AP-HP, Hôpital Paul Brousse, Centre Hépato-Biliaire, INSERM Unit 1193, Université Paris Saclay, Villejuif, France.
AP-HP-Hopital henri Mondor, Université Paris Est, Créteil, France.
Liver Int. 2022 Nov;42(11):2513-2523. doi: 10.1111/liv.15396. Epub 2022 Sep 1.
To report 5-year outcomes of the CERTITUDE study.
An observational study in patients with liver transplantation (LTx) compared the long-term impact of immunosuppression (with/without a calcineurin inhibitor) on renal function, cancers, major cardiovascular events (MACEs) and other safety parameters. All patients completing the 6-month SIMCER study were recruited and analysed according to treatment received at randomization and actual treatment received during the follow-up.
Of the 143 enrolled patients, 119 completed the 5-year follow-up (everolimus [EVR], n = 55; tacrolimus [TAC], n = 64). The mean absolute change in estimated glomerular filtration rate was not statistically different between both groups (TAC, -15.53 ml/min/1.73 m and EVR, -14.56 ml/min/1.73 m ). In the treatment subgroups based on actual treatment received, renal function was preserved better in the EVR subgroup compared with other subgroups (p = .051). Treated biopsy-proven acute rejection was higher in the EVR group (15.4% vs. 6.4%); however, the majority of events were mild in severity. MACE occurred in 9.2% vs. 14.1% of patients in the EVR and TAC groups respectively (p = .370). De novo cancer was reported in 14 and 5 patients in EVR and TAC groups respectively. Hepatocellular carcinoma (HCC) recurrence was observed in the TAC group alone (n = 4). Adverse events and treatment discontinuation owing to an adverse event were higher in the EVR group.
The CERTITUDE study demonstrated that EVR- and TAC-based regimens have comparable efficacy, safety and tolerability up to 5 years post-LTx.
报告 CERTITUDE 研究的 5 年结果。
一项观察性研究纳入了接受肝移植（LTx）的患者，比较了免疫抑制（有无钙调磷酸酶抑制剂）对肾功能、癌症、主要心血管事件（MACE）和其他安全性参数的长期影响。所有完成 6 个月 SIMCER 研究的患者均根据随机分组时的治疗和随访期间的实际治疗进行招募和分析。
在纳入的 143 例患者中，119 例完成了 5 年随访（依维莫司 [EVR]，n=55；他克莫司 [TAC]，n=64）。两组间估算肾小球滤过率的绝对变化无统计学差异（TAC，-15.53ml/min/1.73m；EVR，-14.56ml/min/1.73m）。根据实际治疗分组的亚组分析中，EVR 亚组的肾功能保存更好（p=0.051）。EVR 组治疗后活检证实的急性排斥反应发生率更高（15.4% vs. 6.4%），但大多数为轻度。EVR 和 TAC 组的 MACE 发生率分别为 9.2%和 14.1%（p=0.370）。EVR 和 TAC 组分别有 14 例和 5 例患者新发癌症。仅 TAC 组观察到肝细胞癌（HCC）复发（n=4）。EVR 组不良事件和因不良事件停药的发生率更高。
CERTITUDE 研究表明，EVR 和 TAC 方案在 LTx 后 5 年的疗效、安全性和耐受性相当。
