OBJECTIVE: The aim was to evaluate fingolimod safety and patient profiles in a real-world setting in Buenos Aires, Argentina. METHODS: Relapsing-remitting patients with multiple sclerosis who had been prescribed fingolimod and at least 18 months or more of follow-up were included. Demographic, clinical, and safety issues were described during first dose and follow-up. RESULTS: A total of 145 patients were included, 68% female; mean age, 30 ± 10.5 years; mean disease duration, 6.5 ± 3.1 years; mean fingolimod use, 25 ± 13 months. Eleven patients (7.6%) discontinued fingolimod (7 owing to disease activity/4 owing to desire of pregnancy and personal decisions). Forty-two percent of patients experienced adverse events: headache, fatigue, liver enzyme elevation, and lymphopenia were the most commonly found. No serious cardiac event was reported during the first dose. CONCLUSIONS: The safety and patient profile of fingolimod in a new real-world setting were consistent with information provided from phase III clinical trials.
OBJECTIVE: The aim was to evaluate fingolimod safety and patient profiles in a real-world setting in Buenos Aires, Argentina. METHODS: Relapsing-remitting patients with multiple sclerosis who had been prescribed fingolimod and at least 18 months or more of follow-up were included. Demographic, clinical, and safety issues were described during first dose and follow-up. RESULTS: A total of 145 patients were included, 68% female; mean age, 30 ± 10.5 years; mean disease duration, 6.5 ± 3.1 years; mean fingolimod use, 25 ± 13 months. Eleven patients (7.6%) discontinued fingolimod (7 owing to disease activity/4 owing to desire of pregnancy and personal decisions). Forty-two percent of patients experienced adverse events: headache, fatigue, liver enzyme elevation, and lymphopenia were the most commonly found. No serious cardiac event was reported during the first dose. CONCLUSIONS: The safety and patient profile of fingolimod in a new real-world setting were consistent with information provided from phase III clinical trials.