In March 2020, oral cladribine was licensed in Russian Federation for the treatment of adult patients with highly active relapsing multiple sclerosis as defined by clinical or imaging features. Three years after the introduction into the Russian market, practical aspects in the use of cladribine tablets we evaluated, including data from real-world studies and the experience gained in the own routine clinical practice. Early initiation of cladribine therapy, use of cladribine in treatment naïve patients and patients with suboptimal response to previous disease-modifying therapy, use of cladribine as the treatment of choice in patients with suboptimal response to platform disease-modifying therapy and washout period while switching to cladribine from other disease-modifying therapy. During the discussion thirteen neurologists from federal and regional centers experienced in multiple sclerosis diagnosis and therapy were asked to answer several questions regarding the practical use of cladribine tables and come to consensus opinion. Consent was reached if at least 75% of the experts agreed on a particular statement. The experts agreed on the possibility to switch patients to cladribine from platform disease-modifying therapy in case of MRI activity or neutralizing antibodies in the absence of relapses activity to achieve better disease control, potential cladribine effects on progression independent of relapses, washout period reduction while switching from natalizumab to cladribine. Consensus opinion will help to manage practical questions regarding cladribine usage.

Multiple sclerosis (MS) is an autoimmune-inflammatory and neurodegenerative disease of the central nervous system. The article analyses the ability of cladribine, which due to its selective lymphotoxic effect on activated cells and central effect on immunomodulation in brain tissue underwent successful clinical trials in 2010, when it was (temporarily) approved in Russia.Objective: to analyse the effect of cladribine tablets in daily practice on the course of MS over 3–4 year observational period after immune reconstitution therapy (IRT) in several neurological clinics from different regions of Russia.Material and methods. We collected data on 235 patients from 12 neurological clinics and regional MS centres who were followed for an average of 3.4 years after starting cladribine treatment.Results. An independent analysis of cases in which cladribine tablets were prescribed showed that the reason for prescribing cladribine was highly active MS (HARS) in 159 (67.7%) patients, rapidly progressive MS (RPMS) in 20 (8.5%), active relapsing-remitting MS – in 50 (21.3%) and secondary progressive MS with exacerbations – in 6 (2.5%). Only 12 (5.1%) of these patients had not previously received disease-modifying therapies (DMTs), i.e. in these cases the drug was the first DMT prescribed. Among patients who had received a second-line DMTs before switching to cladribine, 22 had previously received natalizumab, 5 had received ocrelizumab and only 1 had received fingolimod. Remaining patients (n=195) were switched from first-line DMTs. In all cases, a decrease in the frequency of exacerbations was observed during and after completion of the IRT course. Exacerbations between the first and second course of cladribine were observed in 36 patients (15.3% of all treated patients), including in almost half of the cases those who were switched from natalizumab (17 exacerbations or 47.2% of all exacerbations, that developed between the first and second course of therapy) and in three cases – from ocrelizumab (8.3 % of exacerbations that developed between the first and second course of therapy, or 60 % of all those switched from ocrelizumab to cladribine). After completion of full cladribine treatment during the four-year observation period, exacerbations occurred in 14 patients (6% of all patients included in the analysis), six of which occurred after switching from natalizumab.Conclusion. The results are generally consistent with the results of recently published meta-analyses and reviews, but the high likelihood of exacerbations in patients switched from second-line therapies such as natalizumab and ocrelizumab is noteworthy. Both drugs are prescribed for aggressive types of MS with exacerbations (highly active and rapidly progressive) who had a high frequency of exacerbations and an increase in Expanded Disability Status Scale (EDSS) scores prior to being prescribed these drugs. The switch from natalizumab is usually due to an increased risk of developing progressive multifocal encephalopathy with a high titre of antibodies against the JC-virus and the duration of natal izumab use of more than 2 years. It is likely that the resumption of MS activity after discontinuation of natalizumab is quite pronounced, and replacement with treatment with cladribine in tablet form is not able to completely prevent this. In this respect, such a switch does not appear to be optimal, in contrast to cases where first-line drugs are switched to cladribine.

SinnoVex is a drug from the group of bioanalogues of interferon beta-1a for intramuscular administration, which has moderate efficacy in reducing clinical exacerbations of multiple sclerosis (MS), which is most pronounced in the initial treatment of relapsing-remitting MS (RRMS) with low or moderate disease activity.Objective: to analyze the experience with the use of the drug SinnoVex in several parallel studies in the Russian population of patients with RRMS.Material and methods. We analyzed the results of three retrospective post-marketing clinical trials, in which we compared the efficacy and safety of the use of interferon beta-1a for once-weekly intramuscular administration under the trade name SinnoVex in the treatment of the Russian population of patients with RRMS with other MS disease-modifying treatments (DMTs), in particular with high-dose interferons beta-1a and interferons beta-1b for subcutaneous administration. The total number of patients who received therapy with SinnoVex was 235 subjects. The efficacy of the therapy was assessed using the following indicators: average annual frequency of exacerbations, MRI activity, achievement of the NEDA-3 indicator. The safety of the therapy was evaluated based on the occurrence of adverse events (AEs) and their severity as well as the frequency of discontinuation of the drug.Results. Based on the results of the studies presented, no statistically significant differences in the clinical efficacy or tolerability of the intramuscularly administered SinnoVex preparation compared to other drugs of the interferon beta group were found. The spectrum and severity of AEs were in line with expectations; no unexpected AEs were observed.Conclusion. Among the important advantages of the drug are the relatively rare intramuscular injections and rare local skin AEs after injections, which significantly increase the benefit of the drug in young patients. In this regard, SinnoVex is most commonly used as an initial drug as part of an escalation approach to the treatment of RRMS and then needs to be replaced by more highly effective firstor second-line DMTs if efficacy is insufficient.

OBJECTIVE:To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg every 24 weeks during 100 weeks for the treatment of patients with multiple sclerosis (MS), including relapsing-remitting multiple sclerosis (RRMS) and secondary progressive MS (SPMS) with relapses.MATERIAL AND METHODS:The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS (NCT05385744) included 338 adult patients with MS distributed in a 1:1 ratio into two groups: DIV 500 mg and teriflunomide (TRF) 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks, then entered an additional period from weeks 49 to 100, which included three cycles of therapy. The efficacy was assessed based on the results of brain MRI and registration of data on relapses.RESULTS:308 subjects completed 5 therapy cycles according to the study protocol. An analysis of the effectiveness of DIV therapy over 2 years showed a persistent suppression of MRI and clinical activity of the disease in comparison with TRF, which was confirmed by all the studied MRI indicators (including CUA; total number of gadolinium-enhancing (GdE) lesions on T1-weighted scans ; number of new or enlarged lesions on T2-weighted scans; lesions volume change on T2-weighted scans; change in the volume of hypointense lesions on T1-weighted scans). The use of DIV was associated with a statistically significant decrease in ARR compared to TRF (p=0.0001). The ARR in the DIV group was 0.057, in the TRF group - 0.164 with 95% confidential interval for the frequency ratio [0.202; 0.593]. The incidence of GdE lesions on T1-weighted scans in the DIV group was significantly lower than in the TRF group. The average number of such lesions was 0.0±0.08 and 1.0±4.46 in the DIV and TRF groups, respectively (p<0.0001). Progression of EDSS was detected in 18 (10.7%) and 36 (21.3%) patients in the DIV and TRF groups, respectively (p=0.0075). The proportion of patients with relapses was 11.2% (n=19) in the DIV group and 23.1% (n=39) in the TRF group (p=0.0039). In the subpopulation of patients with SPMS, no cases of increase in EDSS were detected, and not a single case of exacerbation was recorded over 2 years of using DIV. Also, DIV has shown a favorable safety profile. Among the adverse reactions (AR), infusion reactions and laboratory abnormalities, such as a decrease in the number of leukocytes, neutrophils, and lymphocytes, were most often recorded. Identified AR were expected, had mild to moderate severity, and resolved without any negative consequences.CONCLUSION:The results of the BCD-132-4/MIRANTIBUS CT indicate a high sustained efficacy and safety of long-term use of DIV in comparison with TRF during 2 years of therapy.

OBJECTIVE:To assess the efficacy and safety of sampeginterferon-β1a (samPEG-IFN-β1a) 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-β1a 180 µg, samPEG-IFN-β1a 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-β1a groups continued to receive therapy with samPEG-IFN-β1a 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-β1a after 104 weeks of the trial.RESULTS:The annualized relapse rate over the second year was 0.16 in the samPEG-IFN-β1a 180 μg group and 0.09 in the samPEG-IFN-β1a 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-β1a 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-β1a was consistent with the known safety profile of IFN-β therapy.CONCLUSION:Treatment with samPEG-IFN-β1a is an effective and safe first-line therapy for relapsing-remitting multiple sclerosis patients.

OBJECTIVE:Clarification of the characteristics and dynamics of changes in the main indicators of visual evoked potentials (VEP) for a reverse chess pattern in patients with multiple sclerosis (MS) at various stages of the disease and severity of disability.MATERIAL AND METHODS:The study of VEP was carried out on 477 subjects, 120 of which were healthy volunteers and 357 patients with MS, including those with clinically isolated syndrome (CIS; 22.7%), remitting course (RT; 55.7%), primary progressive course (PPT; 8.4%), secondary progressive course (VPT; 13.2%). Disability was assessed using the Expanded Disability Status Scale (EDSS).RESULTS:A high sensitivity of VEP in the detection of demyelinating damage to the visual pathways, including subclinical, was noted already at the initial stages of MS, which increases with the progression of the disease from 77.8 to 97.8%. There was a significant increase in latency (r=0.42, p<0.05) and a decrease in amplitude (r= -0.26, p<0.05) of the P100 peak as the EDSS score increased. In patients with MS, 5 patterns of VEP were identified depending on the level and severity of damage to the visual pathways, where pattern 1 is normative VEP, pattern 5 is the absence of VEP recording in case of a pronounced axonal-demyelinating lesion of the visual pathways (prechiasmal/postchiasmal levels). Patterns 1 and 2 are most typical for CIS (22.2 and 53.1%) or RT (20.1 and 26.6%). Patterns 3 and 4 are typical for APT (70 and 20%) and VPT (48.9 and 21.3%), pattern 5 - for VPT (19.1%). Patterns 3-5 predominated in patients with higher EDSS (r=0.54, p<0.05).CONCLUSION:The classification of VEP changes into patterns makes it possible to identify the dissemination of a focal lesion in the projections of the visual pathways, which increases the diagnostic efficiency of the study and makes it possible to assess the severity of MS.

Multiple sclerosis (MS) in children and adolescents is a genuine concern of pediatric neurology that specialists in all countries are dealing with. To date, neither the causes of onset nor the individual components of the pathogenesis of the disease have been reliably clarified, and the modern, changing picture of the clinical manifestation of the disease sometimes complicates timely diagnosis even in adult patients. There are more such questions in pediatric MS.Objective: to study the prevalence and clinical features of MS in children in the Republic of Tatarstan.Material and methods. We conducted a survey and data analysis of 128 children and adolescents aged 0 to 18 years inclusive. The examination of patients included neurological examination according to the classical scheme, neuroimaging examination, neurophysiological examination and cerebrospinal fluid examination. The diagnosis was based on the current (as of the time of diagnosis) criteria of McDonald and the International Pediatrics MS Study Group criteria. The severity of the patients' clinical condition was assessed using the Expanded Disability Status Scale (EDSS).Results. MS was diagnosed in 99 cases (77.3%), clinically isolated syndrome – in 10 (7.8%), acute disseminated encephalomyelitis – in 5 (3.9%), bilateral optic neuritis – in two patients (1.6%), disseminated encephalomyelitis – in one case (0.8%); other central nervous system diseases were diagnosed in 11 (8.6%) patients. After a detailed examination, the group “other diseases of the central nervous system” included such conditions as cerebral angiopathy, neurofibromatosis, brain mass, structural focal epilepsy, sequelae of viral encephalitis, and hereditary leukodystrophy. Among the patients, girls aged 15–17 years predominated. Monofocal manifestations were more frequently observed at debut. Moreover, the absolute predominance of the remitting type of course was also noted.Conclusion. The data obtained suggest a predominance of the predominantly remitting course type of MS with a monofocal onset, which is consistent with data from other studies of MS in pediatric practice.

OBJECTIVE:To find the optimal therapeutic dose of the anti-B cell mAb divozilimab (DIV) based on the efficacy and safety data of intravenous administration at a dose of 125 mg or 500 mg in patients with relapsing remitting multiple sclerosis (RRMS) compared to placebo (PBO) and teriflunomide (TRF). To study the efficacy and safety of DIV within 24 weeks of treatment.MATERIAL AND METHODS:A multicenter, randomized, double-blind and double-masked, placebo-controlled phase 2 clinical trial (CT) BCD-132-2 involved 271 adult patients with RRMS from 25 centres In Russia. Patients were randomly assigned (2:2:2:1) into 4 groups: TRF, DIV 125 mg, DIV 500 mg and PBO. After screening patients entered to the main period, which consisted of one cycle of therapy for 24 weeks. The primary endpoint was the total number of gadolinium-enhancing T1 lesions (Gd+) observed on brain MRI scans after 24 weeks (per scan - involves estimating the mean value of the score from all the MRI assessments performed for each participant in the study).RESULTS:263 patients completed 24 weeks of treatment. Most of the patients in the DIV groups had no lesions on T1-weighted MRI after 24 weeks of treatment (94.44% on 125 mg and 93.06% on 500 mg). In the TRF and PBO groups the values were significantly lower: 68.06% and 56.36% respectively (both p<0.05). The proportions of relapse-free patients in the DIV groups were 93.06% and 97.22% (125 mg and 500 mg, respectively). As expected, DIV reduced the CD19+ B-cells. However, the repopulation rate of CD19+ B-cells in the 125 mg group was more pronounced (mainly due to the recovering pool of CD27-naive B-cells) compared to the 500 mg group. DIV showed a favorable safety profile at both doses.CONCLUSION:Thus, the assessment of 24 weeks treatment demonstrated that DIV is a highly effective, safe and convenient option for the treatment of RRMS patients, both naive and previously treated with disease modifying therapy. A dose of 500 mg is recommended for further efficacy and safety evaluation during phase 3 CT.

OBJECTIVE:To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in comparison with the teriflunomide (TRF). The study of the efficacy and safety of the use of the drug DIV was carried out for 48 weeks of therapy.MATERIAL AND METHODS:The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult patients with RRMS distributed in a 1:1 ratio into two groups: DIV 500 mg and TRF 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks. The primary end point was «Mean annualized relapse rate 48 weeks after the last patient is randomized in the study».RESULTS:321 subjects completed 48 weeks of therapy according to the study protocol. The analysis of the of efficacy data for the primary endpoint successively proved the hypothesis of superiority of the test drug DIV at a dose of 500 mg over the reference drug TRF. A rapid suppression of acute disease activity according to the brain MRI and clinical manifestations of the disease was shown after the first infusion of DIV in patients with RRMS. Thus, after 48 weeks of therapy in patients treated with DIV, there were no T1 gadolinium-enhancing lesions, while in the TRF group such lesions were observed in 20.7% (35/169) of subjects. Evaluation of the CUA per scan showed that the mean values for the estimated period were statistically significantly lower in the DIV drug group compared to the TRF group: the ratio of the adjusted per scan rates (DIV/TRF) was 0.125 [95% CI: 0.089; 0.177]. Over the 48 weeks of therapy, the proportion of subjects with relapses was 9.5% (n=16/169) in the DIV group and 19.5% (33/169) in the TRF group (p=0.0086). DIV has shown a favorable safety profile. Among the adverse reactions (AR), infusion reactions and deviations of laboratory data, such as a decrease in the number of leukocytes, neutrophils, and lymphocytes, were most often recorded. Identified AR were expected, had mild to moderate severity, and resolved without any negative consequences.CONCLUSION:The results of the clinical study indicate the high efficacy and safety of DIV in comparison with TRF.

At the onset, multiple sclerosis (MS) in children is characterized by a phase of active inflammation with extensive demyelination of the white matter of the CNS, which often mimics this nosology with a whole spectrum of inflammatory demyelinating diseases such as ADEM, anti-MOG encephalitis, ONMSD. In order to formalize the diagnostic process, the International Pediatric Multiple Sclerosis Study Group (IPMSSG) proposed diagnostic criteria for the main immune-mediated demyelinating diseases of the CNS in children, which, in theory, should simplify the diagnostic search. However, in practice, the range of nosologies in the course of differential diagnosis is much wider and often it is not possible to establish an unambiguous diagnosis in the early stages. The authors analyze their own clinical observations based on a sample of 100 pediatric patients with a referral diagnosis of «MS?» and describe a clinical case of the onset of highly active MS with an assessment of the dynamics of the clinical and paraclinical course of the disease.

Objective: to evaluate efficacy and safety of the use of a bioactive concentrate of small marine fish (Alflutop) in patients with vertebrogenic sciatica (SC).Patients and methods. The study included 30 patients with persistent (more than 3 months) vetebrogenic SC who underwent inpatient treatment in the neurological department of the Republican Clinical Neurological Center (Kazan). The patients were randomized into two groups: 15 patients of the 1st group received Alflutop (2 ml intramuscularly every other day, 10 injections in total) in addition to standard therapy, and 15 patients of the 2nd group (control) received standard therapy. The effectiveness of therapy was assessed using a visual analogue scale, Roland-Morris and EQ-5D questionnaires, an index of severity and frequency of sciatica.Results and discussion. Patients who received the study drug in addition to standard therapy showed a more rapid decrease in pain intensity, a trend towards a decrease in the severity index of sciatica, while no adverse events were recorded during the entire follow-up.Conclusion. The inclusion of Alflutop in the traditional scheme of inpatient treatment of patients with vertebrogenic SC allows to achieve a significantly greater reduction in the intensity of the pain syndrome after 20 days and 2 months after the start of therapy.

Interferons (IFNs) were first discovered over 60 years ago in a classic experiment by Isaacs and Lindenman showing that type I IFNs have antiviral activity. IFNs are widely used in the treatment of multiple sclerosis, viral hepatitis B and C, and some forms of cancer. Preliminary clinical data support the efficacy of type I IFN against potential pandemic viruses such as Ebola and SARS. Nevertheless, more effective and specific drugs have found their place in the treatment of such diseases. As the COVID-19 (SARS-CoV-2) pandemic is evolving, type I IFN is being re-discussed as one of the main pathogenic drugs, and initial clinical trials have shown promising results in reducing the severity and duration of COVID-19. Although SARS-CoV-2 inhibits the production of IFN-β and prevents a full innate immune response to this virus, it is sensitive to the antiviral activity of externally administered type I IFN. The review presents current data on the classification and mechanisms of action of IFN. Possible options for the optimal use of IFN in the fight against COVID-19 are discussed.

OBJECTIVE To evaluate the efficacy and safety of samPEG-IFN-β1a 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-β1a180 μg (n=114), samPEG-IFN-β1a 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-β1a 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-β1a were equally effective when compared to LIB by the primary endpoint - «Time to first relapse». 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-β1a 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-β1a 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-β1a 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-β1a 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.

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.

The purpose — to study the clinical and epidemiological characteristics of neuromyelitis optica spectrum disorders (NMOSD) in the Republic of Tatarstan (RT). Material and methods. A retrospective analysis of the patients with NMOSD (according to 2015 diagnostic criteria), observed in our Centre in 2017–2021 (n = 35), was carried out. The parameters analyzed were demographic features, age of the disease onset, first clinical manifestations and course of disease, anti-AQP4 serum status, disease modifying therapy, and EDSS on baseline and follow up visits. Results and conclusions. We found that the prevalence of NMOSD in RT in 2021 was 0.9/100,000, the averaged (for 2017–2020) incidence was 0.83/1,000,000 per year. Among 35 patients (average age 43,4 (12,7) years old), 24 (69%) were female and 11 (31%) were male. The most common clinical manifestations at onset included optical neuritis and/or myelitis (94%). Most cases (83%) had relapsing course. Positive anti-AQP4 serum status was revealed in 49% of patients. The probably monophasic disease (n = 6) was observed predominantly in anti-AQP4 negative patients (5 vs. 1). DMT was prescribed to all patients with relapsing NMOSD, the most commonly used agents included corticosteroids, azathioprine and mitoxantron (49, 20, and 11% accordingly). The rate of remission rate for all DMT varied from 35 to 57%. Ultimately all patients with relapsing NMOSD showed EDSS increase over the follow-up period, which was more prominent among anti-AQP4 positive patients (from 3,8 to 5,4 over 4,4 (3,3) years, compared to 2,9 to 3,8 over 4,0 (3,0) years accordingly).

Neuromyelitis optica spectrum disorders (NMOSDs) are autoimmune inflammatory disorders accompanied by central nervous system damage, widespread immunemediated demyelination, and axonal damage, involving mainly the optic nerves, spinal cord, and area postrema. The diagnostic capabilities, administration and routing of patients, and therapeutic approaches to this disease need to be improved. During several expert councils held in 2019–2021 in different regions of the Russian Federation, we discussed multiple issues related to various aspects of medical care for patients with NMOSDs. As a result, the experts developed further steps necessary to improve the medical care to these patients: to write and publish clinical guidelines for the diagnosis and treatment of NMOSDs; to consider the possibility of optimizing the NMOSDs diagnostic program including the aquaporin-4 antibodies (AQP4-IgG) testing; to evaluate the implementation of a set of measures aimed at including the corresponding laboratory investigations into the system of state guarantees (together with the institutions of the Ministry of Health of Russia), if there is clinical and economic feasibility; to include the issues of timely NMOSDs evaluation in educational programs initiated by the scientific medical community, in order to raise awareness of primary care neurologists in relation to the clinical and neuroimaging signs of probable NMOSDs; to assess the possibility of introducing routing schemes for patients with NMOSDs at the regional level; to work out a decision on the collection of NMOSDs epidemiological and clinical data in the Russian Federation.

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.

The need for optimal treatment of the active forms of multiple sclerosis (MS), especially highly active MS (HAMS), poses a number of difficult problems for specialists, including not only the choice of a highly effective disease-modifying drug for MS (DMDMS), but also conditions for the timely and safe switching from other DMDMS. A group of expert neurologists from various clinics in Russia presents a consensus on the practical aspects of switching patients with HAMS from other DMDMS to cladribine tablets, which has been registered in Russia in March 2020. The paper discusses indications for changing therapy and gives indications, contraindications, and conditions for initiating cladribine therapy. It details the procedure and results of the expert consensus, on the basis of which the recommendations have been developed to switch to cladribine tablets from each of the DMDMS registered in Russia for the treatment of MS.