{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:03:07Z","timestamp":1762084987607,"version":"build-2065373602"},"reference-count":22,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T00:00:00Z","timestamp":1683072000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate, at population and individual patient levels, the sustained response of reduction in migraine headache days in patients with migraine treated with galcanezumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a post hoc analysis of double\u2010blind galcanezumab studies in patients with migraine: two 6\u2010month episodic migraine (EM; EVOLVE\u20101\/EVOLVE\u20102), one 3\u2010month chronic migraine (CM; REGAIN), and one 3\u2010month treatment\u2010resistant migraine (CONQUER). Patients received monthly subcutaneous galcanezumab 120\u2009mg (after 240\u2009mg initial loading dose), galcanezumab 240\u2009mg, or placebo. In the EM and CM studies, the proportions of patients with \u226550% and \u226575% (EM only) reduction from baseline in average monthly migraine headache days from Months 1 to 3 and Months 4 to 6 were evaluated. A mean monthly response rate was estimated. The sustained effect was defined as maintaining \u226550% response for \u22653\u2009consecutive months in the patient\u2010level data for EM and CM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 3348 patients with EM or CM from the EVOLVE\u20101\/EVOLVE\u20102 (placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009894, galcanezumab,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009879), REGAIN (placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009558, galcanezumab,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009555), and CONQUER (EM: placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009132, galcanezumab,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009137; CM: placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200998, galcanezumab,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200995) studies were included. Patients were predominantly female, White, and had monthly migraine headache day averages ranging from 9.1 to 9.5\u2009days (EM) and 18.1 to 19.6\u2009days (CM). In patients with EM and CM, 19.0% and 22.6% of galcanezumab\u2010treated patients, respectively, had significantly higher maintenance of \u226550% response for all months in the double\u2010blind period compared to 8.0% and 1.5% of placebo\u2010treated patients. The odds ratios (OR) of achieving clinical response for EM and CM were double with galcanezumab (OR\u2009=\u20093.0 [95% CI 1.8, 4.8] and OR\u2009=\u20096.3 [95% CI 1.7, 22.7], respectively). At the individual patient level, of patients who had \u226575% response at Month 3 in the galcanezumab 120 and 240\u2009mg dose groups and placebo group, 39.9% (55\/138) and 43.0% (61\/142), respectively, of galcanezumab\u2010treated patients maintained \u226575% response during Months 4\u20136 compared to 32.7% (51\/156) with placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>More galcanezumab\u2010treated patients achieved \u226550% response within the first 3\u2009months of treatment compared to placebo; responses were sustained during Months 4\u20136. The odds of achieving \u226550% response were double with galcanezumab.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14494","type":"journal-article","created":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T06:20:24Z","timestamp":1683094824000},"page":"1380-1390","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Sustained response of galcanezumab in migraine prevention: Patient\u2010level data from a post hoc analysis in patients with episodic or chronic migraine"],"prefix":"10.1111","volume":"63","author":[{"given":"Stewart J.","family":"Tepper","sequence":"first","affiliation":[{"name":"Geisel School of Medicine at Dartmouth  Hanover New Hampshire USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Dong","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, and\/or one of its subsidiaries  Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5855-6069","authenticated-orcid":false,"given":"Maurice","family":"Vincent","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, and\/or one of its subsidiaries  Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda A.","family":"Wietecha","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, and\/or one of its subsidiaries  Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,5,3]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13281"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14024"},{"volume-title":"Prescribing Information: Emgality (Galcanezumab)","year":"2019","author":"FDA Labelling Packaging 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