Izquierdo, GuillermoDamas, FátimaPáramo, Maria DoloresRuiz-Peña, Juan LuisNavarro, Guillermo2023-01-252023-01-252017-04-28http://hdl.handle.net/10668/11145Fingolimod approval was based mainly on two clinical trials, FREEDOMS and TRANSFORMS, which demonstrated the efficacy and safety of fingolimod in patients with multiple sclerosis (MS). We present an observational study that validates these trials findings in a real-world setting, whereby the effectiveness and safety of fingolimod was assessed in Seville's' (Spain) clinical practice. This retrospective study in MS patients assessed effectiveness (relapses, EDSS, gadolinium-enhancing T1 and new/enlarged T2-weighted lesions): total cohort (n = 249) and stratified according to prior treatment (glatiramer acetate/interferon beta-1 [immunomodulator], natalizumab, naïve), gender, basal EDSS score, basal Gd+ lesions, ARR prior to treatment, age at treatment initiation and number of prior treatments. A multivariante model was used to assess the ARR with baseline characteristics. The safety profile (adverse events [AEs]) was also described. Fingolimod reduced the annualized relapse rate (ARR) by 75%, 67% and 85% in the total cohort, patients previously treated with immunomodulatory and naïve patients (penAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/AdultDisabled PersonsFemaleFingolimod HydrochlorideHumansMagnetic Resonance ImagingMaleMultiple Sclerosis, Relapsing-RemittingRecurrenceRetrospective StudiesSafetyresearch article28453541open access10.1371/journal.pone.01761741932-6203PMC5409154https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0176174&type=printablehttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409154/pdf