[The results of an open comparative retrospective trial of the course of multiple sclerosis during treatment with infibeta and other interferon-beta bioanalogues and glatiramer acetate]. / Rezul'taty otkrytogo sravnitel'nogo retrospektivnogo issledovaniia osobennostei rasseiannogo skleroza na fone terapii preparatom infibeta i drugimi bioanalogami interferonov beta i glatiramera atsetatom.

AIM: To evaluate the efficacy and safety of the interferon beta-1b bioanalogue 'infibeta' in the treatment of multiple sclerosis (MS) in comparison with other interferon beta bioanalogues and the generic drug glatiramer acetate. MATERIAL AND METHODS: The data of 500 patients with MS treated with different disease-modifying drugs were analyzed. Patients of group 1 (n=95) received infibeta; group 2 (n=108) interferon beta-1b; group 3 (n=83) genfaxon-44; group 4 (n=109) sinnovex; group 5 (n=105) aksoglatiran FS. RESULTS: In all groups, there was a significant decrease in the AARR and an increase in the EDSS score (p<0,05) after 12 and 24 months of treatment (p<0,05) with the best indicators in groups 1-3. After 12 months of treatment, the number of patients without signs of MRI activity was higher in groups 1-3 (48-61%) than in groups 4 and 5 (47, 43%, respectively) (p>0,05). After 24 months of treatment, the number of patients without signs of MRI activity decreased to 41-46% in groups 1-3, and more significantly in group 4 (27%). The percentage of NEDA-3 achieving patients did not significantly differ in the groups (23-32%) after 12 months of treatment. After 24 months of treatment the NEDA-3 declined more in group 4 (19%), least of all in groups 1 and 2 (27, 25%, respectively) (p>0,05). In most cases, the observed adverse events were mild or moderate. Flu-like syndrome was observed rarely in groups 1 and 4 (p<0,05). Injection reactions were observed most commonly in groups 3 and 5 (p<0,05). CONCLUSION: Infibeta, while retaining all the advantages of high-dose interferon beta, has the best tolerability profile, which makes it one of the optimal first line disease-modifying therapy for treatment of patients with MS.

[Biosimilar of interferon-beta 1b in the treatment of multiple sclerosis and the own experience in the use of ronbetal].

The results of using ronbetal, the Russian biosimilar of interferon-beta 1b, in the treatment of multiple sclerosis (MS) are presented. The study included outpatients followed up from February 2008 to March 2012. All patients were assessed neurologically with additional evaluation using the EDSS; a number of exacerbations and their outcomes, disease progression, tolerability of the drug were recorded. No significant differences in the efficacy of ronbetal and betaferon were found. The frequency of exacerbations and MS progression were comparable for both drugs. The same was with the tolerability, with the exception of higher frequency of the flu-like syndrome at the beginning of treatment with ronbetal. A single-step substitution of betaferon for ronbetal often caused the discontinuation of treatment by patients because they were not fully informed about the new drug, need to use a new dose titration scheme and were anxious about side-effects.