Department of Neurology, Dokkyo Medical University, Mibu, Japan.
Medical Safety Management Center, Dokkyo Medical University Hospital, Mibu, Japan.
Cephalalgia. 2023 May;43(5):3331024231177649. doi: 10.1177/03331024231177649.
Real-world data on the effectiveness of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) in migraine patients are needed.
We performed a single-center, real-world study with an observation period of up to 12 months (mean 7.5 ± 3.4 months) after CGRP mAb administration. A total of 228 Japanese patients with episodic or chronic migraine (age, 45.9 ± 13.2 years; 184F; 45 erenumab; 60 galcanezumab; 123 fremanezumab) who were treated with CGRP mAbs for at least three months were ultimately included in this study.
In the total cohort, after CGRP mAb treatment, mean monthly migraine days decreased by 7.2 ± 4.8, 8.3 ± 4.7, and 9.5 ± 5.0 at three, six and 12 months, respectively. The ≥50% monthly migraine day reduction rates at three, six and 12 months were 48.2%, 61.0% and 73.7%, respectively. In the logistic regression analysis, the presence of osmophobia and fewer baseline monthly migraine days contributed to ≥50% responders at three, six and 12 months. The ≥50% responders at three or six months were useful in predicting ≥50% responders at 12 months. In subgroups of patients with difficult-to-treat migraine (those with medication overuse headache or psychiatric comorbidities) and previous CGRP mAb users, monthly migraine days were substantially reduced over 12 months. There was no difference in monthly migraine day reduction over 12 months among three different CGRP mAbs. Adverse reactions were observed in 28 (12.3%) patients, with injection site reactions being the most common (n = 22) though generally mild in severity.
This real-world study confirmed the efficacy and safety of three different CGRP mAbs for prophylactic treatment of patients with migraine.
需要真实世界数据来评估降钙素基因相关肽单克隆抗体（CGRP mAb）在偏头痛患者中的有效性。
我们进行了一项单中心、真实世界研究，观察期最长为 CGRP mAb 给药后 12 个月（平均 7.5±3.4 个月）。共纳入 228 例接受 CGRP mAb 治疗至少 3 个月的日本发作性或慢性偏头痛患者（年龄 45.9±13.2 岁；184 例女性；45 例依那西普；60 例加兰他敏；123 例弗雷美尼单抗）。
在总队列中，CGRP mAb 治疗后，每月偏头痛天数分别减少 7.2±4.8、8.3±4.7 和 9.5±5.0，在 3、6 和 12 个月时；3、6 和 12 个月时≥50%每月偏头痛天数减少率分别为 48.2%、61.0%和 73.7%。在逻辑回归分析中，嗅觉过敏和基线时每月偏头痛天数较少与 3、6 和 12 个月时的≥50%应答者有关。3 或 6 个月时的≥50%应答者可用于预测 12 个月时的≥50%应答者。在难治性偏头痛（药物过度使用性头痛或精神共病）和既往 CGRP mAb 使用者的患者亚组中，12 个月内每月偏头痛天数明显减少。三种不同的 CGRP mAb 在 12 个月内每月偏头痛天数减少无差异。28 例（12.3%）患者出现不良反应，最常见的是注射部位反应（n=22），但通常为轻度。
这项真实世界研究证实了三种不同的 CGRP mAb 用于偏头痛预防性治疗的疗效和安全性。
