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.
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。