Ann Rheum Dis:法西单抗对慢性下腰痛的疗效和安全性

2021-03-17 xiangting MedSci原创

法西单抗是靶向NGF的人IgG1k抗体。这项研究评估了法西单抗对中重度慢性下腰痛(CLBP)的疗效和安全性。

法西单抗是靶向NGF的人IgG1k抗体。这项研究评估了法西单抗对中重度慢性下腰痛(CLBP)的疗效和安全性。

                             

 

使用对乙酰氨基酚、非甾体类抗炎药和阿片类药物后疼痛不能缓解的≥35岁CLBP患者,被随机分为法西单抗6或9mg每4周皮下注射1次(Q4W)、每8周静脉注射9mg(Q8W)或安慰剂组。主要终点是基线到第16周每日平均下腰痛强度(LBPI)数字评分。关键的次要疗效指标包括罗兰·莫里斯残疾问卷(RMDQ)和患者整体评估(PGA)。

结果如下:第16周时,法西单抗9mg Q4W和Q8W组观察到LBPI明显降低(最小二乘均方(标准差)-0.7(0.3);p<0.05),但6mg组未观察到变化(–0.3(0.3);p=0.39)。第16周时,法西单抗9mg静脉注射组的RMDQ和PGA改善最大。16周内,与没有外周骨关节炎(pOA)的患者相比,出现疗效的骨关节炎患者在数量上更多。法西单抗治疗组和安慰剂组分别有274/418(65.6%)患者和94/140(67.1%)患者出现了需要治疗的紧急不良事件(AEs)。法西单抗组的关节不良事件更常见(16例患者发生19个事件(3.8%),安慰剂组为1例患者发生1个事件(0.7%))。

 

由此可见,最大剂量的法西单抗可以改善CLBP的疼痛和功能。大多数关节AEs发生在pOA患者中,这与症状性OA的早期发现一致。未来需要对伴或不伴pOA的CLBP患者进行更多研究,以确定最佳的收益-风险。

 

原始出处:

Paula Dakin. Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial. Ann Rheum Dis. March 2021.

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    2021-10-28 respect
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    2021-03-29 ms5000000673406597

    太好了

    0

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    2021-03-17 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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    2021-03-17 jacob9231

    学习了谢谢

    0

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