{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T15:59:40Z","timestamp":1787759980785,"version":"build-2784847793"},"reference-count":26,"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\/"}],"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 determine the efficacy and safety of fremanezumab administration in Japanese and Korean patients with chronic migraine (CM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Available preventive treatments for CM are limited by various efficacy and safety issues. Fremanezumab, a monoclonal antibody that targets the calcitonin gene\u2010related peptide pathway involved in migraine pathogenesis, has been shown to be effective and well tolerated in large\u2010scale, international Phase 3 trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Randomized, placebo\u2010controlled trial of patients with CM who received subcutaneous fremanezumab monthly (675\u00a0mg at baseline and 225\u00a0mg at weeks 4 and 8), fremanezumab quarterly (675\u00a0mg at baseline and placebo at weeks 4 and 8), or matching placebo. Primary endpoint was the mean change from baseline in the monthly (28\u2010day) average number of headache days of at least moderate severity during the 12\u00a0weeks after the first dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 571 patients randomized (safety set,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0569; full analysis set,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0566), the least\u2010squares mean (\u00b1standard error [SE]) reduction in the average number of headache days of at least moderate severity per month during 12\u00a0weeks was significantly greater with fremanezumab monthly (\u20134.1\u00a0\u00b1\u00a00.4) and fremanezumab quarterly (\u20134.1\u00a0\u00b1\u00a00.4) than with placebo (\u20132.4\u00a0\u00b1\u00a00.4). The difference from the placebo group in the mean change (95% confidence interval [CI]) was \u22121.7\u00a0days (\u22122.54, \u22120.80) for the fremanezumab monthly group and \u22121.7\u00a0days (\u22122.55, \u22120.82) for the fremanezumab quarterly group (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001 vs. placebo for both fremanezumab groups). The percentage of patients with a \u226550% reduction in the average number of headache days of at least moderate severity per month (response rate) was higher with fremanezumab monthly (29.0%) and fremanezumab quarterly (29.1%) than with placebo (13.2%) in addition to other improvements in secondary endpoints, including reduction of acute medication use (mean change from baseline during 12\u2010week period\u00a0\u00b1\u00a0SE: fremanezumab monthly, \u20133.7\u00a0\u00b1\u00a00.4; fremanezumab quarterly, \u20133.9\u00a0\u00b1\u00a00.4; placebo, \u20132.4\u00a0\u00b1\u00a00.4) and improvements in disability scores (mean change from baseline in six\u2010item Headache Impact Test\u00a0score at 4\u00a0weeks after third injection\u00a0\u00b1\u00a0SE: fremanezumab monthly, \u20138.1\u00a0\u00b1\u00a00.7; fremanezumab quarterly, \u20138.0\u00a0\u00b1\u00a00.7; placebo, \u20136.5\u00a0\u00b1\u00a00.7). Fremanezumab was well tolerated with a similar incidence of adverse events including injection\u2010site reactions as placebo (patients with at least one treatment\u2010emergent adverse event: fremanezumab total,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0232 [61.4%]; placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0118 [61.8%]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Fremanezumab effectively prevents CM in Japanese and Korean patients and was well tolerated. No safety signal was detected.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14169","type":"journal-article","created":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T14:34:33Z","timestamp":1627569273000},"page":"1092-1101","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":66,"title":["Efficacy and safety of fremanezumab for chronic 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":"Hisaka","family":"Igarashi","sequence":"additional","affiliation":[{"name":"Headache Care Unit Department of Internal Medicine Fujitsu Clinic Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Hirata","sequence":"additional","affiliation":[{"name":"Headache Center Department of Neurology Dokkyo Medical University Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2678-6956","authenticated-orcid":false,"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[{"name":"Headache Center Department of Neurology Tominaga Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Specialty Clinical Development, Teva Branded Pharmaceutical Products R&amp;D, Inc. 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