Nabavi, S., Abolfazli, R., Etemadrezaei, A., Hosseini, H., Moradi, N., Shahriari, S., Mehdipour, B., Shekarchi, B., Soltanzadeh, A. (2019). 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. Iranian Journal of Pharmaceutical Research, 18(3), 1632-1638. doi: 10.22037/ijpr.2019.14503.12441
Seyed Massood Nabavi; Roya Abolfazli; Ali Etemadrezaei; Hamed Hosseini; Nahid Moradi; Sanaz Shahriari; Baharak Mehdipour; Babak Shekarchi; Akbar Soltanzadeh. "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". Iranian Journal of Pharmaceutical Research, 18, 3, 2019, 1632-1638. doi: 10.22037/ijpr.2019.14503.12441
Nabavi, S., Abolfazli, R., Etemadrezaei, A., Hosseini, H., Moradi, N., Shahriari, S., Mehdipour, B., Shekarchi, B., Soltanzadeh, A. (2019). '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', Iranian Journal of Pharmaceutical Research, 18(3), pp. 1632-1638. doi: 10.22037/ijpr.2019.14503.12441
Nabavi, S., Abolfazli, R., Etemadrezaei, A., Hosseini, H., Moradi, N., Shahriari, S., Mehdipour, B., Shekarchi, B., Soltanzadeh, A. 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. Iranian Journal of Pharmaceutical Research, 2019; 18(3): 1632-1638. doi: 10.22037/ijpr.2019.14503.12441
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
1Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran.
2Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran.
3Actoverco Pharmaceuticals, Tehran, Iran.
4Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran.
5Shefa Neuroscience Research Center, Tehran, Iran.
6Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran.
7Department 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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