PDF(Pubmed)
Abstract：
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.
摘要：
Immifidase最近获得了对高度敏感的成年肾脏移植候选人的早期访问授权，与ABO兼容的已故供体进行了积极的交叉匹配。这些法国共识准则是由一个专家工作组制定的，为了使患者选择均匀化，相关治疗和随访。这一举措是国际努力的一部分，目的是适当分析这种新的昂贵治疗方法在现实生活中的益处和容忍度。符合条件的患者必须符合以下筛选标准：cPRA≥98%，≤65岁，在等待名单上≥3年，活检相关并发症的风险较低。使用Imlifidase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匹配结果，其将显示免疫显性供体特异性抗体(DSA)的MFI>6,000,但在1:10稀释后其值不超过5,000。第二,Immidase后补体依赖性细胞毒性交叉匹配必须为阴性。使用Imlifidase治疗的患者将接受基于类固醇的免疫抑制方案，rATG,高剂量IVIg,利妥昔单抗,他克莫司和霉酚酸。强烈建议对DSA进行频繁的移植后测试和系统的监测肾脏活检，以监测移植后DSA反弹和亚临床排斥反应。
