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Drugs. 2020 Jun;80(9):893-904. doi: 10.1007/s40265-020-01329-5.
Galcanezumab (Emgality) is a humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP), thereby inhibiting its physiological activity, with CGRP playing a key role in the pathophysiology of migraine and headache disorders. In pivotal phase 3 trials, recommended dosages of subcutaneous galcanezumab once monthly were significantly more effective than placebo as preventive therapy in adults with episodic (EVOLVE-1 and -2; over 6 months) or chronic (REGAIN; over 3 months) migraine (± aura), including in patients who had failed several prior preventive migraine drugs (CONQUER; over 3 months). The beneficial effects of galcanezumab preventive treatment in reducing the number of monthly migraine headache days (MHDs) and improving health-related quality of life (HR-QOL) were sustained during up to 1 year of treatment. In adults with episodic cluster headache, galcanezumab treatment was associated with a significant reduction in the weekly frequency of cluster headache attacks across weeks 1-3 compared with placebo (primary endpoint), albeit during weeks 4-8, there was a convergence of results between these treatment groups. Although further evidence from the clinical setting is required to determine its long-term safety profile, given its convenient administration regimen, efficacy and short-term tolerability profile, monthly galcanezumab represents an important emerging option for the prevention of episodic and chronic migraine (± aura) and the treatment of episodic cluster headache.
加巴喷丁（Emgality）是一种针对降钙素基因相关肽（CGRP）的人源化单克隆抗体，从而抑制其生理活性，CGRP 在偏头痛和头痛障碍的病理生理学中起关键作用。在关键的 3 期试验中，每月皮下注射一次推荐剂量的加巴喷丁作为预防疗法，在有发作性（EVOLVE-1 和 -2；超过 6 个月）或慢性（REGAIN；超过 3 个月）偏头痛（± 先兆）的成年患者中，与安慰剂相比，预防效果显著更优，包括那些先前几种预防偏头痛药物治疗失败的患者（CONQUER；超过 3 个月）。加巴喷丁预防治疗可减少每月偏头痛头痛天数（MHDs）并改善健康相关生活质量（HR-QOL），在长达 1 年的治疗期间效果持续。在有发作性丛集性头痛的成年患者中，与安慰剂相比，加巴喷丁治疗可显著降低第 1-3 周每周丛集性头痛发作的频率（主要终点），尽管在第 4-8 周，这些治疗组的结果趋同。尽管需要来自临床环境的进一步证据来确定其长期安全性概况，但鉴于其方便的给药方案、疗效和短期耐受性概况，每月加巴喷丁代表了预防发作性和慢性偏头痛（± 先兆）和治疗发作性丛集性头痛的一个重要新兴选择。
