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).
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)。