Pharmacy department, Hospital General Universitario de Alicante, Alicante, Spain.
Neurology department, Hospital General Universitario de Alicante, Alicante, Spain.
J Clin Pharm Ther. 2022 Jun;47(6):814-823. doi: 10.1111/jcpt.13620. Epub 2022 Feb 25.
WHAT IS KNOWN AND OBJECTIVE?: Erenumab and galcanezumab have shown great results for migraine prevention. However, strict inclusion criteria, absence of concomitant medication and selective outcome report of clinical trials may sometimes be barely representative of the real-world daily practice. Therefore, this study was designed to evaluate effectiveness and safety of these two monoclonal antibodies targeting calcitonin gene-related peptide in real-world patients. METHODS: This observational, retrospective study evaluated the effectiveness and safety of erenumab 140 mg and galcanezumab 120 mg in 142 real-world patients who had previously not responded to three well-established pharmacological alternatives for migraine prevention. To do so, a combination of objective parameters (monthly headache days and acute migraine-specific medication days) and subjective measurements (Migraine Disability Assessment questionnaire, Headache Impact Test and Visual Analogue Scale), validated for clinical research in migraine, were assessed during clinical interview. RESULTS AND DISCUSSION: Findings here reported show that erenumab and galcanezumab reduced monthly headache days, acute migraine specific medication days per month, Headache Impact Test score, Migraine Disability Assessment Test score and Visual Analogue Scale score after 3 and 6 doses (p < 0.01). Additionally, more than 25% of the patients enrolled in the study experienced a reduction by a half in monthly headache days, and more than 50% of the patients also reported a reduction by a half in the number of migraine specific medication days. Both treatments exhibited a great safety profile, rarely leading to discontinuation because of poor tolerance. WHAT IS NEW AND CONCLUSIONS?: Altogether, these results support previous real-life studies regarding effectiveness and safety and provide an interesting insight in how these preventive therapies are also effective in patients diagnosed with difficult to treat migraine who have previously failed, at least, three different drug classes stablished by current neurology guidelines for migraine prevention. Moreover, these data may suggest that erenumab and galcanezumab are able to not only diminish frequency, but also migraine intensity, and that it should be also considered as an effectiveness measure in line with other authors suggestion.
依瑞奈单抗和加兰他敏在偏头痛预防方面显示出了很好的效果。然而，临床试验的严格纳入标准、缺乏伴随药物和选择性结果报告有时可能几乎不能代表真实世界的日常实践。因此，本研究旨在评估针对降钙素基因相关肽的这两种单克隆抗体在真实患者中的有效性和安全性。
这项观察性、回顾性研究评估了依瑞奈单抗 140mg 和加兰他敏 120mg 在 142 名先前对三种经证实的偏头痛预防药物无反应的真实世界患者中的有效性和安全性。为此，使用偏头痛临床研究中经过验证的客观参数（每月头痛天数和急性偏头痛特异性药物天数）和主观测量（偏头痛残疾评估问卷、头痛影响测试和视觉模拟量表）来评估在临床访谈期间的效果。
本报告中的发现表明，依瑞奈单抗和加兰他敏在 3 剂和 6 剂后降低了每月头痛天数、每月急性偏头痛特异性药物天数、头痛影响测试评分、偏头痛残疾评估测试评分和视觉模拟量表评分（p<0.01）。此外，研究中纳入的患者中有超过 25%的患者每月头痛天数减少了一半，超过 50%的患者也报告每月偏头痛特异性药物天数减少了一半。两种治疗方法都具有很好的安全性，很少因耐受性差而导致停药。
总的来说，这些结果支持了先前关于有效性和安全性的真实生活研究，并提供了一个有趣的视角，了解这些预防疗法在先前至少失败了三种不同药物类别的、难以治疗的偏头痛患者中也具有有效性，这些药物类别是目前神经病学指南推荐的偏头痛预防药物。此外，这些数据表明，依瑞奈单抗和加兰他敏不仅能降低偏头痛的频率，还能降低偏头痛的强度，这也应该被视为与其他作者的建议一致的有效性衡量标准。
