Background: High dose Interferon Beta and Fingolimod are efficient in Multiple Sclerosis.

Objectives: Comparison the efficacy of these two drugs in patients with treatment failure on low dose interferon beta.

Materials and Methods: The MS patients (McDonald criteria 2010) with the history of unbeneficial treatment on low dose interferon beta participated in this randomized clinical trial in MS clinic in a university hospital in Isfahan from 2014 to 2016. They were randomly assigned to two groups receiving high dose interferon beta-1a (Recigen) or Fingolimod. The number of relapses, EDSS, and Magnetic Resonance Imaging (MRI) findings were evaluated at the beginning, 3, 9, 12, and 18 months after intervention. The t-test and Mann Whitney U test and ANCOVA in SPSS version 20 were used.

Results: A total of 120 MS patients with the mean age of 38.07±9.0 years included in this study and 35.8% of whom were males.

The mean EDSS was lower in Fingolimod group from the 9th month to the end of intervention (1.80±1.05 vs. 2.17±0.95 in the 9th month and 1.95±0.92 vs. 2.30±0.96 in 18th month). The mean number of relapses was lower in Finglimod group significantly in the 12th and 18th months (0.91±0.76 vs. 1.27±0.77 in the 12th and 0.6±0.55 vs 1.0±0.71 in the 18th month). The mean values of new T2 lesions (1.00 vs. 1.47) and gadolinium enhancing lesions (0.467 vs. 0.817) were lower in Fingolimod group at the end of the study.

Conclusion: Both treatments were beneficial with a significant superiority of Fingolimod.