P.005 Eptinezumab demonstrated efficacy regardless of prior preventive migraine treatment failure: post hoc DELIVER analyses

P Pozo-Rosich, M Ashina, SJ Tepper, S. Jensen, L Pickering Boserup, M Krog Josiassen, B Sperling, JK Bougie, J. Miron
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Abstract

Background: This post hoc analysis evaluated the efficacy of eptinezumab vs placebo across 24 weeks of treatment in the placebo-controlled period of the DELIVER study in subgroups defined by prior treatment failure. Methods: DELIVER (NCT04418765) randomized adults with migraine to eptinezumab 100 mg, 300 mg, or placebo intravenous infusion every 12 weeks. Eligible patients needed documented evidence of 2–4 prior preventive treatment failures within the past 10 years. This post hoc analysis focused on subgroups of patients with prior treatment failure on topiramate, beta blockers, amitriptyline, and/or flunarizine. Results: The full analysis set included 890 patients: 633 previously failed topiramate, 538 failed beta blockers, 508 failed amitriptyline, and 333 failed flunarizine; within each subgroup, most patients had 2 prior treatment failures (51–56%). Across Weeks 1–12 in all subgroups, patients treated with eptinezumab experienced greater reductions from baseline in MMDs than those receiving placebo, with larger reductions observed over Weeks 13–24. Similarly, ≥50% MRRs were higher with eptinezumab than with placebo and increased following a second infusion. Conclusions: Eptinezumab demonstrated greater reductions in MMDs compared with placebo across all subgroups of prior preventive treatment failure, with evidence to suggest that a second dose provides additional benefit.
P.005 无论之前的偏头痛预防性治疗是否失败,Eptinezumab 都能显示出疗效:DELIVER 事后分析
研究背景这项事后分析评估了在DELIVER研究的安慰剂对照期,依替珠单抗与安慰剂在既往治疗失败的亚组中进行24周治疗的疗效。研究方法DELIVER(NCT04418765)将患有偏头痛的成人随机分为100毫克、300毫克或安慰剂,每12周静脉注射一次。符合条件的患者需要有证据证明在过去 10 年中曾有 2-4 次预防性治疗失败。这项事后分析的重点是既往接受过托吡酯、β受体阻滞剂、阿米替林和/或氟桂利嗪治疗失败的亚组患者。分析结果整个分析组包括 890 名患者:其中 633 名患者曾服用托吡酯治疗失败,538 名患者曾服用 beta 受体阻滞剂治疗失败,508 名患者曾服用阿米替林治疗失败,333 名患者曾服用氟桂利嗪治疗失败;在每个亚组中,大多数患者曾有两次治疗失败(51-56%)。在第1-12周的所有亚组中,接受eptinezumab治疗的患者的MMDs从基线降低的幅度大于接受安慰剂治疗的患者,而在第13-24周观察到的降低幅度更大。同样,使用eptinezumab后,≥50%的MRR也高于安慰剂,并且在第二次输注后还会增加。结论在所有既往预防性治疗失败的亚组中,与安慰剂相比,eptinezumab能更大程度地降低MMDs,有证据表明第二次输注能带来更多益处。
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