A non-randomized clinical trial to evaluate the effect of fingolimod on expanded disability status scale score and number of relapses in relapsing-remitting multiple sclerosis patients

BACKGROUND: Multiple sclerosis (MS) is a chronic disease characterized by demyelination, glial activation and axonal degeneration in the central nervous system. At the present, there is no certain remedy for this disease. However, available therapies often attenuate disease progress. METHODS: This study aims at identification of the effect of fingolimod on expanded disability status scale (EDSS) score and number of relapses in relapsing-remitting MS (RRMS) patients in comparison with IFNβ. In the present 12-month non-randomized clinical trial, 55 RRMS patients aged between 18 and 45 with EDSS scores between 0 and 5.5 were divided into two groups. Twenty-five patients received 0.5 mg oral fingolimod once a day for 12 months and 30 patients were under treatment with IFNβ. EDSS scores and number of relapses were recorded for all study participants monthly. RESULTS: No significant difference was found in age and sex of patients recruited in two study groups. EDSS score was significantly lower in treatment group in month 10, 11 and 12 after treatment compared with control group (p values of 0.004, 0.006 and 0.007 respectively). CONCLUSION: Treated patients experienced no relapse during the study period. Fingolimod is effective in reduction of EDSS score and number of relapses in Iranian MS patients.