Assessment of fingolimod versus dimethyl fumarate for the treatment of multiple sclerosis; a 24-month follow-up study.

Background: Oral treatment of multiple sclerosis (MS) using disease-modifying therapies (DMTs) is a challenge worldwide. Fingolimod (FTY) and dimethyl fumarate (DMF) are two approved agents for oral treatment of MS with remarkable efficacy for relapse control and deceleration of disability progression. Therefore, the current study was done to compare disability control, lesions in magnetic resonance imaging (MRI), and adverse effects between the patients treated with FTY and DMF.

Methods: This randomized clinical trial (IR.MUI.REC.1396.3.786) was conducted on 60 patients who were randomly divided into two groups of treatment with 0.5 mg daily dose of FTY (n = 30) and 240 mg dose of DMF twice daily (n = 30). Disability of patients was assessed using the expanded disability status scale (EDSS) within 6 weeks, 12, and 24 months following treatment initiation and MRI was performed for all the patients prior to study initiation and within 24 months. Obtained data were compared between two study groups.

Results: There was no significant difference between two treatment groups based on EDSS scores, brain lesions in MRI, and newly formed plaques (P>0.05). Skin and gastrointestinal-related complaints were the most common adverse effects of DMF while the increase in liver enzyme level and thrombocytopenia were the most common complications of FTY, respectively (P-value = 0.22).

Conclusion: According to our findings, within 24-month follow-up, DMF was neither superior nor inferior to FTY comparing MRI lesions, EDSS scores, and adverse effects. Although, further evaluations with larger sample size are recommended.