From the Albert Einstein College of Medicine and Montefiore Headache Center (R.B.L.), Bronx, NY; Mayo Clinic (D.W.D.), Phoenix, AZ; Department of Neurology (P.J.G.), University of California, Los Angeles; NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), King's College, London, United Kingdom; Harvard Medical School (R.B.), Beth Israel Deaconess Medical Center, Boston, MA; AbbVie Inc. (A.M.A., A.W.K.), Irvine, CA; and AbbVie Inc. (J.L., S.Y.Y., M.F., J.M.T.), Madison, NJ.
Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17.
To examine the efficacy of ubrogepant in the treatment of migraine with mild vs moderate or severe pain.
This was a phase 3, open-label, dose-blinded, 52-week extension trial. Adults with migraine were randomized 1:1:1 (usual care, ubrogepant 50 mg, or ubrogepant 100 mg). Participants treated up to 8 migraine attacks of any pain intensity every 4 weeks. Efficacy outcomes (only collected for ubrogepant) included 2-hour pain freedom (2hPF), freedom from associated symptoms, and from disability. A generalized linear mixed model with binomial distribution and logit link function was used to assess the influence of baseline pain intensity on treatment outcomes in this post hoc analysis.
Data for 19,291 attacks from 808 participants were included. 2hPF rates were higher for attacks treated when pain was mild vs moderate or severe: ubrogepant 50 mg (47.1% vs 23.6%; odds ratio [95% CI] 2.89 [2.57-3.24]) and ubrogepant 100 mg (55.2% vs 26.1%; 3.50 [3.12-3.92]; < 0.0001 both doses). Rates of freedom from photophobia, phonophobia, and nausea 2 hours after treatment were also significantly higher following the treatment of mild vs moderate or severe pain ( < 0.001 all symptoms, both doses). At 2 hours, the proportion of attacks with normal function was more than double for both doses of ubrogepant ( < 0.001). The most common adverse event was upper respiratory tract infection (∼11% both doses). Serious adverse events were reported by 2% in ubrogepant 50 mg and 3% in ubrogepant 100 mg.
Relative to treatment of attacks with moderate or severe pain, treatment with ubrogepant during mild pain resulted in significantly higher rates of freedom from pain, freedom from associated symptoms, and achieving normal function 2 hours after administration.
ClinicalTrials.gov, NCT02873221.
This trial provides Class III evidence that treatment of migraine with ubrogepant when pain is mild vs moderate or severe increases the likelihood of achieving pain freedom, absence of symptoms, and normal function within 2 hours postdose.
研究舒马曲坦治疗轻、中、重度偏头痛的疗效。
这是一项 3 期、开放标签、剂量盲法、52 周扩展试验。偏头痛患者按 1:1:1 随机分为（常规治疗、舒马曲坦 50mg 或 100mg）。参与者每 4 周最多治疗 8 次任何疼痛强度的偏头痛发作。疗效结局（仅收集舒马曲坦的数据）包括 2 小时疼痛缓解（2hPF）、无伴随症状和无残疾。使用二项分布和对数链接函数的广义线性混合模型评估此事后分析中基线疼痛强度对治疗结局的影响。
纳入了 808 名患者的 19291 次发作数据。与中重度疼痛相比，轻中度疼痛发作时接受舒马曲坦治疗的 2hPF 率更高：舒马曲坦 50mg（47.1% vs 23.6%；优势比[95%CI]2.89[2.57-3.24]）和舒马曲坦 100mg（55.2% vs 26.1%；3.50[3.12-3.92]；<0.0001 两种剂量）。治疗后 2 小时，无畏光、畏声和恶心的比例也明显高于中重度疼痛（所有症状均<0.001，两种剂量）。2 小时时，两种剂量的舒马曲坦使攻击后正常功能的比例增加一倍以上（<0.001）。最常见的不良反应是上呼吸道感染（两种剂量均约为 11%）。舒马曲坦 50mg 组有 2%的患者出现严重不良事件，舒马曲坦 100mg 组有 3%的患者出现严重不良事件。
与治疗中重度疼痛的发作相比，舒马曲坦在轻度疼痛时治疗发作可显著提高 2 小时内疼痛缓解、无伴随症状和恢复正常功能的几率。
ClinicalTrials.gov，NCT02873221。
本试验提供 III 级证据表明，与中重度偏头痛相比，轻度疼痛时使用舒马曲坦治疗偏头痛可增加 2 小时内达到疼痛缓解、无伴随症状和正常功能的可能性。
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