Safety of Use of Russian Biosimilars of Interferon Beta-1b in the Treatment of Multiple Sclerosis: a Meta-analysis of Original Studies

Abstract

Presently, an active search for modern drugs for the treatment of multiple sclerosis is ongoing. Since the treatment with original drugs is expensive, therefore, the development of local biosimilars is underway, which at a lower cost should be effective and safe as original ones. The aim of the study is to compare the safety of foreign preparations of interferon beta-1b (Betaferon and Ekstavia) with Russian biosimilars (Ronbetal®, Infibeta®) in the treatment of multiple sclerosis to ensure the possibility of import substitution. In the present study the safety of domestic interferon beta-1b biosimilars in the treatment of multiple sclerosis was studied using a meta-analysis method. There were 3 studies included in the meta-analysis. A total of 778 people participated in the study. The average age of the subjects was 35.92 ± 9.57 years. The main inclusion criteria were a reliable diagnosis of remittent or secondary progressive multiple sclerosis with exacerbations, an EDSS score less than 5.5. The subjects were divided into 2 groups: the first group received therapy with the Russian biosimilars of interferon beta-1b (Ronbetal®, Infibeta®), the second — the foreign ones (Betaferon, Extavia) in therapeutic doses. The duration of therapy was at least 6 weeks. Results. A meta-analysis of three studies showed the following data: the difference in the frequency of local complications such as hyperemia in patients who received Russian and foreign interferon beta-1b analogues statistically insignificant, the relative risk is 1.243 (p > 0.05). No statistically significant differences in the frequency of influenza-like syndrome were also detected: the relative risk is 1.459 (p > 0.05). Conclusion. This study has increased the power of the evidence base in the application of Russian biosimilars. The conducted meta-analysis showed the absence of a statistically significant difference in the incidence of such side effects as the injection site hyperemia and the influenza-like syndrome in domestic biosimilars of interferon beta-1b compared with foreign ones.

Keywords

• interferon beta-1b
• meta-analysis
• multiple sclerosis
• therapeutic equivalence
• biosimilars
• adverse drug reactions