Document Detail

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.
MedLine Citation:
PMID:  23324986     Owner:  NLM     Status:  MEDLINE    
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.
Hartmut Pollmann; Robert Klamroth; Natascha Vidovic; Alexander Y Kriukov; Joshua Epstein; Ingo Abraham; Gerald Spotts; Johannes Oldenburg
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Publication Detail:
Type:  Evaluation Studies; Journal Article     Date:  2013-01-17
Journal Detail:
Title:  Annals of hematology     Volume:  92     ISSN:  1432-0584     ISO Abbreviation:  Ann. Hematol.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-04-08     Completed Date:  2013-05-28     Revised Date:  2013-07-25    
Medline Journal Info:
Nlm Unique ID:  9107334     Medline TA:  Ann Hematol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  689-98     Citation Subset:  IM    
Ambulanzzentrum an der Raphaelsklinik, Institut für Thrombophilie und Hämostaseologie, Loerstraße 19, Münster, Germany.
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MeSH Terms
Chemoprevention* / methods
Child, Preschool
Drug Approval
Factor VIII / administration & dosage*
Hemophilia A / drug therapy*
Infant, Newborn
Middle Aged
Product Surveillance, Postmarketing*
Quality of Life*
Recombinant Proteins / administration & dosage
Serum Albumin / administration & dosage
Young Adult
Reg. No./Substance:
0/F8 protein, human; 0/Recombinant Proteins; 0/Serum Albumin; 9001-27-8/Factor VIII
Erratum In:
Ann Hematol. 2013 Jul;92(7):1005

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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