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Prophylaxis and quality of life in patients with hemophilia A during routine treatment with ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] in Germany: a subgroup analysis of the ADVATE PASS post-approval, non-interventional study

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An Erratum to this article was published on 01 May 2013

Abstract

Antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) was evaluated during routine practice in Germany, among consenting subjects of any age with hemophilia A (HA) and no prior exposure to rAHF-PFM. The treating physician chose the dosing and inhibitor testing frequency. Data were captured for 12 months/subject from diaries and clinic records. Of 152 subjects, 69 % had severe HA, and 89 % had >150 exposure 6 days (ED) at baseline. The majority of subjects (63 %) were treated by continuous prophylaxis (CP). Assignment to CP was more likely for subjects ≥2 years of age and for those with FVIII ≤ 2 %. Median FVIII consumption was 3,548 IU/kg/year for CP and 999 IU/kg/year for continuous on-demand (OD) therapy. Median annual bleed rate was 0.82 for CP and 4.06 for OD. Of 1,218 bleeds, 97 % were home-treated and 68 % of evaluable bleeds involved joints. Based on evaluable subjects' worst ratings, 83/91 (91 %) on CP had a rating of excellent/good for all prophylactic assessments, 55/59 (93 %) on CP and 41/42 (98 %) on OD had a rating of excellent/good for all bleeding assessments. The de novo high-titer FVIII inhibitor rate in subjects with >50 ED at baseline was 1/144 (0.69 %; 95 % CI, 0.02 % to 3.81 %). No high-titer inhibitor occurred in patients with severe HA and >50 ED at baseline. Reduced HRQOL physical scores were predicted by older age (p < 0.0001), HIV positivity (p = 0.02), and presence of ≥1 target joint (p = 0.003). ADVATE rAHF-PFM is safe and efficacious for routine CP or OD management of patients with HA.

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Acknowledgments

The authors thank the following investigators for participating in this study: Guenter Auerswald*, Bremen; Volker Aumann, Magdeburg; Reiner Buchhorn, Bad Mergentheim; Barbara Eifrig, Hamburg; Dirk Franke, Magdeburg; Monika Girisch, Tubingen; Ralf Grossmann, Frankfurt; Karim Kentouche, Jena; Robert Klamroth,* Berlin; Manuela Krause, Frankfurt; Wolfhart Kreuz, Frankfurt; Maximilian Lakomek, Goettingen; Hans-Jurgen Laws, Duesseldorf; Harald Lenk, Leipzig; Bernhard Maak, Saalfeld; Christina Mondorf, Frankfurt; Claudia Niekrens, Delmenhorst; Antje Nimtz-Talaska, Frankfurt; Johannes Oldenburg, Bonn*; Sirak Petros, Leipzig; Hartmut Pollmann, Muenster; Rosemarie Schobess, Halle; Ute Scholz, Leipzig; Christine Schubert, Erfurt; Harry Sirb, Lichtenstein; Gunter, Syrbe, Stadtroda; Andreas Tiede, Hannover; Heiner Trobisch, Duisburg; Mario van Depka-Prondzinski, Hannover; Elini Wendisch, Dresden;Cornelia, Wermes, Hannover; Heiner Wolf, Dresden; Wolfgang Zeller, Hamburg; Rainer Zimmermann, Heidelberg; Rainer Zotz, Duesseldorf. The authors also thank Martha Sensel, PhD, for assistance writing the manuscript, as well as Clara Song, PharmD, for contribution to the manuscript.

*Institution participates in the European Hemophilia Safety Surveillance network.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Ambulanzzentrum an der Raphaelsklinik, Institut für Thrombophilie und Hämostaseologie, Loerstraße 19, 48143, Münster, Germany

    Hartmut Pollmann

  2. Klinik für Innere Medizin, Hämophiliezentrum, Vivantes-Klinikum in Friedrichshain, Berlin, Germany

    Robert Klamroth

  3. Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany

    Natascha Vidovic & Johannes Oldenburg

  4. Baxter Healthcare Corporation, Round Lake, IL, USA

    Alexander Y. Kriukov

  5. Baxter Healthcare Corporation, Westlake Village, CA, USA

    Joshua Epstein & Gerald Spotts

  6. Baxter Deutschland GmbH, Unterschleißheim, Germany

    Ingo Abraham

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  1. Hartmut Pollmann
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Pollmann, H., Klamroth, R., Vidovic, N. et al. Prophylaxis and quality of life in patients with hemophilia A during routine treatment with ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] in Germany: a subgroup analysis of the ADVATE PASS post-approval, non-interventional study. Ann Hematol 92, 689–698 (2013). https://doi.org/10.1007/s00277-013-1678-4

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