Document Detail

Recombinant versus plasma-derived factor VIII products and the development of inhibitors in previously untreated patients with severe hemophilia A: the CANAL cohort study.
MedLine Citation:
PMID:  17218379     Owner:  NLM     Status:  MEDLINE    
It has been suggested that plasma-derived factor VIII products induce fewer inhibitors than recombinant factor VIII products. We investigated the relationship of factor VIII product type and switching between factor VIII products with the risk to develop inhibitors. This multicenter retrospective cohort study included 316 patients with severe hemophilia A born between 1990 and 2000. The outcome was clinically relevant inhibitor development, defined as the occurrence of at least 2 positive inhibitor titers with decreased recovery. The risk of inhibitor development was not clearly lower in plasma-derived compared with recombinant factor VIII products (relative risk [RR], 0.8; 95% confidence interval [CI], 0.5-1.3). Among high-titer inhibitors, the possible reduction in risk was even less pronounced (RR, 0.9; CI, 0.5-1.5). Plasma-derived products with considerable quantities of von Willebrand factor (VWF) carried the same risk for inhibitor development as recombinant factor VIII products (RR, 1.0; CI, 0.6-1.6). Switching between factor VIII products did not increase the risk for inhibitors (RR, 1.1; CI, 0.6-1.8). In conclusion, our findings support neither the notion that plasma-derived factor VIII products with considerable concentrations of VWF confer a lower risk to develop inhibitory antibodies than recombinant factor VIII products, nor that switching between factor VIII product brands increases inhibitor risks in previously untreated patients with severe hemophilia A.
Samantha C Gouw; Johanna G van der Bom; Günter Auerswald; Carmen Escuriola Ettinghausen; Ulf Tedgård; H Marijke van den Berg
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2007-01-11
Journal Detail:
Title:  Blood     Volume:  109     ISSN:  0006-4971     ISO Abbreviation:  Blood     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-05-24     Completed Date:  2007-07-02     Revised Date:  2007-11-28    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  4693-7     Citation Subset:  AIM; IM    
Van Creveldlkiniek, University Medical Center Utrrecht, Utrecht, The Netherlands.
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MeSH Terms
Antibodies / blood,  immunology
Blood Coagulation Factors / antagonists & inhibitors,  chemistry*
Cohort Studies
Factor VIII / adverse effects,  immunology,  therapeutic use*
Hemophilia A / drug therapy*
Plasma / metabolism*
Recombinant Proteins / adverse effects,  therapeutic use*
Regression Analysis
Retrospective Studies
Time Factors
Reg. No./Substance:
0/Antibodies; 0/Blood Coagulation Factors; 0/F8 protein, human; 0/Recombinant Proteins; 9001-27-8/Factor VIII
Comment In:
Blood. 2007 Oct 15;110(8):3084; author reply 3085   [PMID:  17916754 ]

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