{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T12:18:39Z","timestamp":1777119519537,"version":"3.51.4"},"reference-count":17,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T00:00:00Z","timestamp":1616630400000},"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"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess long\u2010term (up to 2\u00a0years) efficacy, tolerability, and safety of erenumab for the prevention of episodic migraine (EM) in Japanese patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Previously published results from the double\u2010blind treatment phase (DBTP) of a phase 2 clinical study have demonstrated the efficacy and safety of erenumab in Japanese patients with EM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients completing the 24\u2010week placebo\u2010controlled DBTP could continue into the 76\u2010week open\u2010label treatment phase (OLTP), receiving erenumab 70 mg or 140\u00a0mg subcutaneously once monthly. The initial dose in the OLTP was erenumab 70\u00a0mg monthly, which was later changed to 140\u00a0mg. After study completion, the following were assessed: change from baseline in monthly migraine days (MMD), change from baseline in monthly acute migraine\u2010specific medication days (MSMD), percentage of patients achieving \u226550% and \u226575% reduction in MMD, change from baseline in the 6\u2010item Headache Impact Test (HIT\u20106\u2122) score, and safety (exposure\u2010adjusted patient\u2010incidence of adverse events [AEs], calculated as number of patients per 100 patient\u2010years).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 475 patients enrolled in the DBTP, 459 (96.6%) continued in the OLTP. The mean (SD) MMD was 7.9 (2.3) at baseline with the overall change from baseline at week 100 of \u20132.9 (4.1) days. The monthly acute MSMD was 5.7 (2.8) at baseline with change from baseline at week 100 of \u22121.7 (3.7) days. The proportion of patients who achieved \u226550% and \u226575% reduction in MMD from baseline at week 100 was 177\/398 (44.5%) and 94\/398 (23.6%), respectively. The HIT\u20106\u2122 score was 58.4 (5.4) at baseline with a change of \u22126.4 (8.2) at week 100. The exposure\u2010adjusted patient\u2010incidence of AEs during the OLTP was 207.1\/100 patient\u2010years for the combined erenumab group, similar to that observed for either erenumab (271.0\/100 patient\u2010years) or placebo (257.3\/100 patient\u2010years) during the DBTP, and no new safety signals were detected during the OLTP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Long\u2010term erenumab treatment in Japanese patients with EM demonstrated sustained efficacy for up to 2\u00a0years, with a safety profile similar to previous studies, supporting erenumab as a potential new therapy for EM prevention in Japan.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14096","type":"journal-article","created":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T06:23:25Z","timestamp":1616653405000},"page":"653-661","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Long\u2010term efficacy and safety during open\u2010label erenumab treatment in Japanese patients with episodic migraine"],"prefix":"10.1111","volume":"61","author":[{"given":"Fumihiko","family":"Sakai","sequence":"first","affiliation":[{"name":"Neurology Saitama International Headache Center Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[{"name":"Headache Center, Department of Neurology Tominaga Hospital Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihisa","family":"Tatsuoka","sequence":"additional","affiliation":[{"name":"Department of Neurology Tatsuoka Neurology Clinic Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Hirata","sequence":"additional","affiliation":[{"name":"Department of Neurology Dokkyo Medical University Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunfa","family":"Cheng","sequence":"additional","affiliation":[{"name":"Global Development Amgen Inc. Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yotaro","family":"Numachi","sequence":"additional","affiliation":[{"name":"Research &amp; Development Amgen K.K. Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng","family":"Peng","sequence":"additional","affiliation":[{"name":"Global Biostatistical Science Amgen Inc. Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fei","family":"Xue","sequence":"additional","affiliation":[{"name":"Global Safety Amgen Inc. Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel D.","family":"Mikol","sequence":"additional","affiliation":[{"name":"Global Development Amgen Inc. Thousand Oaks CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,3,25]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1997.1701015.x"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419851855"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)00019-3"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418759786"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705848"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32534-0"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000004391"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419854082"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30083-2"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13652"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413485658"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1026119331193"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410379890"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413497599"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00506.x"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419888222"}],"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.14096","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.14096","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14096","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:54:21Z","timestamp":1762088061000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14096"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,25]]},"references-count":17,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1111\/head.14096"],"URL":"https:\/\/doi.org\/10.1111\/head.14096","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,25]]},"assertion":[{"value":"2020-09-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-25","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}