{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T23:59:47Z","timestamp":1788998387561,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T00:00:00Z","timestamp":1627516800000},"content-version":"vor","delay-in-days":28,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of two dosing regimens of fremanezumab in Japanese and Korean patients with episodic migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Episodic migraine, which accounts for more than 90% of migraine cases, is inadequately addressed by widely available preventive therapies. Fremanezumab, a monoclonal antibody that selectively targets the trigeminal sensory neuropeptide calcitonin gene\u2010related peptide involved in migraine pathogenesis, has demonstrated efficacy in international Phase 3 trials of patients with both chronic and episodic migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This Phase 3 randomized, placebo\u2010controlled trial randomly assigned patients with episodic migraine to receive subcutaneous fremanezumab monthly (225 mg at baseline, week 4, and week 8), fremanezumab quarterly (675\u00a0mg at baseline and placebo at weeks 4 and 8), or matching placebo. The primary endpoint was the mean change from baseline in the monthly average number of migraine days during the 12\u2010week treatment period after the first dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 357 patients enrolled (safety set,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0356; full analysis set,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0354), the least\u2010squares mean (\u00b1standard error) reductions in the average number of migraine days per month during 12\u00a0weeks were significantly greater with fremanezumab monthly (\u22124.0\u00a0\u00b1\u00a00.4,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0121) and fremanezumab quarterly (\u22124.0\u00a0\u00b1\u00a00.4,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0117) than with placebo (\u22121.0\u00a0\u00b1\u00a00.4,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0116;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.0001 for both comparisons). The proportion of patients reaching at least a 50% reduction in the monthly average number of migraine days during the 12\u2010week period after initial administration was also significantly improved with fremanezumab (fremanezumab monthly, 41.3%; fremanezumab quarterly, 45.3%; placebo, 11.2%;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.0001 for both comparisons) as were other secondary endpoints (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001 for all comparisons between fremanezumab and placebo). Injection\u2010site reactions were more common in fremanezumab\u2010treated patients (fremanezumab monthly, 25.6%; fremanezumab quarterly, 29.7%; placebo, 21.4%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Fremanezumab prevents episodic migraine in Japanese and Korean patients to a similar extent than in previously reported populations with no new safety concerns.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14178","type":"journal-article","created":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T07:53:41Z","timestamp":1627545221000},"page":"1102-1111","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":82,"title":["Efficacy and safety of fremanezumab for episodic migraine prevention: Multicenter, randomized, double\u2010blind, placebo\u2010controlled, parallel\u2010group trial in Japanese and Korean patients"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9385-7991","authenticated-orcid":false,"given":"Fumihiko","family":"Sakai","sequence":"first","affiliation":[{"name":"Saitama International Headache Center Saitama Neuropsychiatric Institute Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0399-6590","authenticated-orcid":false,"given":"Norihiro","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Neurology Shonan Keiiku Hospital Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1053-4682","authenticated-orcid":false,"given":"Byung\u2010Kun","family":"Kim","sequence":"additional","affiliation":[{"name":"Nowon Eulji Medical Center Eulji University School of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihisa","family":"Tatsuoka","sequence":"additional","affiliation":[{"name":"Department of Neurology Tatsuoka Neurology Clinic Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8745-0391","authenticated-orcid":false,"given":"Noboru","family":"Imai","sequence":"additional","affiliation":[{"name":"Department of Neurology Japanese Red Cross Shizuoka Hospital Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc. West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Ishida","sequence":"additional","affiliation":[{"name":"Specialty Clinical Development Teva Branded Pharmaceutical Products R&amp;D, Inc. West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaori","family":"Nagano","sequence":"additional","affiliation":[{"name":"Headquarters of Clinical Development Otsuka Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuhiro","family":"Iba","sequence":"additional","affiliation":[{"name":"Specialty Clinical Development Teva Branded Pharmaceutical Products R&amp;D, Inc. West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Kondo","sequence":"additional","affiliation":[{"name":"Medical Affairs Otsuka Pharmaceutical Co., Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8034-7984","authenticated-orcid":false,"given":"Nobuyuki","family":"Koga","sequence":"additional","affiliation":[{"name":"Medical Affairs Otsuka Pharmaceutical Co., Ltd. Tokushima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,7,29]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12878"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-011-0233-z"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1129-2377-15-68"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419835465"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13157"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102414547138"},{"key":"e_1_2_13_9_1","first-page":"17","article-title":"Migraine headache prophylaxis","volume":"99","author":"Ha H","year":"2019","journal-title":"Am Fam Physician"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1012-1"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0003-1"},{"key":"e_1_2_13_12_1","first-page":"938","article-title":"Therapeutic effects and safety of olcegepant and telcagepant for migraine: a meta\u2010analysis","volume":"8","author":"Yao G","year":"2013","journal-title":"Neural Regen Res"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-018-0955-y"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002801"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00245-8"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31946-4"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418772585"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709038"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000544321.19316.40"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.4853"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000010600"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418771376"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413485658"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102411417901"},{"key":"e_1_2_13_25_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.56.suppl_1.S20"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychires.2010.04.025"}],"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.14178","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.14178","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14178","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T10:00:41Z","timestamp":1762077641000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14178"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7]]},"references-count":25,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["10.1111\/head.14178"],"URL":"https:\/\/doi.org\/10.1111\/head.14178","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7]]},"assertion":[{"value":"2021-02-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}