{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T19:12:01Z","timestamp":1777489921311,"version":"3.51.4"},"reference-count":28,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T00:00:00Z","timestamp":1698796800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/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":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The ongoing Pan-European Real Life (PEARL) phase 4 study is evaluating fremanezumab effectiveness and safety for the prevention of episodic and chronic migraine. This interim analysis reports primary, secondary and exploratory endpoints from when 500 participants completed at least six months of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with episodic migraine or chronic migraine maintaining daily headache diaries were enrolled upon initiation of fremanezumab. Primary endpoint: proportion of participants with \u226550% reduction in monthly migraine days during the six-month period after fremanezumab initiation. Secondary endpoints: mean change from baseline across months 1\u201312 in monthly migraine days, acute migraine medication use, and headache-related disability. Exploratory endpoint: mean change in headache severity from baseline across months 1\u201312. Safety was assessed through adverse events reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Overall, 897 participants were enrolled and 574 included in the effectiveness analyses (episodic migraine, 25.8%; chronic migraine, 74.2%). Of participants with data available, 175\/313 (55.9%) achieved \u226550% monthly migraine days reduction during the six-month period post-initiation. Across months 1\u201312, there were sustained reductions in mean monthly migraine days, acute medication use, disability scores, and headache severity. Few adverse events were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>PEARL interim results support the effectiveness and safety of fremanezumab for migraine prevention in a real-world population across several European countries. Trial registration: encepp.eu: EUPAS35111<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024231214987","type":"journal-article","created":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T09:43:16Z","timestamp":1700559796000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study"],"prefix":"10.1177","volume":"43","author":[{"given":"Messoud","family":"Ashina","sequence":"first","affiliation":[{"name":"Department of Neurology, Danish Headache Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}]},{"given":"Dimos D.","family":"Mitsikostas","sequence":"additional","affiliation":[{"name":"First Department of Neurology, Aeginition Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece"}]},{"given":"Faisal Mohammad","family":"Amin","sequence":"additional","affiliation":[{"name":"Department of Neurology, Danish Headache Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"},{"name":"Department of Neurorehabilitation\/Traumatic Brain Injury, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark"}]},{"given":"Pinar","family":"Kokturk","sequence":"additional","affiliation":[{"name":"Teva Netherlands B.V., Amsterdam, Netherlands"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4668-6098","authenticated-orcid":false,"given":"Christoph J.","family":"Schankin","sequence":"additional","affiliation":[{"name":"Department of Neurology, Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland"}]},{"given":"Gurdal","family":"Sahin","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences of Lund, Lund University, Sk\u00e5neuro Neurology Clinic, Lund, Sweden"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0796-4702","authenticated-orcid":false,"given":"Patricia","family":"Pozo-Rosich","sequence":"additional","affiliation":[{"name":"Headache Unit & Research Group, Vall d\u2019Hebron Hospital & Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain"}]},{"given":"Paul J.","family":"Dorman","sequence":"additional","affiliation":[{"name":"The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK"}]},{"given":"Tom\u00e1\u0161","family":"Ne\u017e\u00e1dal","sequence":"additional","affiliation":[{"name":"Institute of Neuropsychiatric Care, 1st Faculty of Medicine, Charles University, Prague, Czech Republic"}]},{"given":"Anne Christine","family":"Poole","sequence":"additional","affiliation":[{"name":"Private Practice: Oslo Headache Centre, Oslo, Norway"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9611-7400","authenticated-orcid":false,"given":"Isabel Pav\u00e3o","family":"Martins","sequence":"additional","affiliation":[{"name":"Centro de Estudos Egas Moniz, Faculty of Medicine, University of Lisbon, Lisbon, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6581-0483","authenticated-orcid":false,"given":"Marja-Liisa","family":"Sumelahti","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health Technology, University of Tampere, Tampere, Finland"}]},{"given":"Verena","family":"Ramirez Campos","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}]},{"given":"Andrew H.","family":"Ahn","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA"}]},{"given":"Leonidas","family":"Lyras","sequence":"additional","affiliation":[{"name":"Teva Netherlands B.V., Amsterdam, Netherlands"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1513-2113","authenticated-orcid":false,"given":"Cristina","family":"Tassorelli","sequence":"additional","affiliation":[{"name":"Department of Brain & Behavioral Sciences, University of Pavia, Pavia, Italy"},{"name":"IRCCS Mondino Foundation, Pavia, Italy"}]}],"member":"179","published-online":{"date-parts":[[2023,11,21]]},"reference":[{"key":"bibr1-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1915327"},{"key":"bibr2-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"bibr3-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1177\/0333102416678382"},{"key":"bibr4-03331024231214987","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2021-0015"},{"key":"bibr5-03331024231214987","unstructured":"European Medicines Agency. AJOVY\u00ae (fremanezumab), https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ajovy (2022, accessed 13 November)."},{"key":"bibr6-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00249-5"},{"key":"bibr7-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(15)00245-8"},{"key":"bibr8-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.4853"},{"key":"bibr9-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31946-4"},{"key":"bibr10-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709038"},{"key":"bibr11-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01173-8"},{"key":"bibr12-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1111\/head.13997"},{"key":"bibr13-03331024231214987","unstructured":"Food and Drug Administration. Real-world evidence, https:\/\/www.fda.gov\/science-research\/science-and-research-special-topics\/real-world-evidence (2022, accessed 13 November 2023)."},{"key":"bibr14-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-018-0805-y"},{"key":"bibr15-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1111\/head.13956"},{"key":"bibr16-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01396-x"},{"key":"bibr17-03331024231214987","unstructured":"Efficacy of fremanezumab in refractory chronic migraine patients: Real-world data from the Hull Migraine Clinic, UK, https:\/\/www.researchsquare.com\/article\/rs-1340639\/v1 (2022, accessed 13 November 2023)."},{"key":"bibr18-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-023-01561-w"},{"key":"bibr19-03331024231214987","unstructured":"Nasergivehchi S, Cheng F, Hussain M, et\u00a0al. One year outcome of fremanezumab in refractory chronic migraine participants: Real-world data from the Hull Migraine Clinic, UK. Poster presented at: 18th Migraine Trust International Symposium; 8\u201311 September 2022; London, UK. LBA-017."},{"key":"bibr20-03331024231214987","unstructured":"Straube A, Broessner G, Gaul C, et\u00a0al. Fremanezumab for preventive treatment in migraine: The FINESSE study. Poster presented at: American Headache Society 64th Annual Scientific Meeting; 9\u201312 June 2022; Denver, Colorado, USA. P-194."},{"key":"bibr21-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-022-06254-x"},{"key":"bibr22-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"bibr23-03331024231214987","unstructured":"Ashina M, Mitsikostas D, Amin F, et\u00a0al. Effectiveness of fremanezumab for preventive treatment of migraine: The observational PEARL study. Poster presented at: 8th Congress of the European Academy of Neurology; 25\u201328 June 2022; Vienna, Austria. EPR-035."},{"key":"bibr24-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.56.suppl_1.S20"},{"key":"bibr25-03331024231214987","doi-asserted-by":"publisher","DOI":"10.3988\/jcn.2008.4.4.158"},{"key":"bibr26-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01433-9"},{"key":"bibr27-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1111\/head.14051"},{"key":"bibr28-03331024231214987","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2021-003081"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024231214987","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024231214987","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024231214987","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:45:27Z","timestamp":1777387527000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/03331024231214987"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":28,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1177\/03331024231214987"],"URL":"https:\/\/doi.org\/10.1177\/03331024231214987","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]},"article-number":"03331024231214987"}}