[Experience in the use of cladribine for the treatment of patients with highly active forms of multiple sclerosis in the Moscow region]. / Opyt ispol'zovaniya kladribina dlya lecheniya patsientov s vysokoaktivnym techeniem rasseyannogo skleroza v Moskovskoi oblasti.

OBJECTIVE: To assess the efficacy and safety of cladribine in patients with highly active multiple sclerosis (MS) in the Moscow region. MATERIAL AND METHODS: The analysis was based on data from 62 patients treated with cladribine between March 2021 and January 2024. The diagnosis of VAMS was confirmed in 51 patients, PPMS in 4 patients, and SPMS with exacerbations was diagnosed in 7 cases. Of these, 3 patients completely completed therapy more than a year ago, 20 people received 2 courses of the drug less than a year ago, 39 patients underwent 1 course of therapy. The effect of cladribine on reducing disease activity and progression, as well as the safety of therapy, was evaluated. RESULTS: After 1 course, the number of patients with activity decreased by 66.4%, after 2 years of therapy - by 72.7%. The mean annual frequency of exacerbations decreased from 1.32 to 0.2 after 12 months, and to 0.086 exacerbations per year after 24 months. The level of disability assessed by the EDSS scale remained virtually unchanged throughout the follow-up. The most common adverse events were haematological abnormalities in the form of lymphopenia and leukopenia. Most patients had mild grade 1-2 lymphopenia on the toxicity scale and recovered to the recommended values (>0.8·109/l) by the beginning of the second course of therapy. No cases of serious adverse events were reported. CONCLUSIONS: The results obtained indicate the high efficacy and favorable safety profile of cladribine and are consistent with the data of clinical trials of the drug.

[The use of monoclonal antibodies in the treatment of patients with high-active multiple sclerosis in real clinical practice]. / Primenenie monoklonal'nykh antitel v lechenii bol'nykh vysokoaktivnym rasseyannym sklerozom v real'noi klinicheskoi praktike.

OBJECTIVE: To study the efficacy of ocrelizumab (OCR) and natalizumab (NAT) using indicators of activity and progression in patients with highly active multiple sclerosis (HAMS) during the first year of therapy in real clinical practice. MATERIAL AND METHODS: The study included 110 patients with HAMS and 13 patients with rapidly progressive MS (RPMS), aged 19 to 60 years, who received monoclonal antibody (MAT) therapy for 12 months. Group 1 consisted of 77 patients receiving NAT therapy, group 2 of 46 patients receiving OCR therapy. To assess the efficacy of therapy, we used indicators of the average frequency of exacerbations per year, EDSS estimates, and MRI data. RESULTS: EDSS score at the time of initiation of MAT therapy was 2.4±1.0 in group 1 and 2.8±1.2 in group 2 (p=0.047); 12 months after the start of MAT therapy, EDSS score in group 1 decreased slightly (p=0.001), in group 2 it has not changed. The frequency of exacerbations per year after the start of MAT therapy was 0.04±0.2 in group 1 and 0.07±0.2 in group 2 (p<0.0001 in both groups). The number of foci accumulating gadolinium detected during the year was 3 in group 1, one in group 2 (p=0.629 between groups). Subgroups of patients who received line 1 DMT (n=22) or NAT (n=21) before the start of OCR therapy were considered separately. In both subgroups, a stable assessment of EDSS was noted, the average annual number of exacerbations did not differ (p=0.117). In patients with RPMS after a year of MAT therapy, EDSS scores were stable, the average annual frequency of exacerbations was 0.08±0.3 per year. CONCLUSION: The administration of MAT therapy led to a statistically significant decrease in the number of exacerbations and stabilization of neurological deficits during the first year of follow-up. After 12 months of therapy, both groups experienced a dramatic decrease in the average annual number of exacerbations, no increase in disability, and positive dynamics according to MRI results. A similar level of OCR efficacy was found in patients who switched from DMT 1 line therapy and NAT.

[Robotic mechanotherapy in patients with multiple sclerosis with impaired walking function]. / Robotizirovannaya mekhanoterapiya u patsientov s narusheniem funktsii khod'by pri rasseyannom skleroze.

OBJECTIVE: To study an effect of robotic mechanotherapy on the functional condition of patients with multiple sclerosis (MS) with impaired walking function using the ExoAtlet exoskeleton. MATERIALS AND METHODS: A prospective open-source, uncontrolled, single-center study included 44 patients (main group, MG) with remitting course in remission (RRS) and secondary-progressive course (VPRS) of MS with 3 to 8 points on the Extended Disability Status Scale (EDSS). Eighteen people (subgroup 1) of this group were re-examined after 3 months and 8 people completed the second rehabilitation course (subgroup 2). Neurological deficits and functional condition of patients were assessed using the EDSS, the Multiple sclerosis functional composite (MSFC) test, which includes the assessment of walking - Timed 25- Footwalk, the assessment of upper limb functions - 9-HolePegTest (9-HPT), the assessment of mental abilities - Symbol Digit Modalities Test (SDMT). Additionally, cognitive functions were assessed by the Montreal Cognitive Assessment Scale (MoCA). RESULTS: The improvement in the EDSS score was 0.23 points (5%, p<0.001) after the first course and 0.64 points (12%, p<0.02) after 3 months. The study of the pyramid system showed an improvement of this indicator by 0.29 points (10.2%, p<0.02) in patients of MG and by 1 point (32.3%, p<0.05) in subgroup 2. The SDMT subtest showed the improvement by 2.3 points (4.5%, p<0.02) in MG. In subgroup 2, the improvement by 17.1 points (38.9%), p<0.05) before the start of the 2nd course and by 22.9 points (52%, p<0.02) at the end of the 2nd course of rehabilitation was observed. The improvement of the Timed 25-Foot walk test in MG patients was 3.1 seconds (19.6%, p<0.001), the 9-Hole Peg Test on the dominant hand was 1.56 seconds (5.1%, p<0.02), and on the non - dominant hand 2.28 seconds (6.2%, p<0.02). After rehabilitation, the MoCA test showed the significant (p<0.001) improvement in cognitive functions by 1.6 points (6.1%) in MG and by 1.9 points (7.5%, p<0.05) in subgroup 2. CONCLUSION: The results have shown the effectiveness regarding the problems in MS patients and the prospects for further study of the possibilities of robotic assistance to walking and support a vertical posture using the ExoAtlet exoskeleton in order to restore walking function in MS patients with motor deficits.

[A study of the efficacy of infibeta in patients with multiple sclerosis based on NEDA-3]. / Izuchenie éffektivnosti lekarstvennogo preparata infibeta u patsientov c rasseiannym sklerozom na osnovanii kriteriev NEDA-3.

AIM: The two-year study of the efficacy of Ifnb-1B (infibeta) in patients with relapsing-remitting (RRS) and secondary progressive multiple sclerosis (SPMS) in the Moscow region with the criteria NEDA-3. MATERIAL AND METHODS: Three hundred patients, 81 men and 219 women, aged from 18 to 67 years, including 227 with RRS and 73 with SPMS, were studied. The duration of disease was from 0.5 to 39 years, the level of neurological deficit on EDSS scale was from 1 to 6.5 points. All patients received infibeta. RESULTS AND CONCLUSION: During the treatment with infibeta, the chance of exacerbation decreased by an average of 39.4 times (OR 39.4 95% CI; 16.6-122.7) during the first year, by 35.3 times (OR 35.3; 95% CI 13.5-131,2) during the second year. A statistically significant decrease in the probability of exacerbation is also confirmed in the conditional logistic regression model (p<0.001). MRI revealed the signs of exacerbation and progression of the disease only in 11.5% of patients; 54.9% of the patients met the criteria NEDA-3. The highest efficacy of infibeta is noted in patients with RRS, more than 3/4 of them responded to therapy with the absence of both clinical and MRI signs of exacerbation and increase in neurodegeneration. Thus, a good clinical result is achieved in patients with RRS and SPMS treated with infibeta. When using the NEDA-3 criteria, a positive result is achieved in more than half of patients.

[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.