Introduction

Cluster headache (CH) is among the worst painful conditions. The available therapies are scarce and not specific, leaving many patients unsatisfied because of poor efficacy and/or tolerability. Patients not responding to common treatments are offered semi-invasive and invasive procedures with uncertain results. Based on the current understanding of CH pathophysiology, new possible therapeutic approaches come from drugs interfering with Calcitonin Gene Related Peptide (CGRP).

Areas covered

After summarizing the evidence for CGRP involvement in CH pathophysiology, we review the published literature (PubMed) and information (clinicaltrials.gov, EudraCT, EMA and FDA websites) regarding a novel anti-CGRP monoclonal antibody, Galcanezumab, its pharmacological properties, development, and evidence for the treatment of CH. Publications regarding other indications (migraine) are considered for completeness and safety/tolerability profile.

Expert opinion

In one randomized clinical trial, Galcanezumab has proven to be effective and safe as a preventive treatment in episodic CH, with a favorable tolerability profile offering a potential new option in the therapeutic arsenal. Inefficacy of galcanezumab in chronic CH as well as the inefficacy of another monoclonal antibody against CGRP (fremanezumab) in both episodic and chronic CH question the scalability of the drug in CH management. Further, studies comparing galcanezumab to the current standard treatments are highly desirable.

中文翻译：

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Galcanezumab可预防丛集性头痛。

介绍

丛集性头痛（CH）是最严重的疼痛症状。可用的疗法是稀缺的并且不是特异性的，由于疗效和/或耐受性差，使许多患者不满意。对常规治疗无反应的患者将获得半创和有创治疗程序，但结果不确定。基于对CH病理生理学的当前了解，新的可能的治疗方法来自干扰降钙素基因相关肽（CGRP）的药物。

覆盖区域

在总结了CGRP参与CH病理生理的证据后，我们回顾了有关新型抗CGRP单克隆抗体Galcanezumab的公开文献（PubMed）和信息（clinicaltrials.gov，EudraCT，EMA和FDA网站）（其药理特性，发展，和CH治疗的证据。考虑有关其他适应症（偏头痛）的出版物的完整性和安全性/耐受性。

专家意见

在一项随机临床试验中，Galcanezumab已被证明是预防发作性CH的有效方法，并且具有良好的耐受性，为治疗性武库提供了新的选择。galcanezumab在慢性CH中的无效性以及在发作期和慢性CH中两种针对CGRP的单克隆抗体（fremanezumab）的无效性都质疑该药物在CH治疗中的可扩展性。此外，非常需要将加那珠单抗与当前的标准治疗进行比较的研究。