Pharmacokinetics, efficacy and safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in previously treated patients with severe hemophilia A

Results of a prospective, multicenter, open-label phase III study

L. Nemes, T. Lissitchkov, G. Dobaczewski, A. Klukowska, V. Komrska, R. Zimmermann, G. Auerswald, W. Engl, B. Abbühl, B. G. Pavlova, H. J. Ehrlich

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: IMMUNATE® Solvent/Detergent (S/D) is a plasma-derived, human factor VIII (FVIII)/von Willebrand factor (VWF) complex subjected to S/D and vapor heat treatment. Methods: This prospective clinical study evaluated the pharmacokinetics (PK) (compared to IMMUNATE®), efficacy and safety of IMMUNATE S/D in 56 previously treated patients with severe hemophilia A. Subjects received IMMUNATE S/D either on-demand (47/56), as a prophylactic regimen (49/56), or both (40/56). Results: IMMUNATE and IMMUNATES/D were equivalent with respect to the FVIII and VWF PK parameters assessed. Bleeding episodes (623) were reported in 47/56 subjects. For 89% of episodes, subjects required only 1 infusion with a mean dose of 29.6 IU/kg and 96% of episodes had an excellent or good response. The duration of prophylaxis ranged from 0.1 to 5.2 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0-10). No FVIII inhibitory antibodies were observed in 56 subjects after 2,646 treatment exposure days. No related serious adverse events were reported. Conclusion: The introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules in IMMUNATE S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures and prophylaxis.

Original languageEnglish
Pages (from-to)89-97
Number of pages9
JournalActa Haematologica
Volume119
Issue number2
DOIs
Publication statusPublished - Apr 2008

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Hemophilia A
Detergents
Pharmacokinetics
Safety
Hemorrhage
Factor VIII
Therapeutics
Hot Temperature
Prospective Studies
Antibodies
factor VIII, von Willebrand factor drug combination

Keywords

  • Factor VIII
  • Hemophilia A
  • IMMUNATE® S/D
  • Von Willebrand factor

ASJC Scopus subject areas

  • Hematology

Cite this

Pharmacokinetics, efficacy and safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in previously treated patients with severe hemophilia A : Results of a prospective, multicenter, open-label phase III study. / Nemes, L.; Lissitchkov, T.; Dobaczewski, G.; Klukowska, A.; Komrska, V.; Zimmermann, R.; Auerswald, G.; Engl, W.; Abbühl, B.; Pavlova, B. G.; Ehrlich, H. J.

In: Acta Haematologica, Vol. 119, No. 2, 04.2008, p. 89-97.

Research output: Contribution to journalArticle

Nemes, L. ; Lissitchkov, T. ; Dobaczewski, G. ; Klukowska, A. ; Komrska, V. ; Zimmermann, R. ; Auerswald, G. ; Engl, W. ; Abbühl, B. ; Pavlova, B. G. ; Ehrlich, H. J. / Pharmacokinetics, efficacy and safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in previously treated patients with severe hemophilia A : Results of a prospective, multicenter, open-label phase III study. In: Acta Haematologica. 2008 ; Vol. 119, No. 2. pp. 89-97.
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title = "Pharmacokinetics, efficacy and safety of IMMUNATE{\circledR} Solvent/Detergent (IMMUNATE{\circledR} S/D) in previously treated patients with severe hemophilia A: Results of a prospective, multicenter, open-label phase III study",
abstract = "Background: IMMUNATE{\circledR} Solvent/Detergent (S/D) is a plasma-derived, human factor VIII (FVIII)/von Willebrand factor (VWF) complex subjected to S/D and vapor heat treatment. Methods: This prospective clinical study evaluated the pharmacokinetics (PK) (compared to IMMUNATE{\circledR}), efficacy and safety of IMMUNATE S/D in 56 previously treated patients with severe hemophilia A. Subjects received IMMUNATE S/D either on-demand (47/56), as a prophylactic regimen (49/56), or both (40/56). Results: IMMUNATE and IMMUNATES/D were equivalent with respect to the FVIII and VWF PK parameters assessed. Bleeding episodes (623) were reported in 47/56 subjects. For 89{\%} of episodes, subjects required only 1 infusion with a mean dose of 29.6 IU/kg and 96{\%} of episodes had an excellent or good response. The duration of prophylaxis ranged from 0.1 to 5.2 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0-10). No FVIII inhibitory antibodies were observed in 56 subjects after 2,646 treatment exposure days. No related serious adverse events were reported. Conclusion: The introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules in IMMUNATE S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures and prophylaxis.",
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T1 - Pharmacokinetics, efficacy and safety of IMMUNATE® Solvent/Detergent (IMMUNATE® S/D) in previously treated patients with severe hemophilia A

T2 - Results of a prospective, multicenter, open-label phase III study

AU - Nemes, L.

AU - Lissitchkov, T.

AU - Dobaczewski, G.

AU - Klukowska, A.

AU - Komrska, V.

AU - Zimmermann, R.

AU - Auerswald, G.

AU - Engl, W.

AU - Abbühl, B.

AU - Pavlova, B. G.

AU - Ehrlich, H. J.

PY - 2008/4

Y1 - 2008/4

N2 - Background: IMMUNATE® Solvent/Detergent (S/D) is a plasma-derived, human factor VIII (FVIII)/von Willebrand factor (VWF) complex subjected to S/D and vapor heat treatment. Methods: This prospective clinical study evaluated the pharmacokinetics (PK) (compared to IMMUNATE®), efficacy and safety of IMMUNATE S/D in 56 previously treated patients with severe hemophilia A. Subjects received IMMUNATE S/D either on-demand (47/56), as a prophylactic regimen (49/56), or both (40/56). Results: IMMUNATE and IMMUNATES/D were equivalent with respect to the FVIII and VWF PK parameters assessed. Bleeding episodes (623) were reported in 47/56 subjects. For 89% of episodes, subjects required only 1 infusion with a mean dose of 29.6 IU/kg and 96% of episodes had an excellent or good response. The duration of prophylaxis ranged from 0.1 to 5.2 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0-10). No FVIII inhibitory antibodies were observed in 56 subjects after 2,646 treatment exposure days. No related serious adverse events were reported. Conclusion: The introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules in IMMUNATE S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures and prophylaxis.

AB - Background: IMMUNATE® Solvent/Detergent (S/D) is a plasma-derived, human factor VIII (FVIII)/von Willebrand factor (VWF) complex subjected to S/D and vapor heat treatment. Methods: This prospective clinical study evaluated the pharmacokinetics (PK) (compared to IMMUNATE®), efficacy and safety of IMMUNATE S/D in 56 previously treated patients with severe hemophilia A. Subjects received IMMUNATE S/D either on-demand (47/56), as a prophylactic regimen (49/56), or both (40/56). Results: IMMUNATE and IMMUNATES/D were equivalent with respect to the FVIII and VWF PK parameters assessed. Bleeding episodes (623) were reported in 47/56 subjects. For 89% of episodes, subjects required only 1 infusion with a mean dose of 29.6 IU/kg and 96% of episodes had an excellent or good response. The duration of prophylaxis ranged from 0.1 to 5.2 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0-10). No FVIII inhibitory antibodies were observed in 56 subjects after 2,646 treatment exposure days. No related serious adverse events were reported. Conclusion: The introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules in IMMUNATE S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures and prophylaxis.

KW - Factor VIII

KW - Hemophilia A

KW - IMMUNATE® S/D

KW - Von Willebrand factor

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