Ann Rheum Dis:他那珠单抗治疗髋关节或膝关节骨性关节炎的疗效和安全性

2021-04-17 MedSci原创 MedSci原创

他那珠单抗是一种神经生长因子抑制剂,近日,一项双盲、随机、III期研究探讨了他那珠单抗对髋关节或膝关节骨关节炎(OA)的治疗效果,研究结果已发表于Ann Rheum Dis。

他那珠单抗是一种神经生长因子抑制剂,近日,一项双盲、随机、III期研究探讨了他那珠单抗对髋关节或膝关节骨关节炎(OA)的治疗效果,研究结果已发表于Ann Rheum Dis。

2016年3月到2017年12月,研究在欧洲和日本招募了849名中度至重度OA患者,这些患者对标准护理镇痛剂无反应或不能耐受。患者随机接受他那珠单抗2.5 mg或5 mg皮下注射或匹配的安慰剂,每8周一次(三次剂量)。共同主要终点是WOMAC 疼痛和身体功能,以及PGA-OA 从基线到第24周的变化。在整个48周的研究中继续进行关节安全和神经学评估。

 

282名患者接受安慰剂,283名患者接受2.5 mg他那珠单抗,284名患者接受5 mg他那珠单抗。在第24周,与安慰剂组相比,他尼珠单抗5 mg在WOMAC疼痛(最小二乘平均差异±SE -0.62±0.18,p=0.0006)、WOMAC身体功能(-0.71±0.17,p<0.0001)和PGA-OA(-0.19±0.07,p=0.0051)方面较基线有显著改善。对于他那珠单抗2.5 mg组,WOMAC疼痛和身体功能方面也有统计学意义的改善,但PGA-OA没有改善。他那珠单抗2.5 mg组和5 mg组分别有1.4%(4/283)和2.8%(8/284)的患者出现快速进展性骨关节炎(RPOA)。三个治疗组中总关节置换(TJRs)的患者数相似(6.7%-7.8%)。与安慰剂相比,他那珠单抗治疗的患者经历了更多的感觉异常(5 mg)和感觉减退(两种剂量)。

综上所述,该研究结果表明,他那珠单抗 5 mg可显著改善骨关节炎患者的疼痛、身体功能和PGA-OA,但他那珠单抗 2.5 mg仅能改善患者的疼痛和身体功能。但是,与他那珠单抗2.5 mg相比,他那珠单抗5 mg发生RPOA的频率更高。

 

原始出处:

 

Francis Berenbaum, et al., Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296.  

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    2021-04-19 lmm397
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    2021-04-18 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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    2021-04-17 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

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