Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review
Abstract
Introduction: Since 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.
Methods: Embase, 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.
Results: Of 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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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