Reduced acute rejection and superior 1-year renal allograft survival with basiliximab in patients with diabetes mellitus

Background Renal allograft recipients with diabetes mellitus often demonstr ate poorer clinical outcomes than nondiabetic patients. Basiliximab (Simule ct((R))), a chimeric anti-interleukin-a receptor monoclonal antibody, reduc ed the incidence of acute rejection in renal allograft recipients in 2 mult icenter, placebo-controlled, phase III trials. Methods. An analysis of pooled results from the 2 trials was conducted to c ompare the efficacy and safety of basiliximab with placebo in renal transpl ant recipients with and without prior diabetes. Patients received either ba siliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in comb ination with cyclosporine for microemulsion (Neoral((R))) and steroids. Results. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligi ble for intent-to-treat analysis. At 12 months, basiliximab as compared wit h placebo reduced the proportion of patients experiencing first acute rejec tion by 41% in diabetics (P<0.01) and by 29% in nondiabetics (P<0.001). Bio psy-confirmed rejection was reduced by 44% in diabetics (P<0.01) and by 26% in nondiabetics (P<0.01). The first acute rejection episode requiring augm ented immunosuppression other than steroids was reduced by 49% in diabetics (P<0.01) and by 41% in nondiabetics (P<0.001); death, graft loss, or first rejection episode was reduced by 43% in diabetics (P=0.001) and by 22% in nondiabetics (P<0.01). Superior graft survival was maintained in diabetic r ecipients treated with basiliximab versus placebo (96% vs. 86%; P=0.022). T here were no significant differences in safety between basiliximab and plac ebo in both diabetic and nondiabetic patients. Conclusions. Basiliximab is associated with a significant reduction in acut e rejection and an excellent safety profile in renal transplant recipients with and without diabetes mellitus. Superior graft survival was evident in diabetic patients.