ArticleThe journal of headache and pain2023
Long-term effectiveness and tolerability of galcanezumab in patients with migraine excluded from clinical trials: real world evidence of 1055 patients with 1 year follow-up from the Galca-Only registry.
Article in The journal of headache and pain, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses 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.
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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.
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Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Real-world effectiveness and safety of galcanezumab for the treatment of migraine: A systematic review and meta-analysis.Headache · 2026Pooled it
- Effectiveness and safety of anti-CGRP monoclonal antibodies for migraine in patients over 65 years: a systematic review.Pain management · 2025Pooled it
- Real-world experience of galcanezumab in the prevention of migraine in Spain: a systematic literature review.Frontiers in neurology · 2024Pooled it
- Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, in Healthy Chinese Participants.Clinical pharmacology in drug development · 2025Trial
- Persistence and Reasons for Treatment Discontinuation of Anti-CGRP Therapies in Migraine Prophylaxis: A Systematic Review and Meta-analysis of Real-World Studies.Pain and therapy · 2026Review
- 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
- Effectiveness and tolerability of galcanezumab for migraine prevention in patients ≥65 years: A real-life multicenter study.Headache · 2026Article
- Migraine, monoclonal antibodies, and monitoring: a review of pharmacovigilance in the era of biologics.Frontiers in pharmacology · 2026Review
- Prescription of Monoclonal Antibodies Against Calcitonin Gene-Related Peptide for the Prophylaxis of Migraine in Austria: A Retrospective, Longitudinal Analysis of Nationwide Insurance Data.European journal of neurology · 2025Article
- Efficacy of monoclonal antibodies against CGRP in migraine patients with fibromyalgia comorbidity: a retrospective monocentric observational study.The journal of headache and pain · 2025Observational
- Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study.Pain and therapy · 2024Article
Corrections and comments
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Authors and funding
28 authors at 15 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGalcanezumab has shown efficacy and effectiveness in the treatment of episodic and chronic migraine (CM), however, the population represented in randomized clinical trials (RCTs) differs from the population observed in real-world setting. To describe the long-term effectiveness and tolerability of galcanezumab in clinical practice in patients excluded from RCTs.
methodsMulticenter prospective cohort study of consecutive patients with chronic and high-frequency episodic migraine (HFEM) with prior failure to three or more migraine preventive drugs, treated with galcanezumab and followed up for 12 months.
resultsWe enrolled 1055 patients, aged 50 (IQR: 42-58), 82.9% female, 76.4% chronic migraine, 69% with at least one exclusion criteria for RCTs, including age > 65 (n = 121), concomitant use of onabotulinumtoxinA (n = 185), daily headache at baseline (n = 347), chronic painful syndromes (n = 206), fibromyalgia (n = 101) or treatment resistance (n = 957). The median number of prior preventive treatments was 4 (IQR: 3-5). The retention rate was 90.8%, 76.8% and 71.4% at 3, 6 and 12 months. The main reasons for treatment discontinuation were lack of effectiveness (21.1%) and inadequate tolerability (6.6%). The 30%, 50% and 75% responder rates were 62.6%, 49.8% and 24.2% between weeks 8-12; 60.9%, 48.8% and 24.6% between weeks 20-24; and 59.7%, 48.3% and 24.6% between weeks 44-48. Daily headache at baseline (OR: 0.619; 95%CI: 0.469-0.817) and patient's age (OR: 1.016; 95%CI: 1.005-1.026) were associated with 50% response at weeks 20-24. The variables that were associated with a higher reduction of headache days between weeks 20-24 were patient's age (0.068; 95% CI: 0.018-0.119) and headache days per month at baseline (0.451; 95% CI: 0.319-0.583), while psychiatric comorbidity (-1.587; 95% CI: -2.626-0.538) and daily headache at baseline (-2.718; 95% CI: -4.58-0.869) were associated with fewer reduction in the number of headache days between weeks 20-24.
conclusionThis study provides class III evidence of effectiveness and tolerability of galcanezumab in patients with HFEM and CM with comorbidities that would result in exclusion of the pivotal RCTs. Nonetheless, the clinical results over a 12-month period were similar to the efficacy observed in randomized controlled trials. Few patients discontinued the drug due to inadequate tolerability.
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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.