REDUCED ACUTE REJECTION AND SUPERIOR 1-YEAR RENAL ALLOGRAFT SURVIVAL WITH BASILIXIMAB IN PATIENTS WITH DIABETES MELLITUS1

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Abstract
Background. Renal allograft recipients with diabetes mellitus often demonstrate poorer clinical outcomes than nondiabetic patients.Basiliximab (Simulect®), a chimeric anti–interleukin-2 receptor monoclonal antibody, reduced the incidence of acute rejection in renal allograft recipients in 2 multicenter, placebo-controlled, phase III trials. Methods. An analysis of pooled results from the 2 trials was conducted to compare the efficacy and safety of basiliximab with placebo in renal transplant recipients with and without prior diabetes. Patients received either basiliximab (20 mg on day 0 and day 4 posttransplantation) or placebo in combination with cyclosporine for microemulsion (Neoral®) and steroids. Results. A total of 722 patients (150 diabetic, 572 nondiabetic) were eligible for intent-to-treat analysis. At 12 months, basiliximab as compared with placebo reduced the proportion of patients experiencing first acute rejection by 41% in diabetics (P P P P P P P =0.001) and by 22% in nondiabetics (P P =0.022). There were no significant differences in safety between basiliximab and placebo in both diabetic and nondiabetic patients. Conclusions. Basiliximab is associated with a significant reduction in acute rejection and an excellent safety profile in renal transplant recipients with and without diabetes mellitus. Superior graft survival was evident in diabetic patients.