{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T01:05:12Z","timestamp":1747184712224,"version":"3.40.5"},"reference-count":22,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,3,29]],"date-time":"2022-03-29T00:00:00Z","timestamp":1648512000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Euro J of Neurology"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and purpose<\/jats:title><jats:p>Fremanezumab, a fully humanized monoclonal antibody (IgG2\u0394a) that selectively targets calcitonin\u2010gene\u2010related peptide, has demonstrated efficacy as a preventive treatment for adults with episodic migraine or chronic migraine and inadequate response to two to four prior preventive treatment classes in the phase 3b FOCUS study. In this post hoc analysis, efficacy and effects on quality\u2010of\u2010life outcomes for fremanezumab were evaluated in subgroups of patients with and without aura or similar neurological symptoms, here referred to as migraine with or without associated neurological dysfunction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In the FOCUS study, 838 patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab or matched placebo for 12\u00a0weeks of double\u2010blind treatment. For this post hoc analysis, subgroups of patients with migraine with and without associated neurological dysfunction at baseline were identified based on patient response to questions about symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In patients with migraine with associated neurological dysfunction at baseline, fremanezumab significantly reduced monthly average days with neurological symptoms (quarterly, \u22121.7\u00a0days; monthly, \u22121.8\u00a0days) compared to placebo (\u22120.5\u00a0days; both <jats:italic>p<\/jats:italic>\u00a0\u2264\u00a00.01). In comparison with placebo, both dosing regimens of fremanezumab yielded greater reductions in monthly migraine days over 12\u00a0weeks (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.0001) and improvements in Headache Impact Test 6 and Migraine\u2010Specific Quality of Life scores over the last 4\u00a0weeks (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.05), regardless of neurological dysfunction at baseline.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Fremanezumab reduced days with neurological symptoms, effectively prevented migraine, and improved quality of life in patients with migraine with associated neurological dysfunction, including those with previous inadequate response to two to four migraine preventive medication classes.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.15328","type":"journal-article","created":{"date-parts":[[2022,3,18]],"date-time":"2022-03-18T13:06:27Z","timestamp":1647608787000},"page":"2129-2137","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and quality\u2010of\u2010life improvements with fremanezumab treatment in patients with difficult\u2010to\u2010treat migraine with associated neurological dysfunction"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1756-1181","authenticated-orcid":false,"given":"Christian","family":"Lampl","sequence":"first","affiliation":[{"name":"Department of Neurology and Headache Medical Centre Konventhospital Barmherzige Br\u00fcder Linz  Linz Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan M.","family":"Rapoport","sequence":"additional","affiliation":[{"name":"Department of Neurology David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua M.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steve","family":"Barash","sequence":"additional","affiliation":[{"name":"Statistics Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Verena","family":"Ramirez Campos","sequence":"additional","affiliation":[{"name":"Global Medical Affairs Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Seminerio","sequence":"additional","affiliation":[{"name":"North American Medical Affairs Teva Pharmaceuticals USA, Inc.  Parsippany New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Global Clinical Development Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen D.","family":"Silberstein","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center Thomas Jefferson University  Philadelphia Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,3,29]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2003.00509.x"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12150"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413485658"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413479834"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102415584601"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001551"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001535"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1046-4"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.2005.063750"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31946-4"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182535d20"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2009.01999.x"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(09)70135-8"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-018-0113-0"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418769948"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.4853"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709038"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000010600"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000006650"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13708"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2012-000962"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000193"}],"container-title":["European Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.15328","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ene.15328","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.15328","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T20:48:17Z","timestamp":1692737297000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ene.15328"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,29]]},"references-count":22,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1111\/ene.15328"],"URL":"https:\/\/doi.org\/10.1111\/ene.15328","archive":["Portico"],"relation":{},"ISSN":["1351-5101","1468-1331"],"issn-type":[{"type":"print","value":"1351-5101"},{"type":"electronic","value":"1468-1331"}],"subject":[],"published":{"date-parts":[[2022,3,29]]},"assertion":[{"value":"2021-06-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-09","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}