BACKGROUND AND PURPOSE: We evaluated whether there was a difference in the occurrence of relapses pre- and post-COVID-19 vaccination in a nationwide cohort of Danish patients with relapsing multiple sclerosis. METHODS: We conducted a population-based, nationwide cohort study with a cutoff date of 1 October 2022. We used McNemar tests to assess changes in the proportion of patients with recorded relapses within 90 days and 180 days before and after first vaccine dose, and a negative binomial regression model to compare the 90 and 180 days postvaccination annualized relapse rate (ARR) to the 360 days prevaccination ARR. Multivariate Cox regression was used to estimate relapse risk factors. RESULTS: We identified 8169 vaccinated (87.3% Comirnaty) patients without a recorded history of a positive COVID-19 test. We did not find statistically significant changes in the proportion of patients with relapses in the 90 days (1.3% vs. 1.4% of patients, p = 0.627) and 180 days (2.7% vs. 2.6% of patients, p = 0.918) pre- and postvaccination. Also, a comparison of the ARR 360 days before (0.064, 95% confidence interval [CI] = 0.058-0.070) with the ARR 90 (0.057, 95% CI = 0.047-0.069, p = 0.285) and 180 (0.055, 95% CI = 0.048-0.063, p = 0.060) days after vaccination did not show statistically significant differences. Lower age, higher Expanded Disability Status Scale score, and relapse within 360 days before vaccination were associated with a higher risk of relapse. CONCLUSIONS: We did not find evidence of increased relapse activity following the administration of the first dose of the COVID-19 vaccine.
- MeSH
- chronická nemoc MeSH
- COVID-19 * prevence a kontrola MeSH
- kohortové studie MeSH
- lidé MeSH
- recidiva MeSH
- relabující-remitující roztroušená skleróza * MeSH
- roztroušená skleróza * MeSH
- vakcinace MeSH
- vakcíny proti COVID-19 terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Dánsko MeSH
During the COVID-19 pandemic, people with multiple sclerosis (MS) and their healthcare providers have faced unique challenges related to the interaction between SARS-CoV-2, underlying neurological disease and the use of disease-modifying treatments (DMTs). Key concerns arose, primarily related to the possibility that SARS-CoV-2 infection could trigger the initial demyelinating event or exacerbate disease activity. Another major concern was the safety and efficacy of the COVID-19 vaccines, especially for patients undergoing specific treatments that could weaken their antibody responses. In the post-infection phase, identifying long COVID in patients with MS has been complicated due to the large overlap between post-infection sequelae and MS symptoms. In addition, disruptions in health and rehabilitation services have made it difficult for MS patients to access care. This Series article explores current evidence on the interaction between MS and SARS-CoV-2, identifies the challenges posed by the COVID-19 pandemic in the care of patients with MS, and discusses the significant adoption of digital health solutions, including telemedicine and new technology-based rehabilitation approaches. Based on lessons learned, recommendations and future directions are offered for managing patients with MS, rethinking healthcare systems and improving health outcomes in the post-COVID-19 pandemic era.
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
INTRODUCTION: One of the most debilitating problems encountered by people with multiple sclerosis (MS) is the loss of balance and coordination. Our study aimed to comprehensively evaluate the effectiveness of one year of Tai-chi exercise in patients with MS using both subjective and objective methods, including posturography. METHODS: This was a single-group longitudinal one-year study performed from the 1st of January 2019 to the 1st of January 2020. The primary outcomes of interest were the Mini-Balance Evaluation Systems Test (Mini-BESTest) and static posturography measures as objective methods to detect subtle changes associated with postural control/balance impairment. Secondary outcomes were measures of depression, anxiety, cognitive performance, and quality of life. All objective and subjective parameters were assessed four times: at baseline, and after three, six and 12 months of regular Tai-chi training. The difference was calculated as a subtraction of baseline values from every timepoint value for each measurement. If the normality test was passed, parametric one-sample t-test was used, if failed, Wilcoxon signed ranks test was used to test the difference between the baseline and each timepoint. Alpha was set to 0.017 using Bonferroni correction for multiple comparisons. RESULTS: Out of 25 patients with MS enrolled, 15 women with MS (mean age 44.27 years) were included for statistical analyses after completing the 12-month program. After 12 months, significant improvements were found in all objective balance and gait tests: Mini-BESTest (p<0.001), static posturography measures (total area of the centre of foot pressure - TA; p = 0.015), 25 Feet Walk Test (25FWT; p = 0.001), anxiety (Beck Anxiety Inventory - BAI; p = 0.005) and cognition tests (Paced Auditory Serial Addition Test - PASAT; p = 0.003). Measures of depression (Beck Depression Inventory - BDI; p = 0.071), cognition (Symbol Digit Modalities Test - SDMT; p = 0.079), and health-related quality of life (European Quality of Life 5-Dimensions Questionnaire - EQ-5D-5L; p = 0.095) showed a trend of improvement but were not significant, which could be the result of a small sample and increased bias due the type II error. CONCLUSION: According to these preliminary results, this study indicates the possible beneficial effects of long-term Tai-chi training on patients with MS. Although these findings need to be confirmed by further studies with a larger sample of participants of both genders and require more rigorous randomized controlled trials (RCT) design, our findings support the recommendation of regular and long-term Tai-chi exercise in patients with MS. GOV IDENTIFIER (RETROSPECTIVELY REGISTERED): NCT05474209.
- MeSH
- dospělí MeSH
- kognice MeSH
- kvalita života MeSH
- lidé MeSH
- posturální rovnováha MeSH
- prospektivní studie MeSH
- roztroušená skleróza * komplikace terapie MeSH
- taiči * MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
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
INTRODUCTION: Fabry disease (FD) can be undiagnosed in the context of multiple sclerosis (MS) due to similar clinical and paraclinical features. Our study aimed to determine the prevalence (and the necessity of screening) of FD among patients with possible or definite MS. METHODS: In this prospective monocentric observational study, we included consecutive patients enrolled between May 2017 and May 2019 after the first clinical event suggestive of MS. All patients underwent FD screening using dried blood spots in a stepwise manner combining genetic and enzyme testing. Patients were followed until May 2022. RESULTS: We included 160 patients (73.1% female, mean age 33.9 years). The 2017 revised McDonald's criteria for definite MS were fulfilled by 74 (46.3%) patients at the time of study recruitment and 89 (55.6%) patients after 3-5 years of follow-up. None of the patients had a pathogenic GLA variant, and four (2.5%) had a variant of unknown significance (p.A143T, p.S126G, 2 × p.D313Y). In two of these patients, the intrathecal synthesis of oligoclonal bands was absent, and none had hyperproteinorachia or pleocytosis in cerebrospinal fluid. Detailed examination of FD organ manifestations revealed only discrete ocular and kidney involvement in two patients. CONCLUSION: The prevalence of FD in the population of suspected or definite MS patients does not appear to be high. Our results do not support routine FD screening in all patients with a possible diagnosis of MS, but there is an urgent need to search for red flags and include FD in the differential diagnosis of MS.
- MeSH
- diferenciální diagnóza MeSH
- dospělí MeSH
- Fabryho nemoc * diagnóza epidemiologie MeSH
- lidé MeSH
- nepoznaná diagnóza MeSH
- prospektivní studie MeSH
- roztroušená skleróza * diagnóza epidemiologie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
Roztroušená skleróza (RS) je autoimunitně podmíněné onemocnění, v jehož etiopatogenezi hrají spolu s T‐lymfocyty a rezidentními buňkami CNS podstatnou roli i B‐lymfocyty. Zásadním důkazem je výborná efektivita terapie cílící na molekulu CD20 přítomnou na jejich povrchu. První lék z tohoto ranku schválený v našich podmínkách, ocrelizumab, má již desetiletou historii, ve které prokázal skvělou adherenci, perzistenci a vysokou účinnost jak u pacientů s relaps‐remitentní, tak primárně‐progresivní RS. Jeho hojné využití a četné benefity potvrzují i data z českého registru ReMuS. Vzhledem k předpokládanému mechanismu trvalé imunosuprese vedoucí ke zhoršení protiinfekční i protinádorové imunity je však třeba pacienty nadále bedlivě sledovat.
Multiple sclerosis (MS) is an autoimmune disease in which B-lymphocytes, alongside T-lymphocytes and resident CNS cells, play a crucial role in etiopathogenesis. A pivotal demonstration of B-lymphocytes' significance is the remarkable efficacy of CD20-targeted therapies. Ocrelizumab, the first such drug approved in our conditions, has a decade-long history of excellent adherence, persistence and high efficacy in both patients with relapsing-remitting and and primary-progressive MS. Its widespread use and numerous benefits are confirmed also by data from the Czech ReMuS registry. However, its mechanism of sustained immunosuppression, potentially impairing anti-infective and anti-tumor immunity, necessitates continued patient monitoring to ensure safety.
- Klíčová slova
- ocrelizumab,
- MeSH
- adherence k farmakoterapii MeSH
- antigeny CD20 farmakologie terapeutické užití MeSH
- B-lymfocyty * imunologie účinky léků MeSH
- humanizované monoklonální protilátky farmakologie klasifikace terapeutické užití MeSH
- lidé MeSH
- roztroušená skleróza * diagnóza farmakoterapie imunologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
U onemocnění RS má MR nezastupitelnou roli. Pro maximální využití potenciálu této metody, tedy pro časnou a přesnou diagnostiku s určením prognostických markerů, časný signál neefektivity terapie či bezpečnostního problému, ale i pro dostupnost adekvátní péče pro všechny pacienty, je klíčová unifikace managementu MR napříč jednotlivými pracovišti. Zároveň je podstatná komunikace mezi radiologem a neurologem a s tím související standardizace jak žádanky, tak popisu MR. Jednotná forma dat z MR by vedle zkvalitnění péče o individuálního pacienta vedla i k možnosti sběru dat na národní úrovni. Tím by umožnila získat strukturované informace pro výzkum a také využití dat z MR při jednáních s plátci zdravotní péče. Za tímto účelem vznikl pod záštitou Sekce klinické neuroimunologie a likvorologie České neurologické společnosti tento konsenzus českého expertního radiologicko-neurologického panelu vycházející z mezinárodních doporučení Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS). Přichází s návrhem doporučení základního a rozšířeného diagnostického, monitoračního a bezpečnostního protokolu MR, stanovuje frekvenci jednotlivých vyšetření, nutné informace na žádance na MR a představuje normovaný popis diagnostické i monitorační MR u pacientů s podezřením či stanovenou diagnózou RS.
In MS, MRI has an irreplaceable role. The unification of MRI management across different institutions is crucial for maximal use of the potential of this method, i.e., for early and accurate diagnosis with the determination of prognostic markers, early signal of ineffectiveness of therapy or safety problem, but also for availability of adequate care for all patients. At the same time, communication between the radiologist and neurologist and the associated standardization of both the referral form and MRI description are essential. In addition to improving the quality of care for the individual patient, a uniform MRI data format would also lead to the possibility of national data collection. This would allow for structured information for research as well as the use of MRI data in negotiations with healthcare providers. For this purpose under the patronage of the Section of Clinical Neuroimmunology and Liquorology of the Czech Neurological Society, this consensus of the Czech Expert Radiology-Neurology Panel is published based on the international Magnetic Resonance Imaging in Multiple Sclerosis (MAGNIMS) recommendations. It proposes recommendations for a basic and extended diagnostic, monitoring and safety MRI protocol, specifies the frequency of individual examinations, the necessary information on the MRI referral form and presents a standardized description of diagnostic and monitoring MRI in patients with suspected or confirmed diagnosis of MS.
- Klíčová slova
- diagnostická kritéria, žádanka, diagnostický protokol, monitorační protokol,
- MeSH
- klinické protokoly MeSH
- lidé MeSH
- magnetická rezonanční tomografie * normy MeSH
- roztroušená skleróza * diagnostické zobrazování MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- směrnice pro lékařskou praxi MeSH
Prezentovaná kazuistika názorně ukazuje nasazení vysoce účinné terapie již v raných fázích roztroušené sklerózy jako efektivní strategii. Superiorní efektivitu tohoto přístupu potvrzují i četné studie z reálné klinické praxe. Vedle efektivity terapie je nicméně zcela zásadní sledovat i nežádoucí účinky a včasně zakročit. S rozšiřující se paletou chorobu modifikujících terapií (DMT) je další palčivou otázkou vhodná sekvence jednotlivých léčiv. U pacientů léčených některými DMT (S1P modulátory, natalizumab) je nutno při hledání další terapie pomýšlet také na riziko rebound fenoménu. Jednou z variant, která se z dostupných dat zdá být vhodnou, je následné nasazení okrelizumabu. Při vedení terapie nesmíme zapomínat ani na nefarmakologické přístupy.
The presented case report illustrates the use of high-efficacy therapy in the early stages of multiple sclerosis as an effective strategy. Numerous studies from real clinical practice confirm the superior effectiveness of this approach. However, in addition to the effectiveness of the therapy, it is crucial to monitor side effects and to intervene early. With the expanding range of disease-modifying therapies (DMT), the appropriate sequencing of individual drugs is another pressing issue. For patients treated with some DMT (S1P modulators, natalizumab) the risk of rebound phenomenon should also be considered when looking for subsequent therapy. One option that appears to be appropriate from the available data is the initiation of ocrelizumab. Non-pharmacological approaches must not be forgotten in the management of therapy, too.
- Klíčová slova
- okrelizumab, vysoce účinná terapie, úhradová kritéria,
- MeSH
- humanizované monoklonální protilátky farmakologie terapeutické užití MeSH
- lidé MeSH
- mladý dospělý MeSH
- náklady na léky MeSH
- natalizumab farmakologie terapeutické užití MeSH
- neurozobrazování metody MeSH
- roztroušená skleróza * diagnóza farmakoterapie komplikace MeSH
- Check Tag
- lidé MeSH
- mladý dospělý MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- Publikační typ
- abstrakt z konference MeSH