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In this subgroup analysis from the CONQUER study, we report efficacy outcomes from a pre-specified analysis of galcanezumab versus placebo in patients with CM or EM and 3\u20134 prior preventive medication category failures due to inadequate efficacy (after at least 2\u2009months at maximum tolerated dose), or safety or tolerability reasons. The patient population is of particular interest due to evidence of decreased quality of life and increased economic burden among patients with migraine that is inadequately managed and is of interest to decision-makers globally.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Key outcomes included overall mean change from baseline in monthly migraine headache days and proportions of patients achieving \u226530% (CM), \u226550%, and\u2009\u2265\u200975% reduction (response rates) in monthly migraine headache days across Months 1\u20133. Patient functioning and disability were evaluated at Month 3.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of the 462 randomized patients, 186 (40.3%) had a history of 3\u20134 preventive category failures. Galcanezumab versus placebo resulted in significantly (<jats:italic>P<\/jats:italic>\u2009\u2264\u2009.001) larger overall mean reduction in monthly migraine headache days (total: \u2212\u20095.49 versus \u2212\u20091.03; CM: \u2212\u20096.70 versus \u2212\u20091.56; EM: \u2212\u20093.64 versus \u2212\u20090.65). Similarly, the \u226550% response rate was significantly (<jats:italic>P<\/jats:italic>\u2009\u2264\u2009.001) higher with galcanezumab versus placebo (total: 41.0 versus 12.7; CM: 41.5 versus 8.4; EM: 41.1 versus 16.5). In the CM group, the \u226530% response rate was significantly higher in the galcanezumab group than the placebo group (CM, 57.5 versus 19.8, <jats:italic>P<\/jats:italic>\u2009\u2264\u2009.0001) as was the \u226575% response rate (13.3 versus 2.6, <jats:italic>P<\/jats:italic>\u2009\u2264\u2009.05). Galcanezumab also resulted in significant (<jats:italic>P<\/jats:italic>\u2009&lt;\u2009.0001) improvements in patient functioning and reductions in disability.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Galcanezumab was effective in a difficult-to-treat population of patients with CM or EM who had failed 3\u20134 prior preventive medication categories.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>CONQUER. Clinicaltrials.gov identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03559257\">NCT03559257<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s10194-021-01322-7","type":"journal-article","created":{"date-parts":[[2021,9,30]],"date-time":"2021-09-30T05:03:54Z","timestamp":1632978234000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Efficacy of galcanezumab in patients with migraine and history of failure to 3\u20134 preventive medication categories: subgroup analysis from CONQUER study"],"prefix":"10.1186","volume":"22","author":[{"given":"Rose","family":"Okonkwo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antje","family":"Tockhorn-Heidenreich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chad","family":"Stroud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Ange","family":"Paget","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manjit S.","family":"Matharu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Tassorelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,9,30]]},"reference":[{"issue":"1","key":"1322_CR1","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1186\/s10194-020-01208-0","volume":"21","author":"TJ Steiner","year":"2020","unstructured":"Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z, Lifting the burden: the Global Campaign against H (2020) Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. 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All patients provided written informed consent before study participation. The study protocols, for both the studies, were reviewed and approved by the Institutional Review Board, Medical Ethics Committee or Medical Research and Ethics Committee of the participating study sites.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Rose Okonkwo, Antje Tockhorn-Heidenreich, Chad Stroud, and Marie-Ange Paget are employees and potential stockholders of Eli Lilly and Company and\/or one of its subsidiaries. Manjit S. Matharu has received grants or contracts from Abbott and Medtronics, received consulting fees from Allergan, Eli Lilly, Novartis, and TEVA and has received payment or honoraria for lectures, presentations, speakers\u2019 bureaus, manuscript writing or educational events from Allergan, Salvia, Eli Lilly, Novartis and TEVA. Cristina Tassorelli received grants and honoraria for advisory boards, speaker panels or investigation studies from Allergan\/Abbvie, Eli-Lilly, Novartis, Teva and Medscape.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"113"}}