PMID- 33400330 OWN - NLM STAT- MEDLINE DCOM- 20210812 LR - 20210812 IS - 1468-1331 (Electronic) IS - 1351-5101 (Print) IS - 1351-5101 (Linking) VI - 28 IP - 5 DP - 2021 May TI - Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. PG - 1716-1725 LID - 10.1111/ene.14715 [doi] AB - BACKGROUND AND PURPOSE: Although erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3 to 12 months, little is known about long-term therapy. METHODS: This study was an open-label, 5-year treatment phase following a 12-week, double-blind, placebo-controlled trial in adults with episodic migraine. Patients initially received open-label erenumab 70 mg, which increased to 140 mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMDs), monthly acute migraine-specific medication (AMSM) days, and health-related quality of life. RESULTS: Of 383 patients enrolled, 250 switched to 140 mg; 215 (56.1%) completed open-label treatment. Mean (standard error) change in MMDs from baseline of 8.7 (0.2) days was -5.3 (0.3) days; an average reduction of 62.3% at year 5. Among patients using AMSM at baseline (6.3 [2.8] treatment days), mean change in monthly AMSM days was -4.4 (0.3) days at the end of 5 years. Patient-reported outcomes indicated stable improvements in disability, headache impact, and migraine-specific quality of life. Exposure-adjusted patient incidence rates of adverse events (AEs) were 123.0/100 patient-years; AEs were most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs (SAEs) reported by 49 patients (3.8/100 patient-years) were mostly single occurrence. Two fatal adverse events were reported. There were no increases in incidence of AEs, SAEs, or AEs leading to treatment discontinuation over 5 years of exposure. CONCLUSIONS: Treatment with erenumab was associated with reductions in migraine frequency and improvements in health-related quality of life that were maintained for at least 5 years. No new safety signals were observed. CI - (c) 2021 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology. FAU - Ashina, Messoud AU - Ashina M AD - Department of Neurology, Danish Headache Center, Faculty of Health and Medical Sciences, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark. FAU - Goadsby, Peter J AU - Goadsby PJ AUID- ORCID: 0000-0003-3260-5904 AD - NIHR/Wellcome Trust King's Clinical Research Facility, King's College London, London, UK. AD - Department of Neurology, University of California, Los Angeles, CA, USA. FAU - Reuter, Uwe AU - Reuter U AD - Department of Neurology, Charite-Universitatsmedizin Berlin, Berlin, Germany. FAU - Silberstein, Stephen AU - Silberstein S AD - Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA. FAU - Dodick, David W AU - Dodick DW AD - Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA. FAU - Xue, Fei AU - Xue F AD - Amgen Inc., Thousand Oaks, CA, USA. FAU - Zhang, Feng AU - Zhang F AD - Amgen Inc., Thousand Oaks, CA, USA. FAU - Paiva da Silva Lima, Gabriel AU - Paiva da Silva Lima G AD - Amgen Inc., Thousand Oaks, CA, USA. FAU - Cheng, Sunfa AU - Cheng S AD - Amgen Inc., Thousand Oaks, CA, USA. FAU - Mikol, Daniel D AU - Mikol DD AD - Amgen Inc., Thousand Oaks, CA, USA. LA - eng SI - ClinicalTrials.gov/NCT01952574 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210120 PL - England TA - Eur J Neurol JT - European journal of neurology JID - 9506311 RN - 0 (Antibodies, Monoclonal, Humanized) RN - I5I8VB78VT (erenumab) SB - IM CIN - Eur J Neurol. 2021 May;28(5):1439-1440. PMID: 33576558 MH - Adult MH - Antibodies, Monoclonal, Humanized MH - Double-Blind Method MH - Humans MH - *Migraine Disorders/prevention & control MH - *Quality of Life MH - Treatment Outcome PMC - PMC8248354 OTO - NOTNLM OT - CGRP receptor OT - efficacy OT - headache OT - headache frequency OT - monoclonal antibody COIS- Messoud Ashina has received personal fees from Alder BioPharmaceuticals, Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva Pharmaceuticals. He is currently a principal investigator on clinical trials for Allergan, Amgen, Eli Lilly, Lundbeck, and Novartis. Messoud Ashina has no ownership interest and does not own stocks of any pharmaceutical company. He also serves as an Associate Editor of Cephalalgia, Associate Editor of Headache, and Associate Editor of the Journal of Headache and Pain. Messoud Ashina reports research grants from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis. Peter J. Goadsby reports consulting fees, speaking/teaching fees, and/or research grants from Alder BioPharmaceuticals, Allergan, Amgen, Autonomic Technologies, Celgene, Clexio, electroCore, Eli Lilly, eNeura, Epalex, Impel, Mundipharma, Journal Watch, Massachusetts Medical Society, Medico-Legal Journal, Novartis, Oxford University Press, Pfizer, Teva Pharmaceuticals, Trigemina, Inc., UpToDate, WL Gore, and Wolters Kluwer. Uwe Reuter reports consulting fees, speaking/teaching fees, and/or research grants from Allergan, Amgen, Autonomic Technologies, CoLucid, electroCore, Novartis, Pharm Allergan, Eli Lilly, and Teva Pharmaceuticals. Stephen Silberstein reports consultant and/or advisory panel member for and/or honoraria from Alder, Allergan, Amgen, Avanir, Dr. Reddy's, eNeura, electroCore Medical, Medscape, Medtronic, Mitsubishi Tanabe Pharma America, NINDS, Supernus, Trigemina, and Teva Pharmaceuticals. David W. Dodick reports the following conflicts within the past 12 months: Consulting: Aeon, Amgen, Clexio, Cerecin, Allergan, Alder, Biohaven, Linpharma, Promius, Eli Lilly, eNeura, Novartis, Impel, Theranica, WL Gore, Nocira, Xoc, Zosano, Upjohn (Division of Pfizer), Pieris, Revance, and Equinox. Honoraria: CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Majallin LLC, MedLogix Communications, Miller Medical Communications, Southern Headache Society (MAHEC), WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, and Cambridge University Press. Research Support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, and Patient-Centered Outcomes Research Institute (PCORI). Stock Options/Shareholder/Patents/Board of Directors: Aural Analytics (options), ExSano (options), Palion (options), Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options/board), Nocira (options), Ontologics (options/board), King-Devick Technologies (options/board), Precon Health (options/board). Patent 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis. Fei Xue, Feng Zhang, Gabriel Paiva da Silva Lima, Sunfa Cheng, and Daniel D Mikol are employees of and stockholders in Amgen Inc. EDAT- 2021/01/06 06:00 MHDA- 2021/08/13 06:00 PMCR- 2021/07/01 CRDT- 2021/01/05 12:19 PHST- 2020/12/21 00:00 [revised] PHST- 2020/11/15 00:00 [received] PHST- 2021/01/01 00:00 [accepted] PHST- 2021/01/06 06:00 [pubmed] PHST- 2021/08/13 06:00 [medline] PHST- 2021/01/05 12:19 [entrez] PHST- 2021/07/01 00:00 [pmc-release] AID - ENE14715 [pii] AID - 10.1111/ene.14715 [doi] PST - ppublish SO - Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.