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In this study, we evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Episodic migraine and chronic migraine patients completing the 12-week double-blind period of the FOCUS trial entered the 12-week open-label extension and received 3 monthly doses of fremanezumab (225\u2009mg). Changes from baseline in monthly migraine days, monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia\/phonophobia, days with nausea or vomiting, disability scores, and proportion of patients achieving a\u2009\u226550% or \u2009\u226575% reduction in monthly migraine days were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 807 patients who completed the 12-week double-blind treatment period and entered the open-label extension, 772 patients completed the study. In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing regimens, respectively, patients had fewer average monthly migraine days (mean [standard deviation] change from baseline: \u2212\u20094.7 [5.4]; \u2212\u20095.1 [4.7]; \u2212\u20095.5 [5.0]), monthly headache days of at least moderate severity (\u2212\u20094.5 [5.0]; \u2212\u20094.8 [4.5]; \u2212\u20095.2 [4.9]), days per month of acute headache medication use (\u2212\u20094.3 [5.2]; \u2212\u20094.9 [4.6]; \u2212\u20094.8 [4.9]), days with photophobia\/phonophobia (\u2212\u20093.1 [5.3]; \u2212\u20093.4 [5.3]; \u2212\u20094.0 [5.2]), and days with nausea or vomiting (\u2212\u20092.3 [4.6]; \u2212\u20093.1 [4.5]; \u2212\u20093.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of patients, respectively, achieved a\u2009\u226550% reduction and 16%, 15%, and 20%, respectively, achieved a\u2009\u226575% reduction in monthly migraine days. Disability scores were substantially improved in all 3 treatment groups. There were low rates of adverse events leading to discontinuation (&lt;1%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Fremanezumab demonstrated sustained efficacy up to 6\u2009months and was well tolerated in patients with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>ClinicalTrials.gov<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03308968?term=NCT03308968&amp;draw=2&amp;rank=1\">NCT03308968<\/jats:ext-link>(FOCUS).<\/jats:p><\/jats:sec>","DOI":"10.1186\/s10194-021-01279-7","type":"journal-article","created":{"date-parts":[[2021,7,10]],"date-time":"2021-07-10T08:03:27Z","timestamp":1625904207000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6\u2009months of treatment in the phase 3b FOCUS study"],"prefix":"10.1186","volume":"22","author":[{"given":"Messoud","family":"Ashina","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua M.","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Galic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Verena Ramirez","family":"Campos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Barash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoel","family":"Kessler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay","family":"Janka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Christoph","family":"Diener","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,7,10]]},"reference":[{"key":"1279_CR1","doi-asserted-by":"publisher","unstructured":"Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, Bassetti CL, Vos T, Feigin VL (2020) The burden of neurological diseases in Europe: an analysis for the Global Burden of Disease Study 2017. 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All participants provided written informed consent before participation in the study. The final study protocol and informed consent form were reviewed and approved by an independent ethics committee or institutional review board at all 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":"MA has received personal fees from AbbVie\/Allergan, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva Pharmaceuticals. MA is the principal investigator for ongoing AbbVie\/Allergan, Amgen and Lundbeck trials.\u00a0MA has no ownership interest and does not own stocks of any pharmaceutical company. MA serves as associate editor of <i>Cephalalgia\u00a0<\/i>and associate editor of <i>The Journal of Headache and Pain<\/i>. MA is president of the International Headache Society (IHS). JMC, MG, VRC, SB, XN, YK, and LJ are employees of Teva Pharmaceuticals. H-CD has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from Alder BioPharmaceuticals, Allergan, Amgen, electroCore, Ipsen, Eli Lilly, Medtronic, Novartis, Pfizer, Teva Pharmaceuticals, and Weber & Weber; electroCore provided financial support for research projects. H-CD has received research support from the German Research Council, the German Ministry of Education and Research, and the European Union. H-CD serves on the editorial boards of <i>Cephalalgia<\/i> and <i>The Lancet Neurology<\/i>. H-CD chairs the Clinical Guidelines Committee of the German Society of Neurology and is a member of the Clinical Trials Committee of the IHS.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"68"}}