Summary of progress since surveillance began on 1 October 2008
EUHASS Aggregated Data
Aggregated data from the EUHASS adverse event reporting system can be seen here.
Brief, quarterly reports of adverse events are issued at the end of each 3 month period. A more detailed annual report, with analysis of event rates according to diagnosis, treatment status and clotting factor concentrate, is produced after each full year of surveillance.
Reports are distributed to the participating centres, to the pharmaceutical companies who are co-funding the project, as well as to national patient groups (via European Haemophilia Consortium), European and other regulatory authorities (e.g. European Medicines Agency, US Food and Drug Administration) and to healthcare professionals providing care for people with haemophilia and other bleeding disorders in Europe (via European Association for Haemophilia and Allied Disorders).
Fischer K, Iorio A, Hollingsworth R, Makris M, Watson H, Rae J et al. FVIII inhibitor development according to concentrate: Data from the EUHASS registry excluding overlap with other studies. Haemophilia. 2016 Jan 1;22(1):e36-e38.
Inhibitor development in non-severe hemophilia across Europe. K. Fischer, A. Iorio, R. Lassila, F. Peyvandi, G. Calizzani, A. Gatt, T. Lambert, J. Windyga, E.A. Gilman, M. Makris on behalf of the EUHASS participants. Thrombosis and Haemostasis 2015 114 4:670-675
Inhibitor development in haemophilia according to concentrate: Four-year results from the European HAemophilia Safety Surveillance (EUHASS) project. K. Fischer, R. Lassila, F. Peyvandi, G. Calizzani, A. Gatt, T. Lambert, J. Windyga ,A. Iorio, E. Gilman, M. Makris on behalf of the EUHASS participants. Thrombosis and Haemostasis 2015 113 5:968-975
Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies.
Coppola A, Franchini M, Makris M, Santagostino E, Di Minno G and Mannucci PM.
Haemophilia 2012. doi: 10.1111/j.1365-2516.2012.02758.x
Article first published online: 15 FEB 2012
Non-thrombotic-, non-inhibitor-associated adverse reactions to coagulation factor concentrates for treatment of patients with hemophilia and von Willebrand’s disease: a systematic review of prospective studies.
Franchini M, Makris M, Santagostino E, Coppola A and Mannucci PM.
Haemophilia 2012. doi: 10.1111/j.1365-2516.2011.02745.x
Article first published online: 18 JAN 2012
Validity of assessing inhibitor development in haemophilia PUPs using registry data: the EUHASS project.
Fischer K, Lewandowski D, Marijke van den Berg H and Janssen MP.
Haemophilia 2011. doi: 10.1111/j.1365-2516.2011.02687.x
Article first published online: 2 NOV 2011
Monitoring inhibitor development in haemophilia: 2-year results of EUHASS.
Fischer K, Makris M, Calizanni G, Hay C, Ludlam C, Lambert T, Lassila R and Mannucci P.
Journal of Thrombosis and Haemostasis 2011 ; 9 (Suppl. 2): 301
EUHASS: The first 2 years of adverse event monitoring in persons with inherited bleeding disorders in Europe.
Makris M, Fischer K, Calizzani G, Hay C, Ludlam C, Lambert T, Lassila R and Mannucci P.
Journal of Thrombosis and Haemostasis 2011 ; 9 (Suppl. 2): 928
Thrombosis in patients with factor VII deficiency after treatment with concentrate.
Makris M, Stefanska-Windyga E, Horneff S, Peyvandi F, Lissitchkov T, Tagliaferri A, Oldenberg J and Windyga J.
Journal of Thrombosis and Haemostasis 2011 ; 9 (Suppl. 2): 935
EUHASS: The European Haemophilia Safety Surveillance system.
Makris M, Calizzani G, Fischer K, Gilman EA, Hay CRM, Lassila R, Lambert T, Ludlam CA, Mannucci PM.
Thrombosis Research 2011; 127 (Suppl 2): S22- S25
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EUHASS: The first 12 months of a European adverse event reporting system for haemophilia.
Makris M, Calizzani G, Fischer K, Hay CRM, Ludlam CA, Lambert T, Lassila R, Mannucci PM on behalf of the EUHASS participants.
Haemophilia 2010; 16 (Suppl 4):109
Using a registry to monitor inhibitor development in haemophilia: first results of EUHASS.
Fischer K, Makris M, Calizzani G, Hay CRM, Ludlam CA, Lambert T, Lassila R, Mannucci PM on behalf of the EUHASS participants
Haemophilia 2010; 16 (Suppl 4):47
Pharmacovigilance: clinical studies (adverse events)
M. Makris M.
Haemophilia 2010; 16 (Suppl 4): 29
Biovigilance and pharmacovigilance for haemophilia
Weinstein M, Makris M, Ludlam CA.
Haemophilia 2010; 16 (Suppl 5): 17-21
Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review.
Iorio A, Halimeh S, Holzhauer S, Goldenberg N, Marchesini E, Marcucci M, Young G, Bidlingmaier C, Brandao LR, Ettingshausen CE, Gringeri A, Kenet G, Knöfler R, Kreuz W, Kurnik K, Manner D, Santagostino E, Mannucci PM, Nowak-Göttl U.
J. Thromb. Haemost. 2010; 8: 1256-1265
How I treat age-related morbidities in elderly persons with hemophilia.
Mannucci PM, Schutgens REG, Santagostino E, Mauser-Bunschoten EP,
Blood 2009; 114:5256-5263
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