Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
CNRS-UMR 5164 Immuno ConcEpT, Université de Bordeaux, Bordeaux, France.
Transpl Int. 2023 Jun 28;36:11244. doi: 10.3389/ti.2023.11244. eCollection 2023.
Imlifidase recently received early access authorization for highly sensitized adult kidney transplant candidates with a positive crossmatch against an ABO-compatible deceased donor. These French consensus guidelines have been generated by an expert working group, in order to homogenize patient selection, associated treatments and follow-up. This initiative is part of an international effort to analyze properly the benefits and tolerance of this new costly treatment in real-life. Eligible patients must meet the following screening criteria: cPRA ≥ 98%, ≤ 65-year of age, ≥ 3 years on the waiting list, and a low risk of biopsy-related complications. The final decision to use Imlifidase will be based on the two following criteria. First, the results of a virtual crossmatch on recent serum, which shall show a MFI for the immunodominant donor-specific antibodies (DSA) > 6,000 but the value of which does not exceed 5,000 after 1:10 dilution. Second, the post-Imlifidase complement-dependent cytotoxicity crossmatch must be negative. Patients treated with Imlifidase will receive an immunosuppressive regimen based on steroids, rATG, high dose IVIg, rituximab, tacrolimus and mycophenolic acid. Frequent post-transplant testing for DSA and systematic surveillance kidney biopsies are highly recommended to monitor post-transplant DSA rebound and subclinical rejection.
伊米苷酶最近获得了高度致敏成年肾移植候选者的早期准入授权，这些候选者与 ABO 相容的已故供体交叉配型阳性。这些法国共识指南由一个专家工作组制定，旨在统一患者选择、相关治疗和随访。这一举措是国际上努力在真实环境中正确分析这种新的昂贵治疗方法的益处和耐受性的一部分。符合条件的患者必须符合以下筛选标准：cPRA≥98%，≤65 岁，等待名单上≥3 年，且活检相关并发症风险较低。使用伊米苷酶的最终决定将基于以下两个标准。首先，最近血清的虚拟交叉配型结果显示免疫显性供体特异性抗体（DSA）的 MFI＞6000，但在 1:10 稀释后其值不超过 5000。其次，伊米苷酶后的补体依赖性细胞毒性交叉配型必须为阴性。接受伊米苷酶治疗的患者将接受基于类固醇、rATG、高剂量 IVIg、利妥昔单抗、他克莫司和霉酚酸的免疫抑制方案。强烈建议进行频繁的移植后 DSA 检测和系统的肾活检监测，以监测移植后 DSA 反弹和亚临床排斥反应。
