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Evaluation of pharmacokinetics, efficacy and safety of Immunate ® solvent detergent in previously treated patients with severe haemophilia A
Author(s) -
NEMES L.,
LISSITCHKOV T.,
KLUKOWSKA A.,
DOBACZEWSKI G.,
KOMRSKA V.,
ZIMMERMANN R.,
AUERSWALD G.,
ENGL W.,
PAVLOVA B.,
ABBÜHL B.,
EHRLICH H. J.
Publication year - 2007
Publication title -
haemophilia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.213
H-Index - 92
eISSN - 1365-2516
pISSN - 1351-8216
DOI - 10.1111/j.1365-2516.2006.01412.x
Subject(s) - medicine , haemophilia , haemophilia a , pharmacokinetics , adverse effect , von willebrand factor , regimen , population , von willebrand disease , gastroenterology , surgery , platelet , environmental health
Summary. Immunate ® 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 ® ), efficacy and safety of Immunate ® S/D in 56 previously treated patients with severe haemophilia A. Subjects received Immunate ® S/D on‐demand, as a prophylactic regimen or both. The results of the pharmacokinetic population demonstrate that Immunate ® and Immunate ® 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 ® S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures, and prophylaxis.