Albany Medical Center, Albany, NY, United States of America.
Eerie County Medical Center, Buffalo, NY, United States of America.
Transpl Immunol. 2023 Aug;79:101857. doi: 10.1016/j.trim.2023.101857. Epub 2023 May 16.
Belatacept may provide benefit in delayed graft function, but its association with infectious complications is understudied. We aim to assess the incidence of CMV and BK viremia in patients treated with sirolimus or belatacept as part of a three-drug immunosuppression regimen after kidney transplantation.
Kidney transplant recipients from 01/01/2015 to 10/01/2021 were retrospectively reviewed. Maintenance immunosuppression was either tacrolimus, mycophenolate and sirolimus (B) or tacrolimus, mycophenolate, and belatacept (5.0 mg/kg monthly) (B). Primary outcomes of interest were BK and CMV viremia which were followed until the end of the study period. Secondary outcomes included graft function (serum creatinine, eGFR) and acute rejection through 12 months.
Belatacept was initiated in patients with a higher mean kidney donor profile index (B:0.36 vs. B:0.44, p = .02) with more delayed graft function (B:6.1% vs. B:26.1%, p < .001). Belatacept therapy was associated with more "severe" CMV viremia >25,000 copies/mL (B:1.2% vs. B:5.9%, p = .016) and CMV disease (B:0.41% vs. B:4.2%, p = .015). However, there was no difference in the overall incidence of CMV viremia >200 IU/mL (B:9.4% vs. B:13.5%, p = .28). There was no difference in the incidence of BK viremia >200 IU/mL (B:29.7% vs. B:31.1%, p = .78) or BK-associated nephropathy (B:2.4% vs. B:1.7%, p = .58), but belatacept was associated with "severe" BK viremia, defined as >10,000 IU/mL (B:13.0% vs. B:21.8%, p = .03). The mean serum Cr was significantly higher with belatacept therapy at 1-year follow up (B:1.24 mg/dL vs. B:1.43 mg/dL, p = .003). Biopsy-proven acute rejection (B:1.2% vs. B:2.6%, p = .35) and graft loss (B:1.2% vs. B:0.84%, p = .81) were comparable at 12 months.
Belatacept therapy was associated with an increased risk of CMV disease and "severe" CMV and BK viremia. However, this regimen did not increase the overall incidence of infection and facilitated comparable acute rejection and graft loss at 12-month follow up.
巴利昔单抗可能有助于延迟移植物功能，但它与感染并发症的关系尚未得到充分研究。我们旨在评估在接受西罗莫司或巴利昔单抗作为三药免疫抑制方案的一部分的肾移植患者中，巨细胞病毒（CMV）和 BK 病毒血症的发生率。
回顾性分析了 2015 年 1 月 1 日至 2021 年 10 月 1 日的肾移植受者。维持性免疫抑制治疗方案为他克莫司、霉酚酸酯和西罗莫司（B 组）或他克莫司、霉酚酸酯和巴利昔单抗（5.0mg/kg 每月）（B 组）。主要观察终点是 BK 和 CMV 病毒血症，随访至研究结束。次要观察终点包括移植肾功能（血清肌酐、eGFR）和 12 个月内的急性排斥反应。
与 B 组相比，B 组患者的平均肾供者特征指数（B：0.36 比 B：0.44，p = 0.02）更高，且延迟移植物功能的发生率更高（B：6.1%比 B：26.1%，p < 0.001）。巴利昔单抗治疗与更严重的 CMV 病毒血症（>25,000 拷贝/mL，B：1.2%比 B：5.9%，p = 0.016）和 CMV 疾病（B：0.41%比 B：4.2%，p = 0.015）有关。然而，CMV 病毒血症（>200IU/mL，B：9.4%比 B：13.5%，p = 0.28）的总体发生率无差异。BK 病毒血症（>200IU/mL，B：29.7%比 B：31.1%，p = 0.78）或 BK 相关肾病（B：2.4%比 B：1.7%，p = 0.58）的发生率也无差异，但巴利昔单抗与更严重的 BK 病毒血症有关，定义为>10,000IU/mL（B：13.0%比 B：21.8%，p = 0.03）。在 1 年随访时，巴利昔单抗治疗组的血清 Cr 均值明显更高（B：1.24mg/dL 比 B：1.43mg/dL，p = 0.003）。12 个月时，活检证实的急性排斥反应（B：1.2%比 B：2.6%，p = 0.35）和移植物丢失（B：1.2%比 B：0.84%，p = 0.81）的发生率相似。
巴利昔单抗治疗与 CMV 疾病和更严重的 CMV 和 BK 病毒血症风险增加有关。然而，该方案并未增加总体感染发生率，并在 12 个月随访时实现了相当的急性排斥反应和移植物丢失。
