{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T06:17:17Z","timestamp":1772777837639,"version":"3.50.1"},"reference-count":26,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,11,13]],"date-time":"2023-11-13T00:00:00Z","timestamp":1699833600000},"content-version":"vor","delay-in-days":12,"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":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aimed to determine the number needed to treat (NNT), number needed to harm (NNH), and likelihood of being helped or harmed (LHH) in a post hoc analysis of the phase 3b FOCUS trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Fremanezumab, a humanized monoclonal antibody that selectively targets calcitonin gene\u2013related peptide (CGRP), has demonstrated efficacy, tolerability, and safety in adults with episodic migraine (EM) or chronic migraine (CM), with documented previous inadequate response to two to four classes of migraine preventive medications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the 12\u2010week double\u2010blind period of the FOCUS study, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo. NNT was based on responder analysis, defined as \u226550% reduction in monthly average number of migraine days at 12\u2009weeks. NNH was based on discontinuations due to adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among patients with CM (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009509), response rates and discontinuation rates were 27% (45\/169) and 0 for quarterly fremanezumab, 29% (50\/173) and 2% (3\/173) for monthly fremanezumab, and 8% (13\/167) and\u2009&lt;1% (1\/167) for placebo, respectively. These results translated to NNTs of 5.3 and 4.7, NNHs of 1000 and 88, and LHHs of 188 and 19 for quarterly and monthly fremanezumab, respectively. Among patients with EM (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009328), response rates were 47% (50\/107) for quarterly fremanezumab, 43% (47\/110) for monthly fremanezumab, and 10% (11\/111) for placebo. Discontinuation rates were\u2009&lt;1% (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091) in all three groups. These results translated to NNTs of 2.7 and 3.0, NNHs of 1000 and 1000, and LHHs of 368 and 328 for quarterly and monthly fremanezumab, respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The NNT, NNH, and LHH for quarterly and monthly fremanezumab compare favorably with those for traditional oral preventive medications, including topiramate, valproate, and propranolol.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14651","type":"journal-article","created":{"date-parts":[[2023,11,13]],"date-time":"2023-11-13T08:15:30Z","timestamp":1699863330000},"page":"1351-1358","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0951-5804","authenticated-orcid":false,"given":"Messoud","family":"Ashina","sequence":"first","affiliation":[{"name":"Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dimos D.","family":"Mitsikostas","sequence":"additional","affiliation":[{"name":"First Neurology Department, Aeginition Hospital National and Kapodistrian University of Athens  Athens Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Verena","family":"Ramirez\u00a0Campos","sequence":"additional","affiliation":[{"name":"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":"Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc.  West Chester Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans\u2010Christoph","family":"Diener","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics, Biometry and Epidemiology Medical Faculty of the University Duisburg\u2010Essen  Essen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,11,13]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102416678382"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2014.20.1.22"},{"key":"e_1_2_12_4_1","first-page":"27","article-title":"Subcutaneous delivery of sumatriptan in the treatment of migraine and primary headache","volume":"6","author":"Moore JC","year":"2012","journal-title":"Patient Prefer Adherence"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.649143"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clineuro.2020.105900"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024221076485"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-021-01279-7"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31946-4"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32534-0"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30279-9"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(22)00185-5"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.16f11380"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980430)17:8<873::AID-SIM779>3.0.CO;2-I"},{"key":"e_1_2_12_16_1","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2023"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000438"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0522-1"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102418801579"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102421989601"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.58.11.1652"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.4853"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709038"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2007.01326.x"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2006.00684.x"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-017-0813-3"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15016"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14651","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T11:58:56Z","timestamp":1762084736000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14651"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":26,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1111\/head.14651"],"URL":"https:\/\/doi.org\/10.1111\/head.14651","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]},"assertion":[{"value":"2023-01-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}