OBJECTIVE: They compared the efficacy and safety of two biosimilar forms of interferon beta-1a in the treatment of MS: Avonex (Biogen Idec, USA) and CinnoVex (CinnaGen, Iran).
METHODS: In a double blind randomized clinical trial study 84 patients with RRMS with EDSS score of 0-5.5 were randomly allocated to two groups of 42 subjects.
RESULTS: 24 MSers were 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 24months 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 12months and 0.27±1.05, p=0.46 in the Avonex and 0.16±1.06, p=1.0 in the CinnoVex group after 24months. 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 MSers compared with first image (16353±11172) (p=0.01). But number of gadolinium-enhancing lesions in CinnoVex showed statistically significant decrease after 12months (0.08±0.28 vs. 1.00±1.22; p=0.03). However, there were no significant differences between groups after 24months. 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.
“This study is too small and for too short a duration to draw conclusions. In another study we have shown that CinnoVex has more aggregates, i.e. the individual interferon-beta molecules clump together. This means that CinnoVex is probably less potent and has a greater chance of inducing neutralizing anti-interferon-beta antibodies (NABs). As NAbs only appear after a year and take 1 to 2 years to have an impact this study is too short to draw any conclusions.”