{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T03:43:44Z","timestamp":1764906224947,"version":"3.37.3"},"reference-count":48,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/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":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Neurol Sci"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>In 2020, the Italian Medicines Agency (AIFA) approved the reimbursement of calcitonin gene-related peptide (CGRP) pathway monoclonal antibodies (mAbs), including fremanezumab, in patients with a Migraine Disability Assessment Scale (MIDAS) score\u2009\u2265\u200911, with prescription renewals for up to 12\u00a0months in patients with\u2009\u2265\u200950% reduction in MIDAS score at Months 3 and 6. In this sub-analysis of the Pan-European Real Life (PEARL) study, we provide real-world data on fremanezumab use in Italian routine clinical practice (EUPAS35111).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This first interim analysis for Italy was conducted when 300 enrolled adult patients with episodic or chronic migraine (EM, CM) completed 6\u00a0months of treatment with fremanezumab. The primary endpoint is the proportion of patients achieving\u2009\u2265\u200950% reduction in monthly migraine days (MMD) across the 6\u00a0months post-fremanezumab initiation. Secondary endpoints include: proportion of patients achieving\u2009\u2265\u200950% reduction in MIDAS score at Months 3 and 6, and mean change from baseline across Months 1\u20136 in MMD and headache-related disability. Safety was assessed through adverse events (AEs) reported.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 354 patients enrolled at Italian centers, 318 (EM, 35.5%, CM, 64.5%) were included in the effectiveness analysis. Of patients with available data, 109 (61.2%) achieved the primary endpoint. 61.0% and 65.1% achieved\u2009\u2265\u200950% reduction in MMDs at Months 3 and 6, respectively; 79.9% and 81.0% experienced\u2009\u2265\u200950% reduction in MIDAS at the same timepoints.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Fremanezumab was effective and well-tolerated over the first 6\u00a0months of treatment, with approximately 80% of patients meeting Italian criteria for treatment continuation at Months 3 and 6.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10072-024-07357-3","type":"journal-article","created":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T03:02:12Z","timestamp":1709262132000},"page":"2353-2363","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness"],"prefix":"10.1007","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-2113","authenticated-orcid":false,"given":"Cristina","family":"Tassorelli","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Piero","family":"Barbanti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cinzia","family":"Finocchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierangelo","family":"Geppetti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pinar","family":"Kokturk","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Russo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Sacco","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Cepparulo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the PEARL study group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Ambrosini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Monica","family":"Bandettini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Bartolini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Benedetto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filippo","family":"Brighina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabina","family":"Cevoli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gianluca","family":"Coppola","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roberto","family":"De Simone","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Di Fiore","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florindo","family":"D\u2019Onofrio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Gori","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Granato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Guerzoni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosario","family":"Iannacchero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefano","family":"Messina","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Perini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Pia","family":"Prudenzano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Innocenzo","family":"Rainero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Renata","family":"Rao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ester","family":"Reggio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Sarchielli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuliano","family":"Sette","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanna","family":"Usai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariarosaria","family":"Valente","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabrizio","family":"Vernieri","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,3,1]]},"reference":[{"key":"7357_CR1","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1186\/s10194-020-01208-0","volume":"21","author":"TJ Steiner","year":"2020","unstructured":"Steiner TJ, Stovner LJ, Jensen R et al (2020) Migraine remains second among the world\u2019s causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21:137. https:\/\/doi.org\/10.1186\/s10194-020-01208-0","journal-title":"J Headache Pain"},{"issue":"5","key":"7357_CR2","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1016\/S1474-4422(18)30499-X","volume":"18","author":"GBD 2016 Neurology Collaborators","year":"2019","unstructured":"GBD 2016 Neurology Collaborators (2019) Global, regional, and national burden of neurological disorders, 1990\u20132016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 18(5):459\u2013480. https:\/\/doi.org\/10.1016\/S1474-4422(18)30499-X","journal-title":"Lancet Neurol"},{"key":"7357_CR3","doi-asserted-by":"publisher","first-page":"e293","DOI":"10.1097\/j.pain.0000000000002275","volume":"163","author":"S Safiri","year":"2022","unstructured":"Safiri S, Pourfathi H, Eagen A et al (2022) Global, regional, and national burden of migraine in 204 countries and territories, 1990 to 2019. Pain 163:e293\u2013e309. https:\/\/doi.org\/10.1097\/j.pain.0000000000002275","journal-title":"Pain"},{"key":"7357_CR4","doi-asserted-by":"publisher","first-page":"1485","DOI":"10.1016\/S0140-6736(20)32160-7","volume":"397","author":"M Ashina","year":"2021","unstructured":"Ashina M, Katsarava Z, Phu Do T et al (2021) Migraine: epidemiology and systems of care. Lancet 397:1485\u20131495. https:\/\/doi.org\/10.1016\/S0140-6736(20)32160-7","journal-title":"Lancet"},{"issue":"1","key":"7357_CR5","doi-asserted-by":"publisher","first-page":"82","DOI":"10.1186\/s10194-018-0907-6","volume":"19","author":"P Vo","year":"2018","unstructured":"Vo P, Fang J, Bilitou A et al (2018) Patients\u2019 perspective on the burden of migraine in Europe: a cross-sectional analysis of survey data in France, Germany, Italy, Spain and the United Kingdom. J Headache Pain 19(1):82. https:\/\/doi.org\/10.1186\/s10194-018-0907-6","journal-title":"J Headache Pain"},{"issue":"1","key":"7357_CR6","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1186\/1129-2377-15-31","volume":"15","author":"TJ Steiner","year":"2014","unstructured":"Steiner TJ, Stovner LJ, Katsarava Z et al (2014) The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain 15(1):31. https:\/\/doi.org\/10.1186\/1129-2377-15-31","journal-title":"J Headache Pain"},{"issue":"3","key":"7357_CR7","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1007\/s10194-008-0038-6","volume":"9","author":"LJ Stovner","year":"2008","unstructured":"Stovner LJ, Andr\u00e9e C, Committee ES (2008) Impact of headache in Europe: a review for the Eurolight project. J Headache Pain 9(3):139\u2013146. https:\/\/doi.org\/10.1007\/s10194-008-0038-6","journal-title":"J Headache Pain"},{"key":"7357_CR8","unstructured":"The International Headache Society (IHS) (2021) International Classification of Headache Disorders (ICHD-3). The International Headache Society. https:\/\/ichd-3.org\/. Accessed 14 June 2023"},{"key":"7357_CR9","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/s10194-016-0599-8","volume":"17","author":"C Lampl","year":"2016","unstructured":"Lampl C, Thomas H, Stovner LJ et al (2016) Interictal burden attributable to episodic headache: findings from the Eurolight project. J Headache Pain 17:9. https:\/\/doi.org\/10.1186\/s10194-016-0599-8","journal-title":"J Headache Pain"},{"key":"7357_CR10","doi-asserted-by":"publisher","unstructured":"Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition (2004) Cephalalgia 24(Suppl. 1):1\u2013160. https:\/\/doi.org\/10.1111\/j.1468-2982.2003.00824.x","DOI":"10.1111\/j.1468-2982.2003.00824.x"},{"key":"7357_CR11","doi-asserted-by":"publisher","first-page":"97","DOI":"10.1186\/s10194-022-01467-z","volume":"23","author":"L Hubig","year":"2022","unstructured":"Hubig L, Smith T, Williams E et al (2022) Measuring interictal burden among people affected by migraine: a descriptive survey study. J Headache Pain 23:97. https:\/\/doi.org\/10.1186\/s10194-022-01467-z","journal-title":"J Headache Pain"},{"key":"7357_CR12","doi-asserted-by":"publisher","first-page":"1004","DOI":"10.1111\/head.14151","volume":"61","author":"PM Estave","year":"2021","unstructured":"Estave PM, Beeghly S, Anderson R et al (2021) Learning the full impact of migraine through patient voices: A qualitative study. Headache 61:1004\u20131020. https:\/\/doi.org\/10.1111\/head.14151","journal-title":"Headache"},{"issue":"1","key":"7357_CR13","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1016\/S0304-3959(00)00305-5","volume":"88","author":"WF Stewart","year":"2000","unstructured":"Stewart WF, Lipton RB, Kolodner KB et al (2000) Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain 88(1):41\u201352. https:\/\/doi.org\/10.1016\/S0304-3959(00)00305-5","journal-title":"Pain"},{"issue":"3","key":"7357_CR14","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1111\/j.1526-4610.2009.01544.x","volume":"50","author":"KM Sauro","year":"2010","unstructured":"Sauro KM, Rose MS, Becker WJ et al (2010) HIT-6 and MIDAS as measures of headache disability in a headache referral population. Headache 50(3):383\u2013395. https:\/\/doi.org\/10.1111\/j.1526-4610.2009.01544.x","journal-title":"Headache"},{"key":"7357_CR15","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1046\/j.1468-2982.1999.019002107.x","volume":"19","author":"WF Stewart","year":"1999","unstructured":"Stewart WF, Lipton RB, Kolodner K et al (1999) Reliability of the Migraine Disability Assessment (MIDAS) score in a population based sample of headache sufferers. Cephalalgia 19:107\u2013114. https:\/\/doi.org\/10.1046\/j.1468-2982.1999.019002107.x","journal-title":"Cephalalgia"},{"key":"7357_CR16","doi-asserted-by":"publisher","first-page":"1030","DOI":"10.1016\/S0140-6736(19)31946-4","volume":"394","author":"MD Ferrari","year":"2019","unstructured":"Ferrari MD, Diener HC, Ning X et al (2019) Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): A randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 394:1030\u20131040. https:\/\/doi.org\/10.1016\/S0140-6736(19)31946-4","journal-title":"Lancet"},{"key":"7357_CR17","doi-asserted-by":"publisher","first-page":"1999","DOI":"10.1001\/jama.2018.4853","volume":"319","author":"DW Dodick","year":"2018","unstructured":"Dodick DW, Silberstein SD, Bigal ME et al (2018) Effect of fremanezumab compared with placebo for prevention of episodic migraine: A randomized clinical trial. JAMA 319:1999\u20132008. https:\/\/doi.org\/10.1001\/jama.2018.4853","journal-title":"JAMA"},{"issue":"1","key":"7357_CR18","doi-asserted-by":"publisher","first-page":"114","DOI":"10.1186\/s10194-020-01173-8","volume":"21","author":"SD Silberstein","year":"2020","unstructured":"Silberstein SD, Cohen JM, Seminerio MJ et al (2020) The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain 21(1):114. https:\/\/doi.org\/10.1186\/s10194-020-01173-8","journal-title":"J Headache Pain"},{"key":"7357_CR19","doi-asserted-by":"publisher","first-page":"2113","DOI":"10.1056\/NEJMoa1709038","volume":"377","author":"SD Silberstein","year":"2017","unstructured":"Silberstein SD, Dodick DW, Bigal ME et al (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377:2113\u20132122. https:\/\/doi.org\/10.1056\/NEJMoa1709038","journal-title":"N Engl J Med"},{"key":"7357_CR20","doi-asserted-by":"publisher","first-page":"2444","DOI":"10.1111\/head.13997","volume":"60","author":"RB Lipton","year":"2020","unstructured":"Lipton RB, Cohen JM, Bibeau K et al (2020) Reversion from chronic migraine to episodic migraine in patients treated with fremanezumab: post hoc analysis from HALO CM study. Headache 60:2444\u20132453. https:\/\/doi.org\/10.1111\/head.13997","journal-title":"Headache"},{"key":"7357_CR21","doi-asserted-by":"publisher","first-page":"e2487","DOI":"10.1212\/WNL.0000000000010600","volume":"95","author":"PJ Goadsby","year":"2020","unstructured":"Goadsby PJ, Silberstein SD, Yeung PP et al (2020) Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology 95:e2487\u2013e2499. https:\/\/doi.org\/10.1212\/WNL.0000000000010600","journal-title":"Neurology"},{"key":"7357_CR22","doi-asserted-by":"publisher","first-page":"2431","DOI":"10.1111\/head.13994","volume":"60","author":"AM Blumenfeld","year":"2020","unstructured":"Blumenfeld AM, Stevanovic DM, Ortega M et al (2020) No \u201cwearing-off effect\u201d seen in quarterly or monthly dosing of fremanezumab: subanalysis of a randomized long-term study. Headache 60:2431\u20132443. https:\/\/doi.org\/10.1111\/head.13994","journal-title":"Headache"},{"key":"7357_CR23","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/s10194-020-01177-4","volume":"21","author":"DC Buse","year":"2020","unstructured":"Buse DC, Gandhi SK, Cohen JM et al (2020) Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain 21:109. https:\/\/doi.org\/10.1186\/s10194-020-01177-4","journal-title":"J Headache Pain"},{"key":"7357_CR24","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1186\/s10194-023-01561-w","volume":"24","author":"P Barbanti","year":"2023","unstructured":"Barbanti P, Egeo G, Aurilia C et al (2023) Early and sustained efficacy of fremanezumab over 24-weeks in migraine patients with multiple preventive treatment failures: the multicenter, prospective, real-life FRIEND2 study. J Headache Pain 24:30. https:\/\/doi.org\/10.1186\/s10194-023-01561-w","journal-title":"J Headache Pain"},{"key":"7357_CR25","unstructured":"Food and Drug Administration (2022) Real-world evidence. FDA. https:\/\/www.fda.gov\/science-research\/science-and-research-special-topics\/real-world-evidence. Accessed 13 Oct 2022"},{"key":"7357_CR26","doi-asserted-by":"publisher","first-page":"46","DOI":"10.1186\/s10194-022-01396-x","volume":"23","author":"P Barbanti","year":"2022","unstructured":"Barbanti P, Egeo G, Aurilia C et al (2022) Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain 23:46. https:\/\/doi.org\/10.1186\/s10194-022-01396-x","journal-title":"J Headache Pain"},{"issue":"2","key":"7357_CR27","doi-asserted-by":"publisher","first-page":"45","DOI":"10.21203\/rs.3.rs-1340639\/v1","volume":"5","author":"F Cheng","year":"2022","unstructured":"Cheng F, Wu Q, Hussain M et al (2022) Efficacy of fremanezumab in resistant and refractory chronic migraine patients: real-world data from the Hull Migraine Clinic, UK. Adv Neur Neur Sci 5(2):45\u201367. https:\/\/doi.org\/10.21203\/rs.3.rs-1340639\/v1","journal-title":"Adv Neur Neur Sci"},{"issue":"1_suppl","key":"7357_CR28","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1177\/03331024221123848","volume":"42","author":"S Nasergivehchi","year":"2022","unstructured":"Nasergivehchi S, Cheng F, Hussain M et al (2022) One year outcome of fremanezumab in refractory chronic migraine patients: real-world data from the Hull. Cephalalgia 42(1_suppl):130. https:\/\/doi.org\/10.1177\/03331024221123848","journal-title":"Cephalalgia"},{"key":"7357_CR29","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1111\/head.14317","volume":"62","author":"A Straube","year":"2022","unstructured":"Straube A, Broessner G, Gaul C et al (2022) Response to fremanezumab for preventive treatment in migraine in routine clinical practice: first data from the FINESSE study. Headache 62:160\u2013161. https:\/\/doi.org\/10.1111\/head.14317","journal-title":"Headache"},{"key":"7357_CR30","unstructured":"Italian Medicines Agency (AIFA) (2020) Attivazione web e pubblicazione schede di monitoraggio. AIFA. https:\/\/www.aifa.gov.it\/en\/-\/attivazione-web-e-pubblicazione-schede-di-monitoraggio-registro-aimovig. Accessed 6 June 2023"},{"key":"7357_CR31","doi-asserted-by":"publisher","first-page":"871","DOI":"10.1212\/wnl.47.4.871","volume":"47","author":"SD Silberstein","year":"1996","unstructured":"Silberstein SD, Lipton RB, Sliwinski M (1996) Classification of daily and near-daily headaches: Field trial of revised IHS criteria. Neurology 47:871\u2013875. https:\/\/doi.org\/10.1212\/wnl.47.4.871","journal-title":"Neurology"},{"key":"7357_CR32","doi-asserted-by":"publisher","first-page":"647","DOI":"10.2217\/pmt-2021-0015","volume":"11","author":"M Ashina","year":"2021","unstructured":"Ashina M, Amin FM, Kokturk P et al (2021) PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine. Pain Manag 11:647\u2013654. https:\/\/doi.org\/10.2217\/pmt-2021-0015","journal-title":"Pain Manag"},{"issue":"1","key":"7357_CR33","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/0333102417738202","volume":"38","author":"IHC","year":"2018","unstructured":"IHC (2018) The international classification of headache disorders, 3rd edition. Cephalalgia 38(1):1\u2013211. https:\/\/doi.org\/10.1177\/0333102417738202","journal-title":"Cephalalgia"},{"key":"7357_CR34","doi-asserted-by":"publisher","unstructured":"Ashina M, Mitsikostas D, Amin F et al (2022) Effectiveness of fremanezumab for preventive treatment of migraine: the observational PEARL study. 29:192\u2013193. https:\/\/doi.org\/10.1111\/ene.15465","DOI":"10.1111\/ene.15465"},{"issue":"6 Suppl 1","key":"7357_CR35","doi-asserted-by":"publisher","first-page":"S20","DOI":"10.1212\/wnl.56.suppl_1.s20","volume":"56","author":"WF Stewart","year":"2001","unstructured":"Stewart WF, Lipton RB, Dowson AJ et al (2001) Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology 56(6 Suppl 1):S20\u2013S28. https:\/\/doi.org\/10.1212\/wnl.56.suppl_1.s20","journal-title":"Neurology"},{"key":"7357_CR36","unstructured":"QualityMetric, Inc. and GlaxoSmithKline Group of Companies. HIT-6 Scoring Interpretation English Version 1.1. https:\/\/bash.org.uk\/wp-content\/uploads\/2012\/07\/English.pdf. Accessed 1 December 2022"},{"key":"7357_CR37","doi-asserted-by":"publisher","first-page":"126","DOI":"10.1186\/s10194-021-01339-y","volume":"22","author":"GF Caralho","year":"2021","unstructured":"Caralho GF, Luedtke K, Braun T (2021) Minimal important change and responsiveness of the Migraine Disability Assessment Score (MIDAS) questionnaire. J Headache Pain 22:126. https:\/\/doi.org\/10.1186\/s10194-021-01339-y","journal-title":"J Headache Pain"},{"key":"7357_CR38","doi-asserted-by":"publisher","first-page":"710","DOI":"10.1177\/0333102412449933","volume":"32","author":"RF Castien","year":"2012","unstructured":"Castien RF, Blankenstein AH, van der Windt ADWM et al (2012) Minimal clinically important change on the Headache Impact Test-6 questionnaire in patients with chronic tension-type headache. Cephalalgia 32:710\u2013714. https:\/\/doi.org\/10.1177\/0333102412449933","journal-title":"Cephalalgia"},{"key":"7357_CR39","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1186\/s10194-022-01433-9","volume":"23","author":"CK Cullum","year":"2022","unstructured":"Cullum CK, Phu Do T, Ashina M et al (2022) Real-world long-term efcacy and safety of erenumab in adults with chronic migraine: a 52-week, single-center, prospective, observational study. J Headache Pain 23:61. https:\/\/doi.org\/10.1186\/s10194-022-01433-9","journal-title":"J Headache Pain"},{"key":"7357_CR40","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1186\/s10194-022-01431-x","volume":"23","author":"S Sacco","year":"2022","unstructured":"Sacco S, Amin FM, Ashina M et al (2022) European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention \u2013 2022 update. J Headache Pain 23:67. https:\/\/doi.org\/10.1186\/s10194-022-01431-x","journal-title":"J Headache Pain"},{"key":"7357_CR41","unstructured":"National Institute for Health and Care Excellence (NICE) (2022) Fremanezumab for preventing migraine. https:\/\/www.nice.org.uk\/guidance\/ta764\/chapter\/1-Recommendations. NICE. Accessed 6 June 2023"},{"key":"7357_CR42","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1007\/s40263-021-00893-y","volume":"36","author":"LF Iannone","year":"2022","unstructured":"Iannone LF, Fattori D, Benemei S et al (2022) Long-term effectiveness of three anti-CGRP monoclonal antibodies in resistant chronic migraine patients based on the MIDAS score. CNS Drugs 36:191\u2013202. https:\/\/doi.org\/10.1007\/s40263-021-00893-y","journal-title":"CNS Drugs"},{"key":"7357_CR43","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1186\/s10194-022-01480-2","volume":"23","author":"R De Icco","year":"2022","unstructured":"De Icco R, Vaghi G, Allena M et al (2022) Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial. J Headache Pain 23:123. https:\/\/doi.org\/10.1186\/s10194-022-01480-2","journal-title":"J Headache Pain"},{"key":"7357_CR44","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1186\/s10194-022-01411-1","volume":"23","author":"MT Driessen","year":"2022","unstructured":"Driessen MT, Cohen JM, Patterson-Lomba O et al (2022) Real-world effectiveness of fremanezumab in migraine patients initiating treatment in the United States: results from a retrospective chart study. J Headache Pain 23:47. https:\/\/doi.org\/10.1186\/s10194-022-01411-1","journal-title":"J Headache Pain"},{"key":"7357_CR45","first-page":"45","volume":"5","author":"F Cheng","year":"2022","unstructured":"Cheng F, Wu Q, Hussain M et al (2022) Efficacy of fremanezumab in resistant and refractory chronic migraine patients: real-world data from the Hull Migraine Clinic, UK. Adv Neurol Neurosci 5:45\u201367","journal-title":"Adv Neurol Neurosci"},{"issue":"10203","key":"7357_CR46","doi-asserted-by":"publisher","first-page":"1030","DOI":"10.1016\/S0140-6736(19)31946-4","volume":"394","author":"MD Ferrari","year":"2019","unstructured":"Ferrari MD, Diener HC, Ning X et al (2019) Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 394(10203):1030\u20131040. https:\/\/doi.org\/10.1016\/S0140-6736(19)31946-4","journal-title":"Lancet"},{"key":"7357_CR47","doi-asserted-by":"publisher","first-page":"965","DOI":"10.2217\/fon-2020-0951","volume":"17","author":"B Nazha","year":"2021","unstructured":"Nazha B, Yang JC, Owonikoko TK (2021) Benefits and limitations of real-world evidence: lessons from EGFR mutation-positive non-small-cell lung cancer. Future Oncol 17:965\u2013977. https:\/\/doi.org\/10.2217\/fon-2020-0951","journal-title":"Future Oncol"},{"key":"7357_CR48","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1136\/ejhpharm-2021-003081","volume":"29","author":"M Liu","year":"2022","unstructured":"Liu M, Qi Y, Wang W et al (2022) Toward a better understanding about real-world evidence. Eur J Hosp Pharm 29:8\u201311. https:\/\/doi.org\/10.1136\/ejhpharm-2021-003081","journal-title":"Eur J Hosp Pharm"}],"container-title":["Neurological Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10072-024-07357-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10072-024-07357-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10072-024-07357-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,4,16]],"date-time":"2024-04-16T04:44:24Z","timestamp":1713242664000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10072-024-07357-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3,1]]},"references-count":48,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["7357"],"URL":"https:\/\/doi.org\/10.1007\/s10072-024-07357-3","relation":{},"ISSN":["1590-1874","1590-3478"],"issn-type":[{"type":"print","value":"1590-1874"},{"type":"electronic","value":"1590-3478"}],"subject":[],"published":{"date-parts":[[2024,3,1]]},"assertion":[{"value":"26 October 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 January 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 March 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The protocol has been approved by the Independent Ethics Committee\/Institutional Review Board in all 11\u00a0participating European countries (Czech Republic, Denmark, Finland, Greece, Italy, Norway, Portugal, Spain,\u00a0Sweden, Switzerland, and the UK), as required by local regulations, and all relevant local data protection laws are\u00a0followed. Informed consent was obtained from all patients before inclusion in the study; patients agreed for their\u00a0clinical data to be recorded anonymously, retaining the right to withdraw their consent at any time during the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and Informed consent"}},{"value":"CT has received consulting fees or speaking honoraria from AbbVie, Domp\u00e9, Lilly, Lundbeck, Novartis, and Pfizer; has received financial support for attending meetings from Lundbeck and Ipsen; is the past-President of the International Headache Society.PB has received consulting fees from AbbVie, Allergan, Angelini, Assosalute, Bayer, Eli-Lilly, Fondazione Ricerca e Salute, Lundbeck, MSD, Novartis, Teva, Visufarma, and\u00a0Zambon; has received payment or honoraria from AbbVie, Allergan, Angelini, Bayer, Eli-Lilly, Lundbeck, MED, MSD, New Penta, Novartis, Stx-Med, Teva, Visufarma, and\u00a0Zambon; has received support for attending meetings and\/or travel from Lundbeck, Novartis, Teva, and\u00a0Visufarma; has participated on a data safety monitoring board or advisory board for AbbVie, Allergan, Angelini, Bayer, Eli-Lilly, Lundbeck, New Penta, Novartis, Stx-Med, Teva, Visufarma, and\u00a0Zambon; and\u00a0has received other financial or non-financial interests from AbbVie, Amgen, Alder, Allergan, Biohaven, ElectroCore, Eli-Lilly, GSK, Lundbeck, New Penta, Noema Pharma, Novartis, and\u00a0Teva.MC is an employee of Teva Pharmaceuticals\u00a0and has received stock or stock options from Teva.SS has received grants or contracts from Novartis, and\u00a0Uriach; has received consulting fees from AbbVie, Abbott, Allergan, AstraZeneca, Lilly, Lundbeck, NovoNordisk, and\u00a0Pfizer; has received support for attending meetings and\/or travel from Lilly, Lundbeck, Novartis, and\u00a0Teva; is the President Elect for the European Stroke Organisation and second Vice-President for the European Headache Federation; and\u00a0has received receipt of equipment, materials, drugs, medical writing gifts or other services from AbbVie, Allergan, and\u00a0NovoNordisk.AR has received speaker honoraria from\u00a0Allergan, Lilly, Novartis, Teva, and\u00a0Pfizer, and\u00a0serves as an Associate Editor of Frontiers in Neurology (Headache Medicine and Facial Pain session).CF has received payments or honoraria from AbbVie,\u00a0Lilly, Lundbeck, Novartis, and\u00a0Teva, and is the President of Anircef.PK is an employee of Teva Pharmaceuticals.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}