Session Name: Poster Session C: PTLD/Malignancies: All Topics
Session Type: Poster Session
Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:00pm
Presentation Time: 3:30pm-4:00pm
*Purpose: BELA, a selective T-cell costimulation blocker, is approved for the prophylaxis of organ rejection in EBV-seropositive adult kidney transplant recipients. In phase 3 BENEFIT and BENEFIT-EXT, BELA was associated with improved survival and renal function but also with a risk of post-transplant lymphoproliferative disorder (PTLD) estimated at 0.1-0.25 per 100 person-years (p-y) in EBV-seropositive patients (pts). This study examined long-term safety in EBV-seropositive kidney transplant recipients treated with BELA in the post-approval setting.
*Methods: This US-based, prospective, voluntary, multi-center registry (ENLiST) included adult EBV-seropositive kidney-only transplant recipients treated de novo (< 14 days of transplantation) with BELA. Primary objectives were to estimate incidence rates of confirmed PTLD, CNS PTLD, and progressive multifocal encephalopathy (PML). Minimum follow-up was 2 y.
*Results: Between Feb 2012 and Apr 2017, 985 transplant recipients were enrolled; 933 EBV-seropositive pts were treated de novo with BELA. Mean age was 53 y, 63% were male, 54% were white, 65% were CMV seropositive, 95% were on CMV prophylaxis, and 56% received concomitant tacrolimus (TAC) and BELA at transplant; 84% of donors were EBV-seropositive. The mean duration of BELA exposure was 1314 ± 766 d. By study end, 3 cases of non-CNS PTLD, 1 case of CNS PTLD, and no cases of PML were reported. Two pts with non-CNS PTLD received concomitant TAC + BELA at transplant. The cumulative incidence rate was 0.08 per 100 p-y for non-CNS PTLD and 0.03 for CNS PTLD (Table). Incidence rates were comparable between pts with concomitant TAC + BELA at transplant and those without TAC (0.09 and 0.07 per 100 p-y, respectively; P = 0.9601). Of 4 pts with PTLD, 2 died due to PTLD and 2 were alive at study end.
*Conclusions: Incidence rates of PTLD and CNS PTLD among BELA-treated EBV-seropositive pts in the ENLiST registry were consistent with those observed in EBV-seropositive pts in previous clinical trials.
To cite this abstract in AMA style:Larsen C, Vincenti F, Kou T, Shadur C, Bresnahan B, Jordan S, Woodle ES, Goes N, Vella J, Wojciechowski D, Polinsky M, Gomez-Caminero A. Long-Term Safety in Epstein-Barr Virus (EBV)-Seropositive Kidney-Only Transplant Recipients Treated with Belatacept (BELA) in Clinical Practice: Final Study Results from the ENLiST Registry [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-safety-in-epstein-barr-virus-ebv-seropositive-kidney-only-transplant-recipients-treated-with-belatacept-bela-in-clinical-practice-final-study-results-from-the-enlist-registry/. Accessed December 1, 2023.
« Back to 2020 American Transplant Congress