{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T18:31:59Z","timestamp":1793039519613,"version":"4.5.0"},"reference-count":28,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,1,20]],"date-time":"2021-01-20T00:00:00Z","timestamp":1611100800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000042","name":"Amgen Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000042","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Euro J of Neurology"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and purpose<\/jats:title><jats:p>Although erenumab has demonstrated significant reduction in migraine frequency and improved quality of life in studies lasting 3 to 12\u00a0months, little is known about long\u2010term therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This study was an open\u2010label, 5\u2010year treatment phase following a 12\u2010week, double\u2010blind, placebo\u2010controlled trial in adults with episodic migraine. Patients initially received open\u2010label erenumab 70\u00a0mg, which increased to 140\u00a0mg following a protocol amendment. Efficacy analyses included change from baseline in monthly migraine days (MMDs), monthly acute migraine\u2010specific medication (AMSM) days, and health\u2010related quality of life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 383 patients enrolled, 250 switched to 140\u00a0mg; 215 (56.1%) completed open\u2010label treatment. Mean (standard error) change in MMDs from baseline of 8.7 (0.2) days was \u22125.3 (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 \u22124.4 (0.3) days at the end of 5\u00a0years. Patient\u2010reported outcomes indicated stable improvements in disability, headache impact, and migraine\u2010specific quality of life. Exposure\u2010adjusted patient incidence rates of adverse events (AEs) were 123.0\/100 patient\u2010years; AEs were most frequently nasopharyngitis, upper respiratory tract infection, and influenza. Serious AEs (SAEs) reported by 49 patients (3.8\/100 patient\u2010years) 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\u00a0years of exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Treatment with erenumab was associated with reductions in migraine frequency and improvements in health\u2010related quality of life that were maintained for at least 5\u00a0years. No new safety signals were observed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.14715","type":"journal-article","created":{"date-parts":[[2021,1,6]],"date-time":"2021-01-06T06:35:33Z","timestamp":1609914933000},"page":"1716-1725","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":160,"title":["Long\u2010term efficacy and safety of erenumab in migraine prevention: Results from a 5\u2010year, open\u2010label treatment phase of a randomized clinical trial"],"prefix":"10.1111","volume":"28","author":[{"given":"Messoud","family":"Ashina","sequence":"first","affiliation":[{"name":"Department of Neurology Danish Headache Center Faculty of Health and Medical Sciences Rigshospitalet Glostrup University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3260-5904","authenticated-orcid":false,"given":"Peter J.","family":"Goadsby","sequence":"additional","affiliation":[{"name":"NIHR\/Wellcome Trust King's Clinical Research Facility King's College London London UK"},{"name":"Department of Neurology University of California Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Reuter","sequence":"additional","affiliation":[{"name":"Department of Neurology Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Silberstein","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center Thomas Jefferson University Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David W.","family":"Dodick","sequence":"additional","affiliation":[{"name":"Department of Neurology Mayo Clinic Scottsdale AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fei","family":"Xue","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Paiva da Silva Lima","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunfa","family":"Cheng","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel D.","family":"Mikol","sequence":"additional","affiliation":[{"name":"Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,1,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418821662"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418759786"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705848"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32534-0"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00019-3"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30083-2"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007452"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13652"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000004391"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419854082"},{"issue":"1","key":"e_1_2_10_12_1","first-page":"1","article-title":"The international classification of headache disorders (second edition)","volume":"24","author":"Headache Classification Subcommittee of The International Headache Society","year":"2004","journal-title":"Cephalalgia"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1185\/030079901753403207"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026119331193"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410379890"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.2165\/00019053-199813060-00007"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.1998.3804295.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2009.01852.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.56.suppl_1.S20"},{"key":"e_1_2_10_20_1","volume-title":"How much change in headache\u2010related disability is clinically meaningful? Estimating minimally important difference (MID) or change in MIDAS using data from the AMPP Study [abstract]","author":"Lipton R","year":"2017"},{"key":"e_1_2_10_21_1","unstructured":"Maintenance and Support Services Organization (MSSO).Medical Dictionary for Regulatory Activities (MedDRA\u00ae) Introductory Guide MedDRA Version 22.1. A registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Vol MSSO\u2010DI\u20106003\u2010221.2019."},{"key":"e_1_2_10_22_1","unstructured":"US Department of Health and Human Services.Common Terminology Criteria for Adverse Events (CTCAE). Version 4.03 ed.https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03\/CTCAE_4.03_2010\u201006\u201014_QuickReference_5x7.pdf.2010. Accessed July 24 2020."},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419888222"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.100.4.354"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.103.9.1245"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1136\/pgmj.2006.048371"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00506.x"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.61.4.490"}],"container-title":["European Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.14715","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ene.14715","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.14715","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T19:22:14Z","timestamp":1693336934000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ene.14715"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,20]]},"references-count":28,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2021,5]]}},"alternative-id":["10.1111\/ene.14715"],"URL":"https:\/\/doi.org\/10.1111\/ene.14715","archive":["Portico"],"relation":{},"ISSN":["1351-5101","1468-1331"],"issn-type":[{"value":"1351-5101","type":"print"},{"value":"1468-1331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,20]]},"assertion":[{"value":"2020-11-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-01","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}