Department of Pharmacy, NewYork-Presbyterian Hospital, New York, New York, USA.
Division of Nephrology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York, USA; Columbia University Renal Epidemiology Group, New York, New York, USA.
Am J Transplant. 2024 Jun;24(6):1027-1034. doi: 10.1016/j.ajt.2024.02.015. Epub 2024 Feb 21.
Though belatacept is administered with a weight-based dosing schema, there has been higher clearance reported in obese patients. Therefore, we evaluated the association between body mass index (BMI) and transplant outcomes in kidney transplant recipients who were randomized to cyclosporine- or belatacept-based immunosuppression in the BENEFIT and BENEFIT-EXT randomized clinical trials. A total of 666 and 543 patients underwent randomization and transplantation in BENEFIT and BENEFIT-EXT, respectively, of which 1056 had complete data and were included in this analysis. Patients were grouped categorically according to BMI: <25, 25 to <30, and ≥30 kg/m. BMI did influence both the incidence and severity of acute rejection. Obese patients with BMI >30 kg/m in the low intensity belatacept group experienced significantly more rejection at 12 months than did patients with BMI <25 kg/m or BMI 25 to <30 kg/m. In both the moderate intensity belatacept and low intensity belatacept groups, obese patients with BMI >30 kg/m experienced significantly more severe acute rejection than did patients with BMI < 25 kg/m or BMI 25 to <30 kg/m. These results suggest that obese kidney transplant recipients are at an increased risk for acute rejection when under belatacept-based immunosuppression when compared to nonobese patients.
尽管贝利尤单抗采用基于体重的剂量方案进行给药,但肥胖患者的清除率较高。因此,我们评估了体重指数(BMI)与接受环孢素或贝利尤单抗免疫抑制治疗的肾移植受者移植结局之间的关系,这些受者来自 BENEFIT 和 BENEFIT-EXT 随机临床试验。共有 666 例和 543 例患者分别在 BENEFIT 和 BENEFIT-EXT 中接受随机分组和移植,其中 1056 例患者具有完整的数据并纳入本分析。患者根据 BMI 分为以下几类:<25、25-<30 和≥30 kg/m。BMI 确实会影响急性排斥反应的发生率和严重程度。在低强度贝利尤单抗组中,BMI>30 kg/m 的肥胖患者在 12 个月时的排斥反应发生率显著高于 BMI<25 kg/m 或 BMI 25-<30 kg/m 的患者。在中强度贝利尤单抗和低强度贝利尤单抗组中,BMI>30 kg/m 的肥胖患者的严重急性排斥反应发生率均显著高于 BMI<25 kg/m 或 BMI 25-<30 kg/m 的患者。这些结果表明,与非肥胖患者相比,肥胖肾移植受者在接受贝利尤单抗免疫抑制治疗时发生急性排斥反应的风险增加。