在临床实践中接受贝拉西普治疗的爱泼斯坦-巴尔病毒血清阳性仅肾移植受者的长期安全性：ENLiST注册研究的最终结果
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.
作者信息
Larsen Christian P, Vincenti Flavio, D Kou Tzuyung, Shadur Craig A, Bresnahan Barbara, Jordan Stanley C, Woodle E Steve, Goes Nelson, Vella John, Wojciechowski David, Polinsky Martin S, Gomez-Caminero Andres
机构信息
Department of Surgery, Emory University Transplant Center, Atlanta, GA.
Departments of Medicine and Surgery, University of California, San Francisco, Transplant Center, San Francisco, CA.
出版信息
Transplant Direct. 2024 May 17;10(6):e1644. doi: 10.1097/TXD.0000000000001644. eCollection 2024 Jun.
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; = 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.
背景
贝拉西普是一种选择性T细胞共刺激阻滞剂，在3期试验中，它与成年肾移植受者生存率提高及肾功能改善相关，但也存在移植后淋巴细胞增生性疾病（PTLD）风险。该登记研究调查了接受贝拉西普治疗的爱泼斯坦-巴尔病毒（EBV）血清学阳性肾移植受者的长期安全性。
方法
这项基于美国的前瞻性、自愿性、多中心登记研究（评估Nulojix在移植中的长期安全性[ENLiST]）纳入了成年EBV血清学阳性的单纯肾移植受者，这些受者在移植后14天内开始接受贝拉西普初始治疗。主要目标是估计确诊的PTLD、中枢神经系统（CNS）PTLD和进行性多灶性白质脑病（PML）的发病率。最短随访时间为2年。
结果
在985名登记的移植受者中，933名EBV血清学阳性患者接受了贝拉西普治疗，其中523名（56.1%）在移植时同时接受了他克莫司治疗（最长12个月）。到研究结束时，报告了3例非CNS PTLD（发病率为0.08/100人年）、1例CNS PTLD（0.03/100人年），未报告PML病例。2例非CNS PTLD患者同时接受了贝拉西普和他克莫司治疗，1例接受了贝拉西普和淋巴细胞清除疗法。接受贝拉西普和他克莫司联合治疗的患者与未接受他克莫司治疗的患者发病率相当（分别为0.09/100人年和0.用了“他克莫司治疗的患者与未接受他克莫司治疗的患者发病率相当（分别为0.09/100人年和0.07/100人年；P = 0.96）。4例PTLD患者中有2例死亡，2例在研究结束时存活。到研究结束时，累计报告了131例移植物丢失或死亡。
结论
我们在ENLiST登记研究中的结果，一项大型前瞻性真实世界研究，表明接受贝拉西普治疗的EBV血清学阳性移植受者中PTLD和CNS PTLD的发病率与先前3期试验的结果一致。 07/100人年；P = 0.96）。4例PTLD患者中有2例死亡，2例在研究结束时存活。到研究结束时，累计报告了131例移植物丢失或死亡。
结论
我们在ENLiST登记研究中的结果，一项大型前瞻性真实世界研究，表明接受贝拉西普治疗的EBV血清学阳性移植受者中PTLD和CNS PTLD的发病率与先前3期试验的结果一致。
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