Children's Hospital Colorado, Aurora, Colorado, USA.
Section of Cardiology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
Pediatr Transplant. 2023 Mar;27(2):e14438. doi: 10.1111/petr.14438. Epub 2022 Nov 17.
Pediatric heart transplant recipients are at risk for complications from prolonged exposure to immunosuppressive drugs, pharmacokinetic challenges in maintaining consistent immunosuppression, and medication non-adherence. Basiliximab (BAS), an interleukin-2 receptor antagonist, is used for induction therapy across many pediatric heart transplant centers, but use as maintenance immunosuppression has not been well described.
This was a retrospective, single pediatric center cohort study of heart transplant recipients who received BAS for maintenance immunosuppression (defined as >2 monthly doses) from January 1, 2011, to December 31, 2021.
Ten patients met study criteria with a median age of 17.5 (5-22) years and median 9.6 (1.2-18.9) years since transplant at time of BAS initiation. The primary indications for BAS use were recurrent rejection (n = 4), fluctuating immunosuppression levels (n = 3), and renal dysfunction (n = 3). A median of 5.5 (3-32) monthly BAS doses were received. Three patients had a rejection event while on BAS. Calcineurin inhibitor exposure was reduced in 70% of patients. Three of the 10 patients were alive at last follow-up. There was one documented infection during BAS use, and no hypersensitivity reactions.
Monthly BAS infusions were well tolerated and allowed for reduced calcineurin inhibitor exposure in most patients. Mortality commonly occurred despite BAS use, potentially reflecting the acuity of this patient cohort. BAS can be considered for maintenance immunosuppression in pediatric patients with fluctuating immunosuppressive levels and/or renal dysfunction. More studies are needed to determine long-term outcomes and explore expanded use of BAS in the pediatric heart transplant population.
儿科心脏移植受者由于长期暴露于免疫抑制剂、维持一致免疫抑制的药代动力学挑战以及药物依从性差而面临并发症的风险。巴利昔单抗（BAS）是一种白细胞介素-2 受体拮抗剂，被广泛应用于儿科心脏移植中心的诱导治疗，但作为维持性免疫抑制剂的应用尚未得到充分描述。
这是一项回顾性的单中心儿科队列研究，纳入了 2011 年 1 月 1 日至 2021 年 12 月 31 日期间，因维持性免疫抑制（定义为 >2 个每月剂量）而接受 BAS 的心脏移植受者。
10 名患者符合研究标准，中位年龄为 17.5（5-22）岁，在开始接受 BAS 时的中位时间为 9.6（1.2-18.9）年。BAS 使用的主要指征为复发性排斥反应（n=4）、免疫抑制剂水平波动（n=3）和肾功能障碍（n=3）。中位数接受了 5.5（3-32）个每月 BAS 剂量。3 名患者在接受 BAS 治疗时发生排斥反应。70%的患者减少了钙调磷酸酶抑制剂的暴露。10 名患者中有 3 名在最后一次随访时仍存活。BAS 使用期间发生 1 例感染，无过敏反应。
每月接受 BAS 输注治疗耐受性良好，可使大多数患者减少钙调磷酸酶抑制剂的暴露。尽管使用了 BAS，但仍有患者死亡，这可能反映了该患者群体的病情严重程度。BAS 可考虑用于免疫抑制水平波动和/或肾功能障碍的儿科心脏移植患者的维持性免疫抑制治疗。需要更多的研究来确定长期结局，并探索 BAS 在儿科心脏移植人群中的扩展应用。
