Efficacy and Safety of Fremanezumab in Episodic Migraine: A Systematic Review and Meta-analysis
Abstract
Background: Fremanezumab, a calcitonin gene-related peptide monoclonal antibody, is approved for migraine prevention, yet evidence specific to episodic migraine remains limited. We synthesized randomized evidence on its efficacy and safety.
Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD420261385104), we systematically searched PubMed, Embase, and Scopus from inception to June 5, 2026, for placebo-controlled randomized controlled trials (RCTs) evaluating fremanezumab for episodic migraine prevention. Primary outcomes were the ≥50% responder rate and change in monthly migraine days. Random-effects meta-analyses were performed, and risk of bias was assessed using the Cochrane RoB 2 tool.
Results: Four RCTs including 1764 participants were included. Fremanezumab significantly increased the ≥50% responder rate (risk ratio: 1.81, 95% CI: 1.53-2.15) and reduced monthly migraine days (mean difference: -1.98, 95% CI: -2.93 to -1.03), headache days, acute medication-use days, and migraine-related disability. Overall safety was comparable to placebo, with no significant differences in treatment-emergent adverse events, serious adverse events, or treatment discontinuations; injection-site induration occurred more frequently with fremanezumab.
Relevance to patient care and clinical practice: This meta-analysis strengthens the evidence supporting fremanezumab as an effective and generally well-tolerated preventive therapy for…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,764 participants or records.
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