Trial reportCephalalgia : an international journal of headache2019
Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.
Trial report in Cephalalgia : an international journal of headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.
What it found
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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.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
A Randomized, Double Blind, Placebo-Controlled Single Center Phase 2 Pilot Study to Assess the Safety and Efficacy of Off-label Subcutaneous Administration of Erenumab-aooe in Patients With Temporomandibular Disorder
Who cites it
41 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Decoding the long-term safety of anti-CGRP (receptor) mAbs: a meta-analysis and systematic review.The journal of headache and pain · 2026Pooled it
- Optimal Dose of Erenumab for Preventive Treatment of Episodic Migraine: A Systematic Review and Meta-Analysis.Current neuropharmacology · 2022Pooled it
- Pooled it
- Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies.The journal of headache and pain · 2021Trial
- Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study.Cephalalgia : an international journal of headache · 2021Trial
- Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial.European journal of neurology · 2021Trial
- Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study.Neurology · 2020Trial
- Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.Cephalalgia : an international journal of headache · 2019Trial
- Tolerability of switch from erenumab to fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, real-world, observational study.The journal of headache and pain · 2025Observational
- Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study.Journal of neurology · 2023Observational
- A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Novel Migraine Treatments: A ReviewJournal of oral & facial pain and headache · 2023Review
- First Report of Symmetrical Drug-related Intertriginous and Flexural Exanthema (SDRIFE or Baboon Syndrome) After Erenumab Application for Migraine Prevention.Pain and therapy · 2022Article
- Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience.Journal of neurology · 2022Article
- Managing migraine on the frontline: Identifying disease, understanding burden, and incorporating CGRP pathway-targeting therapies in primary care.British journal of pain · 2022Article
- Cardiovascular Disease and Migraine: Are the New Treatments Safe?Current pain and headache reports · 2022Review
- Reducing the Burden of Migraine: Safety and Efficacy of CGRP Pathway-Targeted Preventive Treatments.Journal of clinical medicine · 2022Review
- Twelve-month safety, tolerability and susceptibility to adverse events of prophylactic migraine therapy with erenumab: a retrospective real-world study.The journal of headache and pain · 2022Article
- Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Migraine evolution after the cessation of CGRP(-receptor) antibody prophylaxis: a prospective, longitudinal cohort study.Cephalalgia : an international journal of headache · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreviously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab.
methodsInterim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs.
resultsOf 383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3%) remained in the study, all received 140 mg for ≥1 year. Median (Q1, Q3) exposure (70 or 140 mg) for all patients enrolled was 3.2 (1.3, 3.4) years. The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain. Exposure-adjusted serious adverse event rates were 4.2/100 patient-years. There was no increase in cardiovascular events over time.
conclusionsIn this long-term study of a CGRP-receptor antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of adverse events consistent with shorter-term placebo-controlled studies.
trial registrationClinicalTrials.gov NCT01952574.
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Registered trials
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.