加巴喷丁在真实世界条件下作为慢性丛集性头痛预防性治疗的疗效和安全性：观察性前瞻性研究。

Efficacy and safety of galcanezumab as chronic cluster headache preventive treatment under real world conditions: Observational prospective study.

机构信息

Headache Unit, Neurology Department, Virgen del Rocío University Hospital, Seville, Spain.

出版信息

Cephalalgia. 2024 Mar;44(3):3331024231226181. doi: 10.1177/03331024231226181.

DOI:10.1177/03331024231226181

PMID:38501892

Abstract

BACKGROUND

Calcitonin gene-related peptide has shown to play a central role in cluster headache (CH) pathophysiology. A clinical trial with galcanezumab was carried out in chronic cluster headache (CCH) but did not meet its primay endpoint. However, its off-label use in patients with CCH refractory to other therapies could be considered. We aimed to asses the efficacy and safety of galcanezumab as CCH preventive treatment in a real-life setting.

METHODS

An observational study was conducted. Patients with CCH who received at least one dose of 240 mg of galcanezumab.

RESULTS

Twenty-one patients who tried a mean of 6.3 ± 1.9 preventive therapies, including onabotulinumtoxinA in 90.5%. At baseline, the median of frequency was 60 (37.5-105) monthly attacks with 10 (8.3-10) points in pain intensity (Numerical Rating Scale). After one month, the frequency decreased to 31 (10.5-45) ( = 0.003) with 8.5 (8-9.5) intensity ( = 0.007); 10 (47.6%) patients were 50% responders of whom four (19%) were 75% responders. Of the 15 patients with 3 months of follow-up, seven (46.6%) reduced their frequency by 50% and four (26.6%) by 75%, with 40 (10-60) monthly attacks ( = 0.07) and pain intensity of 8 (5-10) ( = 0.026). Some 52% patients experienced adverse events, mostly mild.

CONCLUSIONS

In our cohort of refractory CCH, galcanezumab was effective in almost 50% of patients. This finding supports individual off-label treatment attempts.

摘要

背景

降钙素基因相关肽在丛集性头痛（CH）的病理生理学中起着核心作用。一项关于加兰他敏的临床试验在慢性丛集性头痛（CCH）中进行，但没有达到其主要终点。然而，对于其他治疗方法无效的 CCH 患者，可以考虑将其作为标签外药物使用。我们旨在评估加兰他敏作为 CCH 预防性治疗的疗效和安全性。

方法

进行了一项观察性研究。接受至少一剂 240mg 加兰他敏的 CCH 患者。

结果

21 名患者尝试了平均 6.3±1.9 种预防性治疗方法，其中 90.5%的患者使用了肉毒杆菌毒素 A。基线时，每月发作频率中位数为 60（37.5-105）次，疼痛强度中位数为 10（8.3-10）分（数字评分量表）。治疗一个月后，频率降至 31（10.5-45）（=0.003），强度降至 8.5（8-9.5）（=0.007）；10 名（47.6%）患者为 50%应答者，其中 4 名（19%）为 75%应答者。在 15 名随访 3 个月的患者中，7 名（46.6%）患者的频率降低了 50%，4 名（26.6%）患者降低了 75%，每月发作频率为 40（10-60）（=0.07），疼痛强度为 8（5-10）（=0.026）。约 52%的患者出现不良反应，多为轻度。