Fremanezumab在耐药和难治性慢性偏头痛患者中的疗效:来自英国Hull偏头痛诊所的真实世界数据

F. Cheng, Qinyao Wu, Maria Hussain, Victoria Wilkinson, L. Wilson, M. Khalil, F. Ahmed
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We measured monthly headache days, migraine days, headache-free days, analgesia medication days, triptan days and Headache Impact Test-6 scores at baseline and during treatment. Results All outcomes significantly improved in results of 182 patients at 4-month follow-up (p<0.0001), with reduced median monthly headache days (by 9 days), migraine days (by 10 days) and Headache Impact Test-6 (by 14.5 points). 80% patients achieved ≥30% migraine reduction, whilst 68% and 42% patients achieved >50% and >75% reduction. 58%, 39% and 17% patients achieved ≥30%, >50% and >75% headache day reduction. OnabotulinumtoxinA-unresponsive patients exhibited substantial responses, with 78%, 66% and 39% patients achieving ≥30%, >50% and >75% migraine reduction. Medication-overuse did not affect responses. 45% patients achieved <15 headache days in any month, and 65% achieved <8 migraine days in any month. 37% achieved both outcomes. 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摘要

背景Fremanezumab是一种有效预防慢性偏头痛的抗降钙素基因相关肽单克隆抗体。我们在英国头痛专科中心(Hull migraine Clinic)评估了fremanezumab对难治性和耐药性慢性偏头痛的预防效果。材料和方法289名患有顽固性和难治性慢性偏头痛的成年患者开始使用氟曼珠单抗,并进行前瞻性随访,在开始使用氟曼珠单抗前保持头痛日记≥1个月,此后持续记录。患者未通过6次中位预防治疗。我们测量了基线和治疗期间每月头痛天数、偏头痛天数、无头痛天数、镇痛药物天数、曲坦天数和头痛影响测试-6评分。结果182名患者在4个月的随访中,所有结果均显著改善(p50%和>75%减少。58%、39%和17%的患者头痛天数减少≥30%、>50%和>75%。Onabotulinumtoxin无反应的患者表现出显著的反应,78%、66%和39%的患者偏头痛减少≥30%,>50%和>75%。过度用药不影响反应。45%的患者在任何一个月头痛天数<15天,65%的患者偏头痛天数<8天任何一个月。37%的人实现了这两种结果。在多变量分析中,基线头痛自由度和较低的头痛影响测试-6分与偏头痛减少≥30%相关(p<0.05),而基线头痛自由率和较低偏头痛天数与任何一个月头痛天数<15天相关(p<0.01),包括OnabotulinumtoxinA无反应患者,无论药物过度使用。基线头痛自由度、较低的偏头痛天数和较低的头痛影响测试-6分预示着优越的反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of Fremanezumab In Resistant and Refractory Chronic Migraine Patients: Real-World Data from The Hull Migraine Clinic, Uk
Background Fremanezumab is an anti-calcitonin gene-related peptide monoclonal antibody efficacious for chronic migraine prophylaxis. We evaluated real-world prophylactic efficacy of fremanezumab for refractory and resistant chronic migraine in a United Kingdom specialist headache centre (Hull Migraine Clinic). Materials and Methods 289 adult patients with resistant and refractory chronic migraine commenced fremanezumab with prospective follow-up, maintaining headache diaries for ≥1-month pre-fremanezumab initiation and continuously thereafter. Patients failed 6 median previous prophylactics. We measured monthly headache days, migraine days, headache-free days, analgesia medication days, triptan days and Headache Impact Test-6 scores at baseline and during treatment. Results All outcomes significantly improved in results of 182 patients at 4-month follow-up (p<0.0001), with reduced median monthly headache days (by 9 days), migraine days (by 10 days) and Headache Impact Test-6 (by 14.5 points). 80% patients achieved ≥30% migraine reduction, whilst 68% and 42% patients achieved >50% and >75% reduction. 58%, 39% and 17% patients achieved ≥30%, >50% and >75% headache day reduction. OnabotulinumtoxinA-unresponsive patients exhibited substantial responses, with 78%, 66% and 39% patients achieving ≥30%, >50% and >75% migraine reduction. Medication-overuse did not affect responses. 45% patients achieved <15 headache days in any month, and 65% achieved <8 migraine days in any month. 37% achieved both outcomes. In multivariate analyses, baseline headache-freedom and lower Headache Impact Test-6 score associated with ≥30% migraine reduction (p<0.05), whilst baseline headache-freedom and lower migraine-days associated with achieving <15 headache days in any month (p<0.01). Conclusion Fremanezumab demonstrates real-world efficacy at 4 months in resistant and refractorychronic migraine, including in OnabotulinumtoxinA-unresponsive patients, irrespective of medication-overuse. Baseline headache-freedom, lower migrainedays and lower Headache Impact Test-6 score heralded superior responses.
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