Objective To evaluate clinical characteristics, effectiveness, and tolerability of preventive anti-CGRP mAbs in the elderly. Anti-CGRP mAbs have demonstrated efficacy and safety in patients with migraine although there is limited information regarding the elderly. Design We performed a multicenter case-control study of cases(patients over 65 years old) and controls(sex-matched patients under 55 years old) with migraine receiving anti-CGRP mAbs. Methods We included the demographic characteristics, effectiveness-reduction in the number of monthly headache days(MHD) and monthly migraine days(MMD),30%,50% and 75% responder rates- and treatment emergent adverse events(TEAEs);the primary endpoint was the 50% response rate regarding MHD at weeks 20-24; exploratory 50% response predictors in the elderly were evaluated. Results 228 patients were included-114 cases,114 controls-. Among cases 84.2%(96/114) were women,79.8%(91/114)CM;mean age of cases 70.1 years old(range:66-86);mean age of controls was 42.9 years old(range:38-49). Cases had a higher percentage of vascular risk factors(p < 0.05),older age of onset(p < 0.001) and more reported prior preventive treatments(p < 0.001). Regarding effectiveness, in cases, 50% response rate was achieved by 59.2%(90/152) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks [5(7.2),8(9.1);p=0.001] and a higher reduction in MMD at 20-24 weeks [10.7(9.1), 9.2(7.7);p=0.04] compared to the control group. The percentage of a TEAEs was similar in the two groups. Diagnosis of EM(p = 0.003) and lower number of MHD at baseline(p < 0.001) were associated with a 50% response in the elderly in univariate analysis. Conclusions Our study provides real world evidence of effectiveness and safety of anti-CGRP mAbs for migraine in patients without upper age-limit and possible predictors of anti-CGRP response in the elderly.

中文翻译：

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预防性抗 CGRP 单克隆抗体治疗 65 岁以上偏头痛患者的有效性、耐受性和反应预测因子：一项多中心真实病例对照研究

目的 评价预防性抗 CGRP 单克隆抗体在老年人中的临床特征、有效性和耐受性。尽管有关老年人的信息有限，但抗 CGRP 单克隆抗体已证明对偏头痛患者有效且安全。设计 我们对接受抗 CGRP mAb 治疗的偏头痛病例（65 岁以上患者）和对照（55 岁以下性别匹配患者）进行了多中心病例对照研究。方法 我们纳入了人口统计学特征、有效性——每月头痛天数（MHD）和每月偏头痛天数（MMD）的减少、30%、50%和75%的缓解率——以及治疗中出现的不良事件（TEAE）；终点是第 20-24 周时 MHD 的缓解率为 50%；评估了老年人中探索性 50% 反应预测因子。结果共纳入患者228例，其中病例114例，对照114例。病例中女性占84.2%（96/114），CM占79.8%（91/114）；病例平均年龄70.1岁（范围：66-86）；对照组平均年龄42.9岁（范围：38-49） ）。病例中血管危险因素的比例较高（p < 0.05），发病年龄较大（p < 0.001），并且报告的既往预防性治疗较多（p < 0.001）。关于有效性，在病例中，20-24周时达到50%的缓解率为59.2%(90/152)，8-12周时MHD降低幅度较小[5(7.2),8(9.1);p= 0.001]，与对照组相比，20-24 周时 MMD 降低幅度更大 [10.7(9.1), 9.2(7.7)；p=0.04]。两组中 TEAE 的百分比相似。在单变量分析中，EM 诊断（p = 0.003）和基线时较低的 MHD 数量（p < 0.001）与老年人的 50% 缓解率相关。结论 我们的研究提供了抗 CGRP 单克隆抗体治疗无年龄上限的偏头痛患者的有效性和安全性的真实世界证据，以及老年人抗 CGRP 反应的可能预测因子。