Objective

To assess the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor in chronic cluster headache (CCH) treatment under real world conditions.

Background

Calcitonin gene-related peptide has an important pathophysiological role in cluster headache. Although the randomised controlled trial with the calcitonin gene-related peptide antibody galcanezumab was negative, chronic cluster headache patients with insufficient response to other preventive treatments have been receiving individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies.

Methods

Data from 22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres.

Results

The number of previous preventive therapies was 6.5 ± 2.4 (mean ± standard deviation, range: 2–11). The average number of attacks per week was 23.3 ± 16.4 at baseline and significantly decreased by −9.2 ± 9.7 in the first month of treatment with a calcitonin gene-related peptide(-receptor) antibody (p < 0.001). Fifty-five percent of the patients were 50% responders and 36% were 75% responders with respect to attack frequency. Significant reduction of attack frequency started at week 1 (−6.8 ± 2.8 attacks, p < 0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (−9.8 ± 7.6, p < 0.001) and pain intensity during attacks (−1.2 ± 2.0, numerical rating scale (NRS) [0–10], p < 0.01) in the first month. In months 2 (n = 14) and 3 (n = 10), reduction of attack frequency from baseline was −8.0 ± 8.4 (p = 0.004) and −9.1 ± 10.0 (p = 0.024), respectively.

Conclusion

Under real-world conditions, individual treatment with calcitonin gene-related peptide(-receptor) antibodies was effective in 55% of our chronic cluster headache patients. This finding supports individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies in chronic cluster headache patients insufficiently responding to other therapies.

中文翻译：

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降钙素基因相关肽（受体）抗体对慢性丛集性头痛的影响：回顾性病例系列的结果支持个体治疗尝试。

客观的

评估针对降钙素基因相关肽 (CGRP) 或其受体的单克隆抗体在现实世界条件下治疗慢性丛集性头痛 (CCH) 的疗效。

背景

降钙素基因相关肽在丛集性头痛中具有重要的病理生理作用。尽管降钙素基因相关肽抗体 galcanezumab 的随机对照试验结果为阴性，但对其他预防性治疗反应不足的慢性丛集性头痛患者一直在接受降钙素基因相关肽（受体）抗体的个别标签外治疗尝试。

方法

在八个头痛中心回顾性收集了 22 名接受至少一剂降钙素基因相关肽（受体）抗体并在头痛日记中记录发作频率的慢性丛集性头痛患者的数据。

结果

既往预防性治疗的次数为 6.5 ± 2.4（平均值 ± 标准差，范围：2-11）。基线时每周平均发作次数为 23.3 ± 16.4，在降钙素基因相关肽（受体）抗体治疗的第一个月显着减少了 -9.2 ± 9.7 ( p  < 0.001)。就发作频率而言，55% 的患者反应率为 50%，36% 为 75%。第 1 周开始显着降低发作频率（-6.8 ± 2.8 次发作，p  < 0.01）。结果证实了每周急性头痛药物的使用显着减少 (-9.8 ± 7.6, p  < 0.001) 和发作期间的疼痛强度 (-1.2 ± 2.0, 数值评定量表 (NRS) [0–10], p < 0.01) 在第一个月。在第 2 个月 (n = 14) 和第 3 个月 (n = 10)，发作频率相对于基线的降低分别为 -8.0 ± 8.4 ( p  = 0.004) 和 -9.1 ± 10.0 ( p  = 0.024)。

结论

在真实世界条件下，降钙素基因相关肽（受体）抗体的个体化治疗对我们 55% 的慢性丛集性头痛患者有效。这一发现支持对其他疗法反应不足的慢性丛集性头痛患者使用降钙素基因相关肽（受体）抗体进行个体标签外治疗的尝试。