[Long-term Efficacy and Safety of Sampeginterferon-ß1a in the Treatment of Relapsing Remitting Multiple Sclerosis: a Randomized, Double-Blind Clinical Trial 104-Week Results]. / Dolgosrochnye dannye po effektivnosti i bezopasnosti preparata sampeginterferon-ß1a u patsientov s remittiruyushchim rasseyannym sklerozom: rezul'taty 104-nedel'nogo randomizirovannogo dvoinogo slepogo klinicheskogo issledovaniya.

OBJECTIVE: To assess the efficacy and safety of sampeginterferon-ß1a (samPEG-IFN-ß1a) 180 µg and 240 µg administered once every 2 weeks compared to placebo and low dose interferon beta-1a (LIB) 30 µg administered once weekly. MATERIAL AND METHODS: Patients with relapsing-remitting multiple sclerosis aged 18-60 years, with Expanded Disability Status Scale score ≤5.5 were randomized at a ratio of 2:2:2:1 to the following groups: samPEG-IFN-ß1a 180 µg, samPEG-IFN-ß1a 240 µg, LIB, placebo. After 20 weeks, the placebo group completed the study. After week 52, the final analysis was performed, which included the primary endpoint analysis, the LIB group patients completed their participation in the study. The patients in samPEG-IFN-ß1a groups continued to receive therapy with samPEG-IFN-ß1a 240 µg until week 100 inclusive. The results of the final analysis after 52 weeks have been previously published. The current article presents a long-term efficacy and safety of samPEG-IFN-ß1a after 104 weeks of the trial. RESULTS: The annualized relapse rate over the second year was 0.16 in the samPEG-IFN-ß1a 180 µg group and 0.09 in the samPEG-IFN-ß1a 240 µg group. By week 104, the proportion of relapse-free patients was 77.0% (87/113) and 83.3% (95/114) in the samPEG-IFN-ß1a 180 µg and 240 µg groups, respectively. There were no negative dynamics of MRI markers, neurological deficit parameters and cognitive functions by scales and tests. The safety profile of samPEG-IFN-ß1a was consistent with the known safety profile of IFN-ß therapy. CONCLUSION: Treatment with samPEG-IFN-ß1a is an effective and safe first-line therapy for relapsing-remitting multiple sclerosis patients.

[Efficacy and safety of sampeginterferon ß-1a in the treatment of relapsing remitting multiple sclerosis: results of 52 weeks of therapy in a randomized, double-blind clinical trial]. / Effektivnost' i bezopasnost' sampeginterferona ß-1a dlya lecheniya remittiruyushchego rasseyannogo skleroza: rezul'taty 52-nedel'nogo randomizirovannogo dvoinogo slepogo klinicheskogo issledovaniya.

OBJECTIVE: To evaluate the efficacy and safety of samPEG-IFN-ß1a 180 µg and 240 µg administered once every 2 weeks for the treatment of relapsing remitting multiple sclerosis (RRMS) compared to placebo and low dose interferon beta-1a (LIB) 30 µg administered once weekly. The primary endpoint after 52 weeks of therapy was the time to first relapse, the hypotheses of non-inferiority and superiority to LIB were tested. MATERIAL AND METHODS: This international, multicenter, double blind, comparative, placebo-controlled clinical study enrolled 399 patients with the diagnosis of RRMS, randomized in 4 groups: samPEG-IFN-ß1a180 µg (n=114), samPEG-IFN-ß1a 240 µg (n=114), LIB (n=114) and placebo (n=57). Placebo group patients participated in the study for 20 weeks. After 52 weeks of therapy and 4 weeks of follow-up, LIB group patients completed their participation in the study, patients from PEG-IFN-ß1a groups continued to receive therapy until week 100 inclusive. The article presents the results of an analysis conducted after the end of 52 weeks of a double-blind, comparative, randomized, placebo-controlled clinical trial. RESULTS: Final analysis of the efficacy and safety was performed after 52 weeks of study. Main statistical hypothesis testing proved that both doses of samPEG-IFN-ß1a were equally effective when compared to LIB by the primary endpoint - «Time to first relapse¼. Due to detection of statistically significant differences in the primary endpoint between the study drug and the reference drug, indicating a greater efficacy of the study drug, an additional testing was carried out and the hypothesis of superiority of samPEG-IFN-ß1a at a dose of 240 µg over the reference LIB was proved. Evaluation of the dynamics of certain key parameters of magnetic resonance imaging (MRI) of the brain and clinical outcomes demonstrated a positive effect of samPEG-IFN-ß1a therapy in the form of decreased activity of the demyelinating process in the brain and reduce the number of relapses. The proportion of patients without new T2 lesions after 52 weeks was 87.6% and 90.4% in 180 µg and 240 µg samPEG-IFN-ß1a groups, versus 72.6% in the LIB group (p=0.0199 and p=0.0033). No progression of multiple sclerosis was shown based on EDSS scale evaluation. During the study, the most common adverse reactions were flu-like symptoms and injection site reactions. CONCLUSION: The new drug samPEG-IFN-ß1a is an effective and safe agent for relapsing remitting multiple sclerosis treatment, while having an advantage over other low-dose interferons in the form of reduced frequency of intramuscular injections.

[Possibilities of art therapy and color therapy in the rehabilitation of multiple sclerosis]. / Vozmozhnosti art-terapii i tsvetoterapii v reabilitatsii pri rasseyannom skleroze.

THE PURPOSE OF THE STUDY: To study the effectiveness of non-drug methods of prevention and rehabilitation of patients with various variants of multiple sclerosis (MS) in outpatient settings. MATERIAL AND METHODS: In a group of 35 patients with limited mobility with various variants of the course of MS, continuous art therapy was performed (art lectures, work with various art materials - markers, pastels, etc.). The average duration of the training cycle in the group was 6 months. Classes were held on an outpatient basis, and if it was impossible to attend classes - remotely. RESULTS: Positive results were obtained in double psychological testing. 68% of patients had decreased levels of depression and anxiety on the HADS scale, 34% of patients refused to take antidepressants. However, positive psychotherapeutic dynamics against the background of art therapy is not a reason to cancel the main basic treatment. CONCLUSION: Art therapy-art therapy and, as its division, color therapy (diagnosis of the condition and treatment of color) is a synthesis of medicine, art and psychology. In MS patients, the following color combinations are recommended when working with art materials:stimulating (red, orange, coral, yellow); soothing (green, blue, blue, purple). Negative colors are excluded - black, gray, dirty shades with a mixture of black or gray.

[A rare clinical case of comorbidity of early-onset Parkinson's disease and remitting multiple sclerosis]. / Redkii klinicheskii sluchai sochetaniya rannego nachala bolezni Parkinsona i remittiruyushchego rasseyannogo skleroza.

Comorbidities of extrapyramidal disorders and multiple sclerosis (MS) are rare. The chance of a combination of MS and Parkinson's disease (PD) is less than 1 in 12.5 million. In total, 42 cases of joint development of these disorders are described in the literature. All described patients had no initial changes in the basal ganglia on MRI, and the development of MS was diagnosed after 1-8 years. Possible common links in the pathogenesis of neurodegenerative disease and MS, as well as the cumulative effect of the two diseases on the severity of axonal degeneration and neuronal loss are discussed. A description of a clinical case of a combination of early onset PD and relapsing-remitting multiple sclerosis is presented.

[Influence of psychopathological factors and personality traits on the results of the study of quality of life in patients with multiple sclerosis]. / Vliianie psikhopatologicheskikh faktorov i osobennostei lichnosti na rezul'taty issledovaniia kachestva zhizni bol'nykh rasseiannym sklerozom.

AIM: To study the influence of psychopathological factors and personality traits on the results of the study of quality of life (QoL) in patients with multiple sclerosis (MS). MATERIAL AND METHODS: Forty-three patients with relapsing MS were included in the study (74.4% female; mean age 33.1 years). SF-36 was used to evaluate QoL. Effects of psychopathological factors, cognitive regulation of emotions and personality traits on QoL were studied. Statistical analysis was performed using multiple linear model. RESULTS AND DISCUSSION: A wide number of strategies of cognitive regulation of emotions has conflicting effects on the physical component of QoL; subscales of anhedonic depression and anxious arousal (MASQ), which probably represent depressive and anxiety disorders, decrease the physical component of QoL. The key factors of the mental component of QoL include psychopathological factors (mostly obsessive-compulsive symptoms) and personality traits (the more intense they are the lower is QoL). Strategies of cognitive regulation of emotions have low impact on the mental component of QoL.

[Results of a phase 1 clinical study of anti-CD20 monoclonal antibody (BCD-132): pharmacokinetics, pharmacodynamics and safety]. / Rezul'taty I fazy klinicheskogo issledovaniia monoklonal'nogo antitela protiv CD20 (BCD-132): farmakokinetika, farmakodinamika i bezopasnost'.

AIM: To study the pharmacokinetics, pharmacodynamics, and immunogenicity of two intravenous dosing regimens of the new anti-B-cells drug BCD-132 (JSC BIOCAD, Russia) at ascending doses in patients with remitting multiple sclerosis. MATERIAL AND METHODS: Twenty-four patients with multiple sclerosis were sequentially randomized in the multicenter open-label uncontrolled multicohort phase I study (3+3 design) and assigned to 4 cohorts (8 groups). Patients in each cohort received an intravenous infusion of BCD-132 at a predefined dose ranging from 100 to 1000 mg based on the planned algorithm of dose escalation if no dose-limiting toxicities occurred. RESULTS: The assessment of the number of cells positive for the main B-cell antigens over time demonstrated a direct effect of BCD-132 on B lymphocytes when used at a wide range of doses (100 to 1000 mg) in patients with remitting multiple sclerosis. No significant variation of the number of T-cells was observed, which clearly proves strict specificity of BCD-132 exclusively to B lymphocytes. CONCLUSION: BCD-132 has an expected pharmacodynamic effect of long-term depletion of CD19+ and CD20+ B lymphocytes and an acceptable safety profile when used to treat patients with remitting multiple sclerosis at all tested doses.

[Changes in the quality of life in patients with multiple sclerosis treated with ocrelizumab]. / Izmeneniia kachestva zhizni patsientov s rasseiannym sklerozom na fone kursa lecheniia okrelizumabom.

AIM: To study the quality of life (QoL) in patients with multiple sclerosis (MS) treated with ocrelizumab for at least 12 months. MATERIAL AND METHODS: Thirty-eight patients were observed, including 13 with primary progressive MS (PPMS), 15 with highly active relapsing-remitting MS (HAMS) and 10 with secondary progressive MS (SPMS) with relapses. QoL was studied using unspecific SF-36 and MS-specific MusiQoL questionnaires. Depression and fatigue were assessed with the Beck Depression Scale (BDS) and the Modified Fatigue Impact Scale (MFIS). RESULTS AND CONCLUSION: Basic characteristics of QoL indexes of the patients were similar to those previously reported for these MS variants. After 6 and 12 months, a significant increase in the indexes of the majority of SF-36 and MusiQoL scales was identified that shows a significant improvement in both physical and psychological domains of QoL. The significant and rapid decrease in depression severity after 6-month treatment with ocrelizumab may at least in part be associated with improvement of indexes of vitality, general health, social relations and the total QoL score.

[The improvement of quality of life of patients with multiple sclerosis over 15-year period]. / Uluchshenie pokazatelei kachestva zhizni bol'nykh rasseiannym sklerozom za 15-letnii period.

In this article, the authors compared the results of the studies on quality of life (SF-36 questionnaire) of large groups of patients with multiple sclerosis conducted in 2000-2003 and 2012-2016 years.

[Primary-progressive multiple sclerosis in Russia: a medical-sociological study involving patients and neurologists]. / Pervichno-progressiruiushchii rasseiannyi skleroz v Rossii: mediko-sotsiologicheskoe issledovanie s uchastiem patsientov i nevrologov.

The main results of a medical-sociological study aimed at the evaluation of the level of satisfaction with treatment in patients with primary progressive multiple sclerosis (PPMS) are presented. The survey was conducted in 19 regions of the Russian Federation and involved 437 patients with confirmed diagnosis of PPMS and 80 neurologists specialized in multiple sclerosis. The research was carried out by the All-Russian Public Organization of Disabled People with Multiple Sclerosis with the participation of the Russian Committee for Treatment and Research in Multiple Sclerosis. This is the first medical-sociological study in the Russian Federation involving patients with PPMS and neurologists. The study revealed typical medical and social problems patients with PPMS faced. A significant decrease in quality-of-life of PPMS patients was shown.

[Additional possible mechanisms of the action of ocrelizumab in multiple sclerosis on example of a case-report]. / Vozmozhnye dopolnitel'nye mekhanizmy deistviia okrelizumaba pri rasseiannom skleroze na primere klinicheskogo sluchaia.

Anti-B-cells products, including the anti-CD20 monoclonal antibody ocrelizumab, are widely coming to multiple sclerosis (MS) therapy. Its clinical-MRI efficacy in MS with relapses as well in primary progressive MS (PPMS) was proved by three phase III clinical studies. One example of the use of ocrelizumab use in aggressive MS showed the possibility of action on the leptomeningeal folliculi, seen at contract-enhancing MRI images.

[The results of a randomized open multicenter comparative study on the tolerability and safety of gilenya (fingolimod) in patients with remitting multiple sclerosis]. / Rezul'taty randomizirovannogo otkrytogo mnogotsentrovogo sravnitel'nogo issledovaniia perenosimosti i bezopasnosti preparata gilenia (fingolimod) u patsientov s remittiruiushchim rasseiannym sklerozom (GIMN).

At the present time, disease modifying drugs (DMD) for treatment of patients with multiple sclerosis are used to reduce the risk of exacerbations and, consequently, slowing the progression of disability in accordance to treatment standards. However, the application of the first line of this therapy is not always successful. In these situations, patients receive second-line DMD. Fingolimod is one of the second-line drugs in Russia. To gain experience in using fingolimod in routine neurological practice, we have conducted a post-marketing research - GIMN.