Fremanezumab for the Treatment of Migraine Complicated by Medication Overuse: A Systematic Review.

IF 2.7 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2025-05-01 Epub Date: 2025-03-22 DOI:10.1007/s40261-025-01433-y

Ibrahim Hajjaj, Carlo Baraldi, Lanfranco Pellesi

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Abstract

Background: Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, such as fremanezumab, are effective for migraine prevention. However, their effectiveness in treating migraine complicated by medication overuse, remains underexplored.

Objective: This systematic review aims to evaluate the effectiveness of fremanezumab in adults with migraine complicated by medication overuse.

Methods: We systematically searched PubMed and Embase (Ovid) databases for studies on fremanezumab, selecting primary studies that included adults with migraine complicated by medication overuse and reported at least one efficacy outcome. The search was performed in January 2024 and then updated in June 2024. Risk of bias for randomized controlled trials was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool, while real-world studies were evaluated using both the ROBINS-I and ROB-ME tools. Data extraction and analysis followed established guidelines.

Results: Our search identified 176 records, of which 2 clinical trials and 7 real-world studies were included. Included studies recruited a total of 1422 adults with migraine complicated by medication overuse. In post hoc analyses from clinical trials, fremanezumab significantly reduced monthly migraine days, days with acute headache medication use, and Headache Impact Test (HIT-6) scores compared to placebo during a 12-week period. The real-world studies reported a reduction in monthly headache days at 6 months, and a high reversion rate from medication overuse headache (MOH) after one year of treatment.

Conclusion: Both post hoc analyses from clinical trials and real-world studies support fremanezumab benefits in reducing migraine frequency, medication use, and headache-related disability in adults with migraine complicated by medication overuse. Given the limited quality of data, further real-world research with standardized reporting criteria is needed to substantiate long-term benefits and establish optimal treatment protocols.

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Fremanezumab治疗偏头痛并发药物滥用：系统综述

背景：针对降钙素基因相关肽（CGRP）途径的单克隆抗体，如fremanezumab，可有效预防偏头痛。然而，它们在治疗偏头痛合并药物滥用方面的有效性仍未得到充分研究。目的：本系统综述旨在评估fremanezumab在成人偏头痛合并药物过度使用中的有效性。方法：我们系统地检索PubMed和Embase （Ovid）数据库中关于fremanezumab的研究，选择包括成人偏头痛合并药物过度使用并报告至少一个疗效结果的主要研究。搜索是在2024年1月进行的，然后在2024年6月更新。随机对照试验的偏倚风险使用Cochrane风险偏倚2 （RoB 2）工具进行评估，而真实研究使用ROBINS-I和robins - me工具进行评估。数据提取和分析遵循既定的指导方针。结果：我们检索了176份记录，其中包括2项临床试验和7项现实研究。纳入的研究共招募了1422名偏头痛合并药物滥用的成年人。在临床试验的事后分析中，与安慰剂相比，在12周期间，fremanezumab显著减少了每月偏头痛天数、急性头痛药物使用天数和头痛影响测试（HIT-6）评分。现实世界的研究报告说，6个月时每月头痛天数减少，治疗一年后药物过度使用头痛（MOH）的复发率很高。结论：临床试验和现实世界研究的事后分析都支持fremanezumab在减少偏头痛频率、药物使用和偏头痛相关残疾方面的益处，这些益处是偏头痛合并药物过度使用的成年人。鉴于数据质量有限，需要进一步的现实世界研究与标准化的报告标准，以证实长期效益和建立最佳的治疗方案。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.