{"title":"Fremanezumab for the Treatment of Migraine Complicated by Medication Overuse: A Systematic Review.","authors":"Ibrahim Hajjaj, Carlo Baraldi, Lanfranco Pellesi","doi":"10.1007/s40261-025-01433-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>This systematic review aims to evaluate the effectiveness of fremanezumab in adults with migraine complicated by medication overuse.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Drug Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40261-025-01433-y","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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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.
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.
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