Spanish Registry of patients with Multiple Sclerosis (MS) treated with fingolimod (GILENYA Registry): safety and effectiveness after four years. Patients without previous treatment subanalysis (P6.395)

Objective: The safety and effectiveness of fingolimod after 4 years of treatment for patients enrolled in the study without previous treatment for MS. Background: The aim of the Spanish Gilenya Registry is to study the evolution of patients being treated with fingolimod in Spain. Design/Methods: Observational, retrospective/prospective and multicenter registry of cases, including all patients with relapsing remitting MS starting treatment with fingolimod in Spain. Results: 99 evaluable patients without previous treatment for MS were included in GILENYA Registry until March 2017. Data available: 54 patients after 1 year of treatment, 31 after 2y, 18 after 3y and 8 after 4y. Mean(±SD) age at baseline was 37.7(±8.8) years, and 67.1% women. Mean(±SD) time since diagnosis of MS was 2.7(±5.4) years. Test for JC virus antibodies was performed in 44/70 patients (62.9%), being seropositive in 42/44 patients (95.5%). Mean(±SD) time under treatment with fingolimod was 34.3(±13.0) months. 4 patients had adverse reactions (6 events), none of them was serious. After 4 years in treatment with fingolimod and compared to the previous year, 85.7% of patients were free from relapses, 86.3% were free of disability progression [EDSS improvement or non-change] and 85.7% were free of clinical activity (no relapses and free from disability progression). Mean(±SD) ARR was 1.53(±1.08) at baseline; 0.15(±0.36) after 1 year of treatment; 0.10(±0.31) after 2y; 0.40(±0.63) after 3y; and 0.00(±0.00) after 4y. This reduction was statically significant during the follow-up versus baseline (p Conclusions: The results obtained in this preliminary analysis support the safety and effectiveness of fingolimod after 4 years of treatment for patients without previous treatment for MS. Disclosure: Dr. Meca Lallana has nothing to disclose. Dr. Oreja-Guevara has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alexion, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva. Dr. Munoz Garcia has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck, Biogen, Teva, Novartis and Genzyme. Dr. Olascoaga Urtaza has nothing to disclose. Dr. Pato has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, Genzyme, Almirall and Bayer. Dr. Ramio has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with biogen-Idec, Merck-Serono, Novartis, Bayer, Genzyme and Teva. Dr. Meca Lallana has nothing to disclose. Dr. Hernandez Perez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Merck, Teva, Biogen Idec, Novartis, Roche, Almirall, Sanofi-Aventis and Genzyme. Dr. Marzo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Novartis and Genzyme. Dr. Alvarez-Cermeno has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer Schering Pharma, Merck Serono, Biogen-Idec, Teva Pharmaceuticals, Sanofi-Aventis, Genzyme and Novartis. Dr. Rodriguez Antiguedad has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen-Idec, Novartis, Merck-Serono, Teva and Genzyme. Dr. Montalban has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Oryzon, Roche, Sanofi and Teva Pharmaceutical. Dr. Fernandez has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Lecturer or participation in advisory boards for: Biogen-Idec, Merck Serono, Teva, Novartis, and Almirall. Dr. Fernandez has received personal compensation in an editorial capacity for Editor of: Revista Espanola de Esclerosis Multiple.