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Objective: To assess the outcomes of long-term treatment in multiple sclerosis (MS) patients with Infibeta (interferon beta-1b)., Material and Methods: The article presents the results a real-world, multicenter, retrospective, observational study of treatment with interferon beta-1b. We enrolled 332 patients with MS who had been receiving Infibeta for at least 8 years. 60.2% of them had a relapsing-remitting MS (RRMS). 73.2% patients received only interferon beta-1b that was initial DMT., Results: During the first year of the treatment, 66% of the patients reported no relapses regardless of the MS type. No relapses in the 8 th year of treatment were observed in 86.9% of patients with RRMS and 77.7% with secondary progressive MS (SPMS). The median number of relapses during the whole follow-up period in RRMS patients was 1. The time to first relapse in the subgroup of patients who received interferon beta as the first treatment was longer compared to other treatment (median 4 and 2, respectively, p =0.0017). 42% of patients with RRMS remained progression-free during 8 years of follow-up. The flu-like syndrome was observed in 61.7% for the first year of treatment; in 36.3% it was periodically and was mild in 71.3%., Conclusion: The study outcomes confirm a high clinical response to the long-term treatment with Infibeta in patients with RRMS and SPMS and demonstrate that interferon beta-1b is one an optimal option for the initial treatment of patients with moderate disease activity.

One of the target areas for the development of the Russian pharmaceutical industry at present is the development of next-in-class drugs medicines. These are original, patent-protected drugs that act on known biological targets, improved or modified in structure and mechanism of action compared to existing, successfully proven medicine. The article presents the results of an expert council on the management of patients with multiple sclerosis and the place of new original medicines of the JSC BIOCAD company (SamPEG-IFN-β1a and divozilimab) in multiple sclerosis therapy algorithm.

Alemtuzumab (Lemtrada) is a recombinant humanized IgG1 kappa monoclonal antibody to the surface cell glycoprotein, a CD52 differentiation cluster. The drug is approved for use in more than 65 countries, including the Russian Federation. The drug is one of the most effective methods of treating patients with aggressive multiple sclerosis, but the risk management plan should be followed. The safety profile of the drug includes infusion-associated reactions, thyroid dysfunction, immune cytopenia, acute cardiovascular events, infections, and other autoimmune diseases. This publication provides updated practical recommendations for the use of the drug and ensuring the safety of patients treated with alemtuzumab.

Multiple sclerosis is a central nervous system disease with autoimmune and neurodegenerative mechanisms of development. This disease can lead to severe disability and neurological defects. Although its etiology and pathogenesis remain unclear, research data show that multiple sclerosis is a multifactorial disease, the development of which depends on environmental factors, as well as a genetic predisposition. The impact of these factors lead to the death of neural cells, accompanied by demyelination of nerves and neuronal dysfunction. Therapy of multiple sclerosis is based on the use of anti-inflammatory and immunomodulating substances, however, there are certain disadvantages associated with the constant use of these drugs and a possible change in dosage over time. This review discusses the pathogenesis of multiple sclerosis and the role of various subpopulations of immune cells in the development of diseases, as well as existing approaches to therapy. It is noted that immunoreconstitution therapy has advantages over immunomodulation and immunosuppression maintenance therapy for some patients. Thus, short courses of therapy provide more adequate treatment for patients and lower risks of adverse events associated with chronic immunosuppression. The review also discusses the data of clinical studies on the immunoreconstitution therapy drugs, such as alemtuzumab, ocrelizumab and cladribine. It is noted that nowadays the exact mechanisms underlying this type of therapy remain unclear. In this regard, further studies are needed to explain the therapeutic effects. It is assumed that patients with a high risk of multiple sclerosis progression are the optimal group of patients for the early use of selective immunoreconstitution therapy. Thus, immunoreconstitution therapy may be the treatment of choice for many patients with highle active multiple sclerosis.

The clinical course of multiple sclerosis (MS) is characterized by great variability. 'Aggressive' MS, a concept used in the last 10 years, is associated with atypical course of the disease, which is manifested by more frequent exacerbations, the rapid increase in disability and pronounced signs of radiological activity according to MRI. The review presents data on the effectiveness of three monoclonal antibody drugs - natalizumab, alemtuzumab and ocrelizumab. In addition, updated data on the safety of monoclonal antibodies are presented to help the physician make a balanced choice of a drug and therapy strategy.

Aim: To study the efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis (SPMS) in the Russian population of the EXPAND study., Material and Methods: Ninety-four patients with SPMS from Russia were included in the analysis. Sixty-three patients received siponimod and 31 patients received placebo. The primary endpoint of the study was time to 3-month confirmed disability progression (3m-CDP) events, other clinical and radiological endpoints were also evaluated., Results: The siponimod group showed a 54% reduction in the risk of 3m-CDP compared with the placebo group (p=0.0334). Secondary endpoints also showed the advantage of the drug over placebo. In the siponimod group, mild adverse events associated with impaired liver function, as well as arterial hypertension, were more common. No patient left the study due to an adverse event., Conclusion: The use of siponimod in patients with SPMS in the Russian population reduced the risk of disability progression. Siponimod showed a favorable safety profile.

Modern multiple sclerosis therapy with disease-modifying drugs is characterized by the risks of dangerous infectious complications. In the last 5 years, there have been several reports of severe, sometimes lethal, listeriosis infection in patients treated with alemtuzumab. This article presents a clinical case of lethal listeriosis meningoencephalitis, which developed within 7 days after the completion of the first cycle of alemtuzumab therapy. In January 2018, a meeting of the expert Council was held, at which the clinical recommendations published in 2017 were revised and updated.

The emergence of modern methods of immunohistochemistry and further development of MRI has led to a deeper understanding of gray matter (GM) pathology in multiple sclerosis (MS). GM involvement can be extensive including both demyelination (cortical lesions) and neuroaxonal damage. The mechanisms of GM damage in MS remain insufficiently studied. There are two concepts: the lesion of GM is primary and is paralleled by changes in white matter (WM), or secondary, i.e. it is a consequence of the pathological process in WM. More research into GM pathology using the latest MRI techniques will contribute to the understanding of pathological changes in both cortical and subcortical GM.

New terminology used by neurologists with multiple sclerosis (MS). The current use of terms 'definite' MS, 'MS signs', 'retrobulbar neuritis' and 'optic neuritis', 'relapse and exacerbation, types of MS course, criteria of effectiveness of MS therapy, NEDA, NEP, NEPAD; the classification therapy methods - 'escalation', 'induction' and therapy of immune reconstitution (TIR), therapy of maintenance/escalation (TME) and discussed.

Multiple sclerosis is a chronic demyelinating and neurodegenerative disease of the central nervous system, in which autoimmune inflammation and oxidative stress play essential pathogenetic roles. Activation and infiltration of immune cells in brain tissues, lipid peroxidation products, mitochondrial dysfunction, defective antioxidant protection, and many other pathological factors result in demyelination, axonal injury and death, and apoptosis of oligodendrocytes and neurons, all of which causes constant progression of the disease. The new oral agent for the treatment of relapsing-remitting multiple sclerosis (RRMS), dimethyl fumarate (DMF), helps change the pathogenetic mechanisms of the disease, thus decreasing the rate of exacerbations, slowing down disease progression, and reducing the risk of radiological progression of the disease.

Long-term disease modifying therapy (DMD) therapy is the basis of modern MS treatment, effiecacy of which is modulated by the patient's adherence to therapy. One of the possible solutions of low adherence improvement is the use of innovative drugs and the development of more convenient regimens of injectable medications. This article gives a brief review of peg-interferon β-1a clinical trials.

The importance of MRI stuides in the control over treatment efficacy in multiple sclerosis and appropriate recommendations on drug substitution during treatment are discussed. We suggest low, middle or high risk in respect to the efficacy of current treatment. Accordingly, drug substitution can be related with the low level of fears for all three criteria or the moderate level for any two criteria or the high level for any one criterion. Since MRI criteria are important, this model appears to be the most rational because the physician can make a decision about treatment escalation if the patient has ≥3 new T2-lesions or ≥3 contrast-enhanced T1-lesions.

Teriflunomide is a novel oral medication for relapsing remitting multiple sclerosis (RRMS), which has demonstrated it's efficacy in relapse rate reduction. It's efficacy has been confirmed by MRI results as well. It is safe and well-tolerated, with mild and transitory side effects. Nevertheless, risk management plan should be applied to minimize and monitor possible adverse events.

Unlabelled: The aim of the study was to assess the capabilities of diffusion kurtosis imaging (DKI) in diagnosis of the glioma proliferative activity and to evaluate a relationship between the glioma proliferative activity index and diffusion parameters of the contralateral normal appearing white matter (CNAWM)., Material and Methods: The study included 47 patients with newly diagnosed brain gliomas (23 low grade, 13 grade III, and 11 grade IV gliomas). We determined a relationship between absolute and normalized parameters of the diffusion tensor (mean (MD), axial (AD), and radial (RD) diffusivities; fractional (FA) and relative (RA) anisotropies) and diffusion kurtosis (mean (MK), axial (AK), and radial (RK) kurtosis; kurtosis anisotropy (KA)) and the proliferative activity index in the most malignant glioma parts (p<0.05). We also established a relationship between the tensor and kurtosis parameters of CNAWM and the glioma proliferative activity index (p<0.05)., Results: The correlation between all the absolute and normalized diffusion parameters and the glioma proliferative activity index, except absolute and normalized FA and RA values, was found to be statistically significant (p<0.05). Kurtosis (MK, AK, and RK) and anisotropy (KA, FA, RA) values increased, and diffusivity (MD, AD, RD) values decreased as the glioma proliferative activity index increased. A strong correlation between the proliferative activity index and absolute RK (r=0,71; p=0.000001) and normalized values of MK (r=0.8; p=0.000001), AK (r=0.71; p=0.000001), RK (r=0.81; p=0.000001), and RD (r=-0.71; p=0.000001) was found. A weak, but statistically significant correlation between the glioma proliferative activity index and diffusion values RK (r=-0.36; p=0.014), KA (r=-0.39; p=0.007), RD (r=0.35; p=0.017), FA (r=-0.42; p=0.003), and RA (r=-0.41; p=0.004) of CNAWM was found., Conclusion: DKI has good capabilities to detect immunohistochemical changes in gliomas. DKI demonstrated a high sensitivity in detection of microstructural changes in the contralateral normal appearing white matter in patients with brain gliomas.

Objective: To study the efficacy and tolerability of generics (interferon beta-1a biosimilans) cinnovex for intramascular introduction and genfaxon-44 for subcutaneous injections in multiple sclerosis (MS)., Material and Methods: One hundred patients were treated with cinnovex and 104 patients were treated with genfaxon-44 during one year. Patient's status was assessed using clinical approach, psychometric scales and MRI., Results and Conclusion: The high percentage of withdrawal of treatment due to the lack of clinical effect and intolerance to the drugs was identified during the treatment. Positive effect with respect to stabilization of MS course was found only in patients who earlier did not receive disease-modifying drugs. Double-blind studies are needed to resolve the question of the adequacy of brand-name drugs and generics.

Pulse-doses of corticosteroids are actively used in the treatment of multiple sclerosis relapses. Short pulse-treatment is usually well-tolerated by patients though side-effects may be observed. We described a rare case of transient global amnesia after the pulse-treatment with corticosteroids. A complex examination excluded other causes of amnesia.

Multiple sclerosis is now regarded as a disease, which is based on genetic predisposition. Trigger mechanism are various exogenous factors. The Epstein-Barr virus is thought to be a trigger. This report provides information about possible mechanisms of the influence of the Epstein-Barr virus on the development of multiple sclerosis.

We summarized the 1-year experience of using the Russian Β-interferon-1b biosimilar (infibeta) in 123 patients including 65 patients with relapsing-remitting multiple sclerosis (RMS) and 58 patients with secondary progressive multiple sclerosis (SPMS). The significant decrease in the frequency of exacerbations per year was seen during the first year of treatment. We also noted the stabilization of the process of disability without the rise in EDSS scores in more than 50% of patients. Good tolerability comparable to that of the original drug was observed during the first year of treatment. There was no refusal from therapy with infibeta, which indicated sufficiently strong adherence to this type of treatment.

Experience of 10-year administration of glatimer acetate (copaxone) in 74 patients with active remitting multiple sclerosis is summarized. The significant decrease in the frequency of exacerbations was seen over these ten years. Disease severity on the EDSS was stable and decreased only to the end of the 10-year period. The positive stable clinical dynamics did not depend on the disease severity at baseline. The drug was well-tolerated that allowed to control the course of multiple sclerosis: 64.8% of patients had no more than one exacerbation over 10 years and in 71.6% patients, the disease progression was absent or minimal (less than one score on EDSS). It has been concluded, that the long-term 10-year treatment with copaxone enables to control the development of disease in many patients.

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.

The experience of the treatment of patients with remitting multiple sclerosis (MS) with intramuscular introduction of beta-interferon-1a (avonex) is presented. Seventeen children and adolescents, aged from 11 to 18 years, and 55 adults, aged over 55 years, were treated for at least one-year period. Results revealed a significant reduction of exacerbations in both groups (from 1.35 to 0.06 in average in adolescents and from 0.86 to 0.17 in adults). The changes were accompanied by the stabilization of MS severity index: EDSS scores have decreased in 23.6% of adults and in 17.6% of adolescents. In both groups, good tolerability of the treatment was noted. There was a low probability of side-effects with the exception of increased frequency of a flu-like syndrome (47% cases) in patients younger than 18 years that demands special attention from children neurologists. The high efficacy and good tolerability and safety profile of beta-interferon-1a give grounds for administering this drug to children and adolescents with MS.

We summarized the 3-year experience of using beta-interferon 1a (44 mcg, subcutaneously) in the form of the preparation rebif in 141 patients including 120 patients with active remitting multiple sclerosis (RMS) and 21 patients with secondary progressive MS (SPMS). All patients were examined every three months. The significant decrease in the frequency of exacerbations per year was seen already during the first year of treatment. EDSS scores remained stable in 47.37% of all RMS cases and in 57.14% of all SPMS cases during the first year. A one point and more increase of EDSS was found only in 5.26% patients during three years of treatment. The drug was well tolerated during the long period, adverse effects were found in 16.31%, with a flu-like syndrome in the first place. Only 1.42% of patients refused treatment. All other patients were highly motivated and adherent to treatment.

A complex study of 50 patients with active typical remitting multiple sclerosis (MS) was carried out. Neuropsychological testing using Wechsler and Stroop tests and MRI of the brain with the morphometric analysis of focal and diffusive changes were used in the study. Patients were stratified into two subgroups by the changes in the performance of neuropsychological tests. The disease course was assessed during five years. In all cases, the natural course of the disease, i.e. when patients did not receive disease modifying drugs, was analyzed. The transition to secondary progressive MS and the marked increase in MS severity on the EDSS were found in the subgroup of patients who demonstrated changes in the neuropsychological test performance. The strongest correlation was observed between EDSS scores and the diffusive atrophy of the brain white matter on MRI. The data of neuropsychological testing and some brain MRI parameters may be recommended as a predictive test in remitting MS.

Adherence to long-term therapy is a necessary condition of successful long-term treatment of the such chronic disabling disease as multiple sclerosis (MS). We studied factors associated with the rejection of treatment with disease modifying drugs (DMD) in 153 patients of the Moscow multiple sclerosis center who received or rejected the DMD treatment by their own choice. The groups were compared by neurological, socio-demographic and neuropsychological characteristics. The EDSS, HADS and the original socio-demographic questionnaire have been administered. Patients receiving glatimer acetate rejected the treatment less often compared to those receiving other DMD. The withdrawal of any DMD in the anamnesis predicted the future rejection of treatment. The first four months was the most risky period with respect to the rejection. Lack of family support, absence of work and age were independent factors associated with the rejection of DMD. Marked anxiety, lack of cooperation and lack of compliance were associated with the patient's rejection of treatment. No significant correlations of the treatment rejection, duration and type of MS course with depression were found.

Multiple sclerosis (MS) is a progressive disease that leads to early disability of young adults at a reproductive age. Motor disturbances caused by progressive pyramidal deficit and cerebellar dysfunction, accompanied by ataxia with frequent falls, and early decrease of physical activity are risk factors of osteoporosis in MS patients. A relapsing-remitting course of the disease with frequent attacks demands multiple courses of steroid therapy. Long-term steroid treatment causes bone loss and development of secondary osteoporosis. We have shown that reduced bone mineral density (BMD) in lumbar spine and femoral neck is associated with high level of EDSS score caused by the combination of moderate pyramidal and cerebellar dysfunction. An additional risk factor of osteoporosis in MS patients is low body weight. The glucocorticoid therapy does not exert a negative impact on BMD in lumbar spine and femoral neck in patients with MS.

The currently available treatment of definite multiple sclerosis (MS) includes different preparations of interferon beta. Recently reported data of pathomorphological, MRI, MR-spectroscopy and immunohistochemical studies suggest that axonal damage secondary to inflammation appears at the very early stage of MS. Early pathological events can predict a future course of the disease. Inflammatory activity in relapsing MS does not confine to episodes of clinical impairment but often develops before the first episode and generally continues during remissions. Patients with clinically isolated syndrome (CIS) and an abnormal brain MRI scan are at high risk of developing clinically definite MS (CDMS). If the presence of lesions predisposes to MS, the number of lesions determines when disability will develop. The results of interferon beta trials in patients with CIS showed significant benefit of the treatment in decreasing risk of CDMS development.

In last decades, practical neurologists are able to use DMT in multiple sclerosis (MS) in every day practice. This paper presents data of 3-year study of DMT (copaxone and betaferon) treatment of 280 patients with definite diagnosis of multiple sclerosis (MS), 166 patients regularly receiving DMT (104--copaxone and 62--betaferon) for, at least, 3 years. Clinical symptoms of the patients, reasons of treatment withdrawal (48--copaxone and 31--betaferon) and the features of MS course after the withdrawal are analyzed. Patients who received betaferon previously had more severe MS course with frequent relapses, half of them had secondary progressive MS course (SPMS) with relapses. This made impossible a direct comparison of the data of two treatment groups. Treatment with copaxone reduced 5 times annual relapse rate, from 1.45 before DMT to 0.27 during these 3 years (p < 0.001), and this reduction remained stable. For 36 months, 40.4% of patients were relapse-free though all of them had, at least, one relapse per year before the treatment. No EDSS progression was observed in 80% of these patients. Treatment with betaferon caused the reduction of relapse rate from 1,84 to 0,69 per year (2.7 times), 8 patients (26%) with previously active RMS being relapse-free for 36 months. In 31 patients with SPMS, the reduction of relapse rate was also significant, from 1.89 to 0.49 (3.8 times, p < 0.001). Twenty-two patients (71%) with previous SPMS did not have EDSS progression for 36 months that indicate the positive effect of the therapy. Side-effects were moderate and were not the main cause of the treatment withdrawal. The latter was caused mainly by clinical un efficacy, most frequently by the increase of EDSS due to transformation of the MS course to SPMS without relapses and poor understanding by the patient of the goals and the possibilities of DMT. These facts stress the significance of improving compliance, motivation and adherence to DMT in everyday neurological practice.

The diagnosis of multiple sclerosis (MS) is a life-altering experience that has far-reaching and diverse implications for newly diagnosed patients and their families. Since the disease is complex and highly variable, it places physical, emotional and social challenges on everyone concerned. A number of responsible decisions must be made, the most difficult one being the consent to long-term therapy. Joint effort of both physicians and patients allow the latter to take up properly new life circumstances, get adequate motivation, right and regular implementation of the long-term treatment plan aiming to prevent the disease progression. The management of many chronic diseases involves medications that must be injected on the frequent basis. In MS, such injections can reduce the frequency of relapses and slow the disease progression. Pretreatment injection self-efficacy expectations, injection anxiety, therapeutic expectations and ability to self-inject are significantly related to adherence. Poor patient adherence to long-term therapy severely compromises the treatment effectiveness.

The latest data on clinical effects of beta-interferon-1b (betaferon) in different clinical types of multile sclerosis (MS) are discussed in this review. All local and systemic side effects of this treatment are discussed as well as possible influence of neutralizing antibodies (NAB) on clinical efficacy of this treatment. Moderate and easily treated side effects as well as the absence of significant evidence for modulation of positive clinical effects of beta-interferons by NAT allow one to consider this medicine as one of the basic methods of MS treatment.

146 patients with multiple sclerosis are treated by copaxone in the Moscow MS Centre. The relaps exacerbation rate decreased by 72%, the relapse rate reduced by 25.6% during the copaxone treatment. EDSS score did not increase both in group with and without relapses. The condition of 2/3 patients was stable. To achieve the best effect of treatment the program of patient support was successfully used in the Moscow MS Centre.

Recently, beta-interferons have become the first line medicine of pathogenic treatment of multiple sclerosis (MS). 75 MS patients from Moscow received the treatment with beta-interferon-1b (betaferon). Clinical, genetic and MRI data on 48 of them were included in detailed statistical analyses. High basic frequency of relapses, absence of atrophy of the brain at the first MRI scans and the presence of HLA-DRB1*15 (less significant DRB1*0301 and DRB1*04) were associated with better clinical effects of one year Betaferon course--decrease of relapses frequency and delay in EDSS progression.