Expanded Disability Status Scale Scale Research Articles

Validity and Reliability of the Lower Extremity Motor Coordination Test (LEMOCOT) in Patients with Multiple Sclerosis

The validity and reliability of the Lower Extremity Motor Coordination Test (LEMOCOT) were assessed in patients with multiple sclerosis (MS). The study involved 60 participants diagnosed with MS (mean age: 48.13 years, range: 24–80 years). Intra-rater reliability was assessed within-day (n = 12), and inter-rater reliability was assessed within-day (n = 45) and between-days (n = 22). For known-groups validity, test scores were compared between participants of different sexes; for convergent validity, test scores were correlated with age, the Five-Repetition Sit-to-Stand test (FSTS), the Berg Balance Scale (BBS), the Lower Extremity Functional Scale (LEFS), and the Expanded Disability Status Scale (EDSS). To test the discriminant validity, the LEMOCOT test scores were correlated with the Mini-Mental State Evaluation (MMSE) and compared according to social history (living alone or not). The LEMOCOT test was tested under three different conditions and found to be very reliable (intraclass correlation coefficient, ICC2,1 > 0.94) with an acceptable error level (standard error of the measurement, SEM, between 1.39 and 3.47 targets and 95% minimum detectable change; MDC95%, between 3.84 and 9.58 targets). Convergent validity was verified, as the LEMOCOT registered very strong correlations with the FSTS test (r = −0.851) and the BBS scale (r = 0.815), a strong correlation with the LEFS scale (r = 0.78), a moderate correlation with the EDSS scale (r = −0.634), all highly significant (p < 0.001), and a weak correlation with age (r = −0.332, p < 0.01). Discriminant validity was also confirmed, as the LEMOCOT demonstrated a weak correlation with the MMSE scale (r = 0.365, p = 0.017) and no differences relative to living environment or sex. The LEMOCOT demonstrated excellent reliability and validity for patients with MS.

Evaluation of willingness to obtain of Covid 19 vaccine in patients with multiple sclerosis.

Assessing vaccine willingness and understanding sources of vaccine hesitancy in individuals with multiple sclerosis (MS) helps healthcare providers approach patients more effectively while respecting their autonomy to encourage coronavirus disease 2019 (COVID-19) vaccination. A descriptive-analytical cross-sectional study using a researcher-made checklist was conducted on MS patients referred to Neshat Clinic of Hamadan during the years 2020-2021. The checklist contained questions about demographic information, MS phenotype, duration of illness, expanded disability status scale (EDSS) score, and COVID-19 vaccination status. The expanded disability status scale (EDSS) is the most commonly used instrument for measuring disability in patients with multiple sclerosis (MS). The EDSS scale ranges from 0 to 10 in increments of 0.5 units, denoting advanced points of disability. Based on the results, 20 individuals (10%) were in the vaccine non-acceptance group, while 181 individuals (90%) were in the vaccine acceptance group. A significant number of relapsing and remitting (RR) type MS patients (90.7%) and all primary progressive (PP) type MS patients (100%) accepted the vaccine. In comparison, vaccine non-acceptance in the secondary progressive (SP) group was relatively higher (20.7%) compared to other types of MS, and this difference was significant (P < 0.05). Additionally, there was a statistically significant relationship between the history of COVID-19 and vaccine acceptance (P < 0.05). The study results demonstrated a high rate of COVID-19 vaccine acceptance among MS patients. MS phenotype, previous infection experiences, and other influences allow for COVID-19 vaccine acceptance among MS patients. This information can improve health programs and communication strategies for COVID-19 and future possible infectious disease vaccination in individuals with MS.

Peripheral Hemolysis in Relation to Iron Rim Presence and Brain Volume in Multiple Sclerosis.

Background:Iron rim lesions (IRLs) represent chronic lesion activity and are associated with a more severe disease course in multiple sclerosis (MS). How the iron rims around the lesions arise in patients with MS (pwMS), and whether peripheral hemolysis may be a source of iron in rim associated macrophages, is unclear.ObjectiveTo determine a potential correlation between peripheral hemolysis parameters and IRL presence in pwMS.MethodsThis retrospective study included pwMS, who underwent a 3T brain MRI between 2015 and 2020 and had a blood sample drawn at ± 2 weeks. Patients with vertigo served as a control group.ResultsWe analyzed 75 pwMS (mean age 37.0 years [SD 9.0], 53.3% female) and 43 controls (mean age 38.3 years [SD 9.8], 51.2% female). Median number of IRLs was 1 (IQR 4), 28 (37.3%) pwMS had no IRLs. IRL patients showed significantly higher Expanded Disability Status Scale (EDSS) compared to non-IRL patients (median EDSS 2.3 [IQR 2.9] vs. 1.3 [IQR 2.9], p = 0.017). Number of IRLs correlated significantly with disease duration (rs = 0.239, p = 0.039), EDSS (rs = 0.387, p < 0.001) and Multiple Sclerosis Severity Scale (MSSS) (rs = 0.289, p = 0.014). There was no significant difference in hemolysis parameters between non-IRL, IRL patients (regardless of gender and/or disease type) and controls, nor between hemolysis parameters and the number of IRLs. Total brain volume was associated with fibrinogen (β= −0.34, 95% CI −1.32 to −0.145, p = 0.016), and absolute cortical and total gray matter volumes were associated with hemoglobin (β = 0.34, 95% CI 3.39–24.68, p = 0.011; β = 0.33, 95% CI 3.29–28.95, p = 0.015; respectively).ConclusionOur data do not suggest an association between hemolysis parameters and IRL presence despite a significant association between these parameters and markers for neurodegeneration.

A comparison between subjective and objective measurements of spasticity in neuromyelitis optica spectrum disorder patients

BackgroundSpasticity is a common and disabling problem in multiple sclerosis (MS), but its effect in other CNS inflammatory demyelinating diseases (CNSIDDs), such as neuromyelitis optica spectrum disorder (NMOSD) is not widely studied. This study aims to compare subjective and objective measurements of spasticity in NMOSD patients and determine associated factors. MethodsA prospective cross-sectional study was performed on CNSIDD patients attending the Multiple Sclerosis and Related Disorders Clinic at Siriraj Hospital, a tertiary hospital in Thailand, from June to November 2020 was performed. MS, NMOSD, and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) patients were included. Patients’ self-rated Numeric Rating Scale (NRS) for spasticity and clinician-evaluated Modified Ashworth Scale (MAS) scores on the same visit were compared and assessed for correlations. Data on characteristics of patients including demographics, number of transverse myelitis (TM) attacks, disease duration, and Expanded Disability Status Scale (EDSS) score were collected. ResultsSeventy-nine CNSIDD patients were included with 25 MS, 53 NMOSD, and 1 MOGAD. There was a statistically significant correlation between NRS and MAS scores (r = 0.934, p < 0.001). Spasticity was more commonly observed in NMOSD patients compared to MS (34% vs 8%, p = 0.016). Clinical characteristics strongly associated with spasticity were higher number of TM attacks (p < 0.001), severe TM attacks (p < 0.001), longitudinally extensive transverse myelitis attacks (p < 0.001), longer disease duration (p = 0.025), higher EDSS (p < 0.001), and pyramidal Functional System Scale scores (p = 0.001). ConclusionsPatients’ self-reported NRS score had a good correlation with clinician-evaluated MAS score for spasticity assessment in NMOSD and CNSIDD patients overall. Number and severity of TM attacks were associated with spasticity. Spastic patients had more disability measured by EDSS.

Порівняльна ефективність гормональної пульс-терапії при рецидивуючому та вторинно-прогредієнтному типах перебігу розсіяного склерозу з різним характером прогнозу. Повідомлення I. Ефективність гормональної пульс-терапії в дебюті та на рецидивуючому етапі п

Проведено дослідження ефективності пульс-терапії глюкокортикоїдами (ГКT) в дебюті та на рецидивуючому етапі (РЕ) у 98 хворих з розсіяним склерозом (РС): 28 осіб (24 жінки і 4 чоловіки) з невизначеним прогнозом при рецидивуючому перебігу (РП) — 1-ша група; 30 осіб (21 жінка і 9 чоловіків) з невизначеним прогнозом при вторинно-прогредієнтному перебігу (ВПП) — 2-га група; 40 осіб (36 жінок і 4 чоловіки) з несприятливим прогнозом при ВПП — 3-тя група. Проводився облік наступних клінічних показників: вік, тривалість захворювання, вік дебюту, тяжкість дебютів, тривалість ремісії після дебюту, тривалість рецидивуючого етапу, тяжкість і число рецидивів на РЕ, середня частота рецидивів і тривалість ремісій на РЕ, ступінь інвалідизації за шкалою EDSS. Проведено 287 курсів ГКТ-терапії: при невизначеному прогнозі РП — 98 (у дебютах — 9, на РЕ — 89); при невизначеному прогнозі ВПП — 99 (у дебютах — 3, на РЕ — 96); при несприятливому прогнозі ВПП — 90 (у дебютах — 8, на РЕ — 82). Клініко-діагностичні критерії ефективності лікування в усіх групах хворих включали динаміку регресу неврологічної симптоматики під впливом першого курсу ГКТ-терапії на етапі дебютів; порівняльну оцінку тривалості ремісії після дебюту при прийомі і без прийому ГКТ; середню частоту рецидивів на РЕ під впливом повторних курсів ГКТ-терапії; тривалість ремісій після 1-го курсу гормональної терапії; тривалість РЕ залежно від тривалості ремісій після першого курсу ГКТ-терапії. У групі хворих з невизначеним прогнозом РП додатково враховувалися: тривалість ремісій перед останнім курсом ГКТ; швидкість прогресування на РЕ; динаміка балів за шкалою інвалідизації EDSS після 1-го і перед останнім курсами ГКТ-терапії. Проведене дослідження показало, що в процесі лікування клінічні показники, що характеризують перебіг дебютів і РЕ, зазнають складної системної реорганізації залежно від типу перебігу та характеру прогнозу. Найбільш ефективною гормональна терапія виявилася при невизначеному прогнозі РП. Для цієї групи хворих було виділено дві категорії ефективності лікування: висока (у 17 осіб) і помірна (в 11 осіб). Критерієм ефективності лікування служила позитивна динаміка більшості клінічних показників. Вона проявлялася швидким і повноцінним регресом неврологічної симптоматики в дебютах, збільшенням тривалості ремісії після дебюту, зменшенням частоти і тяжкості рецидивів на РЕ, збільшенням числа хворих з величиною середньої частоти рецидивів &lt; 1,0, збереженням мінімального неврологічного дефіциту, низькою швидкістю прогресування, нерізкою негативною динамікою балів за шкалою інвалідизації EDSS. У результаті зазначеної реорганізації збільшувалась тривалість РЕ і відбувалося запобігання безпосередньої загрози трансформації РП у ВПП.

Clinical presentation and course of multiple sclerosis in patients with herpesvirus infection

To date, the features of clinical presentation, course, and the effectiveness of therapy for multiple sclerosis (MS) in the presence of persistent herpesvirus infection (PHVI) remain poorly understood.Objective: to evaluate the features of clinical presentation and course of MS in patients with PHVI to optimize patient management.Patients and methods. We examined 122 patients with a clinically definite diagnosis of MS according to McDonald criteria (2010) (82 women and 40 men, age: 18–50 years, mean age – 37.74±11.04 years). MS duration at the time of examination was from 6 months to 20 years (mean – 8.53±7.47 years), mean Expanded Disability Status Scale (EDSS) score – 2.91±1.67. 86% of patients had relapsing-remitting MS; 14% – secondary progressive MS. 98 (80%) patients received disease modifying therapies (DMTs). All patients underwent a comprehensive clinical and neurological examination, magnetic resonance imaging (MRI). 30 healthy donors (20 women and 10 men, age: 19–62 years, mean age: 39.1±12.1 years) were included in the control group. Serum levels of type-specific IgM and IgG antibodies to herpes simplex virus (HSV) 1, 2, 6, Varicella zoster virus (VVZ), Epstein–Barr virus (EBV), cytomegalovirus (CMV) were detected, in some patients – blood and cerebrospinal fluid (CSF) polymerase chain reaction, serum and CSF oligoclonal IgG.Results and discussion. We identified two sub-groups of MS patients: with PHVI reactivation (main group, n=29) and without it (comparison group, n=93). There were a significantly higher VZV (72%) and EBV infection rate (100%) in MS patients compared to the control group (50% and 83%, respectively). Mixed herpesvirus infection prevailed over mono-infection in MS patients. In contrast to controls, the most common viral pattern in MS group was a combination of 4 herpes viruses: HSV 1, 2 + VZV + EBV + CMV (χ2=3.9; p&lt;0.05). Patients in the main group had an unfavorable disease course: earlier MS onset, predominantly polysymptomatic onset, significantly higher relapse rate, faster disease progression, and higher EDSS and Functional Systems Scale (FSS) scores (p &lt;0.05). MRI activity was also associated with EBV infection: new T1Gd+ and T2 foci were associated with an increase in VCA-IgM to EBV level. We also observed decreased DMTs effectiveness (χ2=4,6; p=0,033) and worse DMTs tolerability (χ2=5,3; p=0,022) in the main group.Conclusion. MS patients with PHVI reactivation, have a more unfavorable course of the demyelinating process and, therefore, a greater degree of disability, compared with age-adjusted patients without a viral infection and the same disease duration.

The Impact of Motor Disability and the Level of Fatigue on Adherence to Therapeutic Recommendations in Patients with Multiple Sclerosis Treated with Immunomodulation.

Aim: The aim of the study was to clarify whether the motor disability and the fatigue-related syndrome affect the level of compliance with therapeutic recommendations.Methods: Prospective studies were conducted among 165 patients treated under the drug program - Treatment of Multiple Sclerosis (MS) at the Department of Neurology and Clinical Neuroimmunology of the Regional Specialist Hospital in Grudziadz (Poland). The research was carried out by the method of diagnostic survey, questionnaire technique with the use of standardized research tools. The Adherence in Chronic Diseases Scale (ACDS) was used to assess the level of compliance with therapeutic recommendations. The Expanded Disability Status Scale (EDSS) was used to assess the degree of disability, and the Modified Fatigue Impact Scale (MFIS) was used to assess the degree of disability. The Chi-square test, Shapiro-Wilk test and Kruskal-Wallis were used.Results: The statistical analysis showed that there is a relationship (p=0.0055) between the patient's motor disability assessed in the EDSS scale and the level of compliance with therapeutic recommendations assessed in the ACDS scale. The higher the patient's disability level (EDSS 4.5-6.5), the lower the treatment adherence rate. The conducted research shows that the average score in the MFIS scale for individual levels of compliance with therapeutic recommendations expressed in the ACDS scale is, respectively: for the low level - 38.3 MFIS points, for the medium level - 34.4 MFIS points and for the high level- 33.2 MFIS points. The obtained results were not statistically significant (p=0.6098).Conclusion: It was found that the level of adherence to therapeutic recommendations in patients with relapsing-remitting multiple sclerosis treated with immunomodulation in the study group remained high. There is a relationship between the patient's disability and the level of adherence to therapeutic recommendations.

Quantifying cognition and fatigue to enhance the sensitivity of the EDSS during relapses

Background: Cognition is affected by relapses in persons with multiple sclerosis (PwMS), yet the Expanded Disability Status Scale (EDSS) does not readily detect cognitive changes. Objective: The objective of this study is to improve the detection of cognitive decline during relapses, by incorporating the Symbol Digit Modalities Test (SDMT) into the cerebral Functional System Score (CFSS) of the EDSS. Methods: This prospective study recruited PwMS from three dedicated MS centers. All subjects had EDSS, SDMT, and Fatigue Severity Scale (FSS) administered. Subjects experiencing a relapse were assigned to the relapse group (RG). Matched controls from the larger cohort were assigned to the stable group (SG). RG and SG subjects underwent the same evaluation at relapse and 3 months later. Our main outcomes were a modified CFSS (m-CFSS) and modified EDSS (m-EDSS), incorporating SDMT and FSS, accounting for cognitive performance and fatigue rating, during relapse. Results: The full cohort included 592 subjects; 80 qualified for RG and 72 were matched to the SG. The m-CFSS was significantly higher than CFSS at baseline (median = 2 vs. median = 0, p < 0.001) and relapse (median = 2 vs. median = 1, p < 0.001). The m-EDSS was higher than EDSS (median 3.0 vs. 2.5, p = 0.02) at relapse, where 35 RG subjects (43.8%) had higher m-EDSS than EDSS at relapse. Conclusion: This study demonstrates that incorporating the SDMT and FSS improves the accuracy of the EDSS, by accounting for cognitive changes, during relapse activity.

The Effects of Omega-3 Supplementation on the Expanded Disability Status Scale and Inflammatory Cytokines in Multiple Sclerosis Patients: A Systematic Review and Meta-Analysis.

Recent trial studies have shown that omega-3 supplementation can beneficially improve scores on the Expanded Disability Status Scale (EDSS), which is considered a gold standard for measuring disability and disease severity in Multiple Sclerosis (MS) patients, as well as reducing neuroinflammation. The present systematic review and meta-analysis aimed to evaluate the effect of omega-3 supplementation on EDSS and cytokines in MS. A systematic search was performed on Pubmed, Scopus and Cochrane Library up to October 2018. Studies were reviewed based on the Cochrane handbook, and the preferred reporting items for systematic reviews and meta-analyses (PRISMA). Weighted Mean Difference (WMD) with 95% Confidence Intervals (CI) were pooled using a random effects model in order to compare the effects of omega-3 with placebos. Among 4 trials, omega-3 supplementation had no significant effect on EDSS scale (WMD: -0.07; 95% CI: -0.27 to 0.13; P=0.50), as well as serum levels of IL-1β (WMD: -7.67; 95% CI: -23.31 to 7.97; P=0.34) and IL-6 (WMD: -153.57; 95% CI: -455.36 to 148.23; P=0.32). However, omega-3 significantly reduced TNF-α concentration (WMD: -16.76; 95% CI: -18.63 to -14.88; P < 0.00001) compared to placebo. Overall, omega-3 supplementation may not have a clinically considerable impact on EDSS or proinflammatory markers. However, the existing trials are limited in this context, and further clinical trials are required to confirm the potential effects of the omega-3 supplement on MS disease management.

Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study.

Background:Teriflunomide is a once-daily oral immunomodulatory agent approved for the treatment of relapsing–remitting multiple sclerosis (MS). We aimed to obtain data on the effectiveness, tolerability, and subject satisfaction with teriflunomide (Aubagio®) under clinical practice conditions in unselected MS patients.Methods:This work was a non-interventional, prospective, longitudinal, observational study in 307 sites in Germany.Results:A total of 1128 patients were eligible for the efficacy analysis [67.5% female; mean age (± standard deviation) 44.9 ± 9.7 years, range 20–73 years]. Time since first MS symptoms was 10.6 ± 8.2 years, and time since MS diagnosis was 8.9 ± 7.6 years. Expanded Disability Status Scale (EDSS) score at inclusion was 2.3 ± 1.5 (70.4% with score < 3.5). The mean observation period was 16.3 ± 9.1 months. A total of 75.2% had received previous disease-modifying therapies (DMTs) at any time. Of these patients, 504 (44.7%) received no DMT within 6 months of study entry, 593 patients (52.6%) had DMT discontinued prior to study entry [glatiramer acetate in 10.6%, subcutaneous interferon-beta 1a (IFNβ-1a) in 9.3%, intramuscular IFNβ-1a or IFNβ-1b in 6.6% each, azathioprine oral in 0.4%, other in 7.3%, last medication not known in 12.0%]. The mean annualized relapse rate decreased from 0.87 in the 24 months prior to study entry to 0.35 in the 24 months after study entry (n = 468; p ⩽ 0.001). EDSS and Fatigue Severity Scale remained stable. In patients who received previous MS treatments, Treatment Satisfaction Questionnaire (TSQM-9) values (maximum = 100), for the observation at 24 months improved by 8.1 points for effectiveness, 17.0 points for convenience, and 15.3 points for global satisfaction (p ⩽ 0.001 each, compared with study entry). In the safety cohort (n = 1139), the proportion of patients with adverse events (AEs) of any severity was 35.8%, and with serious events 13.0%. The most frequently reported AEs were diarrhea (n = 55), followed by MS relapse (n = 48), hair thinning (n = 38), and viral upper respiratory tract infection (n = 31).Conclusions:Relapse rate was halved during the observation period in comparison with the same time period before study entry. Patient satisfaction with teriflunomide was high in this real-world observation of patients, the majority of whom switched from other DMTs. The safety and tolerability profile of teriflunomide was similar to that reported in previous clinical trials.

ОСОБЕННОСТИ РЕПРОДУКТИВНОГО ЗДОРОВЬЯ ЖЕНЩИН, БОЛЬНЫХ РАССЕЯННЫМ СКЛЕРОЗОМ

Introduction. The incidence of multiple sclerosis (MS) is two times higher in women, and the debut of the disease falls on young reproductive age, which makes the problem urgent. Purpose: to assess the characteristics of the reproductive health of women with MS in different age periods. Material and methods. A prospective study was carried out in parallel groups and a case-control study of women of early and late reproductive age with a reliable diagnosis of MS. Results. During pregnancy, there was a significant decrease in the frequency of exacerbations of MS in comparison with the pre-gravity period; voluntary infertility and childlessness is registered in 21.3 % and 32 % of women, respectively. An increase in the concentration of follicle stimulating hormone (FSH) means an increase in the degree of disability on the Expanded Disability Status Scale (EDSS) and the duration of the disease. The decrease in the concentration of dehydroepiandrosterone sulfate (DHEA-S) corresponds to a higher degree of disability on the EDSS scale and the duration of the disease. Conclusion. Pregnancy has a protective effect on the clinical course of MS. Infertility in most cases is voluntary, but at the same time hypergonadotropic condition and hypoandrogenia are observed in women with MS already in the early reproductive age, which interferes with the steroid synthetic function of the ovaries and can cause impaired fertility.

Static posturography across the EDSS scale in people with multiple sclerosis: a cross sectional study.

BackgroundPosturography is considered the gold standard objective measure of standing postural control in people with multiple sclerosis (PwMS). This reliable tool provides quantitative data related to risk of falling and white and gray matter brain damage due to MS. Nevertheless, it remains unclear whether and to what extent, postural control declines throughout the disease process.We therefore examined the impact of disability on posturography measures in PwMS.MethodsIn this cross-sectional study, the data pool was divided into seven levels of disability based on the Expanded Disability Status Scale (EDSS) score. The study group comprised 464 PwMS, mean disease duration was 6.2 (SD = 7.5) years and mean age 42.6 (SD = 14.1). Static postural control parameters were obtained from the Zebris FDM-T instrumented Treadmill (Medical GmbH, Germany).ResultsA significant positive correlation between the EDSS and posturography parameters was found. Scores for the ellipse area, center of pressure (CoP) path length and sway rate with eyes open were Spearman’s rho =0.512, 0.527, 0.528; (P-value < 0.001), respectively. Non-significant differences were observed between the EDSS subgroups at the lower end of the spectrum (EDSS 0–2.5) in all posturography parameters. In contrast, MS patients with an EDSS score of 3.0–3.5 demonstrated a significant increase in the ellipse area with eyes open (~108 %) and closed (~169 %), CoP path length with eyes open (~83 %) and closed (~88 %) and sway rate with eyes open (~39 %) and closed (~148 %), compared with those who scored within the range of 0–2.5 in the EDSS. Non-significant differences were observed between MS patients with an EDSS score of 3.0–5.5. MS patients with an EDSS score of 6.0–6.5 were significantly poorer in 4 (out of 6) balance measures compared to other disability subgroups.ConclusionsPosturography CoP trajectories are appropriate outcome measures indicating disability deterioration in PwMS.

RESULTS OF AN OPEN-LABEL COMPARATIVE RANDOMIZED CLINICAL TRIAL OF AXOGLATIRAN® FS (F-SINTEZ, RUSSIA) EFFICIENCY AND SAFETY IN COMPARISON WITH COPAXONE®-TEVA (TEVA PHARMACEUTICAL INDUSTRIES LTD., ISRAEL) IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Objective. Comparison of Axoglatiran® FS (F-Sintez, Russia) and Copaxone®-Teva (Teva Pharmaceutical Industries Ltd., Israel) efficiency and safety in patients with relapsing-remitting multiple sclerosis. Materials and methods. In the study 150 patients with relapsing-remitting multiple sclerosis were randomized into 2 groups: patients in the 1st group (n = 100) received treatment with Axoglatiran® FS, patients in the 2nd group (n = 50) received treatment with Copaxone®-Teva. Vital signs of every patient in the study were monitored accompanied by physical examinations, neurological examinations with EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite) evaluations, magnetic resonance imaging of the brain and lab tests. Results. Mean age (M ± SD) of the patients in the 1st group was 32.8 ± 8.7 years (20–54 years), percentages of men and women were 34 and 66 % respectively, mean age of multiple sclerosis onset was 27.93 ± 7.72 years (11–48 years). Median (Me), lower and upper quartiles estimates [LQ; UQ] on the EDSS scale were 2 [1.5; 3.0] steps (1.0–4.5 steps). In the 2nd group mean age of the patients was 35.2 ± 9.5 years (18–57 years), percentages of men and women were 24 and 76 % respectively, mean age of multiple sclerosis onset was 26.5 ± 6.9 years (18–47 years), EDSS estimates were 2.25 [1.5; 3.5] steps (1–5 steps). In the 1st group 88 (88 %) patients completed the study, in the 2nd group 44 (88 %) patients completed the study. Among them in 73 (82.95 %) patients in the 1st group and 34 (77.27 %) patients in the 2nd group the disease didn’t exacerbate (p > 0.05). In both groups no progression according to the EDSS and MSFC scale was observed (p > 0.05). Magnetic resonance imaging data showed that dynamics of the total number of T2 lesions, contrast-enhancing T1 lesions, atrophy degree estimated using internuclear index were comparable in both groups (p > 0.05). Safety profiles of Axoglatiran® FS and Copaxone®Teva were evaluated as satisfactory in both groups: local reactions were the most common adverse event (57.7 and 63.0 % in the 1st and 2nd groups respectively). Conclusion. Efficiency, safety and tolerability of Axoglatiran® FS is comparable with the reference medicine Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis. This result allows to recommend the use of Axoglatiran® FS in clinical practice.

A COMPARATIVE ANALYSIS OF EFFICACY OF INTERFERON BETA 1-B AND NATALIZUMAB TREATMENT IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Background: Disease modifying drugs for multiple sclerosis have similar indications for use and at the same time, their specifics of the effect on the pathophysiological process. This complicates the choice of an optimal therapy for a given patient. Aim: To assess efficacy of treatment for multiple sclerosis with interferon beta-1b (IFN-β-1b) and natalizumab. Materials and methods: We performed an open label prospective study in 110 patients with multiple sclerosis who were followed up in the Moscow Regional Center of multiple sclerosis from 2012 to 2015. From those, 99 patients with relapsing-remitting multiple sclerosis (disease modifying drugs naïve) were treated with IFN-β-1b, 11 were non-responders to interferon (1 and more attacks for the previous year of therapy with IFN-β-1b) or had progressive course of multiple sclerosis (more than 2 attacks and an increase in the Expanded Disability Status Scale (EDSS) score by 1 and more within 1 year) and were treated with natalizumab. Analysis of treatment efficacy was performed with consideration of their past history, results of a 3-year neuromonitoring with Kurtzke EDSS and Functional System Scale, neuroophthalmologic testing with Farnsworth dichotomous test, and changes in optical coherent tomography parameters. Results: During 3 years of treatment with IFN-β-1b, the mean number of attacks decreased by over 70% (from 1.28±0.7 in the year before treatment to 0.35±0.09 in the 3rd year of treatment; p&lt;0.05), whereas the degree of disability assessed by EDSS increased nonsignificantly by 0.44 (p&gt;0.05). During the follow-up in the natalizumab group, the number of attacks decreased from 2.3±0.04 to 0.13±0.01 (p&lt;0.05), and the degree of disability by EDSS decreased by 0.8 (p&gt;0.05). There was a significant difference between changes in the thickness of peripapillar nervous fibers during 2 years of the follow up, this parameter decreasing by 2.5 mcm in patients treated with IFN-β-1b and by 0.1 mcm in those treated with natalizumab (p&lt;0.01). Conclusion: Although the patients from natalizumab group had initial more severe course of multiple sclerosis, both agents were highly effective, with the most prominent clinical effect observed for natalizumab. The results obtained may serve as a basis for recommendation of the 2nd line disease modifying drugs for patients with aggressive course of the multiple sclerosis and failure of the 1st line disease modifying drugs. Also, we were able to demonstrate the efficacy of neuroophthalmological monitoring in the assessment of disease modifying drugs efficacy. The strict safety policy is essential while using natalizumab.

Autoimmune diseases of children: what can be learned from the experience of pediatric hematologist and oncologists?

Introduction. Today, the problem of therapy of autoimmune diseases has acquired high relevance. The strategy of achievement of success is interaction of doctors of various specializations. One of the advanced approaches to treatment of this group of diseases is joining of efforts with hematologists and oncologists. A variant of such interaction is an example of successful treatment of children with refractory forms of multiple sclerosis or cell therapy with the use of autologous transplantation of hematopoietic stem cells. The article represents a brief review of therapy of autoimmune diseases with the focus on observation of patients with multiple sclerosis. Materials and methods. 13 patients with multiple sclerosis were included into the analysis. Distribution of sexes: 9 girls (69.2 %) and 4 boys (30.8 %). Age median: 16.7 ± 1.7 years. The median of duration of the disease prior to treatment is 15.5 ± 4.1 years. The age of onset of the disease is 4 to 14 years (12.3 ± 1.7 years). The average point in accordance with the Expanded Disability Status Scale (EDSS) is 6.16 ± 0.2 points. A severe refractory course of disease was registered with all patients. Until the moment of commencement of the therapy with the methods represented in the article, the patients received treatment with corticosteroids, interferon, plasmapheresis, and mitoxantrone with negative results. All patients in the group of autologous transplantation commenced the therapy with the signs of autoimmune inflammation. Transfusions of ex vivo cultivated T-regulatory cells were applied in the context of protocol regarding the cell therapy. The conditioning scheme with the use of the combination of cyclophosphamide (200 mg / kg) and atgam drug (160 mg / kg) was used in the case of performance of autologous transplantation. Results. Remission without aggravation episodes was maintained with the patients that received therapy with autologous T-regulatory cells. Rapid improvement in the early post-transplantation period was registered with all children after auto-TGSC. The maximum improvement under the EDSS scale comprised 5.5 points. The article represented the experience of long-term observation of patients of this group (the maximum observation period is 60 months). No serious side effects were registered as a result of the therapy. Only 2 patients at late terms demonstrated repeated aggravation of the disease. Conclusions. Thus, the presented methods of therapy demonstrated their efficiency in the context of refractory forms of multiple sclerosis and can be translated to other types of autoimmune diseases.

Long-term outcomes of autologous hematopoietic stem cell transplantation with reduced-intensity conditioning in multiple sclerosis: physician's and patient's perspectives.

High-dose immunosuppressive therapy (HDIT) with autologous hematopoietic stem cell transplantation (AHSCT) is a promising approach to treatment of multiple sclerosis (MS) patients. In this paper, we present the long-term outcomes of a prospective single-center study with the analysis of the safety and efficacy of HDIT + AHSCT with reduced-intensity BEAM-like conditioning regimen in 99 MS patients: mean age-35years old; male/female-39/60; median Expanded Disability Status Scale (EDSS) = 3.5; 43 relapsing/remitting MS, 56 progressive MS. No transplant-related deaths were observed. The mobilization and transplantation procedures were well tolerated. At 6months post-transplant, neurological improvement or stabilization was observed in all the patients except one. Cumulative incidence of disease progression was 16.7% at 8years after HDIT + AHSCT. Estimated event-free survival at median follow-up of 48.9months was 80%: 83.3% in relapsing/remitting MS vs 75.5% in progressive MS. Sixty-four patients who did not progress during the first 3years post-transplant and were monitored for more than 3years were included in long-term outcome analysis. At the median long-term follow-up of 62months, 47% of patients improved by at least 0.5 points on the EDSS scale as compared to baseline and exhibited improvement during the entire period of follow-up; 45% of patients were stable. No active, new, or enlarging lesions on magnetic resonance imaging were registered in patients without disease progression. AHSCT was accompanied by a significant improvement in patient's quality of life. Due to the fact that patient selection was quite different to the other studies and that the information about disease activity prior in the disease course and its treatment was inhomogeneous, comparison with the results in the literature should be done with caution. Thus, the risk/benefit ratio of HDIT + AHSCT with reduced-intensity BEAM-like conditioning regimen in our population of MS patients is very favorable. The consistency of our long-term clinical and quality of life results, together with the persistence of improvement, is in favor of the efficacy and safety of this treatment approach in MS patients.

Evaluation of the treatment efficacy of patients with multiple sclerosis using Barthel index and Expanded Disability Status Scale

Introduction: Multiple sclerosis (MS) is a chronic, autoimmune and progressive multifocal demyelinating disease of the central nervous system. The aim of this study was to evaluate rehabilitation of patients with multiple sclerosis using BI (Barthel index) and EDDS (Expanded Disability Status Scale).Methods: A clinical observational study was made at the clinic for physical medicine and rehabilitation in Sarajevo. We analyzed 49 patients with MS in relation of gender, age and level of disability at admission and discharge, patient disability were estimated using EDDS scale. The ability of patients in their activities of daily living were also analyzed according to the BI at admission and discharge.Results: Of the total number of patients (n=49) there were 15 men and 34 women. The average age of female patient was 42.38±13.48 and male patient 46.06±9.56. EDDS values were significantly different at the beginning and at the end of the therapy (p=0.001) as was the value of BI (p=0.001).Conclusion: MS patients, after the rehabilitation in hospital conditions show significant recovery and a reduced level of disability; they show higher independence in activities but rehabilitation demands individual approach and adjustment with what patients are currently capable of achieving.

Long-term effects of whole body cryostimulation on uric acid concentration in plasma of secondary progressive multiple sclerosis patients

Background. Uric acid (UA) has been suggested to be a marker of multiple sclerosis (MS) activity. Whole body cryostimulation (WBCT) is a new form of additional treatment and becoming popular in medicine. Objectives. The aims of this study were to determine the long-term effects of WBCT on the level of plasma UA in selected group of MS patients only with secondary progressive (SPMS) clinical form and verify results with functional state of patients assessed by expanded disability status scale (EDSS). Materials and methods. SPMS patients (n = 22) and healthy controls (n = 22) participated in 10 3-min-long exposures of WBCT (one exposure per day). Results were collected before the WBCT treatment and after completion the WBCT series as well as one and three months later. Results. WBCT increased UA concentration in plasma of SPMS patients not only directly after 10 exposures (p < 0.0001) but also one (p < 0.0001) and three (p < 0.005) months later. Furthermore, WBCT causes positive changes in EDSS scale both directly after WBCT (7% lower) and maintain this level 1month later as well as 3 month later (5% lower). Conclusions. WBCT may be used as adjuvant therapy via increase UA blood level; it improves functional status of SPMS patients.

Brain atrophy and lesion load predict long term disability in multiple sclerosis

ObjectiveTo determine whether brain atrophy and lesion volumes predict subsequent 10 year clinical evolution in multiple sclerosis (MS).DesignFrom eight MAGNIMS (MAGNetic resonance Imaging in MS) centres, we retrospectively included 261...

DGI-010 Analysis of the Use of Fingolimod in Patients with Multiple Sclerosis in a University Hospital

Background Multiple Sclerosis (MS) is a chronic, inflammatory and degenerative disease, which affects the Central Nervous System [1].Fingolimod (FTY) is a medicine indicated in the treatment of MS patients with...