{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T05:54:44Z","timestamp":1778219684529,"version":"3.51.4"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,1,25]],"date-time":"2022-01-25T00:00:00Z","timestamp":1643068800000},"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":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The purpose of this study was to propose a definition of \u201cwearing off\u201d at the individual patient\u2010level and determine the percentage of patients with migraine who experience \u201cwearing off\u201d of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Anecdotal reports suggest that some patients may experience \u201cwearing off\u201d of efficacy during the last week of their calcitonin gene\u2010related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population\u2010level, but \u201cwearing off\u201d has not been assessed at the individual patient\u2010level.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Post hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo\u2010controlled studies in a total of 2680 patients with high\u2010frequency episodic migraine (EVOLVE\u20101, EVOLVE\u20102, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. \u201cWearing off\u201d was defined as an increase of greater than or equal to 2\u00a0weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2\u00a0months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The percentage of patients meeting the threshold of \u201cwearing off\u201d was not statistically significantly different among the placebo, galcanezumab 120\u00a0mg, and galcanezumab 240\u00a0mg treatment groups, both in the total population and in patients with a clinically meaningful response (all \u22649.0%). Although the frequency of \u201cwearing off\u201d in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8\/89 or 9.0%) compared to placebo (3\/95 or 3.2%), these differences were not statistically significant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Consistent with previous analyses at the population\u2010level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of \u201cwearing off\u201d in this analysis were low and similar among placebo, galcanezumab 120\u00a0mg, and galcanezumab 240\u00a0mg treatment groups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14257","type":"journal-article","created":{"date-parts":[[2022,1,25]],"date-time":"2022-01-25T08:04:27Z","timestamp":1643097867000},"page":"198-207","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Does \u201cwearing off\u201d of efficacy occur in galcanezumab\u2010treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials"],"prefix":"10.1111","volume":"62","author":[{"given":"Jessica","family":"Ailani","sequence":"first","affiliation":[{"name":"Department of Neurology MedStar Georgetown University Hospital Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dulanji K.","family":"Kuruppu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mallikarjuna","family":"Rettiganti","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tina","family":"Oakes","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krista","family":"Schroeder","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Wietecha","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6559-1014","authenticated-orcid":false,"given":"Martha","family":"Port","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis Indiana USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew M.","family":"Blumenfeld","sequence":"additional","affiliation":[{"name":"The Headache Center of Southern California The Neurology Center Carlsbad California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,1,25]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_13_3_1","volume-title":"Emgality 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