ArticleThe journal of headache and pain2022
Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study).
Article in The journal of headache and pain, 2022. 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 49 papers, 2 of them syntheses that pooled it.
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Who cites it
49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- Methodological considerations on real-world evidence studies of monoclonal antibodies against the CGRP-pathway for migraine: a systematic review.The journal of headache and pain · 2023Pooled it
- Pooled it
- Smartphone-Based Muscle Relaxation for Migraine in the Emergency Department: A Randomized Clinical Trial.JAMA network open · 2025Trial
- The first interim analysis of Italian patients 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 · 2024Trial
- Evaluating the Complementary Nature of Randomized Controlled Trials and Real-World Evidence Using Over 5 Years of Experience with Fremanezumab: A Narrative Review.Advances in therapy · 2026Review
- Observational
- Fremanezumab for the treatment of migraine.Pain management · 2025Review
- Disrupting Migraine Dynamics: A Narrative Review of the Consequences of Modern Anti-CGRP Monoclonal Antibody Therapies.Neurology and therapy · 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
- Real-World Lessons with Fremanezumab as the Third Available CGRP Monoclonal Antibody in a Third-Level Hospital: Focus on the Factors Predicting Response.Journal of clinical medicine · 2025Article
- Article
- Effectiveness of a headache awareness campaign on behavioral change.Frontiers in neurology · 2025Article
- Effectiveness and safety of monthly versus quarterly fremanezumab for migraine prevention: An Italian, multicenter, real-life study.European journal of neurology · 2024Article
- Unlocking the potential of luteolin: A natural migraine management approach through network pharmacology.Journal of traditional and complementary medicine · 2024Article
- Blood pressure monitoring in elderly migraineurs starting an anti-CGRP monoclonal antibody: a real-world prospective study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024Observational
- Application of Artificial Intelligence in the Headache Field.Current pain and headache reports · 2024Review
- Calcitonin Gene-Related Peptide Monoclonal Antibodies: Key Lessons from Real-World Evidence.Brain sciences · 2024Review
- Comparative effectiveness and tolerability of calcitonin gene-related peptide (CGRP) monoclonal antibodies and onabotulinumtoxinA in chronic migraine: A multicenter, real-world study in Taiwan.European journal of neurology · 2024Article
- Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.Neurology and therapy · 2024Article
- Results of a Web-Based Survey on 2565 Greek Migraine Patients in 2023: Demographic Data, Imposed Burden and Satisfaction to Acute and Prophylactic Treatments in the Era of New Treatment Options.Journal of clinical medicine · 2024Article
Corrections and comments
- Erratum issued
- Erratum issued
Authors and funding
15 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFremanezumab has demonstrated to be effective, safe, and tolerated in the prevention of episodic or chronic migraine (CM) in randomized, placebo-controlled trials (RCTs). Real-life studies are needed to explore drug effects in unselected patients in routine circumstances and to provide higher generalizability results. This study explores the effectiveness, safety, and tolerability of fremanezumab in a real-life population of individuals affected by high-frequency episodic (HFEM: 8-14 days/month) or CM.
methodsThis is a 12-week multicenter, prospective, cohort, real-life study. We considered all consecutive patients affected by HFEM or CM visited at 9 Italian headache centers from 28/07/2020 to 11/11/2020. Eligible patients were given subcutaneous fremanezumab at the doses of 225 mg monthly or 675 mg quarterly, according to their preference. Primary study endpoints were the change in monthly migraine days (MMDs) in HFEM and monthly headache days (MHDs) in CM patients at weeks 9-12 compared to baseline. Secondary endpoints encompassed variation in monthly analgesic intake (MAI), Numerical Rating Scale (NRS), HIT-6 and MIDAS scores, and ≥ 50%, ≥ 75% and 100% responder rates at the same time intervals.
resultsSixty-seventh number migraine patients had received ≥ 1 subcutaneous fremanezumab dose and were considered for safety analysis, while 53 patients completed 12 weeks of treatment and were included also in the effectiveness analysis. Fremanezumab was effective in both HFEM and CM, inducing at week 12 a significant reduction in MMDs (-4.6, p < 0.05), MHDs (-9.4, p < 0.001), MAI (-5.7, p < 0.05; -11.1, p < 0.001), NRS (-3.1, p < 0.001; -2.5, p < 0.001), and MIDAS scores (-58.3, p < 0.05; -43.7; p < 0.001). HIT-6 was significantly reduced only in HFEM patients (-18.1, p < 0.001). Remission from CM to episodic migraine and from MO to no-MO occurred in 75% and 67.7% of the patients. The ≥ 50%, ≥ 75% and 100% responder rates at week 12 were 76.5%, 29.4% and 9.9% in HFEM and 58.3%, 25% and 0% in CM. Younger age emerged as a positive response predictor (OR = 0.91; 95% CI 0.85-0.98, p = 0.013). Treatment-emergent adverse events were uncommon (5.7%) and mild. No patient discontinued fremanezumab for any reason.
conclusionsFremanezumab seems more effective in real-life than in RCTs. Younger age emerges as a potential response predictor.
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