Reported inhibitor incidence in FVIII PUP studies: Comparing apples with oranges? [2]

Haemophilia

Volumn 10, Issue 2, 2004, Pages 197-198

  Scharrer, Inge ^a   Ehrlich, H J ^b  

^a UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^b BAXTER BIOSCIENCE   (Austria)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 8 DERIVATIVE; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9;

CLINICAL TRIAL; CONFIDENCE INTERVAL; DISEASE SEVERITY; GENE MUTATION; HEMOPHILIA A; HUMAN; IMMUNOGENICITY; LETTER; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; TREATMENT OUTCOME;

EID: 1542301024     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2004.00887.x     Document Type: Letter

References (12)

1. Wight J, Paisley S. The epidemiology of inhibitors in haemophilia A: a systematic review. Haemophilia 2003; 9: 418-35.
2. Scharrer I, Bray GL, Neutzling O. Incidence of inhibitors in haemophilia A patients - a review of recent studies of recombinant and plasma-derived factor VIII concentrates. Haemophilia 1999; 5: 145-54.
3. Schimpf K, Schwarz HP, Kunschak M. Zero incidence of inhibitors in previously untreated patients who received intermediate purity factor VIII concentrate or factor IX complex. Thromb Haemost 1995; 73: 546-56.
4. Bray GL, Gomperts ED, Courter SG et al. A multicenter study of recombinant factor VIII (recombinate): safety, efficacy, and inhibitor risk in previously untreated patients. Blood 1997; 83: 2428-35.
5. Lusher JM, Abildgaard CF, Arkin S et al. Human recombinant DNA-derived antihemophilic factor in the treatment of previously untreated patients with hemophilia A. JTH, in press.
6. Mannucci PM. Risk of inhibitor development after intermediate purity coagulation factor concentrates: is it truly low? Thromb Haemost 1995; 74: 990-7.
7. Auerswald G, Lusher J, Kreuz W et al. Outcome of a prospective, multinational clinical trial in children treated with a full-length, sucrose formulated rFVIII product. Ann Hematol 2003; 82 (Suppl. 1): 11.
8. Ehrlich HJ, Bray GL, Gomperts ED. Comparison of high responder inhibitor frequency in recent studies of previously untreated patients with hemophilia A. Thromb Haemost 1998; 79: 242-3.
9. White GC, DiMichele D, Mertens K et al. for the ISTH subcommittee. Utilization of previously treated patients (PTPs), noninfected patients (NIPs), and previously untreated patients (PUPs) in the evaluation of new factor VIII and factor IX concentrates. Thromb Haemost 1999; 81: 462.
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. Peerlinck K, Arnout J, Di Giambattista M et al. 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.
12. Scharrer I, Ehrlich HJ. Lack of evidence for increased inhibitor incidence in patients switched from plasma-derived to recombinant factor VIII. Haemophilia 2000; 7: 346-8.