{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T18:12:23Z","timestamp":1791223943569,"version":"4.1.0"},"reference-count":28,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2022,2,4]],"date-time":"2022-02-04T00:00:00Z","timestamp":1643932800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brain Sciences"],"abstract":"<jats:p>Multiple sclerosis (MS) patients receiving natalizumab and who are at risk of developing progressive multifocal leukoencephalopathy (PML) often switch to other high-efficacy disease-modifying therapies including fingolimod as a risk mitigation strategy, which could impact treatment safety and effectiveness. The TRANSITION study aimed to evaluate the safety of fingolimod over two years in patients with MS after switching from natalizumab in a real-world setting. The safety and effectiveness were assessed by monitoring serious and other adverse events (SAEs, AEs). We assessed effectiveness by recording relapses, Expanded Disability Status Scale (EDSS) scores, and MRI activity. Of 637 patients enrolled, 505 completed the study (mean age, 42 years). Overall, 72.8% and 12.7% experienced AEs and SAEs respectively. The most common AEs were fatigue, headache, and urinary tract infection; no cases of PML were observed. Fingolimod treatment resulted in low disease activity. Patients with \u22648 weeks washout period had a markedly lower risk of relapses (4.5%) than those with &gt;8 weeks (51.4%). In patients switching from natalizumab to fingolimod, no new safety signals with overall low relapse activity were observed in patients with washout latencies of \u22648 weeks before fingolimod initiation. Fingolimod was found to be safe and effective in patients transitioning from natalizumab.<\/jats:p>","DOI":"10.3390\/brainsci12020215","type":"journal-article","created":{"date-parts":[[2022,2,4]],"date-time":"2022-02-04T11:35:17Z","timestamp":1643974517000},"page":"215","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION\u2015A 2-Year, Multicenter, Observational, Cohort Study"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3940-8727","authenticated-orcid":false,"given":"Helmut","family":"Butzkueven","sequence":"first","affiliation":[{"name":"Department of Neuroscience, Monash University, Melbourne, VIC 3004, Australia"},{"name":"Department of Neurology, Alfred Hospital, Melbourne, VIC 3004, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul S.","family":"Giacomini","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurosurgery, McGill University, Montreal, QC H3A 0G4, Canada"},{"name":"Multiple Sclerosis Clinic, Montreal Neurological Institute and Hospital, Montreal, QC H3A 2B4, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley","family":"Cohan","sequence":"additional","affiliation":[{"name":"Providence Multiple Sclerosis Center, Portland, OR 97225, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8799-8202","authenticated-orcid":false,"given":"Tjalf","family":"Ziemssen","sequence":"additional","affiliation":[{"name":"Center of Clinical Neurosciences, University Hospital Carl Gustav Carus, 01307 Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Sienkiewicz","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Zhang","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8528-6818","authenticated-orcid":false,"given":"Yvonne","family":"Geissb\u00fchler","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, 4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diego","family":"Silva","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, 4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davorka","family":"Tomic","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, 4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harald","family":"Kropshofer","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, 4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Trojano","sequence":"additional","affiliation":[{"name":"Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, 70121 Bari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,2,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"402","DOI":"10.1056\/NEJMoa0907839","article-title":"Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis","volume":"362","author":"Cohen","year":"2010","journal-title":"N. 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