{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T09:32:48Z","timestamp":1788255168739,"version":"build-2803163510"},"reference-count":21,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,6,21]],"date-time":"2021-06-21T00:00:00Z","timestamp":1624233600000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Erenumab is a human anti\u2010calcitonin gene\u2010related peptide receptor monoclonal antibody approved for migraine prevention. Global studies have demonstrated its efficacy in chronic and episodic migraine (EM). Here we report the outcomes from a Phase 3 study of erenumab in Japanese patients with chronic migraine (CM) or EM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Japanese patients with EM (&lt;15 headache days\/month, including \u22654 migraine days\/month) or CM (\u226515 headache days\/month, including \u22658 migraine days\/month) were randomized 1:1 to placebo or erenumab 70\u00a0mg once monthly for a 24\u2010week double\u2010blind treatment phase (DBTP). The primary endpoint of change from baseline in mean monthly migraine days (MMD) over months 4, 5, and 6 of the DBTP was compared between erenumab and placebo groups. Secondary efficacy and safety endpoints were also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 261 patients were randomized to placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0131) or erenumab 70\u00a0mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0130); all patients were included in the efficacy and safety analyses. The mean (standard deviation) MMD at baseline was 11.84 (5.70) for the placebo group and 12.40 (5.99) for erenumab 70\u00a0mg. The mean (standard error) change in MMD was \u20131.98 (0.38) for the placebo group (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0131) and \u20133.60 (0.38) for erenumab 70\u00a0mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0130). The difference in MMD reduction between groups was \u22121.67 (95% CI: \u20132.56, \u20130.78,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001) for EM and \u20131.57 (95% CI: \u20133.39, 0.24,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.089) for CM. Adverse events (AEs) were consistent with earlier studies. The most frequent AEs (placebo, erenumab) were nasopharyngitis (28.2% and 26.9%, respectively), back pain (4.6% and 5.4%), and constipation (0.8% and 4.6%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Treatment with erenumab 70\u00a0mg once monthly demonstrated favorable efficacy and safety findings in Japanese patients with EM or CM.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14138","type":"journal-article","created":{"date-parts":[[2021,6,21]],"date-time":"2021-06-21T12:13:01Z","timestamp":1624277581000},"page":"927-935","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":72,"title":["Erenumab treatment for migraine prevention in Japanese patients: Efficacy and safety results from a Phase 3, randomized, double\u2010blind, placebo\u2010controlled study"],"prefix":"10.1111","volume":"61","author":[{"given":"Takao","family":"Takeshima","sequence":"first","affiliation":[{"name":"Headache Center Department of Neurology Tominaga Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihiko","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Neurology Saitama International Headache Center Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Hirata","sequence":"additional","affiliation":[{"name":"Headache Center Dokkyo Medical University Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noboru","family":"Imai","sequence":"additional","affiliation":[{"name":"Department of Neurology Japanese Red Cross Shizuoka Hospital Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Matsumori","sequence":"additional","affiliation":[{"name":"Sendai Headache and Neurology Clinic Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuji","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Research &amp; Development Amgen K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Peng","sequence":"additional","affiliation":[{"name":"Global Biostatistical Science Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunfa","family":"Cheng","sequence":"additional","affiliation":[{"name":"Global Development Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel D.","family":"Mikol","sequence":"additional","affiliation":[{"name":"Global Development Amgen Inc. Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,6,21]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252808.97649.21"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1997.1701015.x"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1012-1"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419851855"},{"key":"e_1_2_13_7_1","volume-title":"Aimovig (erenumab\u2010aooe)","year":"2020"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.115.227793"},{"key":"e_1_2_13_9_1","volume-title":"Aimovig (erenumab)","year":"2018"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418759786"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705848"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00019-3"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30083-2"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13652"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_13_16_1","volume-title":"Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0","author":"National Cancer Institute","year":"2010"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2009.01481.x"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14096"},{"key":"e_1_2_13_19_1","volume-title":"Ajovy (fremanezumab\u2010vfrm)","year":"2018"},{"key":"e_1_2_13_20_1","volume-title":"Emgality (galcanezumab\u2010gnlm)","year":"2019"},{"issue":"1","key":"e_1_2_13_21_1","article-title":"Sustained efficacy and long\u2010term safety of erenumab in patients with episodic migraine: 4+ year results of a 5\u2010year, open\u2010label extension study [abstract IOR10]","volume":"59","author":"Ashina M","year":"2019","journal-title":"Headache"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420912726"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14138","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.14138","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14138","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:57:35Z","timestamp":1762088255000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":21,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1111\/head.14138"],"URL":"https:\/\/doi.org\/10.1111\/head.14138","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6]]},"assertion":[{"value":"2021-02-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-21","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}