[Efficacy and safety of Kinezia (fampridine) in the complex therapy of multiple sclerosis]. / Effektivnost' i bezopasnost' preparata Kinezia (fampridin) v kompleksnoi terapii rasseyannogo skleroza.

OBJECTIVE: To analyze the efficacy and safety of fampridine** (Valenta Pharm, Russia) in the complex therapy of multiple sclerosis (MS). MATERIAL AND METHODS: One hundred and twenty-six patients with MS were double blind randomized to receive fampridine (n=60) or placebo (n=66). Fampridine was administered in prolonged-release form (film-coated tablets, 10 mg) at a dose of 10 mg (1 tablet) 2 times a day, for 24 weeks. The placebo group was treated in the same way. From the 12th week, all patients in the placebo group were transferred to therapy with fampridine, 10 mg 2 times a day, for another 12 weeks. Concomitant standard therapy for MS was allowed in both groups (concomitant disease-modifying medications and other treatment). The primary outcome in the study was the proportion of patients with reduced t25fw test time (determining walking speed on a 25-foot path) on at least two out of three visits compared to baseline. The mean change in Multiple Sclerosis Functional Composite (MSFC) scores from baseline was assessed at visits 4-7 (8-24 weeks). RESULTS: The proportion of patients with reduced t25fw test time compared to the baseline level was 31.7% in the fampridine group, which is higher than in the placebo group - 3.0% (p<0.001). The overall result of the Multiple Sclerosis Functional Composite (MSFC) reflected a gradual improvement in the patient's condition during treatment period. The dynamics of MSFC result relative to the baseline level significantly differed (p<0.05) between the fampridine and placebo groups in favor of the fampridine group during all treatment periods. In the fampridine group, adverse events (AE) associated with disorders of the nervous system were more common: headache, dizziness, and coordination disorders. CONCLUSIONS: Fampridine improves walking performance in MS patients. The Russian product fampridine has demonstrated a favorable safety profile.

[The efficacy and safety of siponimod in the Russian population of patients with secondary progressive multiple sclerosis]. / Éffektivnost' i bezopasnost' siponimoda u patsientov s vtorichno-progressiruiushchim rasseiannym sklerozom v rossiiskoi populiatsii.

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.

[The intestinal microbiota composition in patients with multiple sclerosis receiving different disease-modifying therapies DMT]. / Osobennosti sostava mikrobioty kishechnika u patsientov s rasseiannym sklerozom, poluchaiushchikh preparaty, izmeniaiushchie techenie rasseiannogo skleroza.

AIM: To describe characteristics of the intestinal microbiota in patients with multiple sclerosis (MS) treated with glatiramer acetate (GA) or fingolimode (FG) for understanding causal relationships between gut microbiota and autoimmune processes in MS patients. MATERIAL AND METHODS: The study included 34 patients treated with GA (n=17) or FG (n=17). GA was used in a dose of 20 mg/kg subcutaneously once a day, FG in a dose of 0.5 mg daily. All patients were examined during remission. To assess the composition of gut microbiota, bacteriological and real-time PCR techniques were used. DNA was extracted from feces using DNA-EXPRESS kit. RESULTS AND CONCLUSION: There was a decrease in numbers of Escherichia coli with normal enzymatic activity, which was replaced by atypical forms of E. coli, Enterobacter spp. and fungi of the genus Candida, and, during treatment with GA, by atypical forms of E. coli, Proteus spp., Parvimonas micra. These differences indicate the effect of the therapy on the intestinal microbiota composition.

[Provision of alemtuzumab safety is one of the main components of pharmacovigilance]. / Obespechenie bezopasnosti terapii alemtuzumabom - odna iz glavnykh sostavliaiushchikh farmakonadzora.

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 influence of solar and geomagnetic activity on the risk of multiple sclerosis (results of correlation and regression analysis)]. / Vliianie solnechnoi i geomagnitnoi aktivnosti na risk razvitiia rasseiannogo skleroza (rezul'taty korreliatsionnogo i regressionnogo analiza).

AIM: Multiple sclerosis (MS) develops as a result of an interaction between genetic and environmental factors, among them solar (SA) and geomagnetic activity (GMA) attract the particular attention. An impact of SA and GMA on intrauterine and postnatal period in MS was studied. MATERIAL AND METHODS: The study included 358 patients with MS. Correlation (CA) and regression analysis (RA) were used to study the effects of SA and GMA during intrauterine period, the 1st year of life, a year of disease onset, a year before the onset. RESULTS AND CONCLUSIONS: CA revealed the association between the MS onset and mean values of kp-index in the onset year and the year before the onset year, number of days with kp≥4 and kp≥5 in the onset year and the year before the onset year, mean SFU in the onset year. RA revealed the association between the MS onset and mean kp in the year before the onset year and in the onset year, number of days with kp≥7 in the onset year and the year before the onset year, mean kp during pregnancy, number of days with kp≥7 in the 1st year of life and during pregnancy. The influence of high GMA during pregnancy and in the 1st year of life increases the MS risk in the future and the high GMA predisposes to the MS onset in adults. The practical value of the study is that predicting the GMA changes we can try to prevent the onset and relapses in the risk groups.

[Capabilities of positron emission tomography to study mecha-nisms of multiple sclerosis: own data and literature]. / Vozmozhnosti pozitronno-emissionnoi tomografii dlya izucheniya mekhanizmov razvitiya rasseyannogo skleroza (literaturnye i sobstvennye dannye).

The article presents the literature data and results of our own researchon the use of positron emission tomography (PET) with different radiotracersin multiple sclerosis (MS). Informationon the operating principles of PET and PET studies with different radiotracers are considered. The results of PET studiesin different typesof MS, including determinationof the localization of neuronal damagein the corticalgray matter, assessmentof microglial activation, study of the relationship between glucose metabolismin the brain and the severity of cognitive impairmentin MS, can providenew information about the pathogenesis ofMS.

[The role of the solar and geomagnetic activity in the etiology of multiple sclerosis: a review of the literature and prospects of research]. / Rol' solnechnoi i geomagnitnoi aktivnosti v etiologii rasseyannogo skleroza: obzor dannykh literatury i perspektivy issledovaniya.

Despite the great progress in the study of multiple sclerosis (MS), its etiology remains unknown. It is proved that MS occurs in genetically predisposed people under the influence of environmental factors. Among these factors the solar activity (SA) and geomagnetic activity (GA) attract the particular attention. This article presents the review of studies concerning the influence of SA and GA on the incidence and course of MS.

[Regional metabolic changes of supraventricular tissue in patients with relapsing-remitting and secondary-progressive multiple sclerosis]. / Regionarnye osobennosti metabolizma strukturno neizmenennogo veshchestva supraventrikuliarnykh prostranstv golovnogo mozga pri remittiruiushchem i vtorichno-progressiruiushchem tipakh techeniia rasseiannogo skleroza.

AIM: To evaluate and compare the intensity of changes in a regional meta-analysis in relapsing-remitting and secondary-progressive multiple sclerosis (RRS and SPMS). MATERIAL AND METHODS: The results of longitudinal studies of multiple sclerosis (MS) using positron emission tomography, magnetic resonance spectroscopy and diffusion tensor imaging are presented. RESULTS: In MS, metabolic changes precede the structural ones. The markers of neuronal and axonal dysfunction (a decrease in NAA/Cr ratios in the white and grey matters, without the structural changes) are recorded in the early stages. The metabolic changes in the grey matter were recorded mostly in the middle frontal gyrus and posterior cingulate cortex. With the increase of duration and severity of MS, the metabolic changes spread to the other regions of supraventricular areas. The distribution of degeneration zones is related to MS course. CONCLUSION: There is substantial evidence on the irreversible damage of neurons in the medial prefrontal cortex in SPMS that confirms the vulnerability of the frontal cingulate gyrus in MS.

Characteristics of neurological and cognitive status in patients with multiple sclerosis in relation to the location and volumes of demyelination foci and the severity of brain atrophy.

A total of 65 patients with clinically significant diagnoses of remitting multiple sclerosis in the stage of remission were studied. Neurological status was investigated with assessment on the FS and EDSS scales, with neuropsychological testing, and MRI scans (1.5 T). The severity of brain atrophy (in terms of the parenchyma volume) and the total volume of foci on T2 images were assessed as proportions of intracerebral volume. The severity of neurological deficit depended on the volume of intratentorial focal lesions and the level of brain atrophy. Cognitive disorders were identified in 89% of patients, and the severity of these was associated with the level of atrophy and the volume of foci on T2 images in the dominant hemisphere.