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
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
Concerns have been raised regarding pharmacokinetic performance, efficacy and safety of B-domain-deleted recombinant FVIII (BDD rFVIII). The objective of this study was to perform a retrospective survey of half-life measurements, efficacy and safety in patients with severe haemophilia A, switching treatment from full-length factor VIII (FL FVIII) to BDD rFVIII and then back to FL FVIII. We hypothesized that half-life of FVIII would be equal regardless of product and that total factor consumption and bleeding frequency would be indistinguishable. We report on inhibitor development and outcome following surgery. Patients with severe haemophilia A, exposed to BDD rFVIII were identified from a database. A retrospective analysis of laboratory data and medical notes was undertaken. No significant difference was detected between the half-life measurements during the switch from FL FVIII (T/2 median 9.15 h, range 6.4-22) to BDD rFVIII (T/2 median 9.7, range 4.7-16.8) and back to FL FVIII (T/2 median 9.0, range 5.0-19.5). There was no significant difference in coagulation factor usage (BDD rFVIII median 4803 IU kg-1 year-1, range 659-11 304; FL FVIII median 5349, range 1691-10 146), nor bleeds. Eleven received BDD rFVIII to cover surgical procedures, with no reports of excess bleeding. Thirty-three patients received significant exposure to BDD rFVIII and one developed a low titre inhibitor. BDD rFVIII was found to be equivalent to other FVIII products in terms of pharmacokinetics, clinical efficacy and safety in this study group.
B-domain-deleted factor VIII, Clinical outcome, Coagulation factor consumption, Full-length factor VIII, Pharmacokinetics
1237-1242
Rea, C.
de5af262-53e4-4a06-ac84-2a63ff5c7900
Dunkerley, A.
1f23261e-cacb-493e-99bc-a5a6456df4c1
Sørensen, B.
7870097f-91ed-4926-94c9-05ed60fcea96
Rangarajan, S.
9a5e4c7e-55ba-4a3a-b5f6-f1e269d927c3
November 2009
Rea, C.
de5af262-53e4-4a06-ac84-2a63ff5c7900
Dunkerley, A.
1f23261e-cacb-493e-99bc-a5a6456df4c1
Sørensen, B.
7870097f-91ed-4926-94c9-05ed60fcea96
Rangarajan, S.
9a5e4c7e-55ba-4a3a-b5f6-f1e269d927c3
Rea, C., Dunkerley, A., Sørensen, B. and Rangarajan, S.
(2009)
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, 15 (6), .
(doi:10.1111/j.1365-2516.2009.02071.x).
Abstract
Concerns have been raised regarding pharmacokinetic performance, efficacy and safety of B-domain-deleted recombinant FVIII (BDD rFVIII). The objective of this study was to perform a retrospective survey of half-life measurements, efficacy and safety in patients with severe haemophilia A, switching treatment from full-length factor VIII (FL FVIII) to BDD rFVIII and then back to FL FVIII. We hypothesized that half-life of FVIII would be equal regardless of product and that total factor consumption and bleeding frequency would be indistinguishable. We report on inhibitor development and outcome following surgery. Patients with severe haemophilia A, exposed to BDD rFVIII were identified from a database. A retrospective analysis of laboratory data and medical notes was undertaken. No significant difference was detected between the half-life measurements during the switch from FL FVIII (T/2 median 9.15 h, range 6.4-22) to BDD rFVIII (T/2 median 9.7, range 4.7-16.8) and back to FL FVIII (T/2 median 9.0, range 5.0-19.5). There was no significant difference in coagulation factor usage (BDD rFVIII median 4803 IU kg-1 year-1, range 659-11 304; FL FVIII median 5349, range 1691-10 146), nor bleeds. Eleven received BDD rFVIII to cover surgical procedures, with no reports of excess bleeding. Thirty-three patients received significant exposure to BDD rFVIII and one developed a low titre inhibitor. BDD rFVIII was found to be equivalent to other FVIII products in terms of pharmacokinetics, clinical efficacy and safety in this study group.
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Accepted/In Press date: 21 May 2009
e-pub ahead of print date: 2 August 2009
Published date: November 2009
Keywords:
B-domain-deleted factor VIII, Clinical outcome, Coagulation factor consumption, Full-length factor VIII, Pharmacokinetics
Identifiers
Local EPrints ID: 442901
URI: http://eprints.soton.ac.uk/id/eprint/442901
ISSN: 1351-8216
PURE UUID: a587e522-4fd9-4187-99c0-c91bc72c096e
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Date deposited: 30 Jul 2020 16:34
Last modified: 17 Mar 2024 04:02
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Author:
C. Rea
Author:
A. Dunkerley
Author:
B. Sørensen
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