ReviewAdvances in therapy2026
Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review.
Review in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
8 authors.
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Abstract
introductionSince the pivotal phase 3 randomized controlled trials (RCTs) and regulatory approval of fremanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) for migraine prevention, several real-world evidence (RWE) studies have been conducted. In this narrative review, we highlight the complementary value of RCTs and RWE studies, by examining > 6 years of fremanezumab efficacy and effectiveness data.
methodsEmbase, MEDLINE, MEDLINE In-Process, and Cochrane databases, bibliographies, and conference materials were searched for published RCT data and RWE on efficacy and effectiveness outcomes for fremanezumab. Electronic database and conference abstract searches were limited to articles published between January 2017 and September 2023, and January 2022 and September 2023, respectively.
resultsOf 48 publications identified for inclusion, 14 reported data from 10 RCTs and 34 reported data from 23 RWE studies. RCTs were of 8-12 weeks duration (with open-label extensions up to 52 weeks) and generally excluded individuals receiving preventive migraine treatment at baseline, and those with previous preventive treatment failures, previous exposure to CGRP pathway mAbs, or severe comorbidities. Exceptions were the UNITE study, which included participants with migraine and major depressive disorder, and the FOCUS studies, which included those with ≥ 2 prior preventive therapies. Most RWE studies included a broader population than RCTs, and were ≥ 3 months long, with some following participants for up to 2 years. Across RCTs, RWE studies, and population subgroup analyses, fremanezumab was consistently associated with improvements in monthly migraine and headache days, from as early as 4 weeks and sustained for up to 52 weeks.
conclusionWhile RCTs and RWE studies have differing strengths and weaknesses, these evidence-generation approaches have together highlighted the potential benefit of fremanezumab for preventive migraine treatment among broad, heterogenous patient populations.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.