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Long‐term Safety, Tolerability and Efficacy of Daclizumab (Zenapax ® ) in a Two‐dose Regimen in Liver Transplant Recipients
Author(s) -
Koch Martina,
Light Susan,
Kuse Ernst R.
Publication year - 2002
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1034/j.1600-6143.2002.20510.x
Subject(s) - daclizumab , medicine , immunosuppression , regimen , tolerability , transplantation , adverse effect , tacrolimus , gastroenterology , surgery , urology
A major thrust of transplantation research is to find more effective and less broadly toxic immunosuppressive agents. One potential way is the use of monoclonal antibodies directed to IL‐2Rα. Immunoprophylaxis with daclizumab, a humanized anti‐IL‐2Rα monoclonal antibody, has been shown to be effective in the prevention of acute rejection in kidney transplant patients. These results encouraged us to initiate a pilot study in 28 liver transplant patients in 1997. Daclizumab was administered intravenously approximately 6 h after reperfusion (1 mg/kg) and on day 4 post‐transplant (0.5 mg/kg). Additional immunosuppression consisted of cyclosporine A as well as of corticosteroids. Administration of daclizumab was not associated with any side‐effects. We only experienced one acute rejection in a patient on day 17 post‐transplant. It resolved immediately under therapy with prednisolone. The rate of opportunistic infections did not differ from results with conventional immunosuppressive regimens. At 4 years post‐transplant no lymphoproliferative disease was observed. Patient survival at 12, 24, 36 and 48 months post‐transplant was 88.5, 84.6, 80.8 and 73.1%, respectively. Immunoprophylaxis with a two‐dose daclizumab regimen is safe, effective and well tolerated, and does not lead to increased opportunistic infections.