To examine the utilization and clinical outcomes of belatacept in the real clinical setting, a retrospective cohort study was conducted using SRTR data that compared 1-year clinical outcomes between belatacept- and tacrolimus-treated adult kidney transplant recipients (KTR) from June 1, 2011 to December 01, 2014. Primary outcome, defined as incidence of biopsy-proven acute rejection (BPAR), and secondary outcomes, including mean estimated glomerular filtration rate (eGFR) and incidence of new-onset diabetes after transplantation (NODAT), were analyzed in a multivariate Cox model. Subgroup analyses included patients with or without lymphocyte-depleting (LD) induction and those meeting inclusion criteria for the BENEFIT and BENEFIT-EXT trials. Of 50 244 total patients, 417 received belatacept+tacrolimus, 458 received belatacept alone, and 49 369 received tacrolimus alone at hospital discharge. Significantly increased risk of BPAR associated with belatacept alone was identified in the overall study cohort compared to tacrolimus alone, with highest rates in those without LD induction (aHR: 2.65; 95%CI: 1.90-3.70, P<.0001). No significant difference in BPAR was demonstrated between belatacept+tacrolimus and tacrolimus alone. In the subgroup meeting criteria for the BENEFIT-EXT trial, kidney function was superior in KTR given belatacept+tacrolimus and belatacept alone versus tacrolimus alone (eGFR: 65.6 vs. 60.4. vs. 54.3 ml/min/1.73M², respectively, P<.001). The risk of NODAT was significantly lower with belatacept+tacrolimus and belatacept alone versus tacrolimus alone (1.7% vs 2.2% vs 3.8%, respectively, P=.01). Despite improved graft function with belatacept, it may be advisable to add short-term tacrolimus during the first year post-transplant and/or consider LD induction in higher risk patients, as the risk to benefit ratio allows.

CITATION INFORMATION: Wen X, Casey M, Santos A, Hartzema A, Womer K. Comparison of Clinical Outcomes of Belatacept- and Tacrolimus-Based Immunosuppression in Renal Transplant Recipients. Am J Transplant. 2016;16 (suppl 3).

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