Thrombosis and Haemostasis · 1987 · 10 citations · 0 references
ImmunohematologyImmunodeficienciesImmunologyPathologyImmune SystemImmunotherapyInflammationThrombosisLaboratory HematologyHematologyFactor ViiiImmunohaematologyClinical ChemistryBleeding DisorderLaboratory MedicineHealth SciencesMouse Monoclonal AntibodyAllergyGranulocyteHemostasisCoagulopathyMedicineFactor Viii Half-life
Factor VIII:C purified utilizing a mouse monoclonal antibody to FVIII:VWF was used exclusively for 6 months to treat hemorrhages on a demand basis in 7 patients with severe hemophilia A and no inhibitor. The mean age of the patients was 26.1 years with a range of 16-39 years. The dose administered was from 15-18 u/kg at the time of hemorrhage. The patients infused on the average of once every 5 days. One patient required 40-50 u/kg every day for 3 days secondary to an automobile accident. Laboratory assessments included: a fall-off study to determine the factor VIII half-life both when the study commenced and after 6 months on study; inhibitor levels, and ELISA assay to detect antibody to mouse protein. Additionally, immunological data including quantitative T cell subsets and skin testing on each patient was obtained on entrance to the study, at 1 month, 3 months and at conclusion in order to ascertain whether immune function in these patients would improve with the use of purer factor concentrate. The initial mean half-life of the infused concentrate was 15.4 hours ± 2.2 with a range of 12.6 to 18.4 hours. The mean half-life after the patients had been on the concentrate for 6 months was 17.5 ± 5.9 hours (range 11.0 to 29 hours). No inhibitor developed in any patient. Six of seven patients did not develop significant levels of anti-mouse IgG antibody. One patient had a rheumatoid factor which interfered with the ELISA assay for anti-mouse antibody and thus its presence could not be assessed. There were no adverse reactions to the material, and hemostatic efficacy was judged as excellent. There were no significant changes in quantitative T cell subsets. Three out of six patients lost their previous total skin test anergy and two other patients increased the number of antigens to which they reacted. This concentrate proved to be safe and efficacious, to have excellent half-life, and to be associated with apparent improvement in the immune response.