Jaimes Alex, Gómez Andrea, Pajares Olga, Rodríguez-Vico Jaime
Headache Unit, Neurology Department, Fundación Jiménez Díaz University Hospital, Madrid, Spain.
School of Medicine, Autonomous University of Madrid, Madrid, Spain.
Headache. 2025 Apr;65(4):619-630. doi: 10.1111/head.14865. Epub 2024 Dec 27.
To evaluate the effectiveness of first switching between monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) or its receptor in the treatment of migraine.
Although mAbs targeting CGRP or its receptor have emerged as a leading treatment for migraine prevention, a proportion of patients do not respond. While switching between these antibodies is a common clinical practice in such cases, the effectiveness remains a subject of study.
We conducted a retrospective cohort study at a tertiary headache center, analyzing data from clinical records of patients treated with anti-CGRP mAbs from January 2020 to March 2024. Baseline was defined as the monthly headache days (MHDs) in the 3 months prior to the start of the second mAb. The primary endpoint was the change in MHDs at month 3 and month 6 following the switch. Additionally, we evaluated response rates in both periods. Subgroup analyses were conducted based on changes in mechanism of action. Finally, we assessed the influence of the number of doses of the first mAb and the inter-treatment interval.
Out of 1244 initially identified patients, 185 were included in the month-3 analysis and 123 in the month-6 evaluation. The median MHDs decreased from 27.0 (interquartile range [IQR] 16.1, 30.0; range 5.0, 30.7) at baseline to 21.0 (IQR 10.0, 30.0; range 0.0, 30.0; p < 0.001) at month 3, and to 20.0 (IQR 10.0, 30.0; range 0.0, 31.0; p < 0.001) at month 6. Subgroup analyses revealed no significant differences in MHDs between maintaining the same target or changing it (baseline: 28.0 [IQR 16.2, 30.0; range 5.0, 31.0] vs. 27.0 [IQR 6.0, 31.0; range 6.0, 31.0]; month 3: 23.0 [IQR 10.0, 30.0; range 0.0, 31.0] vs. 19.0 [IQR 11.0, 30.0; range 1.0, 31.0], p = 0.144; month 6: 24.0 [IQR 11.0, 30.0; range 0.0, 31.0] vs. 17.0 [IQR 10.0, 30.0; range 3.0, 31.0], p = 0.170). There was no association between a ≥50% reduction in MHDs and the number of previous doses of the first mAb (odds ratio [OR] 1.0; 95% confidence interval [CI] 1.0, 1.1; p = 0.189) or the inter-treatment interval (OR 1.0; 95% CI 0.9, 1.1; p = 0.914).
Switching between anti-CGRP mAbs resulted in a reduction in MHDs, with no significant differences based on the mechanism of action. Factors such as the number of doses of the first mAb and the inter-treatment interval did not appear to predict a ≥50% reduction in MHDs at month 3. Our findings support the viability of switching as an effective treatment option for patients with migraine who do not respond to initial mAb therapy.
评估首次在靶向降钙素基因相关肽(CGRP)或其受体的单克隆抗体(mAb)之间切换治疗偏头痛的有效性。
尽管靶向CGRP或其受体的单克隆抗体已成为预防偏头痛的主要治疗方法,但仍有一部分患者无反应。在这种情况下,在这些抗体之间切换是一种常见的临床做法,但其有效性仍是研究的课题。
我们在一家三级头痛中心进行了一项回顾性队列研究,分析了2020年1月至2024年3月接受抗CGRP单克隆抗体治疗的患者临床记录数据。基线定义为开始使用第二种单克隆抗体前3个月的每月头痛天数(MHDs)。主要终点是切换后第3个月和第6个月MHDs的变化。此外,我们评估了两个时期的反应率。根据作用机制的变化进行亚组分析。最后,我们评估了第一种单克隆抗体的剂量数和治疗间隔的影响。
在最初确定的1244例患者中,185例纳入第3个月分析,123例纳入第6个月评估。MHDs中位数从基线时的27.0(四分位间距[IQR]16.1,30.0;范围5.0,30.7)降至第3个月时的21.0(IQR 10.0,30.0;范围0.0,30.0;p<0.001),以及第6个月时的20.0(IQR 10.0,30.0;范围0.0,31.0;p<0.001)。亚组分析显示,维持相同靶点或改变靶点之间的MHDs无显著差异(基线:28.0[IQR 16.2,30.0;范围5.0,31.0]对27.0[IQR 6.0,31.0;范围6.0,31.0];第3个月:23.0[IQR 10.0,30.0;范围0.0,31.0]对19.0[IQR 11.0,30.0;范围1.0,31.0],p=0.144;第6个月:24.0[IQR 11.0,30.0;范围0.0,31.0]对17.0[IQR 10.0,30.0;范围3.0,31.0],p=0.170)。MHDs降低≥50%与第一种单克隆抗体的既往剂量数(优势比[OR]1.0;95%置信区间[CI]1.0,1.1;p=0.189)或治疗间隔(OR 1.0;95%CI 0.9,1.1;p=0.914)之间无关联。
抗CGRP单克隆抗体之间的切换导致MHDs减少,基于作用机制无显著差异。第一种单克隆抗体的剂量数和治疗间隔等因素似乎无法预测第3个月时MHDs降低≥50%的情况。我们的研究结果支持切换作为对初始单克隆抗体治疗无反应的偏头痛患者的一种有效治疗选择的可行性。