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Multiple Sclerosis is a neurodegenerative disease which shows different phenotypes making difficult for clinicians to make short-term decisions related with treatment and prognosis. Diagnosis is usually retrospective. Learning Healthcare Systems (LHS) can support clinical practice as they are devised as constantly improving modules. LHS can identify insights which allow evidence-based clinical decisions and more accurate prognosis. We are developing a LHS with the aim of reducing uncertainty. We are using ReDCAP to collect patients’ data, both from Clinical Reported Outcomes (CRO) and from Patients Reported Outcomes (PRO). Once analyzed, this data will serve as a foundation to our LHS. We conducted bibliographical research to select those CRO and PRO collected in clinical practice or identified as possible risk factors. We designed a data collection and management protocol based on using ReDCAP. We are following a cohort of 300 patients for 18 months. At the moment, we have included 93 patients and received 64 complete responses and 1 partial response. This data will be used to develop a LHS, able to accurate prognosis as well as to automatically include new data and improve its algorithm. [ABSTRACT FROM AUTHOR]

Objective: To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry., Methods: An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naïve., Results: Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs., Conclusions: The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance., Competing Interests: Meca‐Lallana [Biogen, Genzyme, Merck Serono, Novartis, Roche and TEVA], C. Oreja‐Guevara [Biogen‐Idec, Novartis, Merck‐Serono, Almirall, Teva and Genzyme], D. Muñoz [Merck,Biogen, Teva, Novartis and Genzyme], J. Olascoaga [Biogen Idec, Bayer‐Schering, Genzyme, Merck‐Serono, Novartis and Teva], A. Pato [Novartis, Biogen and Genzyme Almirall], L. Ramió [Biogen Idec, Novartis, Bayer, Merck‐Serono, Genzyme, Teva PharmaceuticalIndustries Ltd.], V. Meca‐Lallana [Almirall, Biogen Idec,Genzyme, Merck Serono, Novartis, Roche, Teva and Terumo], M.A. Hernández [Merck Serono, Novartis, Biogen, Genzyme, TEVA and Almirall ], M.E. Marzo [nothing to disclose ], J.C. Álvarez‐Cermeño [Bayer Schering Pharma, Merk Serono, Biogen‐Idec, Teva Pharmaceuticals, Sanofi‐Aventis, Genzyme, and Novartis ], A. Rodríguez‐Antigüedad [Biogen‐Idec, Novartis, Merck‐Serono, Teva and Genzyme. ], X. Montalbán [Biogen‐Idec, Bayer‐ Schering, Merck‐Serono, Teva, Novartis, and Sanofi‐Genzyme, Bayer‐Schering, Genzyme, Merck‐Serono, Teva, Novartis, Actelion, Almirall, Allergan and Roche.] Ó. Fernández [Biogen‐Idec, Bayer‐ Schering, Genzyme, Merck‐Serono, Teva, Novartis, Actelion, Almirall, Allergan and Roche.] The rest of investigators do not declare any competing interests related to this article.