A randomized prospective trial of OKT3 induction in the current immunosuppression era

Recent improvements in immunosuppression and subsequent decreases in the in cidence of acute rejection have brought into question the benefit of the us e pert-transplant antibody therapy (i.e. induction therapy). In the current era of immunosuppression that includes my- cophenolate mofetil (MMF) and c yclosporine emulsion (Neoral (R) No- vartis, Basle, Switzerland), we design ed and have completed a prospective, randomized trial to address this quest ion. Cadaveric and living donor renal allograft recipients were randomized to receive either OKT3/MMF/delayed Neoral/prednisone or MMF/immediate Neora l/ prednisone without OKT3. The incidence of rejection episodes was the pri mary end point. Patients with delayed graft function were excluded. All rej ection episodes were biopsy proven and all patients have been followed for a minimum of 2 yr. Fifty-four patients received OKT3 induction, of which 6 patients suffered a rejection episode (11%), while patients (27%) not recei ving OKT3 (p = 0.04) had a rejection episode. Four patients in the no OKT3 group suffered multiple rejec- tions, while there were only 2 with more tha n one episode in the OKT3 group. There was no increased incidence of infect ious complications in the group receiving OKT3. Hospital costs tended to be higher in the OKT3-treated group, but were not significantly different. Th e low inci- dence of rejection in the OKT3-treated group was intriguing and validates the use of antibody therapy in the early post-operative periods even in the era of improved baseline immunosuppression.