Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation.
Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation.
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DOI：
10.1111/ajt.16828
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发表时间：
2022-03
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--
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来自化脓性链球菌的IgG降解酶（汉莎生物制药的Imlifidase）是一种新型药物，可切割所有四种人类IgG亚类，具有治疗肾移植和抗体介导的排斥反应中HLA脱敏的潜力。来自肾移植临床试验的数据表明，抗HLA供体特异性抗体的快速降解促进了HLA -不相容移植，这导致imlifidase被欧洲药品管理局有条件地批准用于交叉配型阳性的已故供体肾移植受者的脱敏。随着imilifidase成为临床移植的治疗药物，早期使用imilifidase的经验对供体特异性抗体给药后的动力学、补充治疗单克隆或多克隆IgG抗体的时机以及交叉配伍试验的干扰等方面产生了重要的考虑。鉴于欧洲药品管理局有条件批准imlifidase对交叉配型阳性的已故供体肾脏受体脱敏，本综述讨论了支持使用imlifidase的临床数据和临床实践中遇到的注意事项。
The IgG‐degrading enzyme derived from Streptococcus pyogenes (Imlifidase, Hansa Biopharma) is a novel agent that cleaves all four human subclasses of IgG and has therapeutic potential for HLA desensitization in kidney transplantation and antibody‐mediated rejection. Data from clinical trials in kidney transplantation demonstrated rapid degradation of anti‐HLA donor‐specific antibodies facilitating HLA‐incompatible transplantation, which led to conditional approval of imlifidase by the European Medicines Agency for desensitization in kidney transplant recipients of a deceased donor with a positive cross match. Important considerations arising from the early experiences with imilfidase on kinetics of donor‐specific antibodies after administration, timing of complementary therapeutic monoclonal or polyclonal IgG antibodies, and interference with cross match assays should be recognized as imlifidase emerges as a therapeutic agent for clinical transplantation. In light of conditional approval of imlifidase by the European Medicines Agency to desensitize recipients of a deceased donor kidney with a positive cross match, this review discusses the clinical data supporting the use of imlifidase and considerations encountered in clinical practice.
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