Annals of Hematology

, Volume 92, Issue 5, pp 689–698

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

DOI: 10.1007/s00277-013-1678-4

Cite this article as:
Pollmann, H., Klamroth, R., Vidovic, N. et al. Ann Hematol (2013) 92: 689. doi:10.1007/s00277-013-1678-4

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 VIIIHemophiliaInhibitorProphylaxisQuality of life

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