The toxicities of CNIs and steroids have a negative impact on kidney transplantation. Belatacept is a safe, non-nephrotoxic alternative to CNIs, that may lead to longer allograft survival.

We previously reported that, in the short-term, a steroid- and CNI-free, belatacept-based regimen plus alentuzumab induction and daily sirolimus, was associated with low rejection rates in living donor, DD or ECD kidneys. Herein, we report the long-term results of our pilot study.

A single dose of alentuzumab was given at transplantation, followed by monthly belatacept plus daily sirolimus. Two cohorts were studied, Cohort 1 (n=20), all living donors, and Cohort 2 (n=20) that included LD, DD and ECD recipients, including allosensitized patients. Median follow-up for cohort 1 is 8 years (range 7-9) and for Cohort 2 is 4 years (range 3.5-5.5). One patient in each group withdrew because of pregnancy and another after developing skin Kaposi's sarcoma (in remission on sirolimus monotherapy). Patient survival is 100% and graft survival is 95%. Graft function is excellent in both groups with mean eGFR 76 ml/min for all patients combined at last follow up. Nine patients (4 in cohort 1, and 5 in cohort 2) were converted to MMF because of intolerance to sirolimus. In cohort 1, 7 patients were weaned to bela monotherapy. In cohort 2, the Ki 67 activity was used to guide weaning. In that cohort, 12 patients were eligible, 4 declined and 4 failed wean, requiring reintroduction of sirolimus. Four patients remain on bela monotherapy. The average follow up of patients on bela monotherapy is 5 years (range 3-8), with a mean eGFR of 91 ml/min. In patients who remained on combination bela+sirolimus, the average eGFR is 70 mlmin.

Five patients developed low level DSA with no evidence of AMR by biopsy and normal renal function. The incidence of clinically significant viral infections was low in both groups. Transient BK or EBV viremia developed in 8 patients requiring slight reduction in immunosuppression. No patient had BK nephropathy.

We conclude that a belatacept-based therapy in combination with alentuzumab induction and daily oral sirolimus, prevents allograft rejection and is associated with excellent renal and functional outcomes. A subset of these patients can be weaned to belatacept monotherapy with excellent functional outcomes. Prospective controlled trials of this regimen are warranted.

CITATION INFORMATION: Guasch A., Ghali A., Mead S., Mehta A., Xu H., Kirk A. Long-Term Outcomes of a Steroid-Free, Belatacept-Based Immunosuppressive Regimen Plus Sirolimus Using Alentuzumab Induction in Renal Transplantation Am J Transplant. 2017;17 (suppl 3).

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