Lancet rheumat:靶向滑膜成纤维细胞增殖,类风湿关节炎的新治疗方向?

2021-03-11 Nebula MedSci原创

靶向抑制滑膜成纤维细胞增殖,是否可成为类风湿关节炎的新治疗方向?

目前,类风湿关节炎疗法主要以免疫炎症为目标,可能会产生上限效应。Seliciclib是一种口服的细胞周期蛋白依赖性激酶抑制剂,可抑制滑膜成纤维细胞的增殖。滑膜成纤维细胞尚未在类风湿关节炎治疗中充当靶点。

TRAFIC研究是一项非随机、开放标签、剂量探索性的1b/2a期临床试验,该研究的第1部分旨在明确Seliciclib用于持续使用TNF抑制剂治疗的活动性类风湿关节炎患者的最大耐受剂量,并评估安全性和药代动力学特征。招募了18岁及以上的明确诊断的中重度疾病活动(28关节的疾病活动评分[DAS]>3.2)的类风湿关节炎患者(即使入组时患者已采用抗TNF治疗了至少3个月)。

患者基本特征

2015年10月8日-2017年8月15日,筛查了37位患者,其中15位被分至5个队列接受Seliciclib治疗(200 mg、400 mg、600 mg、800 mg或1000 mg口服;每个剂量水平3位患者)。除了TNF抑制剂之外,还有10位入组患者(67%)正在服用常规的合成抗抗风湿药物。

剂量相关毒性

Seliciclib的最大耐受剂量为 400 mg,此剂量水平时的估计剂量限制性毒性的可能性约为0.35。研究期间发生了两例严重不良反应事件:一例接受600 mg剂量治疗的急性肾损伤和一例接受400 mg剂量治疗的药物诱导性肝损伤,两例都考虑与Seliciclib有关,与Seliciclib已知的安全性问题一致

治疗前后DAS28-CRP评分的变化

此外,在该试验期间,还发生了65例非重度不良反应事件,其中50例考虑与治疗相关。最常见的治疗相关的不良反应事件都比较轻微;20例治疗相关的非重度不良反应事件可归因于剂量限制性毒性。无死亡病例。

治疗相关不良反应

总之,Seliciclib用于对TNF阻滞难治性的类风湿关节炎的最大耐受剂量已明确(400 mg)。此外,无预料之外的安全性问题发生。

原始出处:

Arthur G Pratt, et al. Targeting synovial fibroblast proliferation in rheumatoid arthritis (TRAFIC): an open-label, dose-finding, phase 1b trial. The Lancet Rheumatology. March 09, 2021.

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    2022-01-12 howi
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    2021-04-13 gqylhd

    类风湿关节炎患者的新选择

    0

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    2021-03-13 lmm397
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    2021-03-11 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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