Ann Rheum Dis:NI-0101对甲氨蝶呤反应不足类风湿性关节炎患者的疗效和安全性

2020-01-05 xiangting MedSci原创

这项研究首次证明在人类免疫介导的炎性疾病RA中,仅阻断TLR4通路并不能改善疾病指标。

抗瓜氨酸化蛋白抗体(ACPAs)与结合了Toll样受体(TLR4的瓜氨酸化蛋白形成免疫复合物,该复合物被认为是类风湿性关节炎(RA)的介体。NI-0101是阻断TLR4的第一代人源性单克隆抗体,已通过抑制健康志愿者体内脂多糖诱导的细胞因子释放得到证实。这项研究旨在验证支持使用生物标记物驱动方法治疗这些免疫复合物阳性RA患者的临床前研究。

这是一项安慰剂对照、双盲、随机(21)试验,比较了甲氨蝶呤反应不足的ACPA阳性RA患者使用NI-01015mg/kg,每2周一次,共12周)与安慰剂治疗的耐受性和疗效。疗效指标包括含有C反应蛋白(DAS28-CRP)的疾病活动性评分(28关节计数)、欧洲抗风湿病联盟(EULAR)良好和中度反应以及美国风湿病学会(ACR20ACR50ACR70反应。进行了在生物标志物上定义的亚组分析。报告了药代动力学、药效学和安全性。

90例患者被随机分组​​NI-010161例)和安慰剂(29例));86例患者完成了研究。组间的任何疗效终点均未观察到明显差异。使用基线指标作为协变量的亚组分析未发现任何对NI-0101有反应的人群。安慰剂治疗患者中出现急性不良事件的比例为51.7%,而NI-0101组为52.5%。

这项研究首次证明在人类免疫介导的炎性疾病RA中,仅阻断TLR4通路并不能改善疾病指标。成功靶向RA的先天免疫途径需要更广和/或更早的抑制方法。

原始出处:

Emmanuel Monnet. Efficacy and safety of NI-0101, an anti-toll-like receptor 4 monoclonal antibody, in patients with rheumatoid arthritis after inadequate response to methotrexate: a phase II study. Ann Rheum Dis. December 2019.

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    2020-01-07 lmm397
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    2020-01-05 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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