six percent of bleeding episodes were rated as having an excellent or good response. For most bleeding episodes (89%), subjects required only one infusion with a mean dose of 29.6 IU kg(-1). No FVIII inhibitory antibodies were observed in any subject. No related serious adverse events were reported. Thus, the introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules of Immunate((R)) S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures, and prophylaxis.[1]

References

Evaluation of pharmacokinetics, efficacy and safety of Immunate((R)) solvent detergent in previously treated patients with severe haemophilia A. Nemes, L., Lissitchkov, T., Klukowska, A., Dobaczewski, G., Komrska, V., Zimmermann, R., Auerswald, G., Engl, W., Pavlova, B., Abb??hl, B., Ehrlich, H.J. Haemophilia : the official journal of the World Federation of Hemophilia (2007) [Pubmed]

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