{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T02:25:54Z","timestamp":1790821554621,"version":"4.1.0"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T00:00:00Z","timestamp":1678752000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013412","name":"Sanofi Espa\u00f1a","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013412","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Alemtuzumab (ALZ) is a humanized monoclonal antibody approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis (RRMS) administered in two annual courses. The objective of this study was to describe the effectiveness and safety data of ALZ and to report the health resource utilization in patients receiving this treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this retrospective, non-interventional study, information was retrieved from patients' medical charts at one center in Spain. Included patients were \u226518 years old, and ALZ treatment was initiated between 1 March 2015 and 31 March 2019, according to routine clinical practice and local labeling.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 123 patients, 78% were women. The mean (standard deviation, SD) age of patients at diagnosis was 40.3 (9.1) years, and the mean time since diagnosis was 13.8 (7.3) years. Patients were previously treated with a median (interquartile range; IQR) number of two (2.0\u20133.0) disease-modifying treatments (DMTs). Patients were treated with ALZ for a mean (SD) of 29.7 (13.8) months. ALZ reduced the annualized relapse rate (ARR) (1.5 before vs. 0.05 after;<jats:italic>p<\/jats:italic>&amp;lt; 0.001) and improved the median EDSS (4.63 before vs. 4.00 after;<jats:italic>p<\/jats:italic>&amp;lt; 0.001). Most (90.2%) patients were relapse-free while receiving ALZ. The mean number of gadolinium-enhancing [Gd+] T1 lesions was reduced (1.7 before vs. 0.1 after;<jats:italic>p<\/jats:italic>&amp;lt; 0.001), and the mean number of T2 hyperintense lesions was maintained (35.7 before vs. 35.4 after;<jats:italic>p<\/jats:italic>= 0.392). A total of 27 (21.9%) patients reported 29 autoimmune diseases: hyperthyroidism (12), hypothyroidism (11), idiopathic thrombocytopenic purpura (ITP) (3), alopecia areata (1), chronic urticaria (1), and vitiligo (1). The mean number of health resources (outpatient visits, emergency room visits, hospital admissions, and tests performed in the hospital) used while patients were treated with ALZ progressively decreased from year 1 to year 4, except for a slight increase at year 2 of outpatient visits.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The ReaLMS study provides real-world evidence that ALZ can promote clinical and magnetic resonance imaging disease remission, as well as disability improvement in patients with MS, despite several prior DMT failures. The ALZ safety profile was consistent with data available from clinical trials and other real-world studies. Healthcare resource use was reduced throughout the treatment period.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fneur.2023.1112193","type":"journal-article","created":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T11:37:47Z","timestamp":1678793867000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":9,"title":["Results of treatment with alemtuzumab in a Spanish cohort of patients with multiple sclerosis in the real world: The RealMS study"],"prefix":"10.3389","volume":"14","author":[{"given":"Sara","family":"Eichau","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roc\u00edo","family":"L\u00f3pez Ruiz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Ru\u00edz de Arcos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Luis","family":"Ruiz-Pe\u00f1a","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillermo","family":"Navarro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel \u00c1ngel","family":"Calleja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Luis","family":"Moreno-Amador","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio","family":"Dotor Garc\u00eda-Soto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,3,14]]},"reference":[{"key":"B1","unstructured":"Atlas of MS 2020 \u2013 Epidemiology report2020"},{"key":"B2","doi-asserted-by":"publisher","first-page":"259","DOI":"10.1007\/s11136-005-0891-6","article-title":"Health-related quality of life in multiple sclerosis: The impact of disability, gender and employment status","volume":"15","author":"Miller","year":"2006","journal-title":"Q Life Res."},{"key":"B3","doi-asserted-by":"publisher","first-page":"166","DOI":"10.1177\/1352458517708672","article-title":"New insights into the burden and costs of multiple sclerosis in Europe: results for Spain","volume":"23","author":"Oreja-Guevara","year":"2017","journal-title":"Mult Scler."},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-017-2807-x","article-title":"Impact on healthcare resource utilization of multiple sclerosis in Spain","author":"Sicras-Mainar","year":"2017","journal-title":"BMC Health Serv Res."},{"key":"B5","doi-asserted-by":"publisher","first-page":"1819","DOI":"10.1002\/cncr.28642","article-title":"Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a n\u00e1lisisd controlled phase 3 trial","volume":"380","author":"Cohen","year":"2012","journal-title":"Lancet."},{"key":"B6","doi-asserted-by":"publisher","first-page":"1829","DOI":"10.1016\/S0140-6736(12)61768-1","article-title":"Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a controlled phase 3 trial","volume":"380","author":"Coles","year":"2012","journal-title":"Lancet."},{"key":"B7","doi-asserted-by":"publisher","first-page":"1107","DOI":"10.1212\/wnl.0000000000004313","article-title":"Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy","volume":"89","author":"Havrdova","year":"2017","journal-title":"Neurology."},{"key":"B8","doi-asserted-by":"publisher","first-page":"3343","DOI":"10.1007\/s00415-020-09983-1","article-title":"Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223","volume":"267","author":"Steingo","year":"2020","journal-title":"J Neurol."},{"key":"B9","doi-asserted-by":"crossref","first-page":"1117","DOI":"10.1212\/WNL.0000000000004354","article-title":"Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings","volume":"89","author":"Coles","year":"2017","journal-title":"Neurology."},{"key":"B10","first-page":"342","article-title":"Improvements in quality of life over 6 years in patients with relapsing-remitting multiple sclerosis treated with alemtuzumab: results from the CARE-MS II extension study","volume":"88","author":"Gonz\u00e1lez","year":"2017","journal-title":"Neurology."},{"key":"B11","unstructured":"Lemtrada Prescrribing Information2020"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1016\/j.nrl.2021.06.007","article-title":"Early beginning of alemtuzumab: changing the multiple sclerosis treatment paradigm","author":"Meca-Lallana","year":"2021"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2021.620758","article-title":"Alemtuzumab in a large real-life cohort: interim baseline data of the TREAT-MS study","author":"Ziemssen","year":"2021","journal-title":"Front Neurol."},{"key":"B14","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1212\/WNL.90.15_supplement.P6.357","article-title":"Efficacy and safety of alemtuzumab in real world italian patients switching from natalizumab","volume":"90","author":"Bertolotto","year":"2018","journal-title":"Neurology."},{"key":"B15","doi-asserted-by":"publisher","first-page":"1521","DOI":"10.1007\/s00415-018-8871-2","article-title":"Alemtuzumab as rescue therapy in a cohort of 50 relapsing\u2013remitting MS patients with breakthrough disease on fingolimod: a multi-center observational study","volume":"265","author":"Huhn","year":"2018","journal-title":"J Neurol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"A33","DOI":"10.1136\/jnnp-2018-ANZAN.81","article-title":"Real world experience of treating multiple sclerosis with alemtuzumab","volume":"89","author":"Khalili","year":"2018","journal-title":"J Neurol Neurosurg Psychiatry."},{"key":"B17","doi-asserted-by":"publisher","first-page":"1024","DOI":"10.1007\/s00415-015-7653-3","article-title":"Alemtuzumab as rescue therapy in a cohort of 16 aggressive multiple sclerosis patients previously treated by Mitoxantrone: an observational study","volume":"262","author":"Le Page","year":"2015","journal-title":"J Neurol."},{"key":"B18","doi-asserted-by":"publisher","first-page":"2851","DOI":"10.1007\/s00415-018-9070-x","article-title":"No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study","volume":"265","author":"Prosperini","year":"2018","journal-title":"J Neurol."},{"key":"B19","doi-asserted-by":"publisher","first-page":"259","DOI":"10.3233\/jrs-191029","article-title":"Alemtuzumab for relapsing multiple sclerosis in clinical practice: A four-year retrospective one-center study","volume":"31","author":"Rodr\u00edguez de Castro","year":"2020","journal-title":"Int J Risk Saf Med."},{"key":"B20","doi-asserted-by":"publisher","first-page":"208","DOI":"10.1136\/jnnp-2014-307721","article-title":"Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy","volume":"86","author":"Tuohy","year":"2015","journal-title":"J Neurol Neurosurg Psychiatry."},{"key":"B21","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1177\/1756285617722706","article-title":"Alemtuzumab in the long-term treatment of relapsing-remitting multiple sclerosis: an update on the clinical trial evidence and data from the real world","volume":"10","author":"Ziemssen","year":"2017","journal-title":"Ther Adv Neurol Disord."},{"key":"B22","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1002\/ana.22366","article-title":"Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria","volume":"69","author":"Polman","year":"2011","journal-title":"Ann Neurol."},{"key":"B23","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1016\/s1474-4422(17)30470-2","article-title":"Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria","volume":"17","author":"Thompson","year":"2018","journal-title":"Lancet Neurol."},{"key":"B24","doi-asserted-by":"publisher","first-page":"1352458520985118","DOI":"10.1177\/1352458520985118","article-title":"Effect of applying inclusion and exclusion criteria of phase III clinical trials to multiple sclerosis patients in routine clinical care","volume":"27","author":"Jalusic","year":"2021","journal-title":"Multiple Sclerosis J."},{"key":"B25","doi-asserted-by":"crossref","first-page":"S12006","DOI":"10.1212\/WNL.88.16_supplement.S12.006","article-title":"Alemtuzumab decreased MRI disease activity through 6 years in patients with highly active RRMS and an inadequate response to prior therapy: CARE-MS II extension study","volume":"88","author":"Rovira","year":"2017","journal-title":"Neurology."},{"key":"B26","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1212\/WNL.92.15_supplement.P3.2-057","article-title":"Real-world effectiveness of alemtuzumab in relapsing-remitting Ms patients in germany: interim results of the TREAT-MS study","volume":"92","author":"Akg\u00fcn","year":"2019","journal-title":"Neurology."},{"key":"B27","doi-asserted-by":"publisher","first-page":"2440","DOI":"10.1007\/s00415-019-09424-8","article-title":"Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study","volume":"266","author":"Frau","year":"2019","journal-title":"J Neurol."},{"key":"B28","doi-asserted-by":"publisher","first-page":"1215","DOI":"10.1177\/1352458515614092","article-title":"Alemtuzumab for multiple sclerosis: Long term follow-up in a multi-centre cohort","volume":"22","author":"Willis","year":"2016","journal-title":"Mult Scler."},{"key":"B29","doi-asserted-by":"publisher","first-page":"1007","DOI":"10.1136\/jnnp-2020-325304","article-title":"Impact of previous disease-modifying treatment on effectiveness and safety outcomes, among patients with multiple sclerosis treated with alemtuzumab","volume":"92","author":"Pfeuffer","year":"2021","journal-title":"J Neurol Neurosurg Psychiatry."},{"key":"B30","doi-asserted-by":"publisher","first-page":"973","DOI":"10.1007\/s40263-020-00749-x","article-title":"Efficacy and safety of alemtuzumab through 9 years of follow-up in patients with highly active disease: post hoc analysis of CARE-MS I and II patients in the TOPAZ extension study","volume":"34","author":"Ziemssen","year":"2020","journal-title":"CNS Drugs."},{"key":"B31","doi-asserted-by":"publisher","first-page":"615","DOI":"10.1016\/j.nrleng.2019.11.001","article-title":"Consensus statement on the use of alemtuzumab in daily clinical practice in Spain","volume":"3","author":"Meca-Lallana","year":"2020","journal-title":"Neurologia."},{"key":"B32","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1001\/jama.2018.20588","article-title":"Association of initial disease-modifying therapy with later conversion to secondary progressive multiple sclerosis","volume":"321","author":"Brown","year":"2019","journal-title":"JAMA."},{"key":"B33","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1016\/S1474-4422(20)30067-3","article-title":"Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study","volume":"19","author":"He","year":"2020","journal-title":"Lancet Neurol."},{"key":"B34","doi-asserted-by":"publisher","first-page":"693017","DOI":"10.3389\/fneur.2021.693017","article-title":"Early high efficacy treatment in multiple sclerosis is the best predictor of future disease activity over 1 and 2 years in a norwegian population-based registry","volume":"12","author":"Simonsen","year":"2021","journal-title":"Front Neurol."},{"key":"B35","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1177\/1352458517751049","article-title":"ECTRIMS\/EAN Guideline on the pharmacological treatment of people with multiple sclerosis","volume":"24","author":"Montalban","year":"2018","journal-title":"Mult Scler."},{"key":"B36","doi-asserted-by":"publisher","first-page":"669811","DOI":"10.3389\/fimmu.2021.669811","article-title":"Digital twins for multiple sclerosis","volume":"12","author":"Voigt","year":"2021","journal-title":"Front Immunol."},{"key":"B37","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1186\/s12883-016-0639-7","article-title":"Multiple sclerosis: clinical profiling and data collection as prerequisite for personalized medicine approach","volume":"16","author":"Ziemssen","year":"2016","journal-title":"BMC Neurology"},{"key":"B38","doi-asserted-by":"publisher","first-page":"102945","DOI":"10.1016\/j.msard.2021.102945","article-title":"A real-world single-centre analysis of alemtuzumab and cladribine for multiple sclerosis","volume":"52","author":"Bose","year":"2021","journal-title":"Mult Scler Relat Disord."},{"key":"B39","doi-asserted-by":"publisher","first-page":"968","DOI":"10.1080\/13696998.2018.1489255","article-title":"Cost-minimization analysis of alemtuzumab compared to fingolimod and natalizumab for the treatment of active relapsing-remitting multiple sclerosis in the Netherlands","volume":"21","author":"Piena","year":"2018","journal-title":"J Med Econ."},{"key":"B40","doi-asserted-by":"publisher","first-page":"A428","DOI":"10.1016\/j.jval.2016.09.471","article-title":"Alemtuzumab budget impact for multiple sclerosis treatment in Spain","volume":"19","author":"Casellas","year":"2016","journal-title":"Value Health."}],"container-title":["Frontiers in Neurology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2023.1112193\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,8]],"date-time":"2023-12-08T22:27:20Z","timestamp":1702074440000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fneur.2023.1112193\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,14]]},"references-count":40,"alternative-id":["10.3389\/fneur.2023.1112193"],"URL":"https:\/\/doi.org\/10.3389\/fneur.2023.1112193","relation":{},"ISSN":["1664-2295"],"issn-type":[{"value":"1664-2295","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,14]]},"article-number":"1112193"}}