Switching treatments in haemophilia: Is there a risk of inhibitor development?

European Journal of Haematology

Volumn 94, Issue 4, 2015, Pages 284-289

  Santagostino, Elena ^a   Auerswald, Günter ^b   Benson, Gary ^c   Dolan, Gerry ^d   Jiménez Yuste, Victor ^e   Lambert, Thierry ^f   Ljung, Rolf ^g   Morfini, Massimo ^h   Remor, Eduardo ⁱ   Šalek, Silva Zupančić ^j  

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

^b KLINIKUM BREMEN MITTE   (Germany)

^c Northern Ireland Haemophilia Comprehensive Care Centre   (Ireland)

^d QUEEN S MEDICAL CENTRE   (United Kingdom)

^e HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^f ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^g LUND UNIVERSITY   (Sweden)

^h CAREGGI UNIVERSITY HOSPITAL   (Italy)

ⁱ UNIVERSIDAD AUTÓNOMA DE MADRID   (Spain)

^j KBC Zagreb   (Croatia)

more..

Author keywords

Haemophilia; Inhibitors; Product switching

Indexed keywords

BLOOD CLOTTING FACTOR 8 CONCENTRATE; BLOOD CLOTTING FACTOR 8 INHIBITOR; ALLOANTIBODY; BLOOD CLOTTING FACTOR 8; RECOMBINANT PROTEIN;

DRUG SUBSTITUTION; EVIDENCE BASED PRACTICE; HEMOPHILIA A; HUMAN; INCIDENCE; PATIENT ATTITUDE; PHYSICIAN ATTITUDE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK FACTOR; ANTAGONISTS AND INHIBITORS; IMMUNOLOGY; RISK;

DRUG SUBSTITUTION; FACTOR VIII; HEMOPHILIA A; HUMANS; ISOANTIBODIES; RECOMBINANT PROTEINS; RISK;

EID: 84925411090     PISSN: 09024441     EISSN: 16000609     Source Type: Journal    
DOI: 10.1111/ejh.12433     Document Type: Review

References (24)

1. Pipe S. Antihemophilic factor (recombinant) plasma/albumin-free method for the management and prevention of bleeding episodes in patients with hemophilia A. Biologics 2009;3:117-25.
2. Iorio A, Puccetti P, Makris M. Clotting factor concentrate switching and inhibitor development in hemophilia A. Blood 2012;120:720-7.
3. Mauser-Bunschoten EP, Rosendaal FR, Nieuwenhuis HK, Roosendaal G, Briet E, van den Berg HM. Clinical course of factor VIII inhibitors developed after exposure to a pasteurised Dutch concentrate compared to classic inhibitors in hemophilia A. Thromb Haemost 1994;71:703-6.
4. Peerlinck K, Arnout J, Gilles JG, Saint-Remy JM, Vermylen J. A higher than expected incidence of factor VIII inhibitors in multitransfused haemophilia A patients treated with an intermediate purity pasteurized factor VIII concentrate. Thromb Haemost 1993;69:115-8.
5. Peerlinck K, Arnout J, Di Giambattista M, Gilles JG, Laub R, Jacquemin M, Saint-Remy JM, Vermylen J. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 1997;77:80-6.
6. Matino D, Lillicrap D, Astermark J, et al. Switching clotting factor concentrates: considerations in estimating the risk of immunogenicity. Haemophilia 2014;20:200-6.
7. 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.
8. Aledort LM, Navickis RJ, Wilkes MM. Can B-domain deletion alter the immunogenicity of recombinant factor VIII? A meta-analysis of prospective clinical studies. J Thromb Haemost 2011;9:2180-92.
9. Gouw SC, Van der Bom JG, Marijke van den Berg H. Treatment-related risk factors of inhibitor development in previously untreated patients with hemophilia A: the CANAL cohort study. Blood 2007;109:4648-54.
10. Gouw SC, van den Berg HM, Fischer K, et al. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood 2013;121:4046-55.
11. Iorio A, Halimeh S, Holzhauer S, et al. Rate of inhibitor development in previously untreated hemophilia A patients treated with plasma-derived or recombinant factor VIII concentrates: a systematic review. J Thromb Haemost 2010;8:1256-65.
12. Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia 2003;9:418-35.
13. Chalmers EA, Brown SA, Keeling D, Liesner R, Richards M, Stirling D, Thomas A, Vidler V, Williams MD, Young D. Early factor VIII exposure and subsequent inhibitor development in children with severe haemophilia A. Haemophilia 2007;13:149-55.
14. Goudemand J, Rothschild C, Demiguel V, Vinciguerrat C, Lambert T, Chambost H, Borel-Derlon A, Claeyssens S, Laurian Y, Calvez T. Influence of the type of factor VIII concentrate on the incidence of factor VIII inhibitors in previously untreated patients with severe hemophilia A. Blood 2006;107:46-51.
15. Knobe KE, Sjorin E, Tengborn LI, Petrini P, Ljung RC. Inhibitors in the Swedish population with severe haemophilia A and B: a 20-year survey. Acta Paediatr 2002;91:910-4.
16. Gouw SC, van der Bom JG, Auerswald G, Ettinghausen CE, 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.
17. Gringeri A, Tagliaferri A, Tagariello G, Morfini M, Santagostino E, Mannucci P. Efficacy and inhibitor development in previously treated patients with haemophilia A switched to a B domain-deleted recombinant factor VIII. Br J Haematol 2004;126:398-404.
18. Iorio A, Marcucci M, Makris M. Concentrate-related inhibitor risk: is a difference always real? J Thromb Haemost 2011;9:2176-9.
19. Roussel-Robert V, Torchet MF, Legrand F, Rothschild C, Stieltjes N. Factor VIII inhibitors development following introduction of B-domain-deleted recombinant factor VIII in four hemophilia A previously treated patients. J Thromb Haemost 2003;1:2450-1.
20. Makris M, Calizzani G, Fischer K, Gilman E, Hay C, Lassila R, Lambert T, Ludlam C, Mannucci P. Inhibitor incidence in PUPs and PTPs: data from the first three years of the EUHASS Project. Haemophilia 2012;18:1-208.
21. Fischer K, Makris M, Calizzani G, Hay CRM, Ludlam CA, Lambert T, Lassila R, Mannucci PM. European monitoring of inhibitor development in haemophilia A and B. J Thromb Haemost 2013;11:133-4.
22. ®). Haemophilia 2011;17:407-11.
23. Hay CRM, Palmer B, Chalmers E, Hart D, Liesner R, Rangarajan S, Taks K, Williams M, Collins P. The incidence of factor VIII inhibitors in severe haemophilia A following a major product switch in the UK: a prospective, controlled study. Haemophilia 2012;18:828-32.
24. Rubinger M, Lillicrap D, Rivard GE, Teitel J, Carcao M, Hensman C, Walker I. 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.