The present study was a 12-month non-randomized clinical trial assessing the efficacy of once-daily fingolimod (0.5 mg) on relapse rate and expanded disability status scale (EDSS) score of RRMS patients in comparison with IFNβ. Patients were referred to Farshchian Hospital, Hamadan, Iran during 2015–2016. The study protocol was approved by the ethical committee of Hamadan University of Medical Sciences. Informed consent forms were obtained from all study participants. Availability sampling method was used. Sample size was estimated to be 60 (30 patients in fingolimod-treatment group and 30 IFNβ-treated patients as controls) based on the parameters obtained from previous studies :
D = µ1 − µ2 = 0.3, α = 0.05, β = 20%, power = 80%, µ1 (relapse rate in control group) = 0.4, µ2 (relapse rate in fingolimod treated group) = 0.1
Five patients in the treatment group left the study due to personal reasons. Demographic data, disease duration, EDSS score and previous treatment strategies were recorded from all study participants. The inclusion criteria for treatment group were RRMS based on the revised McDonald criteria , age between 18 and 45, one or more confirmed relapses during the prior year, EDSS score of 0–5.5, intolerance to IFNβ therapy and no relapse or steroid treatment within 30 days before study initiation. Complete blood count, liver function test and Varicella-Zoster immune status were tested in all patients. Patients with primary or secondary progressive MS, history of other chronic disorders, malignancy, pregnancy, macular edema, active bacterial/viral/fungal infection, previous administration of cyclophosphamide/mitoxantrone/monoclonal antibodies, chronic liver disease, elevation of liver enzymes/bilirubin/alkaline phosphatase/creatinine, white blood cell < 3500 or lymphocyte count < 800 were excluded from the study. Patients were evaluated for bradycardia by hourly assessments of pulse and blood pressure for 6 h after fingolimod administration. In addition, an electrocardiogram (ECG) prior was obtained before administration of the first dose and at the end of the study period.
Control group consisted of patients who were under treatment with IFNβ (intramuscular injection of 20 μg of CinnoVex [CinnaGen Co, Tehran, Iran] three-times a week). The inclusion criteria for control group were RRMS based on the revised McDonald criteria , age between 18 and 45, one or more confirmed relapses during the prior year, EDSS score of 0–5.5 and no relapse within 30 days before study initiation. Patients with primary or secondary progressive MS disorder, chronic liver or thyroid disorder or elevated alkaline phosphatase levels were excluded.
Data were analyzed using SPSS version 16. The Kolmogorov–Smirnov test was used for assessment of data distribution. Relapse rate and EDSS score mean values before and after treatment were compared using paired T test and Wilcoxon test based on the normality of data. These values were compared between two study groups using dependent T and Mann–Whitney tests based on the normality of data. Chi square test was used for assessment of association between categorical variables. The relationships between quantitative variables were evaluated using Pearson or ANOVA tests. P values less than 0.05 were considered as significant. EDSS scores in each month were compared using ANOVA test.