Belatacept is a novel CD28 pathway antagonist that was recently approved as a maintenance immunosuppressive agent for kidney transplant recipients. While the pivotal trials for belatacept demonstrated superior long-term renal function when compared to cyclosporine, reports of post-approval experience have been limited to date. Here we report our center's experience with belatacept in 220 renal transplant recipients. Following FDA approval we substituted belatacept for tacrolimus in our standard of care immunosuppression protocol. Recipients also received mycophenolate mofetil, a rapid steroid taper and basiliximab induction in line with product insert recommendations. We compared this group to a historical tacrolimus-based patient cohort of similar composition (tac-n=203). Initial results in 99 patients with the belatacept regimen revealed an unacceptably high rate of biopsy-proven acute rejection (bela-53%). Despite the high rate of rejection patient and graft survival as well as renal allograft function (eGFR) were similar between the groups at 6 months (eGFR bela-58.55±19 ml/min vs tac-57.98±22 ml/min). Post-hoc analysis of belatacept-treated trial patients suggested differences in steroid dosing as well as immunologic risk factors as potential contributors to the high acute rejection rate. Therefore we designed an immunosuppression protocol that combines belatacept maintenance therapy with a limited course of tacrolimus in the early post-transplant period (bela/tac, n=121). The intent was to maximize immunologic protection during the early at-risk period while optimizing long-term renal function and the side effect profile associated with CNI use. The rates and grades of biopsy proven rejection at 6 months post-transplant were similar between the bela/tac protocol (19.8%) and our previous tacrolimus-based cohort (20.7%). Renal allograft function (eGFR) at 6 months post-transplant was similar between groups (bela/tac-58.11±21 ml/min vs tac-57.98.5±22 ml/min). This study describes the largest post-approval experience with belatacept. Use of belatacept in a diverse patient population can be done safely with acceptable short-term outcomes but implementation of this novel immunosuppressive agent needs to be carefully and continuously evaluated to ensure adequate immunosuppression in the early post-transplant period.

Adams, A.: Grant/Research Support, BMS. Chami, A.: Grant/Research Support, BMS. Harler, M.: Employee, BMS. Pastan, S.: Grant/Research Support, BMS. Kirk, A.: Grant/Research Support, BMS. Pearson, T.: Grant/Research Support, BMS. Larsen, C.: Grant/Research Support, BMS.

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