Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Clinician Scientist Programm, Berlin Institute of Health (BIH), Berlin, Germany.
Expert Opin Pharmacother. 2022 Jul;23(10):1143-1153. doi: 10.1080/14656566.2022.2088281. Epub 2022 Jun 13.
Refractory migraine is associated with low quality of life and great socioeconomic burden. Despite high need for effective, tolerable preventive therapies, there has been little research on potential therapeutic options. Monoclonal antibodies (mAbs) against Calcitonin Gene-Related Peptide (CGRP) are the first preventive therapeutic approach for migraine based on the underlying pathophysiology.
Following a brief introduction into the term 'refractory migraine,' the authors reviewavailable treatment options, focusing on current phase III trials of substances acting on the CGRP pathway.
No uniform definition for refractory migraine is available. The vast majority of proposals recommend treatment failure of 2-4 drug classes as a key diagnostic criterion. Phase III studies on CGRP-(receptor) mAbs demonstrated excellent efficacy and tolerability in patients with chronic and episodic migraine including subjects with multiple unsuccessful conventional therapy attempts. However, more comparator trials showing superiority of mAbs versus oral preventatives, such as the HER-MEs study are needed. In summary, with the CGRP antibodies, a group of drugs has entered the market which will most likely not only significantly improve the quality of life of many individual migraine patients but could also reduce indirect health-care costs associated with migraine by reducing recurrent medical consultations.
难治性偏头痛与生活质量低下和巨大的社会经济负担相关。尽管对有效且耐受良好的预防性治疗存在高度需求，但针对潜在治疗选择的研究却很少。降钙素基因相关肽（CGRP）的单克隆抗体（mAbs）是基于潜在病理生理学的第一种偏头痛预防性治疗方法。
在简要介绍“难治性偏头痛”一词后，作者回顾了现有的治疗选择，重点关注了作用于 CGRP 途径的物质的当前 III 期临床试验。
没有统一的难治性偏头痛定义。绝大多数建议将 2-4 种药物类别的治疗失败作为关键诊断标准。CGRP-（受体）mAbs 的 III 期研究在慢性和发作性偏头痛患者中显示出了极好的疗效和耐受性，包括多次常规治疗尝试失败的患者。然而，需要更多的比较试验来证明 mAbs 相对于口服预防性药物（如 HER-MEs 研究）的优势。总的来说，随着 CGRP 抗体的出现，一类药物已经进入市场，它们很可能不仅会显著改善许多偏头痛患者的生活质量，还可以通过减少反复就医来降低与偏头痛相关的间接医疗保健成本。
