{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T19:10:12Z","timestamp":1776798612140,"version":"3.51.2"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,9,18]],"date-time":"2021-09-18T00:00:00Z","timestamp":1631923200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,9,18]],"date-time":"2021-09-18T00:00:00Z","timestamp":1631923200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"amgen k.k"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Headache Pain"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>These subgroup analyses of a Phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of erenumab 70\u2009mg in Japanese migraine patients with\/without prior preventive treatment failure(s) (\u201cfailed-yes\u201d and \u201cfailed-no\u201d subgroups) and with\/without concomitant preventive treatment (\u201cconcomitant preventive-yes\u201d and \u201cconcomitant preventive-no\u201d subgroups).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Overall, 261 patients were randomized; 130 and 131 patients to erenumab 70\u2009mg and placebo, respectively. Subgroup analyses evaluated the change from baseline to Months 4\u20136 in mean monthly migraine days (MMD) (primary endpoint), achievement of a\u2009\u226550% reduction in mean MMD, and change from baseline in mean monthly acute migraine-specific medication (MSM) treatment days. Treatment-emergent adverse events were also evaluated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of the 261 patients randomized, 117 (44.8%) and 92 (35.3%) patients were in the failed-yes and concomitant preventive-yes subgroups, respectively. Erenumab 70\u2009mg demonstrated consistent efficacy across all subgroups, with greater reductions from baseline in mean MMD versus placebo at Months 4\u20136 (treatment difference versus placebo [95% CI], failed-yes: \u2212\u20091.9 [\u2212\u20093.3, \u2212\u20090.4]; failed-no: \u2212\u20091.4 [\u2212\u20092.6, \u2212\u20090.3]; concomitant preventive-yes: \u2212\u20091.7 [\u2212\u20093.3, 0.0]; concomitant preventive-no: \u2212\u20091.6 [\u2212\u20092.6, \u2212\u20090.5]). Similar results were seen for achievement of \u226550% reduction in mean MMD and change from baseline in mean monthly acute MSM treatment days. The safety profile of erenumab 70\u2009mg was similar across subgroups, and similar to placebo in each subgroup.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Erenumab was associated with clinically relevant improvements in all efficacy endpoints and was well tolerated across all subgroups of Japanese migraine patients with\/without prior preventive treatment failure(s) and with\/without concomitant preventive treatment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link>. NCT03812224. Registered January 23, 2019.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s10194-021-01313-8","type":"journal-article","created":{"date-parts":[[2021,9,18]],"date-time":"2021-09-18T20:02:49Z","timestamp":1631995369000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Koichi","family":"Hirata","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumihiko","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noboru","family":"Imai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhiko","family":"Matsumori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryuji","family":"Yoshida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yotaro","family":"Numachi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng","family":"Peng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel D.","family":"Mikol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunfa","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,9,18]]},"reference":[{"key":"1313_CR1","doi-asserted-by":"crossref","unstructured":"Lipton RB, Hamelsky SW, Kolodner KB, Steiner TJ, Stewart WF (2001) Migraine, quality of life, and depression: a population-based case-control study. 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The article has been updated to rectify this.","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study protocol was approved by the ethics committee or institutional review board at each clinical site, and all patients provided a signed informed consent before the start of any study-related procedures. The study was conducted in accordance with the International Council for Harmonisation Good Clinical Practice Guideline and conforms to the provisions of the Declaration of Helsinki. All authors were given access to the study data.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"KH: grants from the Ministry of Health, Labor and Welfare, grants from The Japan Agency for Medical Research and Development, and nonfinancial support from Alexion Pharmaceuticals, Inc. FS: membership of advisory boards for Amgen, Eli Lilly and Company, and Teva Pharmaceuticals. SC, CP, RY, YN, DDM: employees and stockholders of Amgen. NI, TT, YM: these authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"110"}}