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Factor VIII brand and the incidence of factor VIII inhibitors in previously untreated UK children with severe haemophilia A, 2000-2011

Collins, Peter William, Palmer, Benedict P., Chalmers, Elizabeth A., Hart, Daniel P., Liesner, Ri, Rangarajan, Savita, Talks, Katherine, Williams, Michael and Hay, Charles R. M. 2014. Factor VIII brand and the incidence of factor VIII inhibitors in previously untreated UK children with severe haemophilia A, 2000-2011. Blood 124 (23) , pp. 3389-3397. 10.1182/blood-2014-07-580498

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Abstract

The effect of recombinant factor VIII (rFVIII) brand on inhibitor development was investigated in all 407 severe haemophilia A previously untreated patients born in the UK between 1/January/2000 and 31/December/2011. Eighty-eight (22%) had been in the RODIN study. Information was extracted from the National Haemophilia Database. Since exposure days (EDs) were not known for some patients, time from first treatment was used as a surrogate for rFVIII exposure. An inhibitor developed in 118 (29%) patients, 60 high and 58 low titre, after a median (interquartile range) 7.8 (3.3-13.5) months from first exposure and 16 (9-30) EDs. Of 128 patients treated with Kogenate Bayer/Helixate Nexgen 45 (35.2%, 95% CI 27.4-43.8) developed an inhibitor compared with 42/172 (24.4%, 95%CI 18.6-31.4%) with Advate (P=0.04). The adjusted hazard ratio (95% CI) for Kogenate Bayer/Helixate Nexgen compared to Advate was 2.14 (1.12-4.10), P=0.02 for high titre and 1.75 (1.11-2.76), P=0.02 for all inhibitors. When excluding UK-RODIN patients the adjusted HR (95% CI) for high titre inhibitors was 2.00 (0.93-4.34), P=0.08. ReFacto AF was associated with a higher incidence of all, but not high titre, inhibitors than Advate. These results will help inform debate around the relative immunogenicity and use of rFVIII brands.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Subjects: R Medicine > R Medicine (General)
Publisher: American Society of Hematology
ISSN: 0006-4971
Date of Acceptance: 14 October 2014
Last Modified: 04 Jun 2017 08:58
URI: http://orca.cf.ac.uk/id/eprint/88565

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