Background

Many patients with chronic migraine do not achieve clinically meaningful improvement in their headache frequency with monotherapy. The burden associated with chronic migraine calls for a multifaceted treatment approach targeting multiple aspects of migraine pathophysiology.

Objective

The aim of this study was to evaluate the effect of concurrent anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) and onabotulinumtoxinA (onabot) treatment on median monthly migraine days (MMD) in patients with chronic migraine, through a retrospective study.

Methods

The electronic medical records of Cleveland Clinic patients either concurrently (dual therapy) or consecutively (monotherapy) treated with anti-CGRP mAbs and onabot between June 2018 and November 2021 were extracted. Only adult patients (≥ 18 years of age) were included in this study. MMDs for 194 concurrently treated (86.6% female and a median [interquartile range] age of 51 [41–61] years) and 229 consecutively treated (88.2% female and median age of 47 [IQR 39–57] years) patients were examined at baseline, after first therapy of either anti-CGRP mAb or onabot, and following dual therapy for 3 consecutive months. The reduction of MMDs for each treatment group were compared. The same approach was utilized to compare consecutive monotherapy at separate times (n = 229) and dual-therapy groups.

Results

The initial treatment of the dual-therapy group reduced the median (IQR) MMDs from 30 (30–30) to 15 (12–30) [p < 0.0001]. After initiation of dual therapy, the median MMDs was further decreased from 15 (12–30) to 8 (3–22) [p < 0.0001]. A majority [132/194 (68.0%)] of the dual-therapy patients reported a ≥ 50% reduction in MMD and 90/194 (46.4%) reported a ≥ 75% reduction. For the consecutive monotherapy group, median MMDs changed from a baseline of 30 (25–30) to 15 (8–25) from onabot monotherapy and decreased from 25 (15–30) to 12 (4–25) after anti-CGRP mAb monotherapy. Almost half (113/229 [49.3%] from onabot, and 104/229 [45.4%] from anti-CGRP mAb) of these patients achieved a ≥ 50% reduction in MMDs and a minority (38/229 [16.6%] from onabot, and 45/229 [19.7%] from anti-CGRP mAb) achieved a reduction of ≥ 75%. Additionally, dual therapy showed significant improvement in MMDs compared with monotherapy of either treatment (p < 0.0001).

Conclusion

Dual therapy of anti-CGRP mAbs and onabot may be more efficacious than monotherapy, possibly due to their synergistic mechanisms of action.

中文翻译：

---

抗 CGRP 单克隆抗体和 OnabotulinumtoxinA 在治疗慢性偏头痛中的协同作用：真实世界回顾性图表回顾

背景

许多慢性偏头痛患者通过单一疗法并未实现头痛频率的有临床意义的改善。与慢性偏头痛相关的负担需要针对偏头痛病理生理学多个方面的多方面治疗方法。

客观的

本研究的目的是通过回顾性研究，评估抗降钙素基因相关肽 (CGRP) 单克隆抗体 (mAb) 和肉毒杆菌毒素 A (onabot) 联合治疗对慢性偏头痛患者每月中位偏头痛天数 (MMD) 的影响。学习。

方法

提取了克利夫兰诊所 2018 年 6 月至 2021 年 11 月期间同时（双重治疗）或连续（单一治疗）接受抗 CGRP mAb 和 onabot 治疗的患者的电子病历。本研究仅纳入成年患者（≥ 18 岁）。对 194 名同时接受治疗的患者（86.6% 为女性，中位 [四分位距] 年龄为 51 [41–61] 岁）和 229 名连续治疗的患者（88.2% 为女性，中位年龄为 47 [IQR 39–57] 岁）的 MMD 进行了检查基线时、第一次抗 CGRP mAb 或 onabot 治疗后以及连续 3 个月的双重治疗后。比较每个治疗组的 MMD 减少情况。使用相同的方法来比较不同时间的连续单一疗法 ( n  = 229) 和双重疗法组。

结果

双疗法组的初始治疗将中位 (IQR) MMD 从 30 (30-30) 降低至 15 (12-30) [ p  < 0.0001]。开始双重治疗后，中位 MMD 进一步从 15 (12-30) 降至 8 (3-22) [ p  < 0.0001]。大多数 [132/194 (68.0%)] 双重治疗患者报告 MMD 降低 ≥ 50%，90/194 (46.4%) 报告降低 ≥ 75%。对于连续单药治疗组，onabot 单药治疗组的中位 MMD 从基线 30 (25-30) 变为 15 (8-25)，而抗 CGRP mAb 后从 25 (15-30) 降至 12 (4-25)单一疗法。这些患者中几乎一半（来自 onabot 的 113/229 [49.3%]，以及来自抗 CGRP mAb 的 104/229 [45.4%]）的 MMD 减少了≥ 50%，少数（来自 onabot 的 38/229 [16.6%]） onabot 和抗 CGRP mAb 的 45/229 [19.7%]）实现了 ≥ 75% 的减少。此外，与任一治疗的单一疗法相比，双重疗法显示 MMD 显着改善 ( p  < 0.0001)。

结论

抗 CGRP 单克隆抗体和 onabot 的双重治疗可能比单一治疗更有效，这可能是由于它们的协同作用机制。