Long-term safety, tolerability and efficacy of daclizumab (Zenapax) in a two-dose regimen in liver transplant recipients.
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Long-term safety, tolerability and efficacy of daclizumab (Zenapax) in a two-dose regimen in liver transplant recipients. / Niemeyer, Gerit; Koch, Martina; Light, Susan; Kuse, Ernst R; Nashan, Björn.
In: AM J TRANSPLANT, Vol. 2, No. 5, 5, 2002, p. 454-460.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Long-term safety, tolerability and efficacy of daclizumab (Zenapax) in a two-dose regimen in liver transplant recipients.
AU - Niemeyer, Gerit
AU - Koch, Martina
AU - Light, Susan
AU - Kuse, Ernst R
AU - Nashan, Björn
PY - 2002
Y1 - 2002
N2 - 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-2R alpha. Immunoprophylaxis with daclizumab, a humanized anti-IL-2R alpha 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.
AB - 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-2R alpha. Immunoprophylaxis with daclizumab, a humanized anti-IL-2R alpha 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.
M3 - SCORING: Zeitschriftenaufsatz
VL - 2
SP - 454
EP - 460
JO - AM J TRANSPLANT
JF - AM J TRANSPLANT
SN - 1600-6135
IS - 5
M1 - 5
ER -
