{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T20:12:24Z","timestamp":1781727144946,"version":"3.54.5"},"reference-count":35,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T00:00:00Z","timestamp":1621468800000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To describe the methodology and implications of the patient\u2010identified most bothersome symptom (PI\u2010MBS) measure used in the phase 3, multicenter, randomized, double\u2010blind, placebo\u2010controlled, and parallel\u2010group PROMISE\u20102 trial and to evaluate the contribution of this measure to the assessment of the preventive migraine benefits of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Although freedom from MBS is a coprimary endpoint in acute migraine treatment trials, its evaluation in preventive migraine trials is limited. The PROMISE\u20102 study assessed a unique PI\u2010MBS measure as a secondary endpoint.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a secondary analysis of data from the PROMISE\u20102 study. Adults with chronic migraine (CM) were randomized to receive intravenous (IV) eptinezumab 100\u00a0mg, eptinezumab 300\u00a0mg, or placebo, administered on day 0 and every 12\u00a0weeks. At the screening visit, patients were asked to verbally describe the MBS associated with their CM; the question format was open ended. At subsequent visits, patients were asked to rate the overall change in severity of their MBS from study inception to that time point, using a 7\u2010point ordinal scale ranging from \u201cvery much worse\u201d (\u22123) to \u201cvery much improved\u201d (+3). Patients completed the Patient Global Impression of Change (PGIC) assessment during the same visits, using an identical rating scale and recall period. Endpoints were summarized descriptively; post hoc correlations using the methodologies of Pearson and Spearman were calculated to evaluate relationships between PGIC and PI\u2010MBS and between PGIC and mean monthly migraine days (MMDs; primary efficacy endpoint in PROMISE\u20102).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Altogether, 1072 patients received treatment (eptinezumab 100\u00a0mg,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0356; eptinezumab 300\u00a0mg,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0350; placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0366) and were included in the analysis. There were 23 unique MBS identified; those reported by \u226510 patients included light sensitivity (18.7%), nausea\/vomiting (15.1%), pain with activity (13.7%), pain (12.4%), headache (11.2%), sound sensitivity (7.3%), throbbing\/pulsating pain (4.7%), cognitive disruption (4.1%), fatigue (2.4%), mood changes (1.5%), and sensitivity to smell (0.9%). Four weeks after the first dose (week 4), the rates of much or very much improvement in PI\u2010MBS were higher with eptinezumab 100\u00a0mg (45%) and 300\u00a0mg (57%) than with placebo (29%). Four weeks after the second dose (week 16), the proportions with much or very much improvement in PI\u2010MBS had increased to 58%, 65%, and 36%, respectively. At each time point, the percentages of patients with PGIC ratings of much or very much improved were similar to those for patient\u2010reported improvement in PI\u2010MBS. Patient ratings of changes in PI\u2010MBS and PGIC correlated strongly across time points (Pearson,\n                      <jats:italic>r<\/jats:italic>\n                      range, 0.83\u20130.88; Spearman,\n                      <jats:italic>r<\/jats:italic>\n                      range, 0.83\u20130.89); the absolute value of the correlations was greater than the correlation among changes in MMDs and PGIC (Pearson,\n                      <jats:italic>r<\/jats:italic>\n                      range, \u22120.49 to \u22120.52; Spearman,\n                      <jats:italic>r<\/jats:italic>\n                      range, \u22120.49 to \u22120.52).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Among patients with CM in the PROMISE\u20102 study, a broad range of PI\u2010MBS was reported at baseline. Throughout the study, patients treated with eptinezumab reported greater improvement in their PI\u2010MBS severity compared with placebo recipients, and this improvement correlated strongly with PGIC findings. Collectively, these results indicate that PI\u2010MBS is a promising and novel outcome measure for preventive trials of CM and thus may provide a unique patient\u2010centered approach for identifying and measuring the burden of migraine symptoms that matter most to each patient, as well as the benefits of treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14120","type":"journal-article","created":{"date-parts":[[2021,5,20]],"date-time":"2021-05-20T07:48:49Z","timestamp":1621496929000},"page":"766-776","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Patient\u2010identified most bothersome symptom in preventive migraine treatment with eptinezumab: A novel patient\u2010centered outcome"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2652-2897","authenticated-orcid":false,"given":"Richard B.","family":"Lipton","sequence":"first","affiliation":[{"name":"Department of Neurology Albert Einstein College of Medicine Bronx NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9486-6790","authenticated-orcid":false,"given":"David W.","family":"Dodick","sequence":"additional","affiliation":[{"name":"Department of Neurology Mayo Clinic Phoenix AZ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8106-4927","authenticated-orcid":false,"given":"Jessica","family":"Ailani","sequence":"additional","affiliation":[{"name":"Department of Neurology Medstar Georgetown University Hospital Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lora","family":"McGill","sequence":"additional","affiliation":[{"name":"CNS HealthCare Memphis TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe","family":"Hirman","sequence":"additional","affiliation":[{"name":"Pacific Northwest Statistical Consulting Woodinville WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Cady","sequence":"additional","affiliation":[{"name":"Lundbeck La Jolla Research Center San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,5,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2006.01075.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2001.041007646.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.1995.hed3507387.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-018-0933-4"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00034.2015"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-0988-x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.0373-15.2015"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1098-3597(01)90036-5"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13300"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01834.x"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000001303"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-016-0599-8"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-398270-4.00042-2"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2008.00320.x"},{"key":"e_1_2_10_17_1","article-title":"Monoclonal antibodies (mAB) for migraine. 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