One-year outcomes in simultaneous kidney-pancreas transplant recipients receiving an alternative dosing regimen of daclizumab.
The purpose of this study was to compare the safety and efficacy of two dosing regimen of daclizumab with no-antibody induction in simultaneous kidney-pancreas transplant (SKPT) recipients receiving tacrolimus, mycophenolate mofetil, and steroids.


METHODS
A total of 297 SKPT patients were enrolled into this prospective, multicenter, randomized, open-label study. The patients were randomized into three groups: daclizumab 1 mg/kg/dose every 14 days for five doses (group I, n = 107), daclizumab 2 mg/kg/dose every 14 days for two doses (group II, n = 112), and no-antibody induction (group III, n = 78).


RESULTS
There were no differences in baseline characteristics among the three groups, except for a higher proportion of African-Americans in group II. The incidence of composite events (acute rejection, graft loss, or death) at 1 year was 36.4%, 32.7%, and 48.7% for groups I, II, and III, respectively (P <.05, group II vs group III). The incidence of acute rejection was highest in group III (34.6%) compared to groups I and II (22.4% and 22.1%, respectively, P <.05). The mean time to acute rejection was delayed in group II (96 days) compared to 23 days in group I and 20 days in group III (P <.05). The adverse-event profiles were comparable among the three groups, except for a higher incidence of infection and readmissions in group III.


CONCLUSIONS
Daclizumab was safe and effective in reducing the incidence of acute rejection when compared to no induction. The alternative two-dose regimen of daclizumab was as effective as the conventional five-dose regimen and is logistically more desirable.
Stratta
R J
RJ
Department of General Surgery, Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1095, USA. rstratta@wfubmc.edu
Alloway
R R
RR
Lo
A
A
Hodge
E E
EE
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000077561:Daclizumab; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use; D015994:Incidence; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology*; D016035:Pancreas Transplantation / Q000009:adverse effects / Q000276:immunology*; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D017211:Treatment Failure; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab