{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T22:07:08Z","timestamp":1790028428419,"version":"4.0.1"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,12,18]],"date-time":"2020-12-18T00:00:00Z","timestamp":1608249600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the effectiveness, safety, and tolerability of erenumab in a real\u2010life migraine population, while trying to identify responsiveness predictors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Erenumab is a fully human Ig\u20102 monoclonal antibody blocking the calcitonin gene\u2010related peptide receptor, indicated for migraine prophylaxis. Phase II and III trials demonstrated that erenumab is effective, safe, and well tolerated in the prevention of episodic and chronic migraine (CM), showing an early onset of action.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a multicenter, prospective, cohort, and real\u2010life study. We considered for enrolment all consecutive patients aged 18\u201365 affected by high\u2010frequency episodic migraine (HFEM) or CM, with or without medication overuse, visited at nine Italian Headache Centers from December 20, 2018 to September 30, 2019. Each patient was treated with erenumab 70\u00a0mg, administered subcutaneously every 4\u00a0weeks. Treatment duration was planned to last from 6 to 12\u00a0months, depending on the patient's response. The primary endpoint was the change in monthly migraine days (MMDs) at weeks 9\u201312 compared to baseline. Secondary endpoints included changes in monthly analgesics intake, \u226550%, \u226575%, and 100% responder rates and any variation in the Visual Analog Scale (VAS) and Headache Impact Test scores (HIT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 372 migraine patients were treated with at least one dose of erenumab 70\u00a0mg. At weeks 9\u201312, erenumab decreased MMDs by 4.5\u00a0\u00b1\u00a04.1\u00a0days (mean\u00a0\u00b1\u00a0SD) in patients with HFEM and by 9.3\u00a0\u00b1\u00a09.1 (mean\u00a0\u00b1\u00a0SD) days in those with CM compared to baseline. At weeks 9\u201312 VAS score was reduced by 1.9\u00a0\u00b1\u00a01.9 (mean\u00a0\u00b1\u00a0SD), HIT score by 10.7\u00a0\u00b1\u00a08.8 (mean\u00a0\u00b1\u00a0SD), and median monthly analgesics intake passed from 12.0 (interquartile range [IQR] 10.0\u201314.0) to 5.0 (IQR 3.0\u20137.0) in HFEM. In CM patients, VAS was reduced by 1.7\u00a0\u00b1\u00a02.0 (mean\u00a0\u00b1\u00a0SD), HIT by 9.7\u00a0\u00b1\u00a010.4 (mean\u00a0\u00b1\u00a0SD), and median monthly analgesics intake passed from 20.0 (IQR 15.0\u201330.0) to 8.0 (IQR 5.0\u201315.0). At week 12, \u226550% responders were 60\/101 (59.4%) for HFEM and 146\/263 (55.5%) for CM, \u226575% responders were 17\/101 (16.8%) and 59\/263 (22.4%) and 100% responders 1\/101 (1.0%) and 3\/263 (1.1%), respectively. Erenumab responsiveness in HFEM was positively associated with unilateral pain localization (OR: 3.03, 95% CI: 1.24\u20137.40;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.015), whereas in CM responsiveness was positively associated with and baseline migraine frequency (OR: 1.06, 95% CI:1.02\u20131.11;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.031), dopaminergic symptoms (OR: 2.01, 95% CI: 1.14\u20133.52;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.015), and negatively associated with psychiatric comorbidities (OR: 0.43, 95% CI: 0.20\u20130.93;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.003).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Erenumab 70\u00a0mg is effective, safe, and well tolerated in real life. Easily obtainable clinical features might be of help in predicting patient's responsiveness.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14032","type":"journal-article","created":{"date-parts":[[2020,12,18]],"date-time":"2020-12-18T14:15:33Z","timestamp":1608300933000},"page":"363-372","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":93,"title":["Erenumab in the prevention of high\u2010frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real\u2010life study"],"prefix":"10.1111","volume":"61","author":[{"given":"Piero","family":"Barbanti","sequence":"first","affiliation":[{"name":"Headache and Pain Unit IRCCS San Raffaele Pisana Rome Italy"},{"name":"San Raffaele University Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cinzia","family":"Aurilia","sequence":"additional","affiliation":[{"name":"Headache and Pain Unit IRCCS San Raffaele Pisana Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Egeo","sequence":"additional","affiliation":[{"name":"Headache and Pain Unit IRCCS San Raffaele Pisana Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Fofi","sequence":"additional","affiliation":[{"name":"Headache and Pain Unit IRCCS San Raffaele Pisana Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Cevoli","sequence":"additional","affiliation":[{"name":"IRCCS Istituto delle Scienze Neurologiche Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Colombo","sequence":"additional","affiliation":[{"name":"Neurology Unit IRCCS San Raffaele Scientific Institute, Vita\u2010Salute San Raffaele University Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Filippi","sequence":"additional","affiliation":[{"name":"Neurology Unit IRCCS San Raffaele Scientific Institute, Vita\u2010Salute San Raffaele University Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Frediani","sequence":"additional","affiliation":[{"name":"Headache Center ASST Santi Paolo Carlo Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Bono","sequence":"additional","affiliation":[{"name":"Center for Headache and Intracranial Pressure Disorders Neurology Unit, A.O.U. 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