在rATG和Infliximab诱导免疫抑制-RIMINI试验后使用塔克罗利斯
Ondrej Viklicky1,2, Ivan Zahradka1, Gantuja Bold3
1Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Transplantation
|August 1, 2023
概括
这项研究评估了子抗甲基球蛋白和移植患者的因弗利克西马布诱导,使得无菌酸盐的免疫抑制. 该疗法显示了可比的疗效,但具有较高的新型捐赠者特异性抗体的风险.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 免疫学 免疫学 免疫学
- 移植科学 移植科学
背景情况:
- 因弗利西马布向激活的效应细胞,可能允许菌酸在移植免疫抑制中被消除.
- 评估新的诱导策略对于优化移植后管理至关重要.
研究的目的:
- 评估子抗胆小细胞球蛋白和因弗利克西马布诱导在移植中的疗效和安全性.
- 在移植接受者中评估无菌酸盐的免疫抑制疗法.
主要方法:
- 第二阶段,国际,多中心,开放标签,单臂临床试验.
- 67名低风险初级脏移植接受者接受了子抗细胞球蛋白和因弗利西马布诱导.
- 在12个月的时间里,无菌酸盐,以塔克罗利斯为基础的免疫抑制,具有历史匹配的对照队列.
主要成果:
- 有效性失败发生在32.84%的患者中,符合预先定义的标准,与历史队列相似.
- 79.1%的患者在12个月后仍然遵循研究方案.
- 观察到较低的BK复制率 (6%与22.4%相比),但较高的新型捐赠者特异性抗体 (DSAs) (11.9%与1.5%相比).
结论:
- 研究中的免疫抑制疗法表现出与对照组相似的疗效.
- 较高的新出现的DSA表明抗体中介排斥的风险增加.
- 这种诱导策略可能允许菌酸在移植中消除.
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