Servicio de Farmacia, Complejo Hospitalario Universitario de Canarias, Tenerife, Spain.
Servicio de Neurología, Complejo Hospitalario Universitario de Canarias, Tenerife, Spain.
Ann Pharmacother. 2023 Apr;57(4):416-424. doi: 10.1177/10600280221118402. Epub 2022 Aug 18.
Due to the recent introduction of new biologic drugs for chronic migraine, a global evaluation in real clinical practice is necessary.
The objective was to evaluate the effectiveness and safety in real clinical practice of drugs targeting the calcitonin gene-related peptide receptor (CGRPr) in patients with chronic migraine.
Single-center, restrospective study (2019-2022), including patients with chronic migraine treated with erenumab, galcanezumab, or fremanezumab. Effectiveness variables were recorded, namely, number of migraine headache days per month (MHD), Migraine Disability Assessment Scale (MIDAS) score, and Headache Impact Test-6 (HIT-6) score, assessing changes at week 12, 24 from baseline. Toxicity was recorded following the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.
In all, 104 patients were included (46.2% erenumab, 41.3% galcanezumab, 12.5% fremanezumab). A reduction in MHD, MIDAS, and HIT-6 was achieved at weeks 12 and 24 with erenumab (p75% at week 24 than those intensified; = 0.041). There was no difference in efficacy ( = 0.154) or improvement in quality of life ( = 0.783, = 0.150), but there was greater toxicity ( < 0.001) among nonresponders with erenumab 70 mg versus erenumab 140 mg.
The results confirm the effectiveness and safety of anticalcitonin gene-related peptide (CGRP) drugs in real clinical practice. However, the study shows little benefit from erenumab intensification, with similar effectiveness and worse tolerability than the standard dose.
由于最近引入了用于慢性偏头痛的新型生物药物，因此有必要在真实临床实践中进行全球评估。
评估靶向降钙素基因相关肽受体（CGRPr）的药物在慢性偏头痛患者中的真实临床实践中的有效性和安全性。
单中心、回顾性研究（2019-2022 年），包括接受依那西普、加兰他敏或弗雷曼泽布治疗的慢性偏头痛患者。记录有效性变量，即每月偏头痛头痛天数（MHD）、偏头痛残疾评估量表（MIDAS）评分和头痛影响测试-6（HIT-6）评分，评估从基线开始的第 12 周和第 24 周的变化。根据常见不良事件术语标准（CTCAE）v5.0 标准记录毒性。
共纳入 104 例患者（46.2%依那西普、41.3%加兰他敏、12.5%弗雷曼泽布）。依那西普在第 12 周和第 24 周可降低 MHD、MIDAS 和 HIT-6（p<0.001），与未强化组相比，第 24 周时 70mg 依那西普组的缓解率达到 75%；而 140mg 依那西普组的缓解率为 63%（p=0.041）。两组间在疗效（p=0.154）或生活质量改善（p=0.783，p=0.150）方面无差异，但依那西普无应答者的毒性更大（p<0.001），70mg 依那西普组比 140mg 依那西普组更明显。
结果证实了抗降钙素基因相关肽（CGRP）药物在真实临床实践中的有效性和安全性。然而，该研究表明依那西普强化治疗获益不大，与标准剂量相比，疗效相似，但耐受性更差。
