ArticleNeurology and therapy2024
Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.
Article in Neurology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 11 papers, 1 of them a synthesis that pooled it.
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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.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Fremanezumab for the Treatment of Migraine Complicated by Medication Overuse: A Systematic Review.Clinical drug investigation · 2025Pooled it
- The second interim analysis of Italian participants enrolled in the real-world, Pan-European, prospective, observational, Phase 4 PEARL study of fremanezumab effectiveness.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Trial
- Long-term real-world effectiveness and safety of fremanezumab in 1140 patients with migraine and at least 6 months of treatment: third interim analysis of the pan-European PEARL study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025Trial
- ESTELA-Study: Long-Term Effectiveness and Safety of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in Real-World Clinical Practice.Brain and behavior · 2026Article
- Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial.Neurology and therapy · 2026Article
- Real-World Clinical Effectiveness and Migraine-Related Healthcare Resource Utilization in Patients Initiating Fremanezumab in Germany and the United Kingdom.Therapeutics and clinical risk management · 2026Article
- Long-term effectiveness of fremanezumab in episodic and chronic migraine patients in clinical routine - 24-months results from the prospective non-interventional FINESSE study.The journal of headache and pain · 2025Article
- Fremanezumab for the treatment of migraine.Pain management · 2025Review
- A real-world study of the efficacy and tolerability of fremanezumab in migraine patients with a median follow-up of 14 months.Neurological research and practice · 2025Article
- Framing and Management of Migraines in Women: An Expert Opinion on Challenges, Current Approaches, and Future Multidisciplinary Perspectives.Healthcare (Basel, Switzerland) · 2025Article
- Calcitonin Gene-Related Peptide Monoclonal Antibodies: Key Lessons from Real-World Evidence.Brain sciences · 2024Review
Corrections and comments
- Erratum issued
Authors and funding
33 authors at 20 institutions in 1 country.
Funding
Abstract
introductionLong-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and various comorbidities.
methodsA 48-week, prospective, multicenter (n = 26), cohort study assessed fremanezumab's effectiveness, safety, and tolerability in consecutive adults with HFEM or CM with > 3 treatment failures. Primary endpoint was variation from baseline in monthly migraine days (MMD) in HFEM and monthly headache days (MHD) in CM at weeks 45-48. Secondary endpoints were changes in monthly analgesic medications, Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), and the Migraine Disability Assessment Scale (MIDAS) scores and ≥ 50%, ≥ 75%, and 100% responder rates.
resultsOf 533 participants who had received ≥ 1 fremanezumab dose, 130 were treated for ≥ 48 weeks and considered for effectiveness analysis. No participant missed any treatment dosage every other consecutive month during the 12-month period. PRIMARY ENDPOINT: fremanezumab significantly (p < 0.001) reduced both MMD (- 6.4) in HFEM and MHD (- 14.5) in CM. Secondary endpoints: a significant reduction (p < 0.001) was observed in monthly analgesic medications (HFEM - 6.0; CM -16.5), NRS (HFEM - 3.4; CM - 3.4), HIT-6 (HFEM - 16.9; CM - 17.9) and MIDAS score (HFEM - 50.4; CM - 76.6). The ≥ 50%, ≥ 75%, and 100% response rates to fremanezumab were 75.5%, 36.7%, and 2% in HFEM and 71.6%, 44.4%, and 3.7% in CM. Corresponding response rates were 60.5%, 37.2%, and 2.3% in individuals with psychiatric comorbidities, 74.2%, 50%, and 4.8% in CM with medication overuse, and 60.9%, 39.1%, and 4.3% in CM with medication overuse and psychiatric comorbidities. Mild and transient treatment-emergent adverse events occurred in 7.8% of the participants. No subject discontinued the treatment for any reason.
conclusionThis RWE study documents that long-term fremanezumab treatment is highly effective and remarkably well tolerated in subjects with HFEM or CM with multiple (> 3) therapeutic failures, even in the presence of concomitant medication overuse, psychiatric comorbidities, or both. The effectiveness-to-tolerability ratio appears to be better in RWE than in RCTs.
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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 OpenQuestion graph.