Daclizumab (humanized anti-IL2rα mab) prophylaxis for prevention of acute rejection in renal transplant recipients with delayed graft function

Background. The purpose of this retrospective study was to determine the benefits of daclizumab, (Zenapax((R)), Roche Pharmaceuticals) a humanized anti-interleukin-2R alpha (IL-2R alpha) monoclonal antibody, for prevention of acute rejection in renal transplant recipients with delayed graft function (DGF). Methods. Data from two multicenter randomized placebo-controlled trials were pooled. DGF was defined by urine output < 30 cc/hour, decline in serum creatinine of <0.5 mg/dl, or the need for dialysis within the first 24 hours after transplantation. Results. At one year posttransplantation, the incidence of biopsy-proven acute rejection in patients with DGF was reduced from 44% in the placebo group to 28% in the daclizumab group. (P=0.03) Prophylaxis with daclizumab also delayed the onset of the first biopsy-proven acute rejection episode in patients with DGF from 29 +/- 43 days in the placebo group to 73 +/- 70 days in the daclizumab group. (P=0.004) The graft survival rates in patients with DGF at I year posttransplantation were 78% in the placebo group and 82% in the daclizumab treated group. (P=ns) Three patients in the placebo-treated group with DGF experienced graft loss due to acute rejection, whereas no patients in the daclizumab-treated group with DGF had graft loss due to acute rejection. The 1-year patient survival rate in those with DGF in the placebo and daclizumab groups were 93% and 98%, respectively. (P=ns) Conclusions. Daclizumab effectively reduced the incidence and delayed the onset of biopsy-proven acute rejection in this high-risk subgroup of patients with DGF after renal transplantation. Graft and patient survival rates were similar between placebo- and daclizumab-treated patients with DGF.