慢性偏头痛持续时间对靶向降钙素基因相关肽通路单克隆抗体长期疗效的影响——一项真实世界研究

Impact of duration of chronic migraine on long-term effectiveness of monoclonal antibodies targeting the calcitonin gene-related peptide pathway-A real-world study.

作者信息

Ornello Raffaele, Baldini Francesca, Onofri Agnese, Rosignoli Chiara, De Santis Federico, Burgalassi Andrea, Chiarugi Alberto, Geppetti Pierangelo, Sacco Simona, Iannone Luigi Francesco

机构信息

Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.

Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.

出版信息

Headache. 2025 Jan;65(1):61-67. doi: 10.1111/head.14788. Epub 2024 Jul 16.

DOI:10.1111/head.14788

PMID:39012070

Abstract

OBJECTIVE

We assessed whether the effectiveness of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway changes according to the duration of chronic migraine (CM) over 12 months.

BACKGROUND

In most patients, CM is a progressive disease starting with episodic migraine. Longer CM duration might be associated with more difficult treatment, probably because the mechanisms underlying chronicization are strengthened. Therefore, early treatment of CM could lead to better outcomes compared with later treatment.

METHODS

This cohort study included individuals with CM treated with anti-CGRP mAbs in two tertiary headache centers from April 2019 to May 2023. The primary outcome included a change in monthly migraine days (MMDs) from baseline to the third trimester of treatment, 10-12 months. Secondary outcomes established whether response to anti-CGRP mAbs has a more rapid onset in individuals with shorter CM duration compared with longer duration; they included change in MMDs, monthly headache days (MHDs), and days and number of intakes of acute medication during each trimester compared to baseline. Additional outcomes included persisting MMDs, MHDs, and days and number of intakes of acute medication during each trimester of treatment. Patients were compared across tertiles of the overall CM duration.

RESULTS

The study included 335 individuals with CM, with a median (interquartile range [IQR]) age of 48 (39-57) years; 270 (80.6%) were women. Patients in the highest tertile of CM duration (aged 18-60 years) were older than patients in the lower duration tertiles (0-7 years and 8-18 years, respectively), with a median (IQR) age of 56 (48-64) years compared with 42 (31-50) years, and 48 (39-56)years, respectively (p = 0.025); however, this difference was likely due to a correlation between age and disease duration. The change in MMDs from baseline to the last trimester of treatment (10-12 months) was comparable across tertiles of CM duration (median [IQR] -12 [-18 to -5] days, -12 [-17 to -6] days, and -12 [-18 to -4] days; p = 0.946). No difference emerged in secondary outcomes, suggesting a similar time to onset of anti-CGRP mAbs effect across all tertiles of CM duration.

CONCLUSIONS

Our data showed that anti-CGRP mAbs are effective and have a rapid onset of action in CM regardless of disease duration.

摘要

目的

我们评估了靶向降钙素基因相关肽（CGRP）通路的单克隆抗体（mAb）的有效性是否会根据慢性偏头痛（CM）超过12个月的病程而发生变化。

背景

在大多数患者中，CM是一种从发作性偏头痛开始的进行性疾病。CM病程越长，治疗可能越困难，这可能是因为慢性化的潜在机制得到了强化。因此，与后期治疗相比，CM的早期治疗可能会带来更好的结果。

方法

这项队列研究纳入了2019年4月至2023年5月在两个三级头痛中心接受抗CGRP mAb治疗的CM患者。主要结局包括从基线到治疗晚期（10 - 12个月）每月偏头痛天数（MMD）的变化。次要结局确定了与病程较长的个体相比，病程较短的个体对抗CGRP mAb的反应是否起效更快；次要结局包括MMD、每月头痛天数（MHD）的变化，以及与基线相比每个治疗期急性药物摄入的天数和次数。其他结局包括治疗各期持续存在的MMD、MHD以及急性药物摄入的天数和次数。根据CM总病程的三分位数对患者进行比较。

结果

该研究纳入了335例CM患者，年龄中位数（四分位间距[IQR]）为48（39 - 57）岁；270例（80.6%）为女性。CM病程最长三分位数（年龄18 - 60岁）的患者比病程较短三分位数（分别为0 - 7岁和8 - 18岁）的患者年龄更大，年龄中位数（IQR）分别为56（48 - 64）岁、42（31 - 50）岁和48（39 - 56）岁（p = 0.025）；然而，这种差异可能是由于年龄与病程之间的相关性。从基线到治疗最后一期（10 - 12个月）MMD的变化在CM病程的三分位数之间具有可比性（中位数[IQR] - 12[-18至 - 5]天、 - 12[-17至 - 6]天和 - 12[-18至 - 4]天；p = 0.946）。次要结局未出现差异，表明在CM病程的所有三分位数中，抗CGRP mAb起效时间相似。