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Comparison of the Efficacy and Side Effects of Ifn Beta 1-A (Rebif) and a Biosimilar Product (Recigen) in Patients With Multiple Sclerosis



Etemadifar M1 ; Soheilnader S2 ; Shahkarami SMA3 ; Kooshki AM4
Authors
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Authors Affiliations
  1. 1. Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
  2. 2. Department of Neurology, School of Medicine And Student Research committee, Isfahan University of Medical Sciences, Isfahan, Iran
  3. 3. School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Medical Statistics consultant, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

Source: Journal of Isfahan Medical School Published:2012

Abstract

Background: Multiple Sclerosis, or MS, is a chronic demyelinating disorder of the central nervous system affecting over 400,000 people in the US and 2 million individuals worldwide. MS often results in severe disability. Unfortunately, the etiology of multiple sclerosis is unknown and there is no known cure for the disease, and treatments are modest at best. Although, many drugs were found and produced for the treatment of MS, such as Rebif, Avonex and etcetera, these drugs are often very expensive. Recigen, which is an Iranian biosimilar product, is the same as Rebif. In this study we compared the efficacy and side effects of Rebif and Recigen in the treatment of MS. Methods: In a randomized clinical trial 44 patients with EDSS between 0-4 were enrolled and divided into two groups. Of these patients 36 were followed up to the end of the study. The first group was treated by Rebif and the second was treated by Recigen for 24 monts. During the study, EDSS, Relapses drug complications, active plaques and plaque volume were studied and recorded in a special form. Finally all data were entered into the computer and analyzed by SPSS software. The chi-square, student’s t-test and repeated measures ANOVA were used for data analysis. Findings: According to the results of this study the trend of EDSS between two groups was the same, and there was no statistical difference between the two groups (P = 0.13). Moreover, no statistical difference was seen between the two groups in relapse number (P = 0.6). In addition, the plaque volume in both groups decreased, but there was no difference between the two groups. Conclusion: The results of this study showed that Recigen is as effective as rebif and has no significant side effects. © 2012, Isfahan University of Medical Sciences(IUMS). All rights reserved.
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