Effectiveness and safety of monthly versus quarterly fremanezumab for migraine prevention: An Italian, multicenter, real-life study

IF 4.5 2区医学 Q1 CLINICAL NEUROLOGY European Journal of Neurology Pub Date : 2024-09-04 DOI:10.1111/ene.16410

Laura Zanandrea, Roberta Messina, Ilaria Cetta, Federica Genovese, Simone Guerrieri, Fabrizio Vernieri, Claudia Altamura, Sabina Cevoli, Valentina Favoni, Bruno Colombo, Massimo Filippi

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Abstract

Background and Purpose

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.

Methods

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.

Results

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.

Conclusions

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.

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每月一次与每季度一次使用氟马尼珠单抗预防偏头痛的有效性和安全性：一项意大利多中心真实生活研究。

背景和目的：Fremanezumab是一种靶向降钙素基因相关肽的单克隆抗体，用于预防偏头痛，有月剂量（225毫克）和季剂量（675毫克）两种。之前的研究显示这两种治疗方案都具有有效性和安全性，但缺乏实际生活中的比较。本研究旨在比较按月和按季服用氟马尼珠单抗在实际生活中的有效性和安全性：这项意大利前瞻性多中心研究共招募了95名偏头痛患者。在为期 3 个月的治疗期间，患者每月或每季度接受一次氟马尼珠单抗治疗（49 人每月一次，46 人每季度一次）。79名患者接受了为期6个月的治疗（43人每月一次，36人每季度一次）。在基线以及治疗 3 个月和 6 个月后，记录了每月头痛 (MHD) 和偏头痛天数 (MMD)、急性服药天数 (AMD) 和药片数 (AMP)，以及头痛影响测试 (HIT-6)、偏头痛残疾评估 (MIDAS) 测试和数值评定量表 (NRS) 评分。此外，还对不良事件（AE）、应答率和药物过度使用情况进行了调查：结果：按月和按季治疗均可在 3 个月和 6 个月后显著降低 MMD、MHD、AMP、AMD、HIT-6、MIDAS 和 NRS 评分。按月治疗方案在第一季度后MMD和MHD的降低幅度略大，6个月后未观察到明显差异。最常见的不良反应是一过性注射部位反应，组间无差异。各组之间的应答率和药物过度使用的解决情况没有明显差异：结论：按月和按季治疗方案均有效且安全，按月治疗方案仅在治疗的第一季度有优势。

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来源期刊

European Journal of Neurology 医学-临床神经学

CiteScore

9.70

自引率

2.00%

发文量

418

审稿时长

1 months

期刊介绍： The European Journal of Neurology is the official journal of the European Academy of Neurology and covers all areas of clinical and basic research in neurology, including pre-clinical research of immediate translational value for new potential treatments. Emphasis is placed on major diseases of large clinical and socio-economic importance (dementia, stroke, epilepsy, headache, multiple sclerosis, movement disorders, and infectious diseases).