Purpose: Belatacept is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. It was approved by the US Food and Drug Administration (FDA) in June 2011. In the Ph 3 clinical trials, there were 3 reports of post-transplant lymphoproliferative disorder (PTLD) in 404 (0.7%) EBV+ patients receiving the dosing regimen approved for use. As part of the required post-marketing activities, the ENLiST registry was implemented to estimate the risk of, PTLD, CNS PTLD, and progressive multifocal leukoencephalopathy (PML) in de novo renal transplant recipients treated with belatacept. Methods: Adult kidney only transplant recipients de novo treated with belatacept between June 2011 and October 2014 were included in this analysis. De novo treatment was defined as treatment with belatacept within 14 days after transplant. Characteristics of patients enrolled in ENLiST registry were summarized, as were events of PTLD, CNS PTLD, and PML reported to date. Results: As of October 15, 2014, 600 transplant patients were screened and 542 patients from 27 study sites agreed to participate in the study. Of the 542 adult kidney only transplant recipients, 505 (93.2%) patients were de novo treated with belatacept. Of these, 502 were EBV positive at transplant. The mean age of these patients at time of transplant was 53.3 ± 13.6 years. Sixty-two % were male, 51.4% were White, 39.0% were African American, 33.5% had a BMI > 30, 67.9% were CMV seropositive at transplant, and 97.0% were on CMV prophylaxis. The mean duration of belatacept exposure at time of this analysis was 419.5 ± 298.62 days. The loss to follow up rate was 6%. There were 2 reports of PTLD (0.4%), 1 report of CNS PTLD (0.2%) for a total of 3 cases. The exposure adjusted incidence rate of PTLD was 0.32 per 100 person-years (95%CIs: 0.04-1.16) and 0.16 per 100 person-years (95%CIs: 0.00-0.90) for CNS PTLD. There have been no reports of PML. Conclusion: There were two reports of PTLD, one report of CNS PTLD, and no report of PML in the ENLiST registry to date. Study findings suggest that the majority of patients treated with belatacept at time of transplant are EBV+ and the risk of PTLD and CNS PTLD are similar to that observed in the Ph 3 clinical trials.

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