Ravulizumab is a humanized monoclonal antibody targeting the complement C5 protein. This drug has been approved by different regulatory agencies worldwide for the treatment of AQP-4 seropositive NMOSD based on the results of the CHAMPION-NMOSD trial. Similar to eculizumab, ravulizumab offers highly effective prevention of NMOSD relapses. Both molecules demonstrated more than 90% reduction in relapse risk compared to the placebo group. Ravulizumab has a longer half-life allowing extending interval dosing from two to eight weeks compared to eculizumab. Patients taking C5 complement inhibitors have an increased risk of serious meningococcal infections, therefore vaccination is mandatory before treatment initiation.
- Klíčová slova
- studie CHAMPION-NMOSD, Ravulizumab, AQP4-IgG pozitivní NMOSD,
- MeSH
- akvaporin 4 antagonisté a inhibitory imunologie MeSH
- humanizované monoklonální protilátky * farmakologie klasifikace terapeutické užití MeSH
- klinická studie jako téma MeSH
- komplement C5 antagonisté a inhibitory MeSH
- lidé MeSH
- meningokokové infekce imunologie prevence a kontrola MeSH
- neuromyelitis optica * diagnóza farmakoterapie imunologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
Článek představuje možnosti rehabilitační péče (konkrétně fyzioterapie) u osob s roztroušenou sklerózou s těžkým neurologickým deficitem (EDSS ≥ 7,0). Teoretické poznatky jsou ilustrovány daty z naší pilotní studie domácí fyzioterapie u čtyř pacientů.
The article presents the possibilities of rehabilitation care (specifically physiotherapy) for people with multiple sclerosis with severe neurological deficit (EDSS ≥ 7.0). Theoretical findings are illustrated with data from our pilot study of home physiotherapy in 4 patients.
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
Dysphagia is a common symptom of neurological disease, including multiple sclerosis (MS). The DYsphagia in MUltiple Sclerosis (DYMUS) questionnaire was developed as a screening tool for swallowing problems. The purpose of the present study was to validate the Czech version of the DYMUS questionnaire. We validated the questionnaire on a sample of 435 patients with MS and 135 healthy controls (HC) chosen by accidental sampling from larger, long-term studies conducted by the Prague MS Center. For the purposes of this study, we used both electronic (primary method of distribution) and paper-based (backup) versions of the questionnaire. The internal consistency of the whole scale was satisfactory (Cronbach's α =0.833). The DYMUS mean score in HC was 0.215 (standard deviation [SD] = 0.776). Normative data suggested a cut-off value for dysphagia between 1 and 2 points. Principal component analysis (PCA) showed a two-factor structure of the adapted scale. However, the structure did not completely correspond to the originally proposed dimensions of dysphagia for solids and liquids; our data supported dropout of item Q10. Criterion validity was proved by the difference in dysphagia between HC and patients MS (U = 25,546, p < 0.001) and by a positive correlation with the EDSS (Kendall's tau-b = 0.169, p < 0.001) and other patient-reported outcomes. The Czech version of the DYMUS questionnaire is a valid and reliable tool for evaluating swallowing impairment in Czech-speaking patients with MS. Moreover, the questionnaire can be administered electronically, with a paper-based backup.
- MeSH
- hodnocení výsledků péče pacientem MeSH
- lidé MeSH
- poruchy polykání * diagnóza etiologie MeSH
- průzkumy a dotazníky MeSH
- reprodukovatelnost výsledků MeSH
- roztroušená skleróza * komplikace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Publikační typ
- abstrakt z konference MeSH
- Publikační typ
- abstrakt z konference MeSH
Roztroušená skleróza (RS) je chronické autoimunitní onemocnění centrálního nervového systému postihující převážně mladé dospělé. Mezi faktory mající příznivý vliv na průběh nemoci patří časná protizánětlivá léčba a ovlivnění přidružených onemocnění. Nejčastější komorbidity vyskytující se u pacientů s RS s větší frekvencí než v obecné populaci jsou neurologické, psychiatrické, kardiovaskulární, metabolické a autoimunitní. Stejně jako kompenzace komorbidit ovlivňuje průběh RS, je v některých případech spojena dekompenzace RS s horším průběhem přidružených onemocnění. Vzhledem ke společným rizikovým faktorům a částečně společné imunopatogenezi lze zejména u některých autoimunitních onemocnění využít léčbu pokrývající více nemocí. Některé léky ale mohou paradoxně vývoj jiné autoimunity či další choroby potencovat. Specifickou kapitolou jsou pak nežádoucí účinky a komplikace léčby (zejména infekce a malignity) chorobu modifikujících terapií využívaných u pacientů s RS. Případné přerušení terapie však přináší značná rizika a je ho vždy nutné diskutovat s ošetřujícím lékařem RS centra. Zcela klíčová je zde proto úzká mezioborová spolupráce.
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system, mainly affecting young adults. Factors positively influencing its course include early antiinflammatory treatment and the influencing of other comorbidities. The most common comorbidities occurring in MS patients with a higher frequency than in the general population are neurological, psychiatric, cardiovascular, metabolic and autoimmune. Just as comorbidity compensation affects the course of MS, in some cases, MS decompensation is associated with a worse course of associated diseases. Due to common risk factors and partially shared immunopathogenesis, treatment covering multiple conditions can be used, especially for some autoimmune diseases. On the other hand, some drugs may potentiate the development of other autoimmunity or disorder. A special topic is the side effects and complications of treatment (especially infections and malignancies) of disease-modifying therapies used in patients with MS. However, the potential treatment discontinuation carries significant risks and should always be discussed with the MS specialist. Therefore, close interdisciplinary collaboration is crucial.
- MeSH
- autoimunitní nemoci MeSH
- komorbidita MeSH
- lékové interakce MeSH
- lidé MeSH
- nežádoucí účinky léčiv MeSH
- roztroušená skleróza * farmakoterapie komplikace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
BACKGROUND: Rituximab (RTX) and ocrelizumab (OCR), B cell-depleting therapy targeting CD20 molecules, affect the humoral immune response after vaccination. How these therapies influence T-cell-mediated immune response against SARS-CoV-2 after immunization remains unclear. We aimed to evaluate the humoral and cellular immune response to the COVID-19 vaccine in a cohort of patients with multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myasthenia gravis (MG). METHODS: Patients with MS (83), NMOSD (19), or MG (7) undergoing RTX (n=47) or OCR (n=62) treatment were vaccinated twice with the mRNA BNT162b2 vaccine. Antibodies were quantified using the SARS-CoV-2 IgG chemiluminescence immunoassay, targeting the spike protein. SARS-CoV-2-specific T cell responses were quantified by interferon γ release assays (IGRA). The responses were evaluated at two different time points (4-8 weeks and 16-20 weeks following the 2nd dose of the vaccine). Immunocompetent vaccinated individuals (n=41) were included as controls. RESULTS: Almost all immunocompetent controls developed antibodies against the SARS-CoV-2 trimeric spike protein, but only 34.09% of the patients, without a COVID-19 history and undergoing anti-CD20 treatment (via RTX or OCR), seroconverted. This antibody response was higher in patients with intervals of longer than 3 weeks between vaccinations. The duration of therapy was significantly shorter in seroconverted patients (median 24 months), than in the non-seroconverted group. There was no correlation between circulating B cells and the levels of antibodies. Even patients with a low proportion of circulating CD19+ B cells (<1%, 71 patients) had detectable SARS-CoV-2 specific antibody responses. SARS-CoV-2 specific T cell response measured by released interferon γ was detected in 94.39% of the patients, independently of a humoral immune response. CONCLUSION: The majority of MS, MG, and NMOSD patients developed a SARS-CoV-2-specific T cell response. The data suggest that vaccination can induce SARS-CoV-2-specific antibodies in a portion of anti-CD20 treated patients. The seroconversion rate was higher in OCR-treated patients compared to those on RTX. The response represented by levels of antibodies was better in individuals, with intervals of longer than 3 weeks between vaccinations.
- MeSH
- autoimunitní nemoci nervového systému * MeSH
- COVID-19 * MeSH
- glykoprotein S, koronavirus MeSH
- humanizované monoklonální protilátky terapeutické užití MeSH
- lidé MeSH
- myasthenia gravis * MeSH
- protilátky virové MeSH
- rituximab terapeutické užití MeSH
- roztroušená skleróza * farmakoterapie MeSH
- SARS-CoV-2 MeSH
- vakcína BNT162 MeSH
- vakcinace MeSH
- vakcíny proti COVID-19 MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Roztroušená skleróza je závažné chronické neurologické onemocnění, v jehož patogenezi hraje již od začátku úlohu jak zánětlivý proces, tak zánětem spouštěná neurodegenerace. Jejich poměr je podkladem pro klinický fenotyp. Nejnovější klasifikace tuto skutečnost zohledňuje a rozděluje RS na relabující a progresivní (primárně/sekundárně), přičemž oba fenotypy mohou být aktivní nebo neaktivní. Ačkoli u progresivních forem dominuje neurodegenerace, je u všech fenotypů přítomna i zánětlivá složka, kterou lze léčebně ovlivnit. Důležité je proto progresi včas identifikovat a nasadit adekvátní terapii. Prioritou však nadále zůstává ovlivnění RS v časných fázích s cílem oddálení nástupu progrese a komplexní přístup s důrazem na zdravý životní styl a ovlivnění rizikových faktorů.
Multiple sclerosis is a serious chronic neurological disease. In pathogenesis, both the inflammatory process and inflammation-triggered neurodegeneration play a role from the beginning. Their ratio is the basis for the clinical phenotype. The latest classification takes this into account and divides MS into relapsing and progressive (primary/secondary), where both phenotypes might be active or inactive. Although neurodegeneration is predominant in progressive forms, an inflammatory component is present in all phenotypes and can be therapeutically influenced. Therefore, it is important to identify progression early and provide adequate therapy. However, the priority remains to influence MS in its early stages to delay the onset of progression and to take a comprehensive approach with attention to a healthy lifestyle and influencing risk factors.
Multiple sclerosis (MS) is a serious chronic disease of the central nervous system, in whose pathogenesis both autoimmune inflammation and neurodegeneration play a role from the beginning. Therapeutic options for MS have expanded significantly in recent years. Early initiation of high efficacy treatment after the first attack is now at the forefront of interest, as reimbursement criteria now allow it for monoclonal antibodies targeting the CD20 molecule in the Czech Republic. Ofatumumab can also be administered at home, subcutaneously once a month. However, even in light of these favourable prospects, we must not forget the need for a comprehensive individual approach, including non-pharmacological interventions, especially influencing lifestyle factors.
Roztroušená skleróza (RS) je závažné chronické onemocnění centrálního nervového systému, v jehož patogenezi hraje již od počátku roli jak autoimunitní zánět, tak neurodegenerace. Terapeutické možnosti RS se v posledních letech významně posunuly. V popředí zájmu je v současnosti časné nasazení vysoce účinných léků již po první atace, což nově v České republice u monoklonálních protilátek cílících na molekulu CD20 umožňují i úhradová kritéria. Ofatumumab je navíc možno aplikovat i v domácím prostředí, a to subkutánně jednou měsíčně. I ve světle těchto příznivých vyhlídek však nesmíme zapomínat na nutnost komplexního individuálního přístupu včetně nefarmakologických intervencí, zejména ovlivnění faktorů životního stylu.
- Klíčová slova
- ofatumumab,
- MeSH
- humanizované monoklonální protilátky terapeutické užití MeSH
- lidé MeSH
- roztroušená skleróza * diagnóza etiologie farmakoterapie patologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
