Analyses of the FranceCoag cohort support differences in immunogenicity among one plasma-derived and two recombinant factor VIII brands in boys with severe hemophilia A
Thierry Calvez,
Hervé Chambost,
Roseline d’Oiron,
Vincent Dalibard,
Virginie Demiguel,
Alexandra Doncarli,
Yves Gruel,
Yoann Huguenin,
Patrice Lutz,
Chantal Rothschild,
Christine Vinciguerra,
Jenny Goudemand,
for FranceCoag Collaborators
Affiliations
Thierry Calvez
Sorbonne Universités, UPMC Paris 06, Inserm, Institut Pierre Louis d’Épidémiologie et de Santé Publique (IPLESP UMRS 1136), France
Hervé Chambost
Service d’Hématologie Oncologie Pédiatrique, La Timone, APHM, Marseille, France;Aix Marseille University, INSERM, INRA, NORT, Marseille, France
Roseline d’Oiron
Centre Régional de Traitement de l’Hémophilie, Hôpital Bicêtre, Hôpitaux Universitaires Paris Sud, APHP, Le Kremlin Bicêtre, France
Vincent Dalibard
Département d’Hématologie et de Transfusion, Centre Hospitalier Universitaire de Lille, Université Lille 2, EA 2693, Faculté de Médecine, France
Virginie Demiguel
Santé Publique France, French National Public Health Agency, Saint-Maurice, France
Alexandra Doncarli
Santé Publique France, French National Public Health Agency, Saint-Maurice, France
Yves Gruel
Centre Régional de Traitement de l’Hémophilie, Laboratoire d’Hématologie, UMR CNRS 7292, Université François Rabelais, Tours, France
Yoann Huguenin
Service d’Hématologie, Hôpital Pellegrin Tripode, Bordeaux, France
Patrice Lutz
Unité Pédiatrique d’Hématologie Oncologie, Hôpital Hautepierre, Strasbourg, France
Chantal Rothschild
Centre Régional de Traitement de l’Hémophilie, Hôpital Necker, APHP, Paris, France
Christine Vinciguerra
Service d’Hématologie Biologique, Hospices Civils de Lyon, EA 4609, Université de Lyon, France
Jenny Goudemand
Département d’Hématologie et de Transfusion, Centre Hospitalier Universitaire de Lille, Université Lille 2, EA 2693, Faculté de Médecine, France;Institut Pasteur de Lille, EGID, Inserm UMR 1011, Université Lille 2, France
Around one third of boys with severe hemophilia A develop inhibitors (neutralizing antibodies) against their therapeutic factor VIII product. This adverse effect may result in more life-threatening bleeding, disability, impaired quality of life, and costly care. We compared the incidence of inhibitors in boys treated with the three factor VIII products most used in France: one plasma-derived (Factane) and two recombinant products (Advate and Kogenate Bayer). A previously untreated cohort of patients was created in 1994 to investigate risk factors for inhibitor development. We selected boys with severe hemophilia A (factor VIII