Fremanezumab for migraine in clinical practice: a systematic review and meta-analysis

INTRODUCTION: Although the efficacy of fremanezumab in treating migraine has been proven in randomized controlled trials, its effectiveness is not well understood. Consequently, this study purpose was to synthesize and estimate its real-world effectiveness and safety in patients with migraine. METHODS: A systematic search of PubMed, Scopus and Web of Science was conducted from inception to November2025. Real-world studies evaluating fremanezumab effectiveness, measured by monthly migraine days (MMDs), monthly headache days (MHDs), Headache Impact Test (HIT-6) and related outcomes, including safety, were included. Random-effects meta-analyses were performed. RESULTS: One month after treatment initiation, fremanezumab reduced MMD by -5.82 days (95% CI: -6.67, -4.97), MHD by -7.30 days (95% CI: -9.72, -4.87) and HIT-6 scores by -6.84 points (95% CI: -10.30, -3.39). Approximately 50% of patients achieved a ≥ 50% reduction in MMD or MHD within 3 months, with response rates increasing progressively up to 12 months. Adverse event rates were 0.05 (95% CI: 0.02, 0.09) in 6 months and 0.07 (95% CI: 0.03, 0.12) in 12 months, with constipation being the most frequently reported event. CONCLUSION: Fremanezumab is associated with clinically significant reductions in migraine frequency, disability and acute medication used in real-world settings, with a favorable safety profile. PROSPERO: CRD42021266322.