Headache Center, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Expert Opin Emerg Drugs. 2023 Dec;28(2):79-96. doi: 10.1080/14728214.2023.2207819. Epub 2023 Apr 28.
Migraine is a leading cause of years lived with disability and preventive strategies represent a mainstay to reduce health-related disability and improve quality of life of migraine patients. Until a few years ago, migraine prevention was based on drugs developed for other clinical indications and relocated in the migraine therapeutic armamentarium, characterized by unfavorable tolerability profiles. The advent of monoclonal antibodies against Calcitonin Gene-Related Peptide (CGRP) and gepants, CGRP receptor antagonists, has been a turning point in migraine prevention owing to advantageous efficacy, safety and tolerability profiles.Nevertheless, while in an ideal scenario a drug characterized by significant greater efficacy and tolerability compared to existing therapeutic strategies should be adopted as a first-line treatment, cost-effectiveness analyses available for monoclonal antibodies against CGRP pathway tend to limit their administration to more severe migraine phenotypes.
The present narrative review aims to provide a critical appraisal of phase II and III CGRP-mAbs and gepants trials to analyze their use in clinical practice.
Despite monoclonal antibodies against CGRP pathway and gepants can be undoubtedly considered top-of-the-range treatments, there are still issues deserving to be addressed in the coming years as the risk of off-target effects as well as their economic sustainability based on the considerable migraine burden.
偏头痛是导致伤残调整生命年(DALY)的主要原因之一,预防策略是减少与健康相关的残疾和改善偏头痛患者生活质量的主要方法。直到几年前,偏头痛的预防还基于为其他临床适应证开发并重新定位在偏头痛治疗武器库中的药物,这些药物的耐受性较差。降钙素基因相关肽(CGRP)单克隆抗体和 CGRP 受体拮抗剂 gepants 的出现,由于其疗效、安全性和耐受性较好,成为偏头痛预防的一个转折点。然而,尽管在理想情况下,与现有治疗策略相比,具有显著更高疗效和耐受性的药物应作为一线治疗药物,但针对 CGRP 通路的单克隆抗体的成本效益分析往往将其限制用于更严重的偏头痛表型。
本综述旨在对 CGRP-单克隆抗体和 gepants 的 II 期和 III 期临床试验进行批判性评估,以分析它们在临床实践中的应用。
尽管针对 CGRP 通路的单克隆抗体和 gepants 无疑可以被认为是顶级治疗方法,但在未来几年仍有一些问题需要解决,包括脱靶效应的风险以及基于相当大的偏头痛负担的经济可持续性。