A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular Βeta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran

Document Type: Short Comunication

Authors

1 Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran.

2 Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran.

3 Actoverco Pharmaceuticals, Tehran, Iran.

4 Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran.

5 Shefa Neuroscience Research Center, Tehran, Iran.

6 Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran.

7 Department of Neurology, Faculty of Medical, Tehran University of Medical Sciences, Tehran, Iran.

Abstract

We compared the efficacy and safety of a biosimilar form of beta-interferon-1a (Actovex) versus the reference product in the treatment of relapsing remitting multiple sclerosis (RRMS). In a double blind, randomized phase 3 clinical trial, we evaluated 138 patients with RRMS that were allocated to receive the biosimilar medication and the reference treatment (30 μg intramuscular, weekly for one year). We investigated changes in EDSS, relapse rate and MRI changes within one year.
In sixty-nine patients who were allocated to each arm and analyzed mean age and its standard deviation was 32.4 ± 8.8 and 31.5 ± 8 for the biosimilar medication and the reference arm respectively. One-year follow-up revealed a mean difference of 0.084 in EDSS (95% CI: 0.069-0.237) between the two groups in favor of the biosimilar medication. This value did not exceed the predefined non-inferiority margin of 0.1. There were no statistically significant differences in relapse rate and systemic and local adverse events of the two groups. The results show that the biosimilar interferon 1-a is non-inferior to the reference product in terms of efficacy while it demonstrates comparable safety. In conclusion the biosimilar interferon 1-a can be considered as an effective and safe alternative to the reference product due to lower cost and more availability.

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