"The spectrum of MRI findings of progressive multifocal leukoencephalopathy in patients with multiple sclerosis in the Czech Republic"

2019 ◽  
Vol 82/115 (4) ◽  
pp. 381-390
Author(s):  
Manuela Vaněčková ◽  
Alena Martinoková ◽  
Radek Tupý ◽  
Jiří Fiedler ◽  
Ivana Štětkářová ◽  
...  
2021 ◽  
Author(s):  
Veronika Tichá ◽  
Zuzana Počíková ◽  
Josef Vytlačil ◽  
Radka Štěpánová

Abstract Background: Fingolimod, an oral sphingosine 1-phosphate receptor immunomodulator, is approved in Europe for multiple sclerosis (MS) patients with highly active disease despite a full and adequate course of treatment with ≥1 disease-modifying therapy or patients with rapidly evolving severe relapsing–remitting MS. GOLEMS, a 12-month, national, multicenter, non-interventional, single-arm, real-world study showed a favorable benefit–risk profile of fingolimod in patients with MS in the Czech Republic. Here, we evaluated the long-term effectiveness and safety of fingolimod and its impact on disability progression and work capability for up to 48 months in patients with MS.Methods: The endpoints assessed were the incidence and severity of MS relapses in fingolimod-treated patients and the proportion of relapse-free patients up to 48 months of fingolimod treatment, change from baseline in the Expanded Disability Status Scale (EDSS) score, and change from baseline in work capability assessment. Efficacy outcomes were analyzed in the completed and efficacy sets, and safety was evaluated in all the enrolled patients.Results: Of 240 enrolled patients, 237 were included into efficacy set. Patients with a minimum of a 12-month observation period in the core study who continued fingolimod treatment, were eligible to participate in the extension phase. Of 211 patients enrolled in extension study, 155 were evaluated in the completed set. Based on analysis of 48-month period of fingolimod treatment, 95/237 patients (40.1%) in the efficacy set, 54/155 (34.8%) in the completed set were free of relapses. The majority of relapses reported were moderate in intensity. Mean EDSS score remained stable throughout 48-month study period (Baseline, 3.4; Month 48, 3.6). No significant 3 trend was observed in changes in work capability assessment or number of missed days of work. Of 240 enrolled patients, 147 (61.3%) had ≥1 treatment-emergent adverse event (AE) and 20 (8.3%) reported serious AEs. In total, 45 patients (18.8%) permanently discontinued treatment because of AEs related to study drug; two patients reported pregnancy after treatment initiation and subsequently discontinued the treatment; no deaths were reported.Conclusion: GOLEMS study demonstrated the sustained effectiveness and manageable safety profile of fingolimod under real-world conditions over 48 months in patients with MS.Trial registration: Not applicable


2011 ◽  
Vol 18 (5) ◽  
pp. 662-668 ◽  
Author(s):  
J Blahova Dusankova ◽  
T Kalincik ◽  
T Dolezal ◽  
G Kobelt ◽  
E Havrdova

Background: Information about cost of multiple sclerosis (MS) is available from a number of European countries, but no data from the Czech Republic have been published so far. Objective: The objective of this study was to establish the cost of MS in the Czech Republic, overall and by level of disease severity. Methods: Data on demographics, disease history, resource consumption and production losses were collected from 909 patients recruited in 7 MS centres in the Czech Republic. Annual costs were estimated in the societal perspective, using 2007 unit costs. To evaluate the relationship between disability and costs, patients were stratified into those with mild (67%), moderate (27%) and severe (10%) disability using the Expanded Disability Status Scale. Results: Mean total annual costs per patient were €12,272, of which 51% were direct medical costs, 4% direct non-medical costs and 45% indirect costs. The average annual costs in patients with mild, moderate and severe disability amounted to €9905, €14,064 and €22,880, respectively. Conclusion: The total costs of MS in the Czech Republic are estimated at €208.6 million per year. Consistent with other studies, the costs increase significantly with the severity of MS.


2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Tim Sinnecker ◽  
Jalal Othman ◽  
Marc Kühl ◽  
Imke Metz ◽  
Thoralf Niendorf ◽  
...  

Background. Natalizumab- (NTZ-) associated progressive multifocal leukoencephalopathy (PML) is a severe and often disabling infectious central nervous system disease that can become evident in multiple sclerosis (MS) patients after NTZ discontinuation. Recently, novel diagnostic biomarkers for the assessment of PML risk in NTZ treated MS patients such as the anti-JC virus antibody index have been reported, and the clinical relevance of milky-way lesions detectable by MRI has been discussed. Case Presentation and Conclusion. We report a MS patient in whom PML was highly suspected solely based on MRI findings after switching from NTZ to fingolimod despite repeatedly negative (ultrasensitive) polymerase chain reaction (PCR) testing for JC virus DNA in cerebrospinal fluid. The PML diagnosis was histopathologically confirmed by brain biopsy. The occurrence of an immune reconstitution inflammatory syndrome (IRIS) during fingolimod therapy, elevated measures of JCV antibody indices, and the relevance of milky-way-like lesions detectable by (7 T) MRI are discussed.


2017 ◽  
Vol 23 (2_suppl) ◽  
pp. 41-52 ◽  
Author(s):  
Eva Havrdova ◽  
Gisela Kobelt ◽  
Jenny Berg ◽  
Daniela Capsa ◽  
Mia Gannedahl ◽  
...  

Introduction: In order to estimate the value of interventions in multiple sclerosis (MS) – where lifetime costs and outcomes cannot be observed – outcome data have to be combined with costs. This requires that cost data be regularly updated. Objectives and methods: This study is part of a cross-sectional retrospective study in 16 countries collecting data on resource consumption and work capacity, health-related quality of life (HRQoL) and prevalent symptoms for patients with MS. Descriptive analyses are presented by level of severity, in the societal perspective, in CZK 2015. Results: A total of 747 patients (mean age 47 years) participated; 86% were below retirement age and of these, 49% were employed. Employment was related to disease severity, and MS affected productivity at work for 82% of those working. Overall, 92% and 66% of patients experienced fatigue and cognitive difficulties as a problem. Mean utility and annual costs were 0.832 and 257,000CZK at Expanded Disability Status Scale (EDSS) 0–3, 0.530 and 425,500CZK at EDSS 4–6.5 and 0.141 and 489,000CZK at EDSS 7–9. The average cost of a relapse was estimated at 12,600CZK. Conclusion: This study provides current data on MS in the Czech Republic that are important for the development of health policies.


2019 ◽  
Vol 405 ◽  
pp. 363
Author(s):  
M. Vaneckova ◽  
J. Klempir ◽  
D. Pelclova ◽  
O. Bezdicek ◽  
I. Liskova ◽  
...  

2016 ◽  
Vol 10 (1) ◽  
pp. 18-32 ◽  
Author(s):  
Yvonne Benešová ◽  
Aleš Tvaroh

Background: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system, which often causes progressive neurological disability. In addition to motor and sensory dysfunction, cognitive decline and fatigue are frequent manifestations of the disease. Fatigue is probably the most common symptom, with up to 90% of MS individuals reporting fatigue at some point. Cognitive impairment affects about 50% of patients and may be present at all MS stages. The aim of this observational study was to evaluate changes in cognition, fatigue, and disability status in 300 relapsing–remitting MS (RRMS) patients, treated with subcutaneous (sc) interferon (IFN) β-1a over 2 years. Methods: The study was designed as an observational, multicentre, prospective, single-arm, phase IV study carried out in 13 MS centres in the Czech Republic. Cognition status was assessed using the Paced Auditory Serial Addition Task (PASAT), fatigue using the Fatigue Descriptive Scale (FDS), and disability using the Expanded Disability Status Scale (EDSS), at baseline, and after 6, 12 and 24 months. The percentage of patients with changed versus stable cognition, fatigue status and disability was calculated at each time point and the changes in these scores were evaluated. Results: The proportion of patients with cognitive improvement was higher compared with those with a stable or decreased PASAT scores at all time points, and the average cognitive performance improved during the follow-up period. Also the proportion of patients with stable or improved fatigue and EDSS scores was higher compared with those in which FDS or EDSS scores declined, this was found at all time points of the analysed sample. However, the direct effect of IFN β-1a on cognition and fatigue cannot be concluded from this study. Conclusions: The results of this observational study have demonstrated a stable or improved cognitive performance, fatigue status, and disability level in the majority of RRMS patients treated with sc IFN β-1a over a two-year follow-up period, in a real life setting, in the Czech Republic.


2016 ◽  
Vol 37 (2) ◽  
pp. 175-186 ◽  
Author(s):  
Veronika Tichá ◽  
Roman Kodým ◽  
Zuzana Počíková ◽  
Pavla Kadlecová

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