Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Eur J Neurol. 2024 Dec;31(12):e16410. doi: 10.1111/ene.16410. Epub 2024 Sep 4.
Fremanezumab, a monoclonal antibody targeting the calcitonin gene-related peptide for migraine prevention, is available in monthly (225 mg) and quarterly (675 mg) doses. Previous studies showed efficacy and safety for both regimens, but a real-life comparison is lacking. This study aimed to compare the effectiveness and safety of monthly and quarterly fremanezumab in a real-life setting.
This Italian, prospective, multicenter study enrolled 95 migraine patients. During a 3-month treatment period, patients received either monthly or quarterly fremanezumab (49 monthly, 46 quarterly). A 6-month treatment period involved 79 patients (43 monthly, 36 quarterly). Monthly headache (MHD) and migraine days (MMD), number of days (AMD) and pills (AMP) of acute medication intake, and Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS) test, and Numeric Rating Scale (NRS) scores were recorded at baseline and after 3 and 6 months of treatment. Adverse events (AEs), responder rates, and medication overuse were also investigated.
Both monthly and quarterly treatments led to significant reductions in MMD, MHD, AMP, AMD, HIT-6, MIDAS, and NRS scores after 3 and 6 months. The monthly regimen exhibited a slightly greater reduction in MMD and MHD after the first quarter, with no significant difference observed after 6 months. The most common AE was transient injection-site reaction, without between-group differences. Responder rates and resolution of medication overuse did not significantly differ between the groups.
Both monthly and quarterly regimens were effective and safe, with a tendency for an advantage of the monthly regimen only in the first quarter of treatment.
依利替康单抗是一种针对降钙素基因相关肽的单克隆抗体，可用于偏头痛预防，有每月（225mg）和每季度（675mg）两种剂量。此前的研究表明这两种方案均有效且安全，但缺乏真实世界的比较。本研究旨在比较依利替康单抗在真实环境中的每月和每季度方案的有效性和安全性。
这项意大利前瞻性多中心研究纳入了 95 例偏头痛患者。在 3 个月的治疗期间，患者接受每月或每季度依利替康治疗（每月 49 例，每季度 46 例）。在 6 个月的治疗期间，有 79 例患者（每月 43 例，每季度 36 例）入组。在基线时和治疗 3 个月和 6 个月后，记录每月头痛（MHD）和偏头痛天数（MMD）、急性药物摄入天数（AMD）和药丸数（AMP）、头痛影响测试（HIT-6）、偏头痛残疾评估（MIDAS）测试和数字评分量表（NRS）评分。还调查了不良事件（AE）、应答率和药物滥用情况。
每月和每季度治疗均可显著降低 MMD、MHD、AMP、AMD、HIT-6、MIDAS 和 NRS 评分，无论是在治疗 3 个月还是 6 个月后。在第一个季度后，每月方案对 MMD 和 MHD 的降低幅度略大，但在 6 个月后无显著差异。最常见的 AE 是短暂的注射部位反应，各组间无差异。应答率和药物滥用的解决情况在两组之间无显著差异。
每月和每季度方案均有效且安全，每月方案在治疗的第一个季度可能具有优势。
