title: Clinical experience of a new monoclonal antibody purified factor IX: half-life, recovery, and safety in patients with hemophilia B.
abstract: Highly purified factor IX, produced by a monoclonal antibody immunoaffinity technique, contains a high concentration of factor IX with negligible amounts of other vitamin K-dependent coagulation factors. When infused in patients with hemophilia B, monoclonal factor IX concentrate yielded a mean half-life of 34.6 +/- 13.1 (+/- SD) hours and in vivo recovery of 0.67 +/- 0.14 U/dL rise per each U/kg of factor IX infused. Unlike prothrombin complex concentrate (PCC) infusion, monoclonal IX infusion was not associated with rises in factors II, VII, and X, but achieved in vivo recovery and half-life at least comparable to PCC. Long-term use of monoclonal IX as a home-care product provided excellent response in the control of bleeding episodes and was equivalent to previous patient experience with PCC. The results indicate that monoclonal IX concentrate raises factor IX levels effectively, while avoiding extraneous thrombogenic components.
authors.affiliation: Department of Medicine, UMDNJ, Robert Wood Johnson Medical School, New Brunswick 08903.
authors.forename: H C
authors.initials: HC
authors.lastname: Kim
authors.forename: C W
authors.initials: CW
authors.lastname: McMillan
authors.forename: G C
authors.initials: GC
authors.lastname: White
authors.forename: G E
authors.initials: GE
authors.lastname: Bergman
authors.forename: P
authors.initials: P
authors.lastname: Saidi
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal; D001779:Blood Coagulation Factors / Q000494:pharmacology / Q000627:therapeutic use; D005164:Factor IX / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005167:Factor VII / Q000378:metabolism; D005170:Factor X / Q000378:metabolism; D006207:Half-Life; D002836:Hemophilia B / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011516:Prothrombin / Q000378:metabolism
chemical_list: D000911:Antibodies, Monoclonal; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D005167:Factor VII; D011516:Prothrombin; D005164:Factor IX; D005170:Factor X