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Switching clotting factor concentrates: considerations in estimating the risk of immunogenicity
Authors:D. Matino  D. Lillicrap  J. Astermark  G. Dolan  C. Kessler  T. Lambert  M. Makris  J. O'Donnell  S. Pipe  E. Santagostino  J.‐M. Saint‐Remy  W. Schramm  A. Iorio
Affiliation:1. Experimental Medicine and Biochemical Sciences, University of Perugia, , Perugia, Italy;2. Department of Pathology and Molecular Medicine, Richardson Laboratory, Queen's University, , Kingston, ON, Canada;3. Department of Hematology and Coagulation Disorders, Sk?ne University Hospital Malm?/Lund, , Malm?, Sweden;4. University Hospital, Queen's Medical Centre, , Nottingham, UK;5. Georgetown University, Medical Center, Lombardi Cancer Center, , Washington, DC, USA;6. Centre de Traitement des Hémophiles, H?pital de Bicêtre AP–HP, , Le Kremlin Bicêtre, France;7. Department of Cardiovascular Science, University of Sheffield, Royal Hallamshire Hospital, , Sheffield, UK;8. National Centre for Hereditary Coagulation Disorders, St James's Hospital & Trinity College Dublin, , Dublin, Ireland;9. Department of Pediatrics, Division of Pediatric Hematology/Oncology, University of Michigan, , Ann Arbor, Michigan, USA;10. Angelo Bianchi Bonomi Haemophilia and Thrombosis Centre of the IRCCS Maggiore Hospital, Mangiagalli and Regina, Elena Foundation, , Milan, Italy;11. Department of Immunology, University of Leuven, , Leuven, Belgium;12. Department of Transfusion Medicine and Haemostasis, University Hospital of Munich, , Munich, Germany;13. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, , Ontario, Canada
Abstract:The development of neutralizing antibodies to factor VIII (FVIII) is the most serious complication of therapy for haemophilia A. There is now excellent documentation that a large number of both genetic and environmental factors contribute to the risk of FVIII inhibitor incidence. One of the environmental factors that has been proposed as an influence on this complication is the occurrence of FVIII product switching. There are only a small number of clinical studies that have addressed this question, and thus, the amount of objective information available to assess this association is limited. In this review, in addition to summarizing past evidence pertinent to this subject, we present the results of a complementary strategy, a Delphi analysis, to add to the considerations of product switching and FVIII immunogenicity. With the imminent arrival in the clinic of several new FVIII products, the haemophilia community must be prepared to collect prospectively controlled data to better address this important management issue.
Keywords:clotting factor concentrates  haemophilia  immunogenicity  inhibitors
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