{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T13:43:40Z","timestamp":1792417420274,"version":"4.4.0"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,5]]},"abstract":"Abstract<\/jats:title>\n \n Background and Objectives:<\/jats:title>\n Cladribine is an oral immunomodulatory drug approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). The study aimed to evaluate the effectiveness and safety of cladribine in real-world RRMS patients.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n A retrospective multicenter study was conducted, including RRMS patients treated with cladribine during a 2-year follow-up period. The endpoints were: Annual relapse rate (ARR), disability progression (according to the Expanded Disability Status Scale, EDSS), absence of new lesions and\/or gadolinium enhancement on magnetic resonance imaging, and incidence of adverse events (AEs).<\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n A total of 210 patients (74.3% women) were included, with a mean age of 41.96 \u00b1 10.42 years, and 77.6% had received prior treatments. The ARR significantly decreased to 0.16 and 0.16 in the first and second year, respectively (\n P<\/jats:italic>\n < 0.05). Disability, as measured by EDSS, improved during the first year (1.89,\n P<\/jats:italic>\n < 0.05) and remained stable in the second year (1.92,\n P<\/jats:italic>\n = 0.73). Gadolinium-enhancing lesions improved to 0.14 and 0.26 (\n P<\/jats:italic>\n < 0.05). Mild to moderate AEs were reported in 29% (year 1) and 15% (year 2). One case of prostate cancer and one case of urinary sepsis with a fatal outcome were reported.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions:<\/jats:title>\n Cladribine demonstrated clinical and radiological effectiveness in a real-world setting over 2 years, with an acceptable safety profile.<\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/aian.aian_1068_25","type":"journal-article","created":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T17:01:46Z","timestamp":1779469306000},"page":"360-364","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness and Safety of Cladribine in Relapsing-Remitting Multiple Sclerosis in Clinical Practice: A 2-Year Multicenter Retrospective Open-Label Study"],"prefix":"10.4103","volume":"29","author":[{"name":"Multiple Sclerosis Study Group of the Galician Society of Neurology","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M Susana","family":"Fortes-Gonz\u00e1lez","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Complejo Hospitalario Universitario de Vigo, Vigo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leticia","family":"Herrero-Poch","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Complejo Hospitalario Universitario de Vigo, Vigo, Spain"},{"name":"Innovation in Clinical Pharmacy Research Group (i-FARMA-Vigo), Galicia Sur Health Research Institute (IIS Galicia Sur). SERGAS-UVIGO, Vigo, Pontevedra, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Pato-Pato","sequence":"additional","affiliation":[{"name":"Department of Neurology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesus Garcia-de","family":"Soto","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Lucus Augusti, Lugo, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2026,5,22]]},"reference":[{"key":"R1-20261019","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1111\/ene.13819","article-title":"Multiple sclerosis \u2013 A review","volume":"26","author":"Dobson","year":"2019","journal-title":"Eur J Neurol"},{"key":"R2-20261019","first-page":"343","article-title":"Cladribine in the treatment of relapsing multiple sclerosis","volume":"67","author":"Robles-Cedeno","year":"2018","journal-title":"Rev Neurol"},{"key":"R4-20261019","doi-asserted-by":"crossref","first-page":"465","DOI":"10.1177\/1352458520921087","article-title":"Real-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy","volume":"27","author":"Lizak","year":"2021","journal-title":"Mult Scler"},{"key":"R5-20261019","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1177\/13524585211012227","article-title":"Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres","volume":"8","author":"Pfeuffer","year":"2022","journal-title":"Mult Scler"},{"key":"R6-20261019","doi-asserted-by":"crossref","first-page":"3553","DOI":"10.1007\/s00415-023-11700-7","article-title":"Effectiveness and safety profile of cladribine in an Italian real-life cohort of relapsing-remitting multiple sclerosis patients: A monocentric longitudinal observational study","volume":"270","author":"Zanetta","year":"2023","journal-title":"J Neurol"},{"key":"R7-20261019","doi-asserted-by":"crossref","first-page":"104491","DOI":"10.1016\/j.msard.2022.104491","article-title":"Real-world experience of cladribine treatment in relapsing-remitting multiple sclerosis: A Danish nationwide study","volume":"70","author":"Sorensen","year":"2023","journal-title":"Mult Scler Relat Disord"},{"key":"R8-20261019","doi-asserted-by":"crossref","first-page":"416","DOI":"10.1056\/NEJMoa0902533","article-title":"A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis","volume":"362","author":"Giovannoni","year":"2010","journal-title":"N Engl J Med"},{"key":"R9-20261019","doi-asserted-by":"crossref","first-page":"1594","DOI":"10.1177\/1352458517727603","article-title":"Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study","volume":"4","author":"Giovannoni","year":"2018","journal-title":"Mult Scler"},{"key":"R10-20261019","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1097\/WNF.0000000000000598","article-title":"Real-world effectiveness and safety of cladribine in multiple sclerosis: Longitudinal data from the nationwide registry in Argentina","volume":"47","author":"Rojas","year":"2024","journal-title":"Clin Neuropharmacol"},{"key":"R11-20261019","doi-asserted-by":"crossref","first-page":"105052","DOI":"10.1016\/j.msard.2023.105052","article-title":"Real-world treatment patterns and effectiveness of cladribine tablets in patients with relapsing forms of multiple sclerosis in the United States","volume":"79","author":"Song","year":"2023","journal-title":"Mult Scler Relat Disord"},{"key":"R12-20261019","doi-asserted-by":"crossref","first-page":"104735","DOI":"10.1016\/j.msard.2023.104735","article-title":"Safety and effectiveness of cladribine tablets for multiple sclerosis: Results from a single-center real-world cohort","volume":"75","author":"Aerts","year":"2023","journal-title":"Mult Scler Relat Disord"},{"key":"R13-20261019","doi-asserted-by":"crossref","first-page":"123070","DOI":"10.1016\/j.jns.2024.123070","article-title":"Clinical and biological predictors of cladribine effectiveness in multiple sclerosis: A real-world, single centre study considering a two-year interval from year-2 dosing","volume":"462","author":"Manni","year":"2024","journal-title":"J Neurol Sci"},{"key":"R14-20261019","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1007\/s40120-022-00364-6","article-title":"Predictors of cladribine effectiveness and safety in multiple sclerosis: A real-world, multicenter, 2-year follow-up study","volume":"11","author":"Petracca","year":"2022","journal-title":"Neurol Ther"},{"key":"R15-20261019","doi-asserted-by":"crossref","first-page":"107885","DOI":"10.1016\/j.clineuro.2023.107885","article-title":"A prospective observational longitudinal study with a two-year follow-up of multiple sclerosis patients on cladribine","volume":"232","author":"Al-Hashel","year":"2023","journal-title":"Clin Neurol Neurosurg"},{"key":"R16-20261019","doi-asserted-by":"crossref","first-page":"371","DOI":"10.5603\/PJNNS.a2023.0050","article-title":"Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: A real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic","volume":"7","author":"St\u0119pie\u0144","year":"2023","journal-title":"Neurol Neurochir Pol"},{"key":"R17-20261019","doi-asserted-by":"crossref","first-page":"1808","DOI":"10.1177\/13524585231205962","article-title":"Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study","volume":"29","author":"Brochet","year":"2023","journal-title":"Mult 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Scler Relat Disord"}],"container-title":["Annals of Indian Academy of 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