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DACLIZUMAB (HUMANIZED ANTI-IL2R&agr; MAB) PROPHYLAXIS FOR PREVENTION OF ACUTE REJECTION IN RENAL TRANSPLANT RECIPIENTS WITH DELAYED GRAFT FUNCTION1,2

Background. The purpose of this retrospective study was to determine the benefits of daclizumab, (Zenapax®, Roche Pharmaceuticals) a humanized anti-interleukin-2R&agr; (IL-2R&agr;) 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 1 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.