依替班珠单抗治疗慢性偏头痛患者急性头痛药物使用量的变化：PROMISE-2 研究的亚分析。
Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study.
机构信息
Stanford Health Care, Palo Alto, CA, USA.
Jefferson Headache Center, Philadelphia, PA, USA.
出版信息
J Headache Pain. 2022 Sep 6;23(1):115. doi: 10.1186/s10194-022-01482-0.
BACKGROUND
Patients with chronic migraine (CM) treated with eptinezumab in the PROMISE-2 trial achieved greater reductions in migraine and headache frequency, impact, and acute headache medication (AHM) use than did patients who received placebo. This post hoc analysis examines relationships between headache frequency reductions and changes in AHM use in patients in PROMISE-2.
METHODS
PROMISE-2 was a double-blind, placebo-controlled trial conducted in adults with CM. Patients were randomized to eptinezumab 100 mg, 300 mg, or placebo, administered intravenously once every 12 weeks for up to two doses. Patients recorded headache/AHM information daily and for each event in an electronic diary; data from all days with daily reports were included. Shifts in headache frequency and AHM use were assessed in the three populations: total CM population, patients with CM and medication-overuse headache (MOH), and patients with CM and MOH who were ≥ 50% responders during treatment (response over weeks 1-24).
RESULTS
A total of 1072 adults with CM received treatment (eptinezumab, n = 706; placebo, n = 366). Mean baseline headache frequency was 20.5 days; mean baseline AHM days was 13.4; 431 patients had MOH, of which 225 (52.2%) experienced ≥50% response over weeks 1-24. Relative to baseline, the proportion of days with both headache and AHM use decreased 25.1% (eptinezumab) versus 17.0% (placebo) in the total population (N = 1072), 29.2% versus 18.4% in the MOH subpopulation (n = 431), and 38.3% versus 31.5% in the CM with MOH population with ≥50% response subgroup (n = 225) during weeks 1-24. The proportion of days with headache and triptan use decreased 9.1% (eptinezumab) versus 5.8% (placebo), 11.8% versus 7.2%, and 14.5% versus 12.6%, respectively. Reductions in other AHM types were smaller.
CONCLUSIONS
In this post hoc analysis, eptinezumab use in patients with CM was associated with greater decreases in days with headache with AHM overall and with triptans in particular. The magnitude of effect was greater in the subgroup of CM patients with MOH and ≥ 50% response.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02974153 . Eptinezumab reduces headache frequency and acute medication use in patients with chronic migraine.
背景
在 PROMISE-2 试验中，接受依替唑仑单抗治疗的慢性偏头痛 (CM) 患者与接受安慰剂的患者相比，偏头痛和头痛频率、影响以及急性头痛药物 (AHM) 使用率的降低幅度更大。本事后分析检查了 PROMISE-2 中患者头痛频率降低与 AHM 使用变化之间的关系。
方法
PROMISE-2 是一项针对 CM 成人患者的双盲、安慰剂对照试验。患者被随机分配至依替唑仑单抗 100mg、300mg 或安慰剂组，每 12 周静脉注射一次，最多接受两剂治疗。患者使用电子日记每天记录头痛/AHM 信息；包含所有有每日报告的天数的数据。在三个人群中评估了头痛频率和 AHM 使用的变化：总体 CM 人群、伴有药物过度使用性头痛 (MOH) 的 CM 患者和在治疗期间（第 1-24 周应答）≥50%应答的伴有 MOH 的 CM 患者。
结果
共有 1072 名 CM 成年患者接受了治疗（依替唑仑单抗，n=706；安慰剂，n=366）。基线时平均头痛频率为 20.5 天；平均基线 AHM 天数为 13.4 天；431 名患者患有 MOH，其中 225 名（52.2%）在第 1-24 周期间经历了≥50%的应答。与基线相比，在总人群（n=1072）中，头痛和 AHM 使用天数的比例分别下降了 25.1%（依替唑仑单抗）和 17.0%（安慰剂）；在 MOH 亚组（n=431）中，分别下降了 29.2%和 18.4%；在伴有 MOH 的 CM 患者且应答≥50%的亚组（n=225）中，分别下降了 38.3%和 31.5%。在第 1-24 周期间，头痛和曲坦类药物使用天数的比例分别下降了 9.1%（依替唑仑单抗）和 5.8%（安慰剂）、11.8%和 7.2%、14.5%和 12.6%。其他 AHM 类型的减少幅度较小。
结论
在本事后分析中，CM 患者使用依替唑仑单抗治疗与头痛频率的总体降低以及与曲坦类药物的降低有关。在伴有 MOH 和应答≥50%的 CM 患者亚组中，效果的幅度更大。
试验注册
ClinicalTrials.gov 标识符：NCT02974153。依替唑仑单抗可降低慢性偏头痛患者的头痛频率和急性药物使用。
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