Experience with Fingolimod as an Evidence-based Therapy in Relapsing Remitting Multiple Sclerosis: A Central American Case Series

Abstract

Introduction: Central America has an estimated Multiple Sclerosis prevalence rate between 1.0 and 7.1 cases per 100,000 inhabitants. The increase in the global Multiple Sclerosis incidence, the lack of Latin-American representation in clinical studies and the rising availability of therapies to treat this disease, makes it essential to gather regional data. Objective: Obtain real-life evidence data regarding the efficacy and safety of fingolimod in the Central American region, specifically in the countries of Panama, Guatemala and Nicaragua. Patients and Methods: Based on medical records, sociodemographic, clinical, efficacy and safety information of patients with Relapsing Remitting Multiple Sclerosis receiving fingolimod treatment was collected and analyzed. Results: Medical records of 58 patients from Panama, Guatemala and Nicaragua with a diagnosis of Relapsing Remitting Multiple Sclerosis were included. Patients had a mean age of 37.3 ± 10.5 years, 6.98 ± 4.99 years of disease history, a time for diagnosis of 9 months and 22.8 ± 15.1 months of treatment with fingolimod. Under this disease-modifying therapy, a 60.4% reduction in active lesions, a decrease in the number of relapses, an increase in the percentage of remissions, and a 30% reduction in the annualized relapse rate, was observed. Fingolimod´s main indications were: previous treatment failure with other disease-modifying therapies mainly interferons and parenteral administration intolerance. At the time of this analysis, 22.4% of patients treated with fingolimod, experienced at least one adverse event and 92.3% of patients continue treatment with fingolimod. Conclusions: The sociodemographic characteristics, as well as safety and efficacy aspects of fingolimod in the Central American population with Relapsing Remitting Multiple Sclerosis are similar to the results published in postmarketing studies and controlled clinical trials in other regions worldwide