Evaluation of belatacept in clinical trials revealed significant improvements in renal function and cardiovascular risk leading to superior survival. Despite these proven benefits higher rates of rejection have limited its widespread adoption. Evaluation of belatacept-based treatment outside of the context of clinical trials has not yet been reported. Here we report a retrospective analysis of our belatacept-based standard of care immunosuppressive protocol.

Methods: 560 patients underwent renal transplant from Jan 2010-Oct 2013 and received a tacrolimus- or belatacept-based regimen including basiliximab, MMF and steroid. The cohort includes those with high immunologic risk- high PRA/HLA mismatch, prior transplant, etc. Primary outcomes were patient and graft survival. In order to examine the longitudinal GFR values over time among the different treatments, a repeated measure design was used with an unstructured covariance matrix.

Results: Following approval we substituted belatacept for tacrolimus in our immunosuppression protocol. 98 patients received the initial belatacept based regimen (Bela-alone). When compared to patients treated with a standard tacrolimus (Tac-alone, n=206), Bela-alone patients experienced a significantly higher rate of biopsy proven acute rejection (BPAR, 54% vs 20%, p<0.0001) although 3yr patient and graft survival were no different (94% vs 93% & 93% vs 87%). Bela-alone patients had significantly higher eGFR at 3 years when compared to the Tac-alone cohort (63.2 vs 50.2). Given the unacceptably high rate of rejection we elected to employ a short, tapering course of tacrolimus from the time of transplant- either 5 months (Bela/Tac-short, n=87) or 11 months (Bela/Tac-long, n=169). 3yr patient and graft survival were similar to the previous two groups. 1yr BPAR rates were significantly lower in the Bela/Tac-short compared to Bela-alone but still higher then Tac-alone (32%, p=0.04). Increasing the duration- Bela/Tac-long significantly decreased BPAR to an acceptable level, similar to Tac-alone (15%, p=0.89). Both Bela/Tac-short and Bela/Tac-long enjoyed superior renal function (64.2 & 64.1) compared to Tac-alone (50.2).

Conclusions: We have developed a non-depletional, belatacept-based immunosuppression regimen that achieves equivalent patient/graft survival, improved renal function as well as acceptable acute rejection rates and provides a viable strategy for long-term CNI-free immunosuppression.

CITATION INFORMATION: Adams A, Garrett C, Goldstein J, Zhang R, Guasch A, Pastan S, Patzer R, Kirk A, Pearson T, Larsen C. Post-Trial Experience with Belatacept: A Large Single Center Experience. Am J Transplant. 2016;16 (suppl 3).

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