Cherikh Wida S, Kou Tzuyung Douglas, Foutz Julia, Baker Timothy J, Gomez-Caminero Andres
Research Department, United Network for Organ Sharing, Richmond, VA, United States of America.
Worldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, United States of America.
PLoS One. 2025 Jan 10;20(1):e0311935. doi: 10.1371/journal.pone.0311935. eCollection 2025.
Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).
Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.
During the study period (June 15, 2011-June 14, 2016), 94.9% (1631/1719) of belatacept-treated and 89.7% (59,992/66,905) of CNI-treated patients with known EBV serostatus were EBV seropositive. Among EBV-seropositive patients, 50.2% (belatacept) and 56.8% (CNI) received a standard criteria donor kidney, 59.5% and 18.7% received basiliximab induction, and 22.9% and 50.8% received antithymocyte globulin induction. PTLD developed in nine belatacept-treated patients (two with central nervous system [CNS] involvement) and 225 CNI-treated patients (nine with CNS involvement). Four and 81 patients, respectively, died due to PTLD. Kaplan-Meier analysis did not show a significant between-group difference in PTLD estimated incidence rates within 5 years (0.70% versus 0.48%, respectively; p = 0.18). Additionally, estimated PTLD incidence was not significantly different between treatment groups in a propensity score matched cohort.
The majority of adult kidney-only transplant recipients treated with belatacept in routine clinical practice are EBV seropositive. In this study, the risk of PTLD in these patients, while higher than for CNI-based immunosuppression, remained low after adjusting for differences in patient characteristics.
These studies are registered at ClinicalTrials.gov: NCT01670058 and NCT01656343.
贝拉西普已被批准用于预防EB病毒（EBV）血清学阳性的肾移植受者的器官排斥反应，且与移植后淋巴细胞增生性疾病（PTLD）风险相关。
利用器官获取与移植网络的数据，以研究贝拉西普的使用模式，描述患者特征，并评估接受基于贝拉西普或钙调神经磷酸酶抑制剂（CNI）的免疫抑制治疗的EBV血清学阳性的单纯肾移植受者发生PTLD的风险，这是美国食品药品监督管理局要求的安全性监测的一部分。
在研究期间（2011年6月15日至2016年6月14日），已知EBV血清学状态的接受贝拉西普治疗的患者中有94.9%（1631/1719）为EBV血清学阳性，接受CNI治疗的患者中有89.7%（59,992/66,905）为EBV血清学阳性。在EBV血清学阳性患者中，50.2%（贝拉西普组）和56.8%（CNI组）接受了标准标准供体肾，59.5%和18.7%接受了巴利昔单抗诱导治疗，22.9%和50.8%接受了抗胸腺细胞球蛋白诱导治疗。9例接受贝拉西普治疗的患者发生了PTLD（2例有中枢神经系统[CNS]受累），225例接受CNI治疗的患者发生了PTLD（9例有CNS受累）。分别有4例和81例患者因PTLD死亡。Kaplan-Meier分析显示，两组在5年内的PTLD估计发病率之间无显著组间差异（分别为0.70%和0.48%；p = 0.18）。此外，在倾向评分匹配队列中，各治疗组之间的PTLD估计发病率也无显著差异。
在常规临床实践中，接受贝拉西普治疗的大多数成年单纯肾移植受者为EBV血清学阳性。在本研究中，这些患者发生PTLD的风险虽高于基于CNI的免疫抑制治疗，但在调整患者特征差异后仍较低。
这些研究已在ClinicalTrials.gov注册：NCT01670058和NCT01656343。
