Comparing efficacy and side effects of a weekly intramuscular biogeneric/biosimilar interferon beta-1a with Avonex in relapsing remitting multiple sclerosis: A double blind randomized clinical trial

Abstract

Objective: We compared the efficacy and safety of two biosimilar forms of interferon beta-1a in the treatment of multiple sclerosis: Avonex (Biogen Idec, USA) and CinnoVex (CinnaGen, Iran). Methods: In a double blind randomized clinical trial study 84 patients with relapsing remitting multiple sclerosis (RRMS) with Expanded Disability Status Scale (EDSS) score of 0-5.5 were randomly allocated to two groups of 42 subjects. Results: Twenty-four patients lost to follow-up. Finally, 31 patients (mean ± SD of age = 33.7 ± 7.0; 7 males and 24 females) in the Avonex and 29 patients (mean ± SD of age = 32.2 ± 9.2; 8 males and 21 females) in the CinnoVex group completed full 24 months of study period. Decrease in EDSS was 1.05 ± 0.24, p = 0.62 in the Avonex and 0.16 ± 0.88, p = 1.0 in the CinnoVex group after 12 months and 0.27 ± 1.05, p = 0.46 in the Avonex and 0.16 ± 1.06, p = 1.0 in the CinnoVex group after 24 months. There was no statistically significant difference in attack number between two groups (1.0 ± 1.2 in Avonex and 1.2 ± 1.3 in CinnoVex; p = 0.46). Volume of T2-weighted lesions on MRI showed a progressive significant increase in the 12th month (28056 ± 23693) in Avonex treated patients compared with first image (16353 ± 11172) (p = 0.01). But number of gadolinium-enhancing lesions in CinnoVex showed statistically significant decrease after 12 months (0.08 ± 0.28 vs. 1.00 ± 1.22; p = 0.03). However, there were no significant differences between groups after 24 months. There were no significant differences between 2 groups regarding frequency and duration of most considerable side effects, as well. Neutralizing antibodies were not positive in any patients. Conclusion: CinnoVex can be used as a safe and effective alternative to Avonex in treatment of RRMS. © 2012 Elsevier B.V.