BACKGROUND: Cladribine, a selective immune reconstitution therapy, is approved for the treatment of adult patients with highly active multiple sclerosis (MS). OBJECTIVES: Provide experience with cladribine therapy in a real-world setting. METHODS: This is a registry-based retrospective observational cohort study. First, using data from the Czech nationwide registry ReMuS, we analysed patients who initiated cladribine from September 1, 2018 to December 31, 2021. Second, we analysed a subgroup of patients who initiated cladribine between September 1, 2018 to June 30, 2020, thus possessing a follow-up period of at least 2 years. We evaluated demographic and MS characteristics including disease-modifying therapies (DMTs) before and after cladribine administration, relapses, Expanded Disability Status Scale (EDSS), and adherence. RESULTS: In total, 617 patients (335 with follow-up of at least 2 years) started cladribine therapy in the study period (mean age 37.0, mean disease duration 8.4 years, 74.1% females). In most cases, cladribine was administered as a second-line drug, a total of 80.7% had been escalated from a platform DMT. During 2 years before cladribine initiation, the average annualised relapse rate (ARR) was .67. Following cladribine initiation, the ARR decreased to .28 in the first year and .22 in the second year. Overall, across the entire two-year treatment period, 69.0% of patients were relapse-free and the average ARR was .25. As for EDSS development, the median baseline EDSS was 2.5 and remained stable even after 24 months. The adherence to treatment ranged of around 90%. CONCLUSION: This nationwide study confirms the efficacy of cladribine in real-world settings, especially in patients who are not treatment-naïve. In addition, the study shows an exceptionally high adherence rate, a finding that underscores the invaluable role of cladribine, but also the value of registry-based studies in capturing real-world clinical practice.
- Publikační typ
- časopisecké články 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
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
BACKGROUND: Adolescents are most at risk of engaging in violent interaction. Targeting violence risk and protective factors is essential for correctly understanding and assessing their role in potential violence. We aimed to use the Structured Assessment of Violence Risk in Youth (SAVRY) tool within the sample of adolescents to capture violence risk and protective factors and personality variables related to risk and protective factors. We further aimed to identify which violence risk and protective factors were positively or negatively related to violence within personal history and if any personality traits are typical for violent and non-violent adolescents. Identifying broader or underlying constructs within the SAVRY tool factor analysis can enable appropriate therapeutic targeting. METHODS: We used the Czech standardized version of the SAVRY tool. The study sample comprised 175 men and 226 women aged 12-18 years divided into two categories according to the presence or absence of violence in their personal history. Mann-Whitney U test was used to compare numerical variables between the two groups. SAVRY factor analysis with varimax rotation was used to determine the item factors. We administered the High School Personality Questionnaire (HSPQ) to capture adolescents' personality characteristics. RESULTS: In our sample, there were 151 participants with violence in their personal histories and 250 non-violent participants. Non-violent adolescents had higher values for all six SAVRY protective factors. The strongest protective factor was P3, Strong attachment and bonds across gender or a history of violence. Using factor analysis, we identified three SAVRY internal factors: social conduct, assimilation, and maladaptation. The SAVRY protective factors were significantly positively related to several factors in the HSPQ questionnaire. CONCLUSION: The results highlight the significance of protective factors and their relationship with violence prevalence. HSPQ diagnostics could be helpful in clinically targeting personality-based violence risks and protective factors. The therapeutic focus should be on tension, peer rejection, and anxiety. It is also essential to foster positive attitudes toward authority, prosocial behavior, and attitudes toward school. These strategies can help strengthen protective factors of the SAVRY.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: When the novel coronavirus disease 2019 (COVID-19) appeared, concerns about its course in patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) arose. This study aimed to evaluate the incidence, severity and risk factors of the more severe COVID-19 course among MS and NMOSD patients. METHODS: From March 1, 2020, to February 28, 2021, 12 MS centres, representing 70% of the Czech MS and NMOSD population, reported laboratory-confirmed COVID-19 cases via the Czech nationwide register of MS and NMOSD patients (ReMuS). The main outcome was COVID-19 severity assessed on an 8-point scale with a cut-off at 4 (radiologically confirmed pneumonia) according to the World Health Organisation´s (WHO) COVID-19 severity assessment. RESULTS: We identified 958 MS and 13 NMOSD patients, 50 MS and 4 NMOSD patients had pneumonia, 3 MS and 2 NMOSD patients died. The incidence of COVID-19 among patients with MS seems to be similar to the general Czech population. A multivariate logistic regression determined that higher body mass index (BMI [OR 1.07, 95% CI, 1.00-1.14]), older age (OR per 10 years 2.01, 95% CI, 1.41-2.91), high-dose glucocorticoid treatment during the 2 months before COVID-19 onset (OR 2.83, 95% CI, 0.10-7.48) and anti-CD20 therapy (OR 7.04, 95% CI, 3.10-15.87) were independent variables associated with pneumonia in MS patients. Increase odds of pneumonia in anti-CD20 treated MS patients compared to patients with other disease-modifying therapy (same age, sex, BMI, high-dose glucocorticoid treatment during the 2 months before COVID-19 onset, presence of pulmonary comorbidity) were confirmed by propensity score matching (OR 8.90, 95% CI, 3.04-33.24). Reports on COVID-19 infection in patients with NMOSD are scarce, however, data available up to now suggest a high risk of a more severe COVID-19 course as well as a higher mortality rate among NMOSD patients. In our cohort, 4 NMOSD patients (30.77%) had the more severe COVID-19 course and 2 patients (15.39%) died. CONCLUSION: The majority of MS patients had a mild COVID-19 course contrary to NMOSD patients, however, higher BMI and age, anti-CD20 therapy and high-dose glucocorticoid treatment during the 2 months before COVID-19 onset were associated with pneumonia. Based on this study, we have already started an early administration of anti-SARS-CoV-2 monoclonal antibodies and preferential vaccination in the risk group of patients.
- MeSH
- COVID-19 * MeSH
- kojenec MeSH
- lidé MeSH
- neuromyelitis optica * komplikace epidemiologie MeSH
- pandemie MeSH
- roztroušená skleróza * komplikace farmakoterapie epidemiologie MeSH
- SARS-CoV-2 MeSH
- senioři MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
Cíl: Podělit se o první klinické zkušenosti s léčbou perorálním kladribinem formou analýzy dat z národního registru ReMuS®. Soubor a metodika: Předkládáme analýzu souboru všech pacientů, kteří zahájili léčbu perorálním kladribinem v období od 1. 9. 2018 do 31. 12. 2020, a detailnější analýzu podsouboru 222 pacientů, kteří užili plnou kumulativní dávku. Analýzy zahrnují relapsy, disabilitu, zaměstnanost a sociální dávky, v podsouboru pak také MR aktivitu. Data byla získána ze všech 15 center pro léčbu demyelinizačních onemocnění a vyhodnocena metodami deskriptivní statistiky. Výsledky: Celý soubor obsahuje 436 pacientů (75,5 % žen) věkového průměru 37,0 let a hmotnosti 71,9 kg. Průměrná doba trvání nemoci byla 8,4 roku, vstupní Expanded Disability Status Scale (EDSS) skóre 2,8, roční výskyt relapsů 1,07 před zahájením léčby. U 90 % pacientů nedošlo po 20,8 (90. kvantil) měsíce k progresi disability, v prvním a druhém roce po zahájení léčby zůstaly bez relapsu přibližně tři čtvrtiny pacientů. U 85 % pacientů v definované podskupině nedošlo k významné MR aktivitě. Změna léčby na jiný lék modifikující průběh nemoci proběhla u 12 pacientů. Závěr: V souladu s registračními studiemi ukazují naše data vysoký podíl pacientů bez relapsů, bez progrese postižení a bez aktivity na MR, dále pak velmi nízký podíl pacientů se změnou léčby.
Aim: Our objective was to share our first clinical experience with oral cladribine gathered through the analysis of data of the national ReMuS® registry. Patients and methods: Our sample includes data of all patients who initiated oral cladribine treatment since September 1, 2018 till December 31, 2020. We also analyzed, in more detail, the subgroup of 222 patients who were assumed to complete the full cumulative dose. Our analyses included relapses, disability, employment status and financial social support, and also MRI activity in the subgroup. Data were obtained from all 15 centers for treatment of MS and analyzed in terms of descriptive statistics. Results: A total sample comprised of 436 patients, 75.5% of them females, mean age 37.0 years, and mean weight 71.9 kg. Mean duration since the disease onset was 8.4 years with a mean baseline EDSS (Expanded Disability Status Scale) score of 2.8. Mean annualized relapse rate was 1.07 prior to treatment initiation. After treatment initiation, the confirmed disability progression was not reached in 90% of patients until 20.8 (90th quantile) months after follow up. Approximately three quarters of patients stayed relapse-free in year one and two. In the defined subgroup, 85% of patients had no significant MRI activity. A switch to another disease-modifying drug was performed in 12 patients. Conclusion: In accordance with the pivotal trials, our data demonstrate a high proportion of patients without relapses, disability progression and MRI activity, and a very low proportion of patients with a treatment change.
Východisko: Diabetická nefropatie (DN) představuje celosvětově jednu z hlavních příčin chronického selhání ledvin (CHRS). V poslední lobě téměř 24% pacientů v Evropě, kteří zahájí pravidelné dialyzační léčení (PDL), má DN jako primární renální chorobu (PRD) vedoucí k CHRS. Není však k dispozici mnoho údajů zabývajících se vlivem PRD na přežívání diabetiků v PDL. Cíl: Cílem studie bylo zjistit, zda PRD ovlivřiuje přežívání u diabetiků vedených v Registru dialyzovaných pacientů (RDP) v České republice (ČR). Metodika: RDP shromažďuje od r. 2006 individuální data chronicky dialyzovaných pacientů v ČR a v současné době zahrnuje kolem dvou třetin hemodialyzovaných pacientů. Do studie byli zařazeni všichni pacienti, kteří vstoupili do PDL 1.1. 2006 až 30. 6.2014 a byla registrována jejich PRD. Následně bylo analyzováno jejich přežívání. Zjištěná data jsme porovnali u diabetiků a nediabetiků podle PRD, věku a pohlaví. Výsledky: Studovanou populaci tvořilo 6913 pacientů, z čehož diabetiků bylo 2807 (40,6 %). PRD byly zjištěny následovně: DN mělo 2039 pacientů (29,5 %), nediabetické nefropatie (NDRD) u diabetiků 768 pacientů (11.1 %), chronické glomerulonefritidy (GN) 739 pacientů (10,7 %), polycystickou chorobu ledvin (PCHL) 330 pacientů (4,8 %), vaskulární nefrosklerózu (VASC) 742 pacientů (10,8 %), tubulointersticiální nefritidu (TIN) 853 pacientů (12,3%) a jinou PRD mělo celkem 646 pacientů (9,3 %); u 796 pacientů (11,5%) nebylo možné PRD přesně určit (nCKD). Celkově bylo mužů 59% a věk nad 70 let mělo 48%. Celkový průměr přežití činil 4,9 roku a zároveň 75% pacientů přežilo téměř dva roky (1,97 roku). Nenašli jsme statisticky významný rozdíl přežití mezi ženami a muži (p = 0,603) a také nebylo rozdílné přežití mezi skupinami nad a pod 70 let (p = 0,079). Pětileté přežívání měli signifikantně lepší nediabetici (50%) vs. DN (42%) vs. NDRD (37 %). Závěr: DN představuje nejčastější příčinu CHRS v ČR, ostatní skupiny (NDRD, GN, VASC, TIN. nCKD) jsou přibližné stejné početné. Podle očekávání jsme prokázali signifikantní negativní efekt přítomnosti diabetů na přežití pacientů nezávisle na PRD. U podskupiny diabetiků jsme překvapivě zjistili signifikantně delší přežití pro skupinu DN než NDRD, důvody nejsou jasné. Pohlaví neovlivnilo přežití.
Background: Diabetes mellitus has become the leading cause of end-stage renal disease (ESRD) worldwide. Recently, almost 24% of patients (pts) entering renal replacement therapy (RRT) in Europe has been referred as having diabetic nephropathy (DN) as the primary renal disease (PRD) leading to ESRD. Data on the influence of PRD on the survival of diabetic pts in RRT are lacking. Aim: The aim of our study was to compare survival data of diabetic pts on maintenance haemodialysis treatment (HD), i.e. > 3 months, from the Czech Republic (CR) according to their PRD. Methods: We used the data from the Czech Registry of Dialysis Patients (RDP) which currently covers about 2/3 of allpts treated on HD in CR. All pts entering HD in period 1. 1. 2006 - 30. 6. 2014 with registered PRD were enrolled into the study and their survival was analysed. The data were compared according to PRD, diabetic status, age and gender. Results: Study population included 6913 pts from which 2807 (40.6%) were diabetics. PRD were disclosed as following: 2039 pts (29.5%) suffered from diabetic nephropathy (DN), 768 (11.1) from non-diabetic renal disease (NDRD) but being diabetics, 739 (10 .7) from chronic glomerulonephritis (GN), 330 (4.8) from polycystic kidney disease (PCHL), 742 (10.8) from vascular nephrosclerosis (VASC), 853 (12.3) from tubulointerstitial nephritis while 646 (9.3) had other PRD; PRD was not possible to define preciously ( nCKD) in 796 pts (11.5%). Altogether 59% of pts were men and 48% were over 70-y old. The overall mean survival reached 4.9 years, 75% of pts survived 2 years. There was no overall survival difference between men and women (p = 0.603) and between age groups under and over 70-y, too (p = 0.079). Five years survival was shown to be significantly better in non-diabetics (50%) vs. DN (42%) and vs. NDRD (37% ). Conclusions: DN represents the most common cause of ESRD in Czech Republic, other groups (NDRD, GN, VASC, TIN, nCKD) are represented almost equally. As expected, we proved a strong impact of the diabetes presence on pts survival despite the group of PRD. Surprisingly, survival of DN pts was found higher compared to NDRD (p = 0.001); reasons for that can be speculated. Gender did not influence the survival.
- Klíčová slova
- nediabetická nefropatie, Registr dialyzovaných pacientů,
- MeSH
- chronické selhání ledvin epidemiologie etiologie MeSH
- diabetes mellitus epidemiologie MeSH
- diabetické nefropatie epidemiologie MeSH
- dialýza ledvin * mortalita MeSH
- glomerulonefritida epidemiologie MeSH
- intersticiální nefritida epidemiologie MeSH
- Kaplanův-Meierův odhad MeSH
- komplikace diabetu * epidemiologie MeSH
- lidé MeSH
- nefroskleróza epidemiologie MeSH
- nemoci ledvin epidemiologie MeSH
- rozložení podle pohlaví MeSH
- senioři MeSH
- věkové rozložení MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
