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Blood, 1 June 2007, Vol. 109, No. 11, pp. 4693-4697. Prepublished online as a Blood First Edition Paper on January 11, 2007; DOI 10.1182/blood-2006-11-056317. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2006-11-056317v1 109/11/4693    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Gouw, S. C. Articles by van den Berg, H. M. Search for Related Content PubMed PubMed Citation Articles by Gouw, S. C. Articles by van den Berg, H. M. Related Collections Hemostasis, Thrombosis, and Vascular Biology Clinical Trials and Observations Related Articles in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Recombinant versus plasma-derived factor VIII products and the development of inhibitors in previously untreated patients with severe hemophilia A: the CANAL cohort study Samantha C. Gouw1,2, Johanna G. van der Bom3, Günter Auerswald4, Carmen Escuriola Ettinghausen5, Ulf Tedgård6, H. Marijke van den Berg1, for the CANAL Study group 1 Van Creveldkliniek, University Medical Center Utrecht, the Netherlands; 2 Department of Pediatrics, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands; 3 Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands; 4 Prof Hess-Kinderklinik, Zentrum fur Kinderheilkunde und Jugendmedizin, Bremen, Germany; 5 Centre of Pediatrics III, Department of Hematology, Oncology and Haemostaseology, Johann-Wolfgang-Goethe University Hospital, Frankfurt AM Main, Germany; 6 Department of Pediatrics, University of Lund, University Hospital, Malmö, Sweden 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. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Articles in Blood Online: Immunogenicity of factor VIII concentrates in patients with hemophilia: a randomized clinical trial is warranted Alessandro Gringeri and Pier Mannuccio Mannucci Blood 2007 110: 3084. [Full Text] [PDF] Response: Immunogenicity of factor VIII concentrates in patients with hemophilia: the next sensible step Johanna G. van der Bom, Samantha C. Gouw, and H. Marijke van den Berg Blood 2007 110: 3085. [Full Text] [PDF] Associations between type of product and inhibitors in previously untreated patients (PUPs) with severe hemophilia: switches and particular products can disturb analysis Thierry Calvez, Yves Laurian, and Jenny Goudemand Blood 2007 110: 1073-1074. [Full Text] [PDF] Response: Plasma-derived or recombinant factor VIII products and inhibitors in previously untreated patients with severe hemophilia Johanna G. van der Bom, Samantha C. Gouw, and H. Marijke van den Berg Blood 2007 110: 1074-1075. [Full Text] [PDF] Inhibitors in hemophilia: nature or nurture? Thomas Abshire Blood 2007 109: 4596. [Full Text] [PDF] This article has been cited by other articles: J. Krudysz-Amblo, B. Parhami-Seren, S. Butenas, K. E. Brummel-Ziedins, E. D. Gomperts, G. E. Rivard, and K. G. Mann Quantitation of anti-factor VIII antibodies in human plasma Blood, March 12, 2009; 113(11): 2587 - 2594. [Abstract] [Full Text] [PDF] C. L. Kempton and G. C. White II How we treat a hemophilia A patient with a factor VIII inhibitor Blood, January 1, 2009; 113(1): 11 - 17. [Abstract] [Full Text] [PDF] A. Gringeri and P. M. Mannucci Immunogenicity of factor VIII concentrates in patients with hemophilia: a randomized clinical trial is warranted Blood, October 15, 2007; 110(8): 3084 - 3084. [Full Text] [PDF] J. G. van der Bom, S. C. Gouw, and H. M. van den Berg Response: Immunogenicity of factor VIII concentrates in patients with hemophilia: the next sensible step Blood, October 15, 2007; 110(8): 3085 - 3085. [Full Text] [PDF] S. Delignat, S. Dasgupta, S. Andre, A.-M. Navarrete, S. V. Kaveri, J. Bayry, M.-H. Andre, S. Chtourou, Z. Tellier, and S. Lacroix-Desmazes Comparison of the immunogenicity of different therapeutic preparations of human factor VIII in the murine model of hemophilia A Haematologica, October 1, 2007; 92(10): 1423 - 1426. [Abstract] [Full Text] [PDF] J. G. van der Bom, S. C. Gouw, and H. M. van den Berg Response: Plasma-derived or recombinant factor VIII products and inhibitors in previously untreated patients with severe hemophilia Blood, August 1, 2007; 110(3): 1074 - 1075. [Full Text] [PDF] T. Calvez, Y. Laurian, and J. Goudemand Associations between type of product and inhibitors in previously untreated patients (PUPs) with severe hemophilia: switches and particular products can disturb analysis Blood, August 1, 2007; 110(3): 1073 - 1074. [Full Text] [PDF]

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