Annals of Hematology

, Volume 92, Issue 5, pp 689–698 | Cite as

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

  • Hartmut Pollmann
  • Robert Klamroth
  • Natascha Vidovic
  • Alexander Y. Kriukov
  • Joshua Epstein
  • Ingo Abraham
  • Gerald Spotts
  • Johannes Oldenburg
Original Article

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.

Keywords

Factor VIII Hemophilia Inhibitor Prophylaxis Quality of life 

Notes

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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Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  • Hartmut Pollmann
    • 1
  • Robert Klamroth
    • 2
  • Natascha Vidovic
    • 3
  • Alexander Y. Kriukov
    • 4
  • Joshua Epstein
    • 5
  • Ingo Abraham
    • 6
  • Gerald Spotts
    • 5
  • Johannes Oldenburg
    • 3
  1. 1.Ambulanzzentrum an der RaphaelsklinikInstitut für Thrombophilie und HämostaseologieMünsterGermany
  2. 2.Klinik für Innere Medizin, HämophiliezentrumVivantes-Klinikum in FriedrichshainBerlinGermany
  3. 3.Institute of Experimental Haematology and Transfusion MedicineUniversity Clinic BonnBonnGermany
  4. 4.Baxter Healthcare CorporationRound LakeUSA
  5. 5.Baxter Healthcare CorporationWestlake VillageUSA
  6. 6.Baxter Deutschland GmbHUnterschleißheimGermany

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