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Abstract：
BACKGROUND: In the DELIVER study, eptinezumab reduced monthly migraine days (MMDs) more than placebo in patients with 2-4 prior preventive migraine treatment failures. This post hoc analysis evaluated the efficacy of eptinezumab across the 24-week placebo-controlled period of the DELIVER study in subgroups defined by prior treatment failure type.
METHODS: DELIVER (NCT04418765) randomized adults with migraine to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously every 12 weeks. Changes from baseline in MMDs and percentages of patients with ≥ 50% reduction from baseline in MMDs (≥ 50% migraine responder rates [MRRs]) were summarized in subgroups of patients defined by prior treatment failure type. Subgroups were not mutually exclusive and included patients for whom topiramate, beta blockers (metoprolol, propranolol), amitriptyline, and/or flunarizine had failed.
RESULTS: Across Weeks 1-12 in all subgroups, patients treated with eptinezumab experienced greater reductions from baseline in MMDs than those receiving placebo (reductions ranged from 4.5-5.5 vs 1.6-2.4, respectively), with larger reductions over Weeks 13-24. Similarly, ≥ 50% MRRs were consistently higher with eptinezumab than placebo and increased following a second infusion.
CONCLUSIONS: In all subgroups, regardless of prior preventive treatment failure type, eptinezumab demonstrated greater reductions in MMDs and higher MRRs compared with placebo.
BACKGROUND: ClinicalTrials.gov (Identifier: NCT04418765).
METHODS: DELIVER (NCT04418765) randomized adults with migraine to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously every 12 weeks. Changes from baseline in MMDs and percentages of patients with ≥ 50% reduction from baseline in MMDs (≥ 50% migraine responder rates [MRRs]) were summarized in subgroups of patients defined by prior treatment failure type. Subgroups were not mutually exclusive and included patients for whom topiramate, beta blockers (metoprolol, propranolol), amitriptyline, and/or flunarizine had failed.
RESULTS: Across Weeks 1-12 in all subgroups, patients treated with eptinezumab experienced greater reductions from baseline in MMDs than those receiving placebo (reductions ranged from 4.5-5.5 vs 1.6-2.4, respectively), with larger reductions over Weeks 13-24. Similarly, ≥ 50% MRRs were consistently higher with eptinezumab than placebo and increased following a second infusion.
CONCLUSIONS: In all subgroups, regardless of prior preventive treatment failure type, eptinezumab demonstrated greater reductions in MMDs and higher MRRs compared with placebo.
BACKGROUND: ClinicalTrials.gov (Identifier: NCT04418765).
摘要：
背景：在DELIVER研究中，在2-4例既往预防性偏头痛治疗失败的患者中,eptinezumab比安慰剂组减少每月偏头痛天数(MMD).该事后分析评估了在DELIVER研究的24周安慰剂对照期中由先前治疗失败类型定义的亚组中的eptinezumab的功效。
方法：DELIVER（NCT04418765）将患有偏头痛的成年人随机分为100mg，300毫克，或安慰剂，每12周静脉给药。在先前治疗失败类型定义的患者亚组中，总结了MMD从基线的变化以及MMD从基线降低≥50％的患者百分比（偏头痛反应率≥50％[MRR]）。亚组并不相互排斥，包括托吡酯患者，β受体阻滞剂（美托洛尔，普萘洛尔），阿米替林,和/或氟桂利嗪失败。
结果：在所有亚组的第1-12周，与接受安慰剂治疗的患者相比,接受eptinezumab治疗的患者的MMD比基线降低更大(降低范围分别为4.5-5.5和1.6-2.4),在第13-24周期间，降幅更大。同样，eptinezumab组的MRR≥50%始终高于安慰剂组，并在第二次输注后增加。
结论：在所有亚组中，无论以前的预防性治疗失败类型，与安慰剂相比,eptinezumab的MMD降低幅度更大,MRR也更高.
背景：ClinicalTrials.gov（标识符：NCT04418765）。
方法：DELIVER（NCT04418765）将患有偏头痛的成年人随机分为100mg，300毫克，或安慰剂，每12周静脉给药。在先前治疗失败类型定义的患者亚组中，总结了MMD从基线的变化以及MMD从基线降低≥50％的患者百分比（偏头痛反应率≥50％[MRR]）。亚组并不相互排斥，包括托吡酯患者，β受体阻滞剂（美托洛尔，普萘洛尔），阿米替林,和/或氟桂利嗪失败。
结果：在所有亚组的第1-12周，与接受安慰剂治疗的患者相比,接受eptinezumab治疗的患者的MMD比基线降低更大(降低范围分别为4.5-5.5和1.6-2.4),在第13-24周期间，降幅更大。同样，eptinezumab组的MRR≥50%始终高于安慰剂组，并在第二次输注后增加。
结论：在所有亚组中，无论以前的预防性治疗失败类型，与安慰剂相比,eptinezumab的MMD降低幅度更大,MRR也更高.
背景：ClinicalTrials.gov（标识符：NCT04418765）。
