Fingolimod versus High Dose Interferon Beta-1a in Multiple Sclerosis: A Randomized Clinical Trial

Background: High dose Interferon Beta and Fingolimod are efficient inMultiple Sclerosis.Objectives: Comparison the efficacy of these two drugs in patients withtreatment failure on low dose interferon beta.Materials and Methods: The MS patients (McDonald criteria 2010) with thehistory of unbeneficial treatment on low dose interferon beta participated in thisrandomized clinical trial in MS clinic in a university hospital in Isfahan from2014 to 2016. They were randomly assigned to two groups receiving high doseinterferon beta-1a (Recigen) or Fingolimod. The number of relapses, EDSS,and Magnetic Resonance Imaging (MRI) findings were evaluated at thebeginning, 3, 9, 12, and 18 months after intervention. The t-test and MannWhitney 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 yearsincluded in this study and 35.8% of whom were males.The mean EDSS was lower in Fingolimod group from the 9th month to the endof 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 inFinglimod 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 meanvalues 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 ofFingolimod.

کلیدواژه ها:

Fingolimod ، Interferon Beta ، Multiple Sclerosis