A Prospective, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Two Dosing Regimens of Daclizumab Compared to No Antibody Induction in Simultaneous Kidney–Pancreas Transplantation: Results at 3 Years

Abstract

This is a report of outcomes at 36 months of a prospective, multicenter study comparing the safety and efficacy of two dosing regimens of daclizumab with no antibody induction in simultaneous kidney–pancreas transplant (SKPT) patients receiving tacrolimus, mycophenolate mofetil, and prednisone. A total of 298 SKPT patients were randomized into one of three groups: daclizumab 1 mg/kg/dose every 14 days for 5 doses (group 1, n = 107); daclizumab 2 mg/kg/dose for 2 doses (group 2, n = 113); and no antibody induction (group 3, n = 78). There were no differences in baseline characteristics among the three groups, and results were analyzed by an intent-to-treat analysis. The incidence of composite events (acute rejection [AR], any allograft lost, or death) at 3 years was 49%, 43%, and 55% in groups 1, 2, and 3, respectively ( P = .278). The cumulative incidences of AR were not statistically different among the three groups ( P = .178). The mean time to first AR was delayed in groups 2 (288 days) and 1 (245 days) compared to group 3 (145 days, P = .07). There were no differences in patient or allograft survival rates among the three groups, and the rates of serious adverse events, infections, and hospital readmissions were also comparable. Excellent dual graft function in patients with surviving grafts was observed in all three groups at 3 years. Conclusions The alternative 2-dose regimen of daclizumab was as safe and effective as the conventional 5-dose regimen compared to no antibody induction in SKPT patients, but no long-term benefits were noted.