Abstract：
OBJECTIVE: To evaluate clinical characteristics, effectiveness, and tolerability of preventive anti- calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) in the elderly. Anti-CGRP mAbs have demonstrated efficacy and safety in patients with migraine although there is limited information regarding the elderly.
METHODS: 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: In total, 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 < .05),older age of onset (P < .001) and more reported prior preventive treatments (P < .001). Regarding effectiveness in cases, 50% response rate was achieved by 57.5% (42/73) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks (5 [7.2], 8 [9.1]; P = .001) and a higher reduction in MMD at 20-24 weeks (10.7 [9.1], 9.2 [7.7]; P = .04) compared to the control group. The percentage of TEAEs was similar in the 2 groups. Diagnosis of episodic migraine (EM) (P = .03) and lower number of MHD at baseline (P = .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.
METHODS: 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: In total, 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 < .05),older age of onset (P < .001) and more reported prior preventive treatments (P < .001). Regarding effectiveness in cases, 50% response rate was achieved by 57.5% (42/73) at 20-24 weeks, with lower reduction in the MHD at 8-12 weeks (5 [7.2], 8 [9.1]; P = .001) and a higher reduction in MMD at 20-24 weeks (10.7 [9.1], 9.2 [7.7]; P = .04) compared to the control group. The percentage of TEAEs was similar in the 2 groups. Diagnosis of episodic migraine (EM) (P = .03) and lower number of MHD at baseline (P = .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.
摘要：
目的：评估临床特征，有效性,老年人预防性抗CGRP单克隆抗体的耐受性。抗CGRP单克隆抗体已证明在偏头痛患者中的有效性和安全性，尽管有关老年人的信息有限。
方法：我们对接受抗CGRP单克隆抗体治疗的偏头痛患者（65岁以上的患者）和对照（55岁以下的性别匹配患者）进行了多中心病例对照研究。
方法：我们包括了人口统计特征，有效性-减少每月头痛天数（MHD）和每月偏头痛天数（MMD），30%,50％和75％的应答率和治疗紧急不良事件（TEAE）；主要终点是20-24周时MHD的50％应答率；评估了老年人的探索性50％应答预测因子。
结果：共纳入228例患者-114例，114控制-。其中84.2%(96/114)为女性，79.8%(91/114)CM;病例平均年龄70.1岁(范围:66-86岁);对照组平均年龄42.9岁(范围:38-49岁)。病例的血管危险因素百分比较高（p<0.05），发病年龄较大（p<0.001），先前报道的预防性治疗更多（p<0.001）。关于有效性，在案例中,50％的反应率在20-24周达到59.2％（90/152），在8-12周时MHD降低较低[5（7.2），8（9.1）；p=0.001]，并且在20-24周时MMD的降低更高[10.7（9.1），9.2（7.7）；p=0.04]与对照组相比。两组中TEAE的百分比相似。单变量分析中，诊断为EM（p=0.003）和基线时MHD数量较低（p<0.001）与老年人的50％反应相关。
结论：我们的研究为无年龄上限的偏头痛患者抗CGRP单克隆抗体的有效性和安全性提供了真实世界的证据，并可能预测老年人抗CGRP反应。
方法：我们对接受抗CGRP单克隆抗体治疗的偏头痛患者（65岁以上的患者）和对照（55岁以下的性别匹配患者）进行了多中心病例对照研究。
方法：我们包括了人口统计特征，有效性-减少每月头痛天数（MHD）和每月偏头痛天数（MMD），30%,50％和75％的应答率和治疗紧急不良事件（TEAE）；主要终点是20-24周时MHD的50％应答率；评估了老年人的探索性50％应答预测因子。
结果：共纳入228例患者-114例，114控制-。其中84.2%(96/114)为女性，79.8%(91/114)CM;病例平均年龄70.1岁(范围:66-86岁);对照组平均年龄42.9岁(范围:38-49岁)。病例的血管危险因素百分比较高（p<0.05），发病年龄较大（p<0.001），先前报道的预防性治疗更多（p<0.001）。关于有效性，在案例中,50％的反应率在20-24周达到59.2％（90/152），在8-12周时MHD降低较低[5（7.2），8（9.1）；p=0.001]，并且在20-24周时MMD的降低更高[10.7（9.1），9.2（7.7）；p=0.04]与对照组相比。两组中TEAE的百分比相似。单变量分析中，诊断为EM（p=0.003）和基线时MHD数量较低（p<0.001）与老年人的50％反应相关。
结论：我们的研究为无年龄上限的偏头痛患者抗CGRP单克隆抗体的有效性和安全性提供了真实世界的证据，并可能预测老年人抗CGRP反应。
