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

Evelyn Singleton; Jude Smith; Mary Kavanagh; Beatrice Nolan; Barry White

doi:10.1160/TH07-06-0408

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2007; 98(06): 1188-1192
DOI: 10.1160/TH07-06-0408

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

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

Evelyn Singleton

¹National Centre for Hereditary Coagulation Disorders, Saint James’s Hospital, Dublin, Ireland

,

Jude Smith

¹National Centre for Hereditary Coagulation Disorders, Saint James’s Hospital, Dublin, Ireland

,

Mary Kavanagh

¹National Centre for Hereditary Coagulation Disorders, Saint James’s Hospital, Dublin, Ireland

,

Beatrice Nolan

¹National Centre for Hereditary Coagulation Disorders, Saint James’s Hospital, Dublin, Ireland

,

Barry White

¹National Centre for Hereditary Coagulation Disorders, Saint James’s Hospital, Dublin, Ireland

› Institutsangaben

Abstract

Summary

This retrospective survey of haemophilia A patients from multiple treatment centres in Ireland assessed the development of inhibitors following a switch in the prescribed treatment from recombinant factor VIII (rFVIII) produced by Chinese hamster ovary (CHO) cells (rFVIII-CHO) to rFVIII produced by baby hamster kidney (BHK) cells (rFVIII-BHK). Ninety-four patients participated in the survey. Most patients (89.4%) had severe haemophilia. One of 77 (1.3%) patients with no inhibitor history developed an inhibitor. This was a patient with moderate haemophilia A who developed a transient, low-titre (1 BU) de novo inhibitor following surgery. Recurrent inhibitors were detected in three of 17 patients with an inhibitor history during the 20-month post-switch study period. All patients continued on rFVIII-BHK therapy, and all tested negative for inhibitors at the time of their last inhibitor assay during the observation period. These results are consistent with the low levels of inhibitor formation demonstrated in phase III studies of previously treated patients receiving BHK-produced rFVIII and support the low risk of inhibitor formation following a change from rFVIIICHO to rFVIII-BHK.

Keywords

Recombinant factor VIII - FVIII inhibitor - FVIII-CHO - FVIII-BHK

Volltext

Referenzen

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