Institute of Psychiatry, Psychology and Neuroscience, Headache Research-Wolfson CARD, King's College London, London, UK.
Headache and Facial Pain Service, Guy's and St Thomas' NHS Foundation Trust, London, UK.
J Headache Pain. 2022 Nov 4;23(1):139. doi: 10.1186/s10194-022-01507-8.
Controlled and real-world evidence have demonstrated the efficacy of calcitonin gene related peptide (CGRP) monoclonal antibodies (MABs) in migraine. However, data on the over-one-year sustained effectiveness of CGRP MABs in resistant chronic migraine (CM) is sparse. METHODS: This is a two-year real-world prospective analysis of an ongoing single centre audit conducted in patients with resistant CM. Patients received monthly erenumab for six months before assessing its effectiveness. Responders were considered those who achieved at least 30% reduction in monthly migraine days (MMD) by month 6, compared to baseline. Secondary outcomes were also analysed, including changes of the Headache Impact Test version 6 (HIT-6).
One hundred sixty-four patients [135 (82.3%) females; mean age 46 SD 14) years] were included in the audit and 160 patients analysed. Patients had failed a mean of 8.4 preventive treatments at baseline. At month 6, 76 patients (48%) were 30% responders to erenumab, 50 patients (31%) were 50% responders and 25 (15%) were 75% responders. The mean reduction in MMD at month 6 was 7.5 days compared to baseline (P < 0.001). At month 12 and month 18, 61 patients (38%) and 52 patients (33%) remained 30% responders respectively. At month 24, 36 patients (23%) remained 30% responders, 25 patients (16%) and 13 patients (8%) were respectively 50% and 75% responders. Compared to 95% of patients at baseline, at months 6, 12 and 24, 46%, 29% and 16% of responders respectively had severe disability. At least one adverse event at month 6, 12, 18 and 24 was reported by 49%, 19%, 11% and 3% of patients. By month 6, 13% of patients discontinued the treatment because of side effects, often constipation.
Long-term sustained effectiveness of erenumab was reported only by a minority of resistant CM patients. Although more research in resistant migraine is needed, Erenumab can provide long-term meaningful reduction in migraine load and migraine-related disability in some patients.
已有对照和真实世界的证据表明降钙素基因相关肽（CGRP）单克隆抗体（MAB）在偏头痛中的疗效。然而，关于 CGRP MAB 在耐药性慢性偏头痛（CM）中持续一年以上的有效性的数据很少。方法：这是一项对正在进行的单中心审查进行的为期两年的真实世界前瞻性分析，该审查在耐药性 CM 患者中进行。患者在接受六个月的每月依那西普治疗后，评估其疗效。应答者被定义为与基线相比，每月偏头痛天数（MMD）减少至少 30%的患者。还分析了次要结局，包括头痛影响测试第 6 版（HIT-6）的变化。结果：该审计纳入了 164 名患者[135 名（82.3%）女性；平均年龄 46 岁，标准差 14 岁]，并对 160 名患者进行了分析。基线时，患者平均失败了 8.4 种预防治疗。在第 6 个月时，76 名患者（48%）对依那西普的应答率为 30%，50 名患者（31%）为 50%，25 名患者（15%）为 75%。与基线相比，第 6 个月时 MMD 的平均减少为 7.5 天（P<0.001）。在第 12 个月和第 18 个月时，分别有 61 名（38%）和 52 名（33%）患者持续应答率为 30%。在第 24 个月时，分别有 36 名（23%）、25 名（16%）和 13 名（8%）患者持续应答率为 30%、50%和 75%。与基线时的 95%的患者相比，分别有 46%、29%和 16%的应答者在第 6、12 和 24 个月时的残疾严重程度为重度。在第 6、12、18 和 24 个月时，分别有 49%、19%、11%和 3%的患者报告了至少一种不良反应。在第 6 个月时，由于副作用（通常为便秘），有 13%的患者停止了治疗。结论：只有少数耐药性 CM 患者报告了依那西普的长期持续疗效。尽管需要对耐药性偏头痛进行更多研究，但依那西普可在一些患者中提供长期有意义的偏头痛发作频率减少和偏头痛相关残疾程度减轻。
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