Neutralizing antibodies in multiple sclerosis patients on weekly intramuscular Avonex and biosimilar interferon beta-1a (CinnoVex): comparing results of measurements in two different laboratories.

The appearance of neutralizing antibodies (NAbs) has significant clinical and regulatory consequences for interferons in patients with multiple sclerosis (MS). In a double blind, randomized clinical trial, 84 patients with relapsing remitting MS were enrolled in a 24month study period. Patients were randomly assigned into two groups receiving 30mcg weekly intramuscular injections of either Avonex® (Biogen Idec, USA; 42 patients) or CinnoVex® (CinnaGen Co, Iran; 42 patients). NAb titer was drawn for all patients every 6months and assayed using cytopathic effect assay (CPE) method in Tehran, Iran. To validate the measure done in the Iranian lab, 45 sera with adequate volume and proper storing condition were selected and sent to be rechecked using luciferase reporter gene assay (LA) method for verification in 2 phases in Vancouver, Canada. The cut-off point of 20 TRU was considered for positivity. The two labs found the same three samples to be positive (2 samples from patients received Avonex and 1 received CinnoVex) and 42 to be negative. They had the following values using the Kawade formula as recommended by international standards; 2238, 89 and 302 (TRu/ml) using CPE assay versus 2464, 290 and 169 (TRu/ml) using LA method. As similar results were obtained from CinnoVex or Avonex in our study, we suggest that both medications will have a similar immunogenetic profile.

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.

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.