NEJM:鲁索利替尼二线治疗慢性移植物抗宿主病效果显著

2021-07-15 MedSci原创 MedSci原创

于中重度糖皮质激素耐受性或糖皮质激素依赖性慢性移植物抗宿主病患者, 鲁索利替尼在提高治疗响应率,延长无病生存期以及改善症状得分方面优于现有治疗手段。

慢性移植物抗宿主病(GVHD)是异体干细胞移植后的严重并发症,30-70%的异基因干细胞移植患者会出现慢性GVHD,是导致并发症和非复发相关死亡的主要原因。慢性GVHD患者的一线治疗方案为糖皮质激素治疗,但约50%的患者为糖皮质激素耐受性或糖皮质激素依赖性,目前缺少糖皮质激素治疗以外的二线GVHD治疗手段。在先前的回顾性队列研究中,JAK1-JAK2抑制剂鲁索利替尼表现出对糖皮质激素耐受性或糖皮质激素依赖性慢性GVHD的治疗效果,近日研究人员开展III期临床研究,考察了其应用前景。

12岁以上,中重度糖皮质激素耐受性或糖皮质激素依赖性慢性GVHD患者参与研究,随机接受鲁索利替尼治疗(10mg,每日2次)或对照(10种常见治疗方案)。研究的主要终点为24周时的治疗响应,关键的次要终点包括无病生存以及Lee症状量表评分变化。

329名患者参与研究,其中鲁索利替尼组165人,对照组164人,24周时,鲁索利替尼组治疗响应率高于对照组(49.7% vs 25.6%,OR=2.99)。鲁索利替尼组的无病生存期显著长于对照组(超过18.6个月 vs 5.7个月,HR=0.37),Lee症状量表评分改善率更高(24.2% vs 11.9%,OR=2.62)。24周时,最常见的(发生率>10%)3级及以上不良事件包括血小板减少(鲁索利替尼组为15.2%,对照组为10.1%)和贫血(分别为12.7%和7.6%)。组间巨细胞病毒感染和再激活发生率相似。

组间治疗响应率及无病生存率差异

研究认为,于中重度糖皮质激素耐受性或糖皮质激素依赖性慢性移植物抗宿主病患者, 鲁索利替尼在提高治疗响应率,延长无病生存期以及改善症状得分方面优于现有治疗手段。

原始出处:

Robert Zeiser et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med,July 15,2021.

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    2021-10-23 xuyong535
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    2021-07-17 wincls
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    2021-07-16 ms2658711348342440

    学习了 谢谢

    0

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    2021-07-16 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

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    2021-07-16 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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