Antihirudin antibodies following low-dose subcutaneous treatment with desirudin for thrombosis prophylaxis after hip-replacement surgery: incidence and clinical relevance.
Recombinant hirudin has been found to be immunogenic in patients treated with lepirudin following heparin-induced thrombocytopenia (HIT). We assessed the incidence of immunoglobulin G (IgG) antihirudin antibodies by enzyme-linked immunosorbent assay in 112 patients enrolled in a dose-finding study with desirudin. Patients received desirudin subcutaneously following orthopedic hip surgery at 10 mg twice a day (n = 17), 15 mg twice a day (n = 75), and 20 mg twice a day (n = 20). Of 112 patients, 11 (9.8%) developed antihirudin antibodies independently of the dose. The rate of immunization did not differ from that observed in HIT patients treated with lepirudin (P =.113). Plasma concentrations of desirudin did not differ between antihirudin antibody-positive and -negative patients. Antihirudin antibodies had no impact on incidences of deep vein thrombosis and/or pulmonary embolism, allergic reactions, and hemorrhage. However, the total number of immunized patients observed was low and so infrequent (but severe) effects of antihirudin antibodies cannot be excluded.
Greinacher
Andreas
A
Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald, Greifswald, Germany. greinach@uni-greifswald.de
Eichler
Petra
P
Albrecht
Dorothea
D
Strobel
Ulrike
U
Pötzsch
Bernd
B
Eriksson
Bengt I
BI
D000906:Antibodies / Q000097:blood*; D000925:Anticoagulants / Q000008:administration & dosage / Q000276:immunology*; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects* / Q000379:methods; D024764:Hirudin Therapy / Q000009:adverse effects; D006629:Hirudins / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000276:immunology*; D006801:Humans; D015994:Incidence; D007279:Injections, Subcutaneous; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000276:immunology*; D013921:Thrombocytopenia / Q000139:chemically induced / Q000276:immunology; D013927:Thrombosis / Q000188:drug therapy / Q000517:prevention & control; D016896:Treatment Outcome
D000906:Antibodies; D000925:Anticoagulants; D006629:Hirudins; D011994:Recombinant Proteins; C060225:desirudin