[Comparative, placebo-controlled clinical study of efficacy and safety of glatiramer acetate 20 mg in patients with relapsing-remitting multiple sclerosis: results of the first year of the study]. / Sravnitel'noe platsebo-kontroliruemoe klinicheskoe issledovanie effektivnosti i bezopasnosti preparatov glatiramera atsetata 20 mg u patsientov s remittiruyushchim rasseyannym sklerozom: rezul'taty pervogo goda nablyudeniya.

The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD¼, Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) in patients with relapsing-remitting multiple sclerosis. METHODS: 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: BCD-063, copaxone-Teva and placebo, at a ratio of 2:2:1, respectively. RESULTS AND CONCLUSION: Efficacy analysis after 48 weeks of therapy demonstrated no differences between BCD-063 group and copaxone-Teva group in both MRI parameters and frequency of relapses. The mean (SD) of number of MRI-confirmed relapses per patient per year (the primary endpoint) in BCD-063 group was 0.098361 (0.351422), in copaxone-Teva group - 0.098361 (0, 351 422) and in placebo group - 0.178571 (0.390021). There were also no differences between the groups for all other efficacy parameters (EDSS and MSFC). Both investigational BCD-063 and copaxone-Teva demonstrated a favorable safety profile. The data obtained from the present study confirm the therapeutic equivalence of BCD-063 (CJSC BIOCAD, Russia) and copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.

[Low contrast non-color vision in patients with multiple sclerosis]. / Nizkokontrastnoe cherno-beloe zrenie u bol'nykh rasseiannym sklerozom.

OBJECTIVE: Vision impairment is one of the most typical characteristics of multiple sclerosis (MS). This pathology develops due to the lesions of optic nerves and optic tracts in the brain or eye movement dysfunction. Low contrast vision impairment is very frequent and early detected. We assessed low contrast non-color vision in patients with MS. MATERIAL AND METHODS: We examined 56 MS patients and 33 healthy controls. Computed optometric testing was used (grey-colored digits of the standard size were shown against the background of the different shade of grey on the computer monitor). RESULTS AND CONCLUSION: The results demonstrated low-contrast vision dysfunction while high-contrast vision remained intact. The level of low-contrast vision in MS patients differed significantly from that in the controls. The higher severity of visual disturbances was identified during high illumination. The direct correlation between the degree of low-contrast vision dysfunction and the level of disability on EDSS was found.

[Additional indicators of the assessment of efficacy of disease modifying drugs (preliminary results)].

The working experience of the Moscow oblast center for multiple sclerosis is analyzed. Along with standard methods of treatment efficacy evaluation, a cytokines (tumor necrosis factor alpha, gamma-interferon, interleukins 10 and 17) measurement, a morphological study of CD4 and CD8 lymphocytes with cell microelectrophoresis, a complex of morphometric and optic cell parameters using laser computed phase-interference microscopy and cell optic coherent tomography of the eye's retina are used. Preliminary results of the efficacy of these methods are presented.

[The experience of using fingolimod (gilenya) in patients with relapsing-remitting multiple sclerosis].

We present the results of a one-year follow-up study of 11 patients treated with gilenya. The results of cardiomonitoring (ECG and daily arterial pressure monitoring) during the treatment with the first dose of the drug are presented. No clinically significant disturbances of functions in patients without cardiovascular diseases were noted. In these cases, no progression of disease was identified. Relapses were not observed in 82% of patients.

[Results of a comparative clinical trial of the Russian Β - interferon-1b bioanalogue (infibeta)].

Results of annual comparative clinical research of the Russian biosimilar of beta-IFN - 1в at 122 patients with multiple sclerosis are presented. There were positive dynamics on EDSS scores in both groups (in the main group and group of control) in a year of treatment. There were positive dynamics in frequency of relapses in the main group (with 1.5 to 0.4 in a year) and in group of control (with 1.4 to 0.37 in a year). Positive dynamics according to MRI was also fixed in both groups. In both groups, good tolerability of the treatment was noted. This research didn't reveal essential distinctions on efficiency and safety parameters in both groups.