Roztroušená skleróza je závažné neurologické onemocnění, kterým v České republice trpí asi dvacet tisíc pacientů. Bez léčby vede u většiny nemocných k významné disabilitě. Nemoc stále neumíme vyléčit, díky moderní, bohužel nákladné terapii, ji ale umíme u podstatné části pacientů zpomalit. Nové léky přináší nepochybně vyšší efektivitu, současně ale i větší riziko možných nežádoucích účinků, které je třeba velmi pečlivě monitorovat. Základem pro správný management péče o pacienta jsou vedle dat z registračních studií data o účinnosti a bezpečnosti léčby z reálné klinické praxe. Tato data lze získat cestou kvalitních registrů. V České republice od roku 2013 sbírá data registr ReMuS, který je zřizován neziskovým subjektem Nadačním fondem IMPULS ve spolupráci s odbornou společností. Za pět let trvání počet pacientů narostl více jak 9×, k 30. 6. 2018 jsou v registru vložena data více než třinácti tisíc pacientů ve všech stadiích nemoci. Registr poskytuje pravidelně důležitá průřezová data o demografii, tíži nemoci, typu léčby, práceschopnosti, začíná poskytovat i první významné longitudinální výstupy. Více informací lze nalézt na stránkách www.multiplesclerosis.cz.

Multiple Sclerosis is a serious neurological illness affecting approximately 20,000 patients in the Czech Republic. Without treatment,the majority of patients develop a severe disability. Although there is still no cure for the disease, we can at least slowdown its progress thanks to modern, but costly therapy. The modern drugs are undoubtfully more effective; however, they alsopose a higher risk of developing various adverse events that must be carefully monitored. The basics of proper patient treatmentmanagement primarily rely on the data from the registration studies as well as the data regarding the treatment effectivity andsafety obtained from real clinical practice. The latter data can be collected via high-quality registries. In the Czech Republic, theregistry ReMuS founded and run by a non-governmental organization the Endowment Fund IMPULS together with the scientificcommunity has been collecting the data since 2013. Over the five years of its existence, the number of patients monitored by ReMuShas increased more than ninefold; the registry contained data of more than 13 thousand patients in all phases of the disease asof June 30, 2018. The registry regularly provides important cross-sectional data on the demographics, the severity of the disease,the type of treatment, and the ability to work, and has also started to provide first longitudinal analysis. More information can beobtained at www.multiplesclerosis.cz.

• Klíčová slova
• IMPULS, ReMuS,
• MeSH
• antirevmatika MeSH
• lidé MeSH
• registrace * statistika a číselné údaje   MeSH
• roztroušená skleróza * epidemiologie   farmakoterapie   MeSH
• sběr dat metody   MeSH
• Check Tag
• lidé MeSH
• Geografické názvy
• Česká republika MeSH

BACKGROUND: Proper management of multiple sclerosis (MS) requires feedback from clinical practice via registries. OBJECTIVE: To introduce the Czech national multiple sclerosis registry, ReMuS, and explore the availability and use of disease-modifying drugs (DMD). METHODS: The analysis focused on patients who started their first DMD, either with first-line or second-line medication and was based on reimbursement criteria set by Czech regulators. Baseline information was used to predict relapses after DMD initiation and to compare patients that started DMD in different years. RESULTS: A total of 3,328 patients started DMD treatment for MS between 2013 and 2016; 3,203 on first-line and 125 on second-line medication. The proportion of patients starting on second-line drugs increased from 1.8% in 2013 to 4.7% in 2016. The occurrence of a relapse within one year of DMD initiation was significantly related to (1) the Expanded Disability Status Scale (EDSS) score immediately prior to starting DMD and (2) the number of previous relapses. Both parameters were significantly lower in patients starting in later years of the explored interval. CONCLUSION: Data from the ReMuS registry highlights improvements made in the management of MS in the Czech Republic. However, a relatively low percentage of patients started treatment using second-line drugs, in contrast to trends in other countries.

• MeSH
• dospělí MeSH
• imunologické faktory terapeutické užití   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• progrese nemoci MeSH
• recidiva MeSH
• registrace MeSH
• roztroušená skleróza farmakoterapie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

Roztroušená skleróza (RS) je závažné neurologické onemocnění, které v České republice postihuje odhadem 20 tisíc pacientů. Nemoc zatím neumíme vyléčit, jedinou účinnou prevencí nevratné disability je včasné zahájení protizánětlivé terapie s trvalým monitoringem a úpravou terapie dle individuální aktivity nemoci. Zásadní význam pro vyhodnocení efektu a bezpečnosti léčby mají data z reálné klinické praxe. V České republice od r. 2013 pravidelný sběr těchto dat zajištuje celostátní registr ReMuS, jehož zřizovatelem je Nadační fond Impuls ve spolupráci s odbornou neurologickou společností. K 31. 12. 2019 byla v registru data od 16 300 pacientů, z toho 14 823 pacientů mělo zaznamenánu alespoň jednu návštěvu v RS centru v průběhu r. 2019. Článek přináší výběr aktuálních dat o demografii, klinických parametrech a léčbě v registru ReMuS.

Multiple sclerosis is a serious neurological disease that affects an estimated 20,000 patients in the Czech Republic. We are not yet able to cure the disease, the only effective prevention of irreversible disability is the timely initiation of anti-inflammatory therapy with continuous monitoring and adjustment of therapy according to individual activity of the disease. Data from real clinical practice are crucial for evaluating the efficacy and safety of treatment. In the Czech Republic since 2013, the regular collection of this data has been ensured by the nationwide ReMuS register, the founder of which is the Endowment Fund Impuls in cooperation with the Czech Neurological society. As of 31 December 2019, data from 16,300 patients were in the registry, of which 14,823 patients had at least 1 visit to the MS center during 2019. The article presents a selection of current data on demography, clinical parameters and treatment in the ReMuS registry.

• MeSH
• komorbidita MeSH
• lékařská informatika statistika a číselné údaje   MeSH
• lidé MeSH
• nežádoucí účinky léčiv epidemiologie   MeSH
• postižení MeSH
• registrace * statistika a číselné údaje   MeSH
• roztroušená skleróza * epidemiologie   farmakoterapie   MeSH
• statistika jako téma MeSH
• Check Tag
• lidé MeSH

AIMS: Multiple sclerosis treatment strategies are changing in the Czech Republic. According to data from 2013-2021, the proportion of patients starting high-efficacy disease-modifying therapies is increasing. In this survey, we describe the actual data trends in multiple sclerosis (MS) patients beginning their first disease‐modifying therapies (DMTs) from 2013 to 2021. The secondary objective was to present the history, data collection, and scientific potential of the Czech National MS registry (ReMuS). METHODS: First, using descriptive statistics, we analysed the data for patients starting their first DMTs, either platform (including dimethyl fumarate) or high-efficacy DMTs (HE-DMTs), for each successive year. Second, a detailed description of the history, data collection, completeness, quality optimising procedures, and legal policies of ReMuS is provided. RESULTS: Based on the dataset from December 31, 2021, the total number of monitored patients with MS in ReMuS increased from 9,019 in 2013 (referred from 7 of 15 MS centres) to 12,940 in 2016 (referred from all 15 Czech MS centres) to 17,478 in 2021. In these years, the percentage of patients treated with DMTs in the registry ranged from 76 to 83%, but the proportion of patients treated with HE-DMTs changed from 16.2% in 2013 to 37.1% in 2021. During the follow-up period, a total of 8,491 treatment-naive patients received DMTs. The proportion of patients (all MS phenotypes) starting HE-DMTs increased from 2.1% in 2013 to 18.5% in 2021. CONCLUSION: Patient registries, including ReMuS, provide an essential quality data source, especially in light of the increasing percentage of patients on HE-DMTs. Although early initiation of HE-DMT can provide considerable benefits, it also carries greater potential risks. Consistent long-term follow-up of patients in real‐world clinical practice, which only registries allow, is therefore crucial to evaluate the efficacy and safety of therapeutic strategies, for epidemiological research and to assist decision making by healthcare providers and regulatory bodies.

• MeSH
• dospělí MeSH
• imunologické faktory terapeutické užití   MeSH
• imunosupresiva terapeutické užití   MeSH
• lidé MeSH
• registrace * MeSH
• roztroušená skleróza * farmakoterapie   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

Background: Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Well-established drugs used for MS patients after the first demyelinating event in the Czech Republic include glatiramer acetate (GA), interferon beta-1a (IFNβ-1a), IFN beta-1b (IFNβ-1b), peginterferon beta-1a (peg-IFNβ-1a), and teriflunomide. Objective: The objective of this observational study was to compare the effectiveness of the abovementioned drugs in patients with MS who initiated their therapy after the first demyelinating event. Patients were followed for up to 2 years in real clinical practice in the Czech Republic. Methods: A total of 1,654 MS patients treated after the first demyelinating event and followed up for 2 years were enrolled. Evaluation parameters (endpoints) included the annualized relapse rate (ARR), time to next relapse, change in the Expanded Disability Status Scale (EDSS) score, and time of confirmed disease progression (CDP). When patients ended the therapy before the observational period, the reason for ending the therapy among different treatments was compared. Results: No significant difference was found among the groups of patients treated with IFNβ-1a/1b, GA, or teriflunomide for the following parameters: time to the first relapse, change in the EDSS score, and the proportion of patients with CDP. Compared to IFNβ-1a (44 mcg), a significant increase in the percentage of relapse-free patients was found for GA, but this treatment effect was not confirmed by the validation analysis. Compared to the other drugs, there was a significant difference in the reasons for terminating GA therapy. Conclusion: Small differences were found among GA, IFNβ and teriflunomide therapies, with no significant impact on the final outcome after 2 years. Therefore, in clinical practice, we recommend choosing the drug based on individual potential risk from long-term therapy and on patient preferences and clinical characteristics.

• Publikační typ
• časopisecké články MeSH

BACKGROUND: A special care of MS women planning a pregnancy is highly demanding especially in the terms of disease modifying treatment (DMD) decisions and counselling regarding periods of conception, pregnancy and postpartum period. OBJECTIVE: To provide data about impact of pregnancy, delivery or miscarriage/artificial abortion on MS disease course in Czech women with MS based on analysis of retrospective data from the Czech national registry ReMuS. METHODS: The analysis focused on women with MS with at least one record of pregnancy in the registry. Clinical data (EDSS, relapses) were collected prior to conception, during pregnancy and after delivery or miscarriage/artificial abortion. These data were analysed according to baseline characteristics of DMD treatment prior to conception and according to breastfeeding status. RESULTS: A total of 1 533 pregnancies were analysed from the period of 2013 until 31st December 2019. The occurrence of relapses and worse EDSS was significantly related to the treatment with escalation therapy prior to conception. Relapses were significantly more frequent in women who breastfed less than 3 months than in women who breastfed more than 3 months or did not breastfeed at all. Patients treated with either fingolimod or natalizumab prior to pregnancy were significantly more likely to develop relapses during pregnancy. CONCLUSION: Pregnancy and postpartum period were generally safe for Czech women with MS. Better disease outcomes were observed in those who had been treated with first line injectable DMDs prior to conception and those who either breastfed more than 3 months or did not breastfeed at all. We confirmed the assumption of rebound phenomenon of MS after discontinuation of treatment due to planned pregnancy both for fingolimod and natalizumab.

• MeSH
• fingolimod hydrochlorid terapeutické užití   MeSH
• lidé MeSH
• natalizumab terapeutické užití   MeSH
• retrospektivní studie MeSH
• roztroušená skleróza * chemicky indukované   farmakoterapie   epidemiologie   MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

INTRODUCTION: The influence of breastfeeding and it ́s duration on the course of multiple sclerosis (MS) is unclear. Here we analyzed a real-world data for breastfeeding women with MS and their disease course collected from a Czech national registry ReMuS. OBJECTIVES: To identify risk factors associated with not initiating breastfeeding after delivery, to analyze the impact of breastfeeding on the MS disease course, evaluate the assumption, that breastfeeding is not harmful in MS patients, and compare the disease course by breastfeeding status. MATERIALS AND METHODS: Using propensity score matching we compared Expanded Disability Status Scale (EDSS), confirmed disease worsening (CDW) and annual relapse rate (ARR) in breastfeeding and non-breastfeeding MS patients according to disease duration, disease modifying treatment (DMT) before pregnancy, last EDSS score before conception, age, and ARR during pregnancy. We also compared these parameters between breastfeeding patients not using a DMT and non-breastfeeding patients who resumed DMT within 3 months after delivery. EDSS, ARR, and CDW were collected at 12, 24, and 36 months after delivery. RESULTS: A total of 1681 pregnancies that ended in delivery were analyzed from 2013 through 2020. Change in ARR and EDSS values and 6-months CDW did not significantly differ between the analyzed groups. Compared with non-breastfeeding women who resumed DMT early after delivery, breastfeeding women with MS did not experience worse clinical outcomes even without initiating a DMT. DISCUSSION: Breastfeeding in Czech women with MS did not negatively affect the disease course and can be supported. Patients with MS can be treated with certain DMTs alongside breastfeeding and there is no need to stop breastfeeding, if the patient is clinically stable.

• MeSH
• kojení MeSH
• lidé MeSH
• progrese nemoci MeSH
• recidiva MeSH
• relabující-remitující roztroušená skleróza * farmakoterapie   MeSH
• roztroušená skleróza * farmakoterapie   epidemiologie   MeSH
• těhotenství MeSH
• Check Tag
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH