Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
Dartmouth Headache Center, Neurology Department, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.
Headache. 2018 Nov;58 Suppl 3:276-290. doi: 10.1111/head.13417.
OBJECTIVE: To briefly update and correct the available data on anti-calcitonin gene-related peptide (CGRP) therapies for headache since the American Headache Society 60th Scientific Meeting, San Francisco, June 2018. BACKGROUND: CGRP is a target for primary headache therapies. METHODS: The author briefly reviews the new data and publications on gepants and anti-CGRP and anti-CGRP receptor monoclonal antibodies since the writing of his previous review in May 2018, with an emphasis on data provided at the American Headache Society 60th Scientific Meeting, San Francisco, June 2018. RESULTS: The US Food and Drug Administration (FDA) approved erenumab-aooe, an anti-CGRP receptor monoclonal antibody, for the prevention of migraine on May 17, 2018. On September 14, 2018, the FDA approved fremanezumab-vfrm and on September 26, 2018, the FDA approved galcanezumab-gnlm, both anti-CGRP ligand monoclonal antibodies for the prevention of migraine. Galcanezumab showed effectiveness in preventing episodic cluster headache as well, although has not yet been submitted to the FDA for this indication. Both galcanezumab and fremanezumab failed to prevent chronic cluster headache. Eptinezumab will likely be submitted to the FDA for prevention of migraine later in 2018. Two gepants, ubrogepant and rimegepant, have completed positive pivotal trials for the acute treatment of migraine, but have not yet been submitted to the FDA for this indication. A press release with data on the effectiveness of daily atogepant in migraine prevention provides some details. An announcement at the meeting suggests daily rimegepant will be tested for prevention as well. CONCLUSIONS: The development of anti-CGRP therapies opens a new era in the acute and preventive treatment of primary headache disorders.
目的:简要更新和更正自 2018 年 6 月旧金山美国头痛学会第 60 次科学会议以来有关抗降钙素基因相关肽(CGRP)治疗头痛的现有数据。
背景:CGRP 是原发性头痛治疗的靶点。
方法:作者简要回顾了自 2018 年 5 月撰写上一篇综述以来关于 gepants 和抗 CGRP 及抗 CGRP 受体单克隆抗体的新数据和出版物,重点介绍了 2018 年 6 月旧金山美国头痛学会第 60 次科学会议提供的数据。
结果:美国食品和药物管理局(FDA)于 2018 年 5 月 17 日批准了 erenumab-aooe,一种抗 CGRP 受体单克隆抗体,用于偏头痛的预防。2018 年 9 月 14 日,FDA 批准了 fremanezumab-vfrm,2018 年 9 月 26 日,FDA 批准了 galcanezumab-gnlm,均为抗 CGRP 配体单克隆抗体,用于偏头痛的预防。加那曲肽也显示出预防阵发性丛集性头痛的有效性,尽管尚未向 FDA 提交该适应证。加那曲肽和 fremanezumab 均未能预防慢性丛集性头痛。Eptinezumab 可能会在 2018 年晚些时候提交给 FDA 用于预防偏头痛。两种 gepants,ubrogepant 和 rimegepant,已完成急性偏头痛治疗的阳性关键试验,但尚未向 FDA 提交该适应证。一份关于每日 atogepant 在偏头痛预防中的有效性数据的新闻稿提供了一些细节。会议上的一则公告表明,每日 rimegepant 也将用于预防测试。
结论:抗 CGRP 治疗的发展开创了原发性头痛疾病急性和预防治疗的新时代。
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