{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T04:47:58Z","timestamp":1789274878725,"version":"build-2803163510"},"reference-count":34,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T00:00:00Z","timestamp":1628553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006259","name":"Teva Pharmaceutical Industries","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006259","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Migraine is associated with depression as well as negative impact on quality of life and work productivity. Fremanezumab, a fully humanized monoclonal antibody (IgG2\u0394a), selectively targets the calcitonin gene\u2010related peptide and has proven efficacy for the preventive treatment of migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>In this open\u2010label extension (OLE) of the phase 3b FOCUS study, we assessed patient\u2010reported outcomes (PROs) over time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients with episodic migraine (EM) and chronic migraine (CM) completing the 12\u2010week, double\u2010blind (DB) period of the FOCUS trial entered the 12\u2010week OLE and received three monthly doses of fremanezumab (225\u00a0mg). PROs included the Migraine\u2010Specific Quality of Life (MSQoL) questionnaire (role function\u2014restrictive [RFR], role function\u2014preventive [RFP], and emotional function [EF] domains), EuroQol\u20105\u2010Dimension\u20105\u2010Level (EQ\u20105D\u20105L) questionnaire, Patient Global Impression of Change (PGIC) assessment, Work Productivity and Activity Impairment (WPAI) questionnaire, and 9\u2010Item Patient Health Questionnaire (PHQ\u20109).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 838 patients were randomized in the DB period, 807 entered the OLE at 3\u00a0months, and 772 were still enrolled at 6\u00a0months. At 6\u00a0months, patients in the quarterly fremanezumab, monthly fremanezumab, and placebo DB randomization groups, respectively, reported improvements in RFR (mean [standard deviation] change from baseline: 24.6 [21.9]; 22.9 [21.3]; 20.8 [26.5]), RFP (19.6 [20.0]; 18.3 [19.7]; 16.0 [19.9]), and EF (22.5 [24.2]; 19.1 [23.6]; 17.2 [24.7]) domains of the MSQoL questionnaire, the EQ\u20105D\u20105L questionnaire (8.0 [19.6]; 7.3 [21.1]; 6.6 [21.0]), all four domains of the WPAI questionnaire, and the PHQ\u20109 (\u22122.4 [5.3]; \u22121.6 [5.5]; \u22122.0 [4.9]); 77.1% (209\/271), 75.4% (205\/272), and 68.8% (181\/263) of patients were identified as PGIC responders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Among patients with EM or CM and prior inadequate response to multiple migraine\u2010preventive medication classes, progressive improvements in MSQoL, depression, and work productivity were achieved during 6\u00a0months of fremanezumab treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14196","type":"journal-article","created":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T04:26:22Z","timestamp":1628569582000},"page":"1376-1386","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Improvements in quality of life and work productivity with up to 6\u00a0months of fremanezumab treatment in patients with episodic and chronic migraine and documented inadequate response to 2 to 4 classes of migraine\u2010preventive medications in the phase 3b FOCUS study"],"prefix":"10.1111","volume":"61","author":[{"given":"Egilius L. 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West Chester PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn C.","family":"Buse","sequence":"additional","affiliation":[{"name":"Department of Neurology Albert Einstein College of Medicine New York NY 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