1. Antibodies to heterologous proteins in hemophilia A patients receiving recombinant factor VIII (Recombinate)
- Author
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Gordon L. Bray, Edward D. Gomperts, Kirsten Christiansen, Hanne Berg Ravn, and Jørgen Ingerslev
- Subjects
Adult ,Male ,Heterologous ,Antibodies, Heterophile ,CHO Cells ,Hemophilia A ,Immunoglobulin G ,law.invention ,Mice ,Cricetulus ,Immune system ,Antibody Specificity ,law ,Cricetinae ,Coagulopathy ,Animals ,Humans ,Medicine ,Prospective Studies ,Bovine serum albumin ,Child ,Factor VIII ,biology ,business.industry ,Chinese hamster ovary cell ,Serum Albumin, Bovine ,Hematology ,medicine.disease ,Recombinant Proteins ,Antibodies, Anti-Idiotypic ,Culture Media ,Child, Preschool ,Immunology ,Recombinant DNA ,biology.protein ,Cattle ,Immunization ,Antibody ,Drug Contamination ,business - Abstract
SummaryAs a consequence of the manufacturing process, trace quantities of Chinese hamster ovary cell protein, bovine serum albumin and murine immunoglobulin G are present in Recombinate™ recombinant human factor VIII (rhFVIII). The development of antibodies (Abs) to these heterologous proteins was evaluated during long-term rhFVIII therapy of hemophilia A in 68 previously treated and 73 previously untreated patients. Ab prevalence was also assessed in 157 non-hemophilic subjects. Abs against heterologous proteins could be detected in varying percentages of patients and non-hemophilic subjects. Abs arose in patients sporadically, and levels were typically low. There were no adverse events associated with development or presence of anti-heterologous protein Abs. These data indicate that sustained immune responses to trace levels of heterologous proteins are very infrequent during long-term rhFVIII therapy.
- Published
- 2002