Switching clotting factor concentrates: Considerations in estimating the risk of immunogenicity

Haemophilia

Volumn 20, Issue 2, 2014, Pages 200-206

  Matino, D ^a   Lillicrap, D ^b   Astermark, J ^c   Dolan, G ^d   Kessler, C ^e   Lambert, T ^f   Makris, M ^g   O'Donnell, J ^h   Pipe, S ⁱ   Santagostino, E ^j   Saint Remy, J M ^k   Schramm, W ^l   Iorio, A ^m  

^a UNIVERSITY OF PERUGIA   (Italy)

^b QUEEN S UNIVERSITY   (Canada)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d QUEEN S MEDICAL CENTRE   (United Kingdom)

^e GEORGETOWN UNIVERSITY   (United States)

^f BICÊTRE HOSPITAL   (France)

^g UNIVERSITY OF SHEFFIELD   (United Kingdom)

^h ST JAMES S HOSPITAL   (Ireland)

ⁱ UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^j FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^k UNIVERSITY OF LEUVEN   (Belgium)

^l LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^m MCMASTER UNIVERSITY   (Canada)

more..

Author keywords

Clotting factor concentrates; Haemophilia; Immunogenicity; Inhibitors

Indexed keywords

CLOTTING FACTOR CONCENTRATES; HAEMOPHILIA; IMMUNOGENICITY; INHIBITORS;

ANTIBODIES, NEUTRALIZING; DRUG SUBSTITUTION; FACTOR VIII; HEMOPHILIA A; HUMANS; INCIDENCE;

EID: 84894269397     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12283     Document Type: Article

References (23)

1. Key NS, Negrier C. Coagulation factor concentrates: past, present, and future. Lancet 2007; 370: 439-48.
2. Hoyer LW. Factor VIII inhibitors: a continuing problem. J Lab Clin Med 1993; 121: 385-7.
3. Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia 2003; 9: 418-35.
4. Darby SC, Keeling DM, Spooner RJ et al. The incidence of factor VIII and factor IX inhibitors in the hemophilia population of the UK and their effect on subsequent mortality, 1977-99. J Thromb Haemost 2004; 2: 1047-54.
5. McMillan CW, Shapiro SS, Whitehurst D, Hoyer LW, Rao AV, Lazerson J. The natural history of factor VIII:C inhibitors in patients with hemophilia A: a national cooperative study. II. Observations on the initial development of factor VIII:C inhibitors. Blood 1988; 71: 344-8.
6. Kempton CL, Soucie JM, Abshire TC. Incidence of inhibitors in a cohort of 838 males with hemophilia A previously treated with factor VIII concentrates Journal of thrombosis and haemostasis. Thromb Haemost 2006; 4: 2576-81.
7. Astermark J. Prevention and prediction of inhibitor risk. Haemophilia 2012; 18(Suppl 4): 38-42.
8. Hay CRM, Palmer B, Chalmers E et al. Incidence of factor VIII inhibitors throughout life in severe hemophilia A in the United Kingdom. Blood 2011; 117: 6367-70.
9. Vermylen J, Peerlinck K. Epidemic of factor VIII inhibitors linked to factor VIII-P. Acta Clin Belg 1991; 46: 419-20.
10. Rosendaal FR, Nieuwenhuis HK, Van den Berg HM et al. A sudden increase in factor VIII inhibitor development in multitransfused hemophilia A patients in The Netherlands. Dutch Hemophilia Study Group. Blood 1993; 81: 2180-6.
11. Giles AR, Rivard GE, Teitel J, Walker I. Surveillance for factor VIII inhibitor development in the Canadian Hemophilia A population following the widespread introduction of recombinant factor VIII replacement therapy. Transfusion Sci 1998; 19: 139-48.
12. Rubinger M, Lillicrap D, Rivard GE et al. A prospective surveillance study of factor VIII inhibitor development in the Canadian haemophilia A population following the switch to a recombinant factor VIII product formulated with sucrose. Haemophilia 2008; 14: 281-6.
13. Baglin T, Beacham E. Is a change of factor VIII product a risk factor for the development of a factor VIII inhibitor? Thromb Haemost 1998; 80: 1036-7.
14. Rea C, Dunkerley A, Sørensen B, Rangarajan S. Pharmacokinetics, coagulation factor consumption and clinical efficacy in patients being switched from full-length FVIII treatment to B-domain-deleted r-FVIII and back to full-length FVIII. Haemophilia 2009; 15: 1237-42.
15. Singleton E, Smith J, Kavanagh M, Nolan B, White B. Low risk of inhibitor formation in haemophilia patients after a change in treatment from Chinese hamster ovary cell-produced to baby hamster kidney cell-produced recombinant factor VIII. Thromb Haemost 2007; 98: 1188-92.
16. ®). Haemophilia 2011; 17: 407-11.
17. Gouw SC, Van der Bom JG, Auerswald G, Escuriola EC, Tedgard U, Van den Berg HM. Recombinant versus plasma-derived factor VIII products and the development of inhibitors in previously untreated patients with severe hemophilia A: the CANAL cohort study. Blood 2007; 109: 4693-7.
18. Gouw SC, Van der Bom JG, Ljung R et al. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.
19. Christiansen MLS, Balling KW, Persson E et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia 2010; 16: 878-87.
20. Stennicke HR, Kjalke M, Karpf DM et al. A novel B-domain O-glycoPEGylated FVIII (N8-GP) demonstrates full efficacy and prolonged effect in hemophilic mice models. Blood Jan 18 2013; 121: 2108-16.
21. Powell JS, Josephson NC, Quon D et al. Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients. Blood 2012; 119: 3031-7.
22. Makris M, Calizzani G, Fischer K et al. EUHASS: the European Haemophilia Safety Surveillance system. Thromb Res 2011; 127(Suppl): S22-5.
23. Siegmund B, Pollmann H, Richter H, Orlovic M, Gottstein S, Klamroth R. Inhibitor development against FVIII in previously treated patients with haemophilia A. A retrospective data collection. Hämostaseologie 2010; 30: S37-9.