This study aims to compare the clinical efficacy and safety profile of Ziferon (interferon beta-1b) and Betaferon. A total of 41 patients with relapsing forms of multiple sclerosis (MS) are selected from the MS outpatient clinic affiliated to Tehran University of Medical Sciences, Tehran, Iran. The patients are randomly assigned to two groups. Each group either receives Ziferon 250 mcg subcutaneously (SC) on alternate days or Betaferon 250 mcg SC on alternate days. Clinical and para-clinical outcomes, such as mean relapse rate/year score, mean expanded disability status scale (EDSS)/year score, the cumulative number, and the volume of gadolinium-enhancing lesions, in addition to the cumulative number of new T2 lesions and safety profile, are evaluated for each group during the years of treatment. There are no significant differences in the magnetic resonance imaging (MRI) outcomes (change in total lesion volume, new lesion per T2-weighted scan, and gadolinium-enhancing lesions per T1-weighted scan from baseline; P = 0.236, P = 0.56 and P = 0.496 respectively were observed). There is no significant difference in the relapse rate between the Ziferon and Betaferon treated groups (P = 0.56). No unexpected safety events occur. The number of patients who discontinued the study due to adverse events is almost the same between the two groups. The evidence gained demonstrates the non-inferiority and bio-similarity of Ziferon to Betaferon, in terms of efficacy and safety profile.
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