Comparison of safety and efficacy of Ziferon and Betaferon in patients with remitting -relapsing multiple sclerosis
Author’s Names and Affiliations:
Gheini MR1, Sahraian MR1, Azimi AR1, Nasermoghadasi AR1, Abdoli M1, Rahimi G1, Ghazaeian M2*.
1 Sina MS Research Center, Neuroscience Institute, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
2 Department of Clinical Pharmacy, Faculty of pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Interferon beta (IFNb) is the most used immunomodulatory treatment choice for relapsing- remitting (RR) multiple sclerosis (MS) [1, 2]. Interferon beta is available for MS treatment in recombinant forms, as interferon beta-1a or interferon beta-1b [3-6].
Ziferon (interferon Beta-1b) is a product of Zistdaru Danesh Biopharmaceutical Company which is belonged to a family of naturally occurring proteins, produced by eukaryotic cells in response to viral infection and other biologic agents.
Ziferon is specifically indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and in patients who have experienced a first clinical episode of MS.
The aim of this study to evaluate the bio-similarity of Ziferon to Betaferon and to provide further evidence for the safety and efficacy of Ziferon in patients with relapsing multiple sclerosis.
41 consecutive patients with relapsing forms of MS were enrolled from the MS Tehran Medical University out-patient clinic. The patients were randomized to receive either: (a) Ziferon® 250 mcg subcutaneously (SC) alternate day, or (b) Betaferon® 250 mcg SC in alternate day.
Clinical and para-clinical outcome including Mean relapse rate/year, mean EDSS/year, the cumulative number and volume of gadolinium-enhancing lesions, as well as the cumulative number of new T2 lesions and safety profile were evaluated for each group during the years of treatment.
Figure 1: Patient flow chart
No difference in MRI outcome (the change in total lesion volume, New lesion per T2-weighted scan and gadolinium-enhancing lesions per T1-weighted scan from baseline (P-value: 0.236, 0.56, 0.496, respectively was observed). There was no difference in relapse rate between Ziferon® mg and Betaferon® (P-value: 0.56). There were no unexpected safety findings. The number of participants who dropped out of the studies because of adverse events was similar between two groups.
Common AEs (≥10% in any group) reported more frequently included Flu like syndrome, Injection site reaction, Liver test abnormalities, headache and Depression. Overall occurrence of common AEs was similar in both treatment groups.
In conclusion of study, the evidence shows non-inferiority of bio-similar to original INF-beta 1b products in the efficacy and safety profile.
These data suggest that Ziferon is an effective option for patients with RRMS with an acceptable safety profile and efficacy results.
Study supported by Zistdaru Danesh biopharmaceutical company.