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治疗复发性多发性硬化症的儿科患者的特里弗卢诺米德:开放式扩展TERIKIDS的标签

Tanuja Chitnis¹, Brenda Banwell², Ludwig Kappos³

¹Massachusetts General Hospital for Children, Boston, MA, USA.

Multiple sclerosis (Houndmills, Basingstoke, England)

|April 15, 2024

概括

特里弗卢诺米德在减少儿童复发性多发性硬化症活动方面表现出有效性. 该药物在TERIKIDS研究扩展中表现出可控的耐受性,没有新的安全问题.

科学领域:

儿科神经学儿科神经学
免疫学免疫学免疫学
临床试验临床试验

背景情况:

在TERIKIDS研究中,对患有复发性多发性硬化症 (MS) 的儿科患者的特里弗卢诺米德进行了研究.
了解teriflunomide在这个人群中的长期疗效和安全性至关重要.

研究的目的:

在TERIKIDS开放扩展研究中评估持续的特里弗卢诺米德治疗的疗效,安全性和耐受性.
评估Teriflunomide对患有复发性MS的儿童疾病活动和进展的长期影响.

主要方法:

患有复发性多发性硬化症的儿童最初在双盲期 (长达96周) 随机分配给安慰剂或特里弗卢诺米德 (14毫克成人相当剂量).
然后,参与者进入了开放式延长期,在随机化后接受了多达192周的特里弗卢诺米德.
疗效终点包括临床复发风险和MRI病变负担;整个过程中监测了安全性.

主要成果:

与安慰剂相比,teriflunomide治疗显著降低了加多增强T1病变 (43%) 和新的/扩大的T2病变 (49%) 的风险.
随着teriflunomide的使用,观察到减少24周持续残疾进展的趋势.
与安全相关的中止发生率较低的teriflunomide/teriflunomide组 (4.0%) 与安慰剂/teriflunomide (13.5%) 相比,尽管发生了两例胰腺炎.

结论:

特里弗卢诺米德有效地降低了儿科复发性MS的长期焦点炎症活性.
该药物表现出一般可控的耐受性,没有发现新的安全信号.
进一步的研究可能会加强临床疗效的研究结果,但terriflunomide对治疗儿科多发性硬化症有希望.

关键词:

有关特里弗卢诺胺的青少年青少年青少年青少年孩子孩子孩子孩子孩子孩子临床试验临床试验临床试验临床试验临床试验复发性多发性硬化症复发性多发性硬化症安全分析安全分析.

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