Headache and Neurosonology Unit, Neurology, Campus Bio-Medico University Hospital, Via Alvaro del Portillo, 200, 00128, Rome, Italy.
Neurology, Neurorehabilitation and Neurophysiology Units, IRCCS Ospedale San Raffaele and University 'Vita e Salute', Milan, Italy.
J Headache Pain. 2021 Dec 18;22(1):154. doi: 10.1186/s10194-021-01363-y.
Monoclonal antibodies anti-calcitonin gene-related peptide (mAbs anti-CGRP) pathway are effective and safe on migraine prevention. However, some drug agencies limited these treatments to one year due to their high costs. This study aimed at evaluating the effect of discontinuing mAbs anti-CGRP on monthly migraine days (MMDs) and disability in high-frequency episodic (HFEM) and chronic migraine (CM) patients.
This observational longitudinal cohort study was conducted at 10 Italian headache centres. Consecutive adult patients were followed-up for three months (F-UP1-3) after discontinuation of a one-year erenumab/galcanezumab treatment. The primary endpoint was the change in F-UP MMDs. Secondary endpoints included variation in pain intensity (Numerical Rating Scale, NRS), monthly acute medication intake (MAMI), and HIT-6 scores. We also assessed from F-UP1 to 3 the ≥50% response rate, relapse rate to CM, and recurrence of Medication Overuse (MO).
We enrolled 154 patients (72.1% female, 48.2 ± 11.1 years, 107 CM, 47 HFEM); 91 were treated with erenumab, 63 with galcanezumab. From F-UP1 to F-UP3, MMDs, MAMI, NRS, and HIT-6 progressively increased but were still lower at F-UP3 than baseline (Friedman's analysis of rank, p < .001). In the F-UP1-3 visits, ≥50% response rate frequency did not differ significantly between CM and HFEM patients. However, the median reduction in response rate at F-UP3 was higher in HFEM (- 47.7% [25th, - 79.5; 75th,-17.0]) than in CM patients (- 25.5% [25th, - 47.1; 75th, - 3.3]; Mann-Whitney U test; p = .032). Of the 84 baseline CM patients who had reverted to episodic migraine, 28 (33.3%) relapsed to CM at F-UP1, 35 (41.7%) at F-UP2, 39 (46.4%) at F-UP3. Of the 64 baseline patients suffering of medication overuse headache ceasing MO, 15 (18.3%) relapsed to MO at F-UP1, 26 (31.6%) at F-UP2, and 30 (42.3%, 11 missing data) at F-UP3. Lower MMDs, MAMI, NRS, and HIT-6 and higher response rate in the last month of therapy characterized patients with ≥50% response rate at F-UP1 and F-UP3 (Mann-Whitney U test; consistently p < .01).
Migraine frequency and disability gradually increased after mAbs anti-CGRP interruption. Most patients did not relapse to MO or CM despite the increase in MMDs. Our data suggest to reconsider mAbs anti-CGRP discontinuation.
抗降钙素基因相关肽（mAbs anti-CGRP）单克隆抗体在偏头痛预防方面有效且安全。然而，由于其成本较高，一些药物机构将这些治疗方法限制在一年以内。本研究旨在评估停止 mAbs anti-CGRP 对高频发作性偏头痛（HFEM）和慢性偏头痛（CM）患者每月偏头痛天数（MMD）和残疾的影响。
这是一项在意大利 10 个头痛中心进行的观察性纵向队列研究。连续的成年患者在停止为期一年的依那西普/加奈昔单抗治疗后进行了三个月的随访（F-UP1-3）。主要终点是 F-UP MMDs 的变化。次要终点包括疼痛强度的变化（数字评分量表，NRS）、每月急性药物摄入（MAMI）和 HIT-6 评分。我们还评估了从 F-UP1 到 3 的≥50%反应率、CM 复发率和药物过度使用（MO）的复发率。
我们共纳入了 154 名患者（72.1%为女性，48.2±11.1 岁，107 例 CM，47 例 HFEM）；91 例接受依那西普治疗，63 例接受加奈昔单抗治疗。从 F-UP1 到 F-UP3，MMDs、MAMI、NRS 和 HIT-6 逐渐增加，但 F-UP3 仍低于基线（Friedman 分析等级，p<0.001）。在 F-UP1-3 就诊中，CM 和 HFEM 患者的≥50%反应率频率没有显著差异。然而，HFEM 患者在 F-UP3 时反应率的中位数下降幅度更高（-47.7%[25%，-79.5；75%，-17.0]），而 CM 患者则为-25.5%（25%，-47.1；75%，-3.3%；Mann-Whitney U 检验；p=0.032）。在 84 名基线 CM 患者中，有 28 名（33.3%）在 F-UP1 时复发为偏头痛，35 名（41.7%）在 F-UP2 时复发，39 名（46.4%）在 F-UP3 时复发。在 64 名基线患有药物过度使用性头痛的患者中，有 15 名（18.3%）在 F-UP1 时复发为 MO，26 名（31.6%）在 F-UP2 时复发，30 名（42.3%，11 名数据缺失）在 F-UP3 时复发。在最后一个月的治疗中，MMDs、MAMI、NRS 和 HIT-6 更低，反应率更高，这表明 F-UP1 和 F-UP3 时≥50%的患者具有更高的反应率（Mann-Whitney U 检验；一致 p<0.01）。
停止 mAbs anti-CGRP 治疗后，偏头痛的频率和残疾程度逐渐增加。尽管 MMDs 增加，但大多数患者没有复发为 MO 或 CM。我们的数据表明需要重新考虑停止 mAbs anti-CGRP。
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