Lack of Immune Response to Mouse IgG in Hemophilia A Patients Treated Chronically with Monoclate^®, a Monoclonal Antibody Affinity Purified Factor VIII Preparation

Summary

Hemophilia A is caused by factor VIII deficiency that historically has been treated with either a cryoprecipitate fraction of serum or factor VIII concentrate. Recently, the availability of affinity isolated factor VIII (Monoclate^®) has allowed for a highly purified preparation for the chronic therapy of hemophilia A. This factor VIII preparation contains a trace quantity (<50 ng/ 100 I. U.) of mouse IgG. Immunoassays for the measurement of human IgG, IgJVl and IgE anti-mouse TgG antihody (HAMA) were developed and used to measure HAMA levels in hemophilia A patients undergoing chronic therapy with Monoclate^® in three different clinical studies. Natural antibodies to mouse IgG were observed in patient sera prior to Monoclate^® infusion. Data is presented demonstrating that induction of HAMA upon Monoclate^® treatment does not occur. The low level of mouse IgG contained in Monoclate^® appears to be below the threshold of immunogenicity. Most importantly, clinical symptoms related to hypersensitivity or anaphylaxis were never observed in any patient undergoing chronic therapy with Monoclate^® in these clinical studies.

• References

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