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Purified factor IX using monoclonal immunoaffinity technique: clinical
trials in hemophilia B and comparison to prothrombin complex concentrates
HC Kim, CW McMillan, GC White, GE Bergman, MW Horton and P Saidi
Division of Hematology-Oncology, UMDNJ-Robert Wood Johnson Medical School,
New Brunswick.
Replacement therapy for hemophilia B (factor IX deficiency) using
prothrombin complex concentrate (PCC) has been associated with serious
complications of thromboembolic events and transmission of viral
infections. Monoclonal antibody-purified factor IX (Mononine) provides a
highly purified factor IX concentrate, while eliminating other vitamin
K-dependent factors (II, VII, and X). Mononine was evaluated for in vivo
recovery, half-life, and for its safety and efficacy in 10 patients with
hemophilia B. The in vivo recovery of factor IX with Mononine was a 0.67
+/- 0.14 U/dL (mean +/- SD) increase per 1U/kg of infused factor IX, and
the biologic half-life (t1/2), determined using the terminal phase of
elimination, was 22.6 +/- 8.1 hours. Comparison of in vivo recovery of
other vitamin K-dependent factors following a single infusion of either
Mononine or PCC showed that, whereas Mononine infusion caused no changes in
other vitamin K-dependent factors or in prothrombin activation fragment
(F1+2), PCC infusion was associated with significant increases of factors
II (2.7 U/dL per 1 U/dL of IX increase) and X (2.2 U/dL for 1 U/dL for 1
U/dL of IX). Patients who used Mononine as their sole therapeutic material
during the 12-month period showed an excellent response in hemostasis for
their bleeding episodes. Their experience with long-term use of Mononine
was at least equivalent to their previous experience with PCC in the
frequency and amount of factor usage. No patients developed antibody
against mouse IgG or an increase in IX inhibitor during the 12-month
period. These results indicate that monoclonal antibody-purified factor IX
concentrate provides hemostatically effective factor IX replacement while
avoiding extraneous thrombogenic substances.
Volume 79,
Issue 3,
pp. 568-575,
02/01/1992
Copyright © 1992 by The American Society of Hematology
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