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第二次TULIP临床试验使阿斯利康的狼疮药物——干扰素阻滞剂anifrolumab复活

2019-09-02 不详 MedSci原创

一年前AstraZeneca的系统性红斑狼疮治疗药物anifrolumab的临床研究宣布失败,然而目前该药物在新的临床试验中得以复活。

一年前AstraZeneca的系统性红斑狼疮治疗药物anifrolumab的临床研究宣布失败,然而目前该药物在新的临床试验中得以复活。

AZ现已完成了anifrolumab(一种I型干扰素阻滞剂)的两项3期试验,结果截然不同。去年,基于SRI4量表的评价,460名患者的TULIP 1研究中抗体未能达到降低疾病活动的目的。但是到今年涉及373名患者的TULIP 2研究中,该药物在52周后使用不同的量表 - 基于英国群岛狼疮评估组的综合狼疮评估(BICLA),在疾病活动上达到了目标。

狼疮是一种免疫系统攻击正常细胞和组织,引起炎症和器官损伤的疾病。BICLA和SRI4都是公认的针对该疾病的药物测试方法,但重点略有不同。

BICLA反应需要在所有器官中部分改善并且没有突发,而SRI4需要完全改善疾病的某些表现,但不是所有器官。同时,除了不同的规模,TULIP 2也仅使用了第一次试验中使用的最高剂量的anifrolumab(300mg)。

然而目前的规模尚不能支持该药物通过监管申请, AZ现在必须确定一项阳性试验是否足以申请监管批准anifrolumab,或者是否进行第二次验证性试验。

在这方面,研发主管Mene Pangalos简单地说:"这些都是重要的结果,我们现在将审查完整的数据集并努力将这种潜在的新治疗方法带给患者的途径。"

原始出处:


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    2020-06-26 huangshifeng
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    2019-12-26 snf701207
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    2020-07-04 zhyy88
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