Transplantation Direct (Jun 2024)

Long-term Safety in Epstein–Barr Virus–Seropositive Kidney-only Transplant Recipients Treated With Belatacept in Clinical Practice: Final Study Results From the ENLiST Registry

  • Christian P. Larsen, MD, PhD,
  • Flavio Vincenti, MD,
  • Tzuyung D. Kou, PhD, MPH, MA,
  • Craig A. Shadur, MD,
  • Barbara Bresnahan, MD,
  • Stanley C. Jordan, MD,
  • E. Steve Woodle, MD,
  • Nelson Goes, MD,
  • John Vella, MD,
  • David Wojciechowski, DO,
  • Martin S. Polinsky, MD,
  • Andres Gomez-Caminero, PhD, MPH

DOI
https://doi.org/10.1097/TXD.0000000000001644
Journal volume & issue
Vol. 10, no. 6
p. e1644

Abstract

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Background. Belatacept, a selective T-cell costimulation blocker, was associated with improved survival and renal function but also with a risk of posttransplant lymphoproliferative disorder (PTLD) in adult kidney transplant recipients in phase 3 trials. This registry examined long-term safety in Epstein–Barr virus (EBV)–seropositive kidney transplant recipients treated with belatacept. Methods. This US-based, prospective, voluntary, multicenter registry (Evaluating Nulojix Long-Term Safety in Transplant [ENLiST]) included adult EBV-seropositive kidney-only transplant recipients treated de novo (within 14 d of transplantation) with belatacept. Primary objectives were to estimate incidence rates of confirmed PTLD, central nervous system (CNS) PTLD, and progressive multifocal encephalopathy (PML). The minimum follow-up was 2 y. Results. Of 985 enrolled transplant recipients, 933 EBV-seropositive patients received belatacept, with 523 (56.1%) receiving concomitant tacrolimus at transplant (for up to 12 mo). By study end, 3 cases of non-CNS PTLD (incidence rate, 0.08/100 person-years), 1 case of CNS PTLD (0.03/100 person-years), and no cases of PML had been reported. Two patients with non-CNS PTLD received concomitant belatacept and tacrolimus and 1 received belatacept and lymphocyte-depleting therapy. Incidence rates were comparable between patients who received concomitant belatacept and tacrolimus and those who did not receive tacrolimus (0.09/100 person-years and 0.07/100 person-years, respectively; P = 0.96). Two of 4 patients with PTLD died, and 2 were alive at the end of the study. Cumulatively, 131 graft losses or deaths were reported by study end. Conclusions. Our results from the ENLiST registry, a large, prospective real-world study, showed that the incidence rates of PTLD and CNS PTLD in belatacept-treated EBV-seropositive transplant recipients were consistent with findings from previous phase 3 trials.