难治性慢性偏头痛患者依瑞奈尤单抗的前瞻性真实世界分析。
A prospective real-world analysis of erenumab in refractory chronic migraine.
机构信息
The Headache Centre, Pain Management and Neuromodulation Centre, Guy's and St Thomas NHS Foundation Trust, London, UK.
Headache Research-Wolfson CARD, Institute of Psychology, Psychiatry and Neuroscience, King's College London, London, UK.
出版信息
J Headache Pain. 2020 Jun 1;21(1):61. doi: 10.1186/s10194-020-01127-0.
BACKGROUND
Clinical trials have shown the safety and clinical superiority of erenumab compared to placebo in chronic migraine (CM). The aim of this analysis is to evaluate the effectiveness and tolerability of erenumab in a real-world setting in patients with refractory CM.
METHODS
This is a prospective single centre real-world audit conducted in patients with CM with and without medication overuse, refractory to established preventive medications, who received monthly erenumab for 6 months.
RESULTS
Of 164 patients treated, 162 patients (female = 135, mean age 46 ± 14.3 years old) were included in the audit. Patients had failed a mean of 8.4 preventive treatments at baseline and 91% of patients failed Botulinum toxin type A at baseline. The mean reduction in monthly migraine days was 6.0 days at month 3 (P = 0.002) and 7.5 days at month 6 (P < 0.001) compared to baseline. The mean reduction in monthly headache days was 6.3 days (P < 0.001) at month 3 and 6.8 days (P < 0.001) at month 6. At month 3, 49%, 35% and 13% and at month 6, 60%, 38% and 22% of patients obtained at least a 30%, 50% and 75% reduction in migraine days, respectively. The percentage of patients with medication overuse was reduced from 54% at baseline to 20% at month 3 and to 25% at month 6. Compared to baseline, the mean reduction of Headache Impact Test-6 score was 7.7 points at month 3 (from 67.6 ± 0.4 to 59.9 ± 0.9) (P < 0.001) and of 7.5 points at month 6 (60.1 ± 1.3) (P = 0.01). The percentage of patients with severe headache-related disability (HIT-6: 60-78) was reduced from 96% at baseline to 68% after three monthly treatments and to 59% after six treatments. At least one side effect was reported by 48% of patients at month 1, 22% at month 3 and 15% at month 6. Constipation (20%) and cold/flu-like symptoms (15%) were the most frequent adverse events reported.
CONCLUSION
Erenumab may be an effective and well tolerated therapy for medically refractory CM patients with and without medication overuse.
背景
临床试验已经证明依瑞奈单抗相较于安慰剂在慢性偏头痛（CM）患者中的安全性和临床优越性。本分析旨在评估依瑞奈单抗在难治性 CM 患者的真实世界环境中的有效性和耐受性。
方法
这是一项前瞻性单中心真实世界研究，纳入了伴有或不伴有药物滥用的 CM 患者，这些患者对已确立的预防药物无反应，每月接受依瑞奈单抗治疗 6 个月。
结果
在接受治疗的 164 名患者中，162 名患者（女性=135 名，平均年龄 46±14.3 岁）纳入了本次审计。患者基线时平均接受了 8.4 种预防性治疗，91%的患者基线时 Botulinum toxin type A 治疗失败。与基线相比，第 3 个月时每月偏头痛天数减少 6.0 天（P=0.002），第 6 个月时每月偏头痛天数减少 7.5 天（P<0.001）。第 3 个月时每月头痛天数减少 6.3 天（P<0.001），第 6 个月时每月头痛天数减少 6.8 天（P<0.001）。第 3 个月时，分别有 49%、35%和 13%的患者，第 6 个月时，分别有 60%、38%和 22%的患者偏头痛天数减少至少 30%、50%和 75%。药物滥用的患者比例从基线时的 54%降至第 3 个月时的 20%，第 6 个月时的 25%。与基线相比，第 3 个月时头痛影响测试-6 评分平均降低 7.7 分（从 67.6±0.4 降至 59.9±0.9）（P<0.001），第 6 个月时平均降低 7.5 分（60.1±1.3）（P=0.01）。严重头痛相关残疾（HIT-6：60-78）的患者比例从基线时的 96%降至第 3 个月时的 68%，降至第 6 个月时的 59%。第 1 个月有 48%的患者报告至少有一种不良反应，第 3 个月时为 22%，第 6 个月时为 15%。最常报告的不良事件为便秘（20%）和类似感冒/流感样症状（15%）。
结论
依瑞奈单抗可能是一种有效且耐受良好的治疗药物，适用于伴有或不伴有药物滥用的难治性 CM 患者。
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