Clin Exp Rheumatol:2期临床试验结果证实尼塔奇单抗对活动性强直性脊柱炎良好的疗效和安全性

2021-05-03 MedSci原创 MedSci原创

尼塔奇单抗(NTK)是一种靶向白细胞介素-17A的人源化单克隆抗体,此前在健康志愿者中进行了1期试验。本文,研究人员报告了一项2期试验的结果,该试验旨在评估安全性和药代动力学(PK),以确定NTK在活

尼塔奇单抗(NTK)是一种靶向白细胞介素-17A的人源化单克隆抗体,此前在健康志愿者中进行了1期试验。本文,研究人员报告了一项2期试验的结果,该试验旨在评估安全性和药代动力学(PK),以确定NTK在活动性强直性脊柱炎(AS)患者目标人群中的治疗剂量,研究已发表于Clin Exp Rheumatol。

研究共纳入了89名活动性强直性脊柱炎患者,均接受了非甾体抗炎药物(NSAID)的治疗,随机分组在第0、1、2周接受40、80或120mg的皮下NTK或安慰剂,此后每两周一次直到第12周。主要终点是实现脊柱关节炎评估改善≥20%的患者比例。

 

结果显示,在第16周,40、80和120 mg NTK组ASAS20的反应率分别为72.73%[1.69%;58.05%],81.82%[12.36%;65.56%]和90.91%[23.71%;72.39%],安慰剂组的反应率为42.86%。预定的临床无意义的差异幅度为10%。80和120mg剂量的NTK优于安慰剂。最常见的不良事件(AEs)是淋巴细胞减少、中性粒细胞减少和无症状性细菌尿。没有观察到剂量依赖性的毒性或严重不良事件(SAE)。最有效的剂量是120mg,患者对治疗的反应最快,安全性良好。

综上所述,该研究结果证实了NTK对活动性AS的疗效和良好的安全性。将继续进行3期试验以评估NTK 120mg对AS患者1年的疗效。

 

原始出处:

 

Shandor Erdes, et al., Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults. Clin Exp Rheumatol. Jan-Feb 2020;38(1):27-34.  

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    2021-08-18 zywlvao
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    2021-05-03 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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