J Headache Pain:依普奈珠单抗预防慢性偏头痛的有效性和安全性:PROMISE-2 III期研究结果

2021-06-07 MedSci原创 MedSci原创

PROMISE-2是一项3期、随机、双盲、安慰剂对照研究,评估降钙素基因相关肽靶向单克隆抗体依普奈珠单抗(ALD403)重复静脉注射(IV)剂量对慢性偏头痛成人患者预防偏头痛的有效性和安全性。近日,研

PROMISE-2是一项3期、随机、双盲、安慰剂对照研究,评估降钙素基因相关肽靶向单克隆抗体依普奈珠单抗(ALD403)重复静脉注射(IV)剂量对慢性偏头痛成人患者预防偏头痛的有效性和安全性。近日,研究人员报告了PROMISE-2治疗24周的结果,已发表于J Headache Pain。

患者最多接受两次30分钟的静脉注射,分别为100毫克、300毫克或安慰剂,间隔12周。患者在每日电子日记中记录偏头痛和头痛的终点。在整个32周的研究期间(筛选、第0天、第2、4、8、12、16、20、24和32周),在定期安排的门诊中进行额外的评估,包括患者报告的结果。

 

结果,共有1072名成人患者接受了治疗:依普奈珠单抗100毫克,n = 356;依普奈珠单抗300毫克,n = 350;安慰剂,n = 366。第一次用药间隔期间观察到患者平均每月偏头痛天数减少(100毫克,-7.7天;300毫克,-8.2天;安慰剂,-5.6天),在额外用药后进一步减少(100毫克,-8.2天;300毫克,-8.8天;安慰剂,-6.2天),与安慰剂相比,两种剂量的依普奈珠单抗都表现出比基线更大的减少量。第二次用药后,≥50%和≥75%的偏头痛应答率(MRRs)有所增加,与安慰剂患者相比,有更多的伊匹单抗治疗的患者出现偏头痛应答(第13-24周≥50%的MRRs:100毫克,61.0%;300毫克,64.0%;安慰剂,44.0%;以及13-24周≥75%的MRRs:100毫克,39.3%;300毫克,43.1%;安慰剂,23.8%)。在第12周第二次给药后,患者报告结果(包括头痛影响测试和患者全球变化印象)得到改善的患者百分比增加,并且在所有时间点上,依普奈珠单抗都比安慰剂大。在治疗突发不良事件的发生率、性质和严重程度方面,第二剂量没有发现新的安全问题。

综上,在第0天静脉注射依普奈珠单抗100毫克或300毫克,并在第12周重复注射,可在整整24周内提供持续的偏头痛预防效果,并在慢性偏头痛患者中表现出可接受的安全性。

 

原始出处:

 

Stephen Silberstein, Merle Diamond, et al., Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020 Oct 6;21(1):120. doi: 10.1186/s10194-020-01186-3.

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    2022-04-18 juliusluan78
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    2021-06-10 zt123

    学习了一下

    0

  6. 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createdBy=a60b18898917, createdName=sunylz, createdTime=Wed Jun 09 14:55:30 CST 2021, time=2021-06-09, status=1, ipAttribution=)]
    2021-06-09 般若傻瓜
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    2021-06-09 sunylz

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