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1.
Proc Natl Acad Sci U S A ; 117(36): 22402-22412, 2020 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-32839304

RESUMO

Multiple sclerosis (MS), an autoimmune disease of the central nervous system, generally starts as the relapsing remitting form (RRMS), but often shifts into secondary progressive MS (SPMS). SPMS represents a more advanced stage of MS, characterized by accumulating disabilities and refractoriness to medications. The aim of this study was to clarify the microbial and functional differences in gut microbiomes of the different stages of MS. Here, we compared gut microbiomes of patients with RRMS, SPMS, and two closely related disorders with healthy controls (HCs) by 16S rRNA gene and whole metagenomic sequencing data from fecal samples and by fecal metabolites. Each patient group had a number of species having significant changes in abundance in comparison with HCs, including short-chain fatty acid (SCFA)-producing bacteria reduced in MS. Changes in some species had close association with clinical severity of the patients. A marked reduction in butyrate and propionate biosynthesis and corresponding metabolic changes were confirmed in RRMS compared with HCs. Although bacterial composition analysis showed limited differences between the patient groups, metagenomic functional data disclosed an increase in microbial genes involved in DNA mismatch repair in SPMS as compared to RRMS. Together with an increased ratio of cysteine persulfide to cysteine in SPMS revealed by sulfur metabolomics, we postulate that excessive DNA oxidation could take place in the gut of SPMS. Thus, gut ecological and functional microenvironments were significantly altered in the different stages of MS. In particular, reduced SCFA biosynthesis in RRMS and elevated oxidative level in SPMS were characteristic.


Assuntos
Microbioma Gastrointestinal , Esclerose Múltipla Crônica Progressiva/microbiologia , Esclerose Múltipla Recidivante-Remitente/microbiologia , Adulto , Estudos de Casos e Controles , Cisteína/metabolismo , Ácidos Graxos Voláteis/metabolismo , Fezes/microbiologia , Feminino , Microbioma Gastrointestinal/genética , Microbioma Gastrointestinal/fisiologia , Humanos , Masculino , Metagenoma/genética , Esclerose Múltipla Crônica Progressiva/epidemiologia , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Estresse Oxidativo/fisiologia , Enxofre/metabolismo
2.
Drug Discov Ther ; 14(3): 122-128, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32669520

RESUMO

The aim of this study is to investigate the potential neuroprotective effect of high-doses vitamins B1, B6 and B12 in patients with relapsing-remitting multiple sclerosis (RRMS) and persistent visual loss after acute optic neuritis (AON). Sixteen patients (20 eyes) diagnosed with RRMS and visual permanent disability following AON were enrolled for the present open, pilot study. Each patient was treated with oral high-doses 300 mg of vitamin B1, 450 mg of vitamin B6 and 1,500 mcg of vitamin B12, as add-on treatment to concomitant disease-modifying therapies (DMTs) for consecutive 90 days. Outcome measures were to determine changes from baseline to month three in visual acuity (VA) and visual field (VF) testing, with correlations with clinical parameters. Logistical regression was performed to evaluate predictors of final VA. A statistically significant improvement was registered in visual acuity (p = 0.002) and foveal sensitivity threshold (FT) (p = 0.006) at follow-up compared to baseline. A similar trend was demonstrated for mean deviation (MD) (p < 0.0001), and pattern standard deviation (PSD) (p < 0.0001). Age at the time of inclusion was positively correlated with latency time (rho = 0.47, p = 0.03), while showing a negative correlation with visual acuity (rho = - 0.45, p = 0.04) and foveal sensitivity threshold (rho = - 0.6, p = 0.005) at follow up. A statistically significant correlation was demonstrated between foveal sensitivity threshold and visual acuity at baseline (rho = 0.79, p < 0.0001). In a linear regression model, the main predictor of visual acuity at follow up was the foveal sensitivity threshold (B = 1.39; p < 0.0001). Supplemental high-dose vitamins B1, B6 and B12 resulted as effective therapy to improve visual function parameters in MS-related visual persistent disability.


Assuntos
Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Tiamina/administração & dosagem , Transtornos da Visão/tratamento farmacológico , Vitamina B 12/administração & dosagem , Vitamina B 6/administração & dosagem , Adulto , Feminino , Humanos , Masculino , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Projetos Piloto , Transtornos da Visão/diagnóstico , Transtornos da Visão/epidemiologia , Complexo Vitamínico B/administração & dosagem
3.
Medicine (Baltimore) ; 99(27): e20885, 2020 Jul 02.
Artigo em Inglês | MEDLINE | ID: mdl-32629678

RESUMO

BACKGROUND: The relapse is character of relapsing-remitting multiple sclerosis. The therapeutic goal is to reduce the risk of relapse. Factors associated with relapses can help to manage and prevent relapses. In addition, patients and doctors all pay attention to it. However, there are differences between studies. Our aim is to summarize factors associated with relapses in relapsing-remitting multiple sclerosis (RRMS). METHODS: PubMed, EMBASE, Web of science, Cochrane library, CNKI, Wanfang, SinoMed, and VIP were searched to identify risk factors about relapses in RRMS, which should be in cohort or case-control studies. This article was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The quality of studies was evaluated by the Newcastle-Ottawa Scale (NOS). Meta-analysis, subgroup and sensitivity analyses, and publication bias were all performed with Stata. This research has been registered on the international prospective register of systematic reviews (PROSPERO, CRD42019120502). RESULTS: 43 articles were included. Infection, postpartum period, risk gene, stress, and vitamin D were risk factors for relapses in RRMS. Pregnancy period was the protective factor. Among those, infection increased the risk of relapses in infection period (relative risk [RR], 2.07 [confidence interval (CI), 1.64 to 2.60]). Women in the postpartum period increased the risk of relapses compared with women before pregnancy (RR, 1.43 [CI, 1.19 to 1.72]), or women in pregnancy period (RR, 2.07 [CI, 1.49 to 2.88]). Women in the pregnancy period decreased the risk of relapses (RR, 0.56 [CI, 0.37 to 0.84]) compared with women before pregnancy. However, fewer studies, heterogeneity, and sample size were the limitations. CONCLUSION: It is reliable to adopt results about infection, pregnancy period, and postpartum period.


Assuntos
Esclerose Múltipla Recidivante-Remitente/fisiopatologia , Comorbidade , Humanos , Infecções/epidemiologia , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Período Pós-Parto , Recidiva , Fatores de Risco , Estresse Psicológico/epidemiologia , Vitamina D/sangue
4.
Artigo em Inglês | MEDLINE | ID: mdl-32587103

RESUMO

OBJECTIVE: To evaluate disease activity in patients with relapsing-remitting MS (RRMS) receiving rituximab with an extended dosing interval. METHODS: In the context of COVID-19 pandemic, this was an interim analysis of an ongoing prospective observational study of patients who were stable on rituximab for at least 6 months and who had a planned extended dosing interval of 24 months. Only data for patients with active RRMS before rituximab were analyzed. RESULTS: Among 177 patients receiving rituximab, 33 had RRMS and MRI activity before rituximab and at least 8 months of follow-up after the last infusion. The mean (SD) age was 40 (14) years, 25 were females, the mean disease duration was 10 (6.8) years, the mean annual relapse rate (ARR) before rituximab was 1.7 (1.3), and the median Expanded Disability Status Scale (EDSS) score before rituximab was 4.5 (1-7). Before extended dosing, when rituximab was infused every 6 months, the mean (SD) ARR decreased to 0.04 (0.1) (p < 0.0001) and the EDSS score to 4 (0-7) (p = 0.04). At the time of this analysis, the median follow-up since the last infusion was 11 (8-31) months. No patient showed relapse or disability progression. In total, 30 patients had at least 1 MRI performed since the last infusion (median time between the last MRI and the last infusion 10 [8-31] months). No MRI showed activity. The CD19+ cell proportion was >1% for 10 of 25 patients at the last count (median time 8 [6-25] months). CONCLUSIONS: An extended dosing interval for rituximab for patients with stable MS during the COVID-19 pandemic may be associated with a low risk of disease activity.


Assuntos
Betacoronavirus , Infecções por Coronavirus/tratamento farmacológico , Fatores Imunológicos/administração & dosagem , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Pandemias , Pneumonia Viral/tratamento farmacológico , Rituximab/administração & dosagem , Adulto , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Estudos Prospectivos
5.
Fortschr Neurol Psychiatr ; 88(6): 379-385, 2020 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-32557466

RESUMO

AIMS AND METHODOLOGY: Description of basic data, common symptoms and their medical, non-drug and combined symptomatic treatment in a large sample of MS patients undergoing outpatient treatment of the German NeuroTransData (NTD) physician network. RESULTS: Currently there are 21,407 patients in the registry. Average age is 49.0 ± 13.0 years, 72,3 % of them female, average disease duration is 14.3 ± 8,9 years. Relapsing-remitting MS (RRMS) was present in 77 %, secondary-progressive MS (SPMS) 15 %, PPMS 5 %. The mean EDSS score of the total sample was 2.8 (range 0,5-8). Fatigue was the most common symptom in all subtypes (96 %), followed by spasticity (all 31 %, SPMS: 47 %; PPMS 36 %). Regarding symptomatic drug treatment, non-drug treatment and combined treatment, there was a wide range of variation. While spasticity was treated in 81 %, only 21 % of patients with fatigue receiving any form of therapy, Also, fecal and urine incontinence often remained untreated in 69 % resp. 56 % of cases. CONCLUSIONS: Setup, development and maintenance of a registry for a complex and chronic disease like MS represents an instrument to assess and improve patient care in the outpatient setting. Our results are hard to compare with the DMSG-registry, another German, more hospital-based data collection. However, both registries identify fatigue as the most common symptom in MS.


Assuntos
Esclerose Múltipla/epidemiologia , Sistema de Registros , Fadiga/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Crônica Progressiva/epidemiologia , Esclerose Múltipla Recidivante-Remitente/epidemiologia
6.
PLoS One ; 15(5): e0231846, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32357176

RESUMO

BACKGROUND: Multiple Sclerosis (MS) is a chronic inflammatory, immune mediated disease of the central nervous system, with Relapsing Remitting MS (RRMS) being the most common type. Within the last years, the status of high disease activity (HDA) has become increasingly important for clinical decisions. Nevertheless, little is known about the incidence, the characteristics, and the current treatment of patients with RRMS and HDA in Germany. Therefore, this study aims to estimate the incidence of HDA in a German RRMS patient population, to characterize this population and to describe current drug treatment routines and further healthcare utilization of these patients. METHODS: A claims data analyses has been conducted, using a sample of the InGef Research Database that comprises data of approximately four million insured persons from around 70 German statutory health insurances (SHI). The study was conducted in a retrospective cohort design, including the years 2012-2016. Identification of RRMS population based on ICD-10 code (ICD-10-GM: G35.1). For identification of HDA, criteria from other studies as well as expert opinions have been used. Information on incidence, characteristics and current treatment of patients with RRMS and HDA was considered. RESULTS: The overall HDA incidence within the RRMS population was 8.5% for 2016. It was highest for the age group of 0-19 years (29.4% women, 33.3% men) and lowest for the age group of ≥ 50 years (4.3% women, 5.6% men). Mean age of patients with RRMS and incident HDA was 38.4 years (SD: 11.8) and women accounted for 67.8%. Analyses of drug utilization showed that 82.4% received at least one disease-modifying drug (DMD) in 2016. A percentage of 49.8% of patients received drugs for relapse therapy. A share of 55% of RRMS patients with HDA had at least one hospitalization with a mean length of stay of 13.9 days (SD: 18.3 days) in 2016. The average number of outpatient physician contacts was 28.1 (SD: 14.0). CONCLUSIONS: This study based on representative Germany-wide claims data from the SHI showed a high incidence of HDA especially within the young RRMS population. Future research should consider HDA as an important criterion for the quality of care for MS patients.


Assuntos
Esclerose Múltipla Recidivante-Remitente , Adolescente , Adulto , Criança , Pré-Escolar , Estudos de Coortes , Comorbidade , Feminino , Alemanha , Humanos , Incidência , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla/epidemiologia , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Estudos Retrospectivos , Adulto Jovem
7.
Acta Neurol Scand ; 142(3): 267-274, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32392359

RESUMO

OBJECTIVES: To analyze the frequency and demographic characteristics of multiple sclerosis (MS) in the Council of Santiago de Compostela (SPAIN). MATERIAL AND METHODS: The patients diagnosed with MS according to the McDonald 2010 diagnostic criteria were identified within the population of the District of Santiago de Compostela. Several sources were used (records and databases from Hospital, General Practitioners, Private Clinics, and the MS Patients Association). Demographic and clinical data were obtained from the electronic files. RESULTS: The incidence of MS between 2010 and 2015 was 8/100 000/year (95% CI: 6-10), and the prevalence on December 31, 2015, was 152/100 000 (95% CI: 127-176). The age-standardized prevalence (using the European Standard Population 2013) was 137 (95% CI: 114-159) and the incidence of 7 (95% CI: 2-12). The female:male ratio was 1.84, the mean age at the first symptom was 32.23 years, the diagnosis was delayed 3.12 years, and the mean EDSS was 2.82. 71.17% had relapsing-remitting MS, 16.55% secondary progressive MS, 7.59% primary progressive MS, and 0.69% progressive relapsing MS. A disease-modifying treatment was established in 62.76% of patients in a mean of 1.96 years after the diagnosis. CONCLUSIONS: The northwest of Spain is a high-risk area for MS, with frequencies similar to other Atlantic regions and higher than the rest of the country.


Assuntos
Esclerose Múltipla/epidemiologia , Adolescente , Adulto , Fatores Etários , Idade de Início , Idoso , Idoso de 80 Anos ou mais , Criança , Bases de Dados Factuais , Diagnóstico Tardio , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/mortalidade , Esclerose Múltipla Crônica Progressiva/epidemiologia , Esclerose Múltipla Crônica Progressiva/mortalidade , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/mortalidade , Prevalência , Fatores Sexuais , Espanha/epidemiologia , Adulto Jovem
8.
PLoS One ; 15(5): e0233575, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32453803

RESUMO

The natural history of relapsing remitting multiple sclerosis (RRMS) is variable and prediction of individual prognosis challenging. The inability to reliably predict prognosis at diagnosis has important implications for informed decision making especially in relation to disease modifying therapies. We conducted a systematic review in order to collate, describe and assess the methodological quality of published prediction models in RRMS. We searched Medline, Embase and Web of Science. Two reviewers independently screened abstracts and full text for eligibility and assessed risk of bias. Studies reporting development or validation of prediction models for RRMS in adults were included. Data collection was guided by the checklist for critical appraisal and data extraction for systematic reviews (CHARMS) and applicability and methodological quality assessment by the prediction model risk of bias assessment tool (PROBAST). 30 studies were included in the review. Applicability was assessed as high risk of concern in 27 studies. Risk of bias was assessed as high for all studies. The single most frequently included predictor was baseline EDSS (n = 11). T2 Lesion volume or number and brain atrophy were each retained in seven studies. Five studies included external validation and none included impact analysis. Although a number of prediction models for RRMS have been reported, most are at high risk of bias and lack external validation and impact analysis, restricting their application to routine clinical practice.


Assuntos
Esclerose Múltipla Recidivante-Remitente/terapia , Esclerose Múltipla/terapia , Prognóstico , Tomada de Decisões , Progressão da Doença , Humanos , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/fisiopatologia , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/fisiopatologia
9.
Neurol Sci ; 41(6): 1369-1371, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32440979

RESUMO

BACKGROUND: As a consequence of the coronavirus disease 2019 (COVID-19) pandemic, a large amount of consultations will be delivered through tele-medicine, especially for diseases causing chronic disability and requiring immunomodulatory treatments, such as multiple sclerosis (MS). METHODS: We have hereby reviewed available tools for tele-neurology examination in MS, including components of neurological examination that can be assessed through video, patient-reported outcome measures (PROMs), and digital technology. RESULTS: Overall, we have suggested a battery for assessing MS disability and relapses on tele-medicine, which brings together conventional examination, PROMs (e.g., Patient Determined Disease Steps, MS Impact Scale), and cognitive tests (Symbol Digit Modalities Test) that can be delivered remotely and in multiple languages. DISCUSSION: The use of common tools for neurological examination could improve tele-neurology practice for both general neurologists and MS specialists, and quality of care for people with MS.


Assuntos
Avaliação da Deficiência , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/terapia , Neurologia/métodos , Telemedicina/métodos , Betacoronavirus , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Humanos , Esclerose Múltipla/diagnóstico , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/terapia , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Neurologia/tendências , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Telemedicina/tendências
10.
Mult Scler Relat Disord ; 43: 102195, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32460086

RESUMO

OBJECTIVE: To determine whether the course of COVID-19 is more severe in patients with MS and if MS disease-modifying treatments (DMTs) affect the risk of contracting the disease. METHODS: In a cross-sectional survey, data were collected by sending a questionnaire to 2000 patients with a demyelinating disease through an online portal system. Collected data included the current MS DMT and patient-reported disability level, history of recent sick contact, recent fever, respiratory symptoms, diagnosis with COVID-19, and the disposition after the diagnosis. We defined a COVID-19-suspect group as patients having fever and cough or fever and shortness of breath, or a presumptive diagnosis based on suggestive chest computed tomography. We calculated the proportion of COVID-19-suspect patients and compared their demographics, clinical characteristics, and DMT categories with the rest of survey-responders, using univariable and multivariable models. RESULTS: Out of 712 patients, 34 (4.8%) fulfilled our criteria for being in the COVID-19-suspect group. Only two patients required hospitalization. No patient required intensive care. In a multivariable model, disease duration (p-value=0.017), DMT category (p-value=0.030), and history of sick contact (p-values<0.001) were associated with the risk of being in the COVID-19-suspect group. Being on B-cell depleting antibodies (as compared to non-cell depleting, non-cell trafficking inhibitor DMTs) was associated with a 2.6-fold increase in the risk of being in the COVID-19-suspect group. (RR: 3.55, 95%CI: 1.45, 8.68, p-value=0.005). CONCLUSIONS: The course of infection in patients with MS suspected of having COVID-19 was mild to moderate, and all patients had a full recovery. B-cell depleting antibodies may increase the susceptibility to contracting COVID-19.


Assuntos
Infecções por Coronavirus/imunologia , Hospedeiro Imunocomprometido/imunologia , Fatores Imunológicos/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Pneumonia Viral/imunologia , Adulto , Anticorpos Monoclonais Humanizados/uso terapêutico , Linfócitos B/imunologia , Betacoronavirus , Infecções por Coronavirus/complicações , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/fisiopatologia , Tosse , Estudos Transversais , Crotonatos/uso terapêutico , Fumarato de Dimetilo/uso terapêutico , Suscetibilidade a Doenças , Dispneia , Epidemias , Feminino , Febre , Cloridrato de Fingolimode/uso terapêutico , Acetato de Glatiramer/uso terapêutico , Hospitalização/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Interferons/uso terapêutico , Irã (Geográfico)/epidemiologia , Pulmão/diagnóstico por imagem , Depleção Linfocítica , Masculino , Esclerose Múltipla/complicações , Esclerose Múltipla Crônica Progressiva/tratamento farmacológico , Esclerose Múltipla Crônica Progressiva/epidemiologia , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Natalizumab/uso terapêutico , Pandemias , Pneumonia Viral/complicações , Pneumonia Viral/epidemiologia , Pneumonia Viral/fisiopatologia , Rituximab/uso terapêutico , Índice de Gravidade de Doença , Toluidinas/uso terapêutico , Tomografia Computadorizada por Raios X
11.
Neurology ; 94(22): e2373-e2383, 2020 06 02.
Artigo em Inglês | MEDLINE | ID: mdl-32430312

RESUMO

OBJECTIVE: Disease-modifying treatments (DMTs) are the gold standard for slowing disability progression in multiple sclerosis (MS), but their effects on cognitive impairment, a key symptom of the disease, are mostly unknown. We conducted a systematic review and meta-analysis to evaluate the differential effects of DMTs on cognitive test performance in relapsing-remitting MS (RRMS). METHODS: PubMed, Scopus, and Cochrane Library were searched for studies reporting longitudinal cognitive performance data related to all major DMTs. The standardized mean difference (Hedges g) between baseline and follow-up cognitive assessment was used as the main effect size measure. RESULTS: Forty-four studies, including 55 distinct MS patient samples, were found eligible for the systematic review. Twenty-five studies were related to platform therapies (mainly ß-interferon [n = 17] and glatiramer acetate [n = 4]), whereas 22 studies were related to escalation therapies (mainly natalizumab [n = 14] and fingolimod [n = 6]). Reported data were mostly confined to the cognitive domain processing speed. A meta-analysis including 41 studies and 7,131 patients revealed a small to moderate positive effect on cognitive test performance of DMTs in general (g = 0.27, 95% confidence interval [CI] = [0.21-0.33]), but no statistically significant differences between platform (g = 0.27, 95% CI = [0.18-0.35]) and escalation therapies (g = 0.28, 95% CI = [0.19-0.37]) or between any single DMT and ß-interferon. CONCLUSIONS: DMTs are effective in improving cognitive test performance in RRMS, but a treatment escalation mainly to amend cognition is not supported by the current evidence. Given the multitude of DMTs and their widespread use, the available data regarding differential treatment effects on cognitive impairment are remarkably scant. Clinical drug trials that use more extensive cognitive outcome measures are urgently needed.


Assuntos
Cognição/efeitos dos fármacos , Disfunção Cognitiva/tratamento farmacológico , Imunossupressores/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Cognição/fisiologia , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/psicologia , Cloridrato de Fingolimode/farmacologia , Cloridrato de Fingolimode/uso terapêutico , Acetato de Glatiramer/farmacologia , Acetato de Glatiramer/uso terapêutico , Humanos , Fatores Imunológicos/farmacologia , Fatores Imunológicos/uso terapêutico , Imunossupressores/farmacologia , Interferon beta/farmacologia , Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/psicologia , Natalizumab/farmacologia , Natalizumab/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
12.
Value Health ; 23(3): 328-334, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32197728

RESUMO

OBJECTIVES: Disease-modifying therapies (DMTs) reduce relapse rates and disability progression for relapsing multiple sclerosis (MS). Although 25% to 30% of all US patients with MS are Medicare beneficiaries, limited information exists on this population. This is the first study using national Medicare data to (1) describe characteristics of patients with MS using DMTs, (2) estimate adherence to DMTs over a 1-year and 3-year follow-up, and (3) examine factors associated with DMT adherence. METHODS: This retrospective claims analysis used 2011-2014 100% Medicare files. Monthly adherence to MS DMTs was defined as the proportion of days covered ≥0.80 with any DMT in each month for 1-year (n = 36 593) and 3-year (n = 17 599) follow-up samples of MS DMT users. Generalized estimating equation logistic regressions were used to estimate factors associated with adherence to DMTs. RESULTS: Over 90% of patients were eligible for Medicare owing to disability, and about three-quarters qualified for low-income subsidies. A downward trend in DMT adherence was observed over time in both samples. Monthly adherence dropped significantly between December of the prior year to January of the following year (from 76% to 65% in the 1-year follow-up sample and similar drops seen across all years in the 3-year follow-up sample). Multivariable regressions indicated characteristics such as being low-income, having a disability, and having high patient out-of-pocket DMT costs associated with poor adherence to DMTs. CONCLUSION: Our study provides important insights into the characteristics and DMT adherence of Medicare patients with MS and highlights the need for interventions and policies mitigating barriers to adherence in this population.


Assuntos
Acesso aos Serviços de Saúde , Fatores Imunológicos/uso terapêutico , Medicare , Adesão à Medicação , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Demandas Administrativas em Assistência à Saúde , Adulto , Idoso , Data Warehousing , Bases de Dados Factuais , Avaliação da Deficiência , Custos de Medicamentos , Definição da Elegibilidade , Feminino , Gastos em Saúde , Acesso aos Serviços de Saúde/economia , Humanos , Fatores Imunológicos/efeitos adversos , Fatores Imunológicos/economia , Renda , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Esclerose Múltipla Recidivante-Remitente/economia , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Estudos Retrospectivos , Fatores de Tempo , Estados Unidos/epidemiologia
13.
BMC Neurol ; 20(1): 52, 2020 Feb 12.
Artigo em Inglês | MEDLINE | ID: mdl-32050931

RESUMO

BACKGROUND: Information of Previous studies on the prevalence of MS, including our study conducted 12 years ago, used to shape global prevalence map of MS. According to those results, Iran placed in medium-prevalence MS region in the world Atlas of MS 2013.This study aimed to investigate the prevalence of MS in Mazandaran province after 12 years and the need for possible changes in the global map of the prevalence of MS. METHODS: We included all MS patients living in Mazandaran province in 2018 in this descriptive cross-sectional study. We updated our pre-existing registration questionnaires which included demographic information and medical data of MS patients by interview. We obtained the demographic profile of Mazandaran province from the most recent census in 2016 and the National Civil Registry of the Mazandaran province for calculating prevalence of MS. RESULTS: The total number of MS patients in Mazandaran was 2418 (25.8% male and 74.2% female) with a female to male ratio of 2.9. Based on the local population of 3,332,556, (50.4% male and 49.6% female), this study showed a prevalence of 72.5 per 100,000 for MS in this region. The prevalence of this disease by gender was 37.1 per 100,000 for men and 108.5 per 100,000 for women. The mean (SD) age of the patients at the time of the study was 38.5 (10.1) years with a minimum of 15 and a maximum of 75 years. The most common type of MS was Relapsing-Remitting MS with 86%. CONCLUSIONS: All recent studies showed significant upward trend in the prevalence of MS around the world. Based on the results of our study and many other studies in Iran, the Atlas of MS prevalence map needs to be update. Iran's status should be changed to the high-prevalence of MS in the new Atlas. Due to the increasing prevalence of MS, we suggest an adjustment in the Global MS Prevalence Scale.


Assuntos
Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla/epidemiologia , Adolescente , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Irã (Geográfico)/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Sistema de Registros , Inquéritos e Questionários , Adulto Jovem
14.
Acta Neurol Scand ; 141(6): 491-499, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31990978

RESUMO

OBJECTIVES: The use of rituximab (RTX) in multiple sclerosis (MS) is a rapidly increasing choice of disease-modifying therapy. Efficacy outside specialized university hospital-based care is not yet systematically investigated. Our aim was to evaluate off-label RTX treatment for MS at a general hospital in Sweden. MATERIALS AND METHODS: Subjects with definite MS with at least one rituximab infusion were eligible for inclusion in this retrospective, observational study. Effect was evaluated by monitoring clinical disability, annual relapse rate, new lesions on MRI, and safety by the incidence and severity of adverse events. RESULTS: Among the 83 included subjects, 15 had clinical worsening of disease during the median 23.5 (1-76) months of follow-up after RTX initiation: 7/66 with relapsing-remitting multiple sclerosis (RRMS) and 8/17 with progressive subtypes (PMS). Cumulative survival without worsening was 86% in RRMS and 30% in PMS. The annual relapse rate before RTX vs follow-up dropped from 0.38 to 0.05 (P < .00001). Subjects with new enhancing lesions on MRI during the first year before RTX initiation vs the year after dropped from 0.94 to 0.024 (P < .00001) and was only seen in RRMS (1.05-0.31, P = .00003). Adverse events were mainly mild. Thirty-six out of 53 non-infusion-related adverse events were infections, of which four were serious, including a case of pneumonia with concomitant late-onset neutropenia. CONCLUSIONS: Rituximab was as effective and safe when given at a general hospital outpatient clinic compared with results from previous university hospital-based studies. Vigilance is required concerning severe adverse events.


Assuntos
Hospitais Gerais/métodos , Fatores Imunológicos/uso terapêutico , Esclerose Múltipla/diagnóstico por imagem , Esclerose Múltipla/tratamento farmacológico , Rituximab/uso terapêutico , Adolescente , Adulto , Idoso , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Imagem por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/epidemiologia , Esclerose Múltipla Recidivante-Remitente/diagnóstico por imagem , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Sistema de Registros , Estudos Retrospectivos , Suécia/epidemiologia , Adulto Jovem
15.
Mult Scler ; 26(1): 79-90, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31397221

RESUMO

BACKGROUND: The risk factors for conversion from relapsing-remitting to secondary progressive multiple sclerosis remain highly contested. OBJECTIVE: The aim of this study was to determine the demographic, clinical and paraclinical features that influence the risk of conversion to secondary progressive multiple sclerosis. METHODS: Patients with adult-onset relapsing-remitting multiple sclerosis and at least four recorded disability scores were selected from MSBase, a global observational cohort. The risk of conversion to objectively defined secondary progressive multiple sclerosis was evaluated at multiple time points per patient using multivariable marginal Cox regression models. Sensitivity analyses were performed. RESULTS: A total of 15,717 patients were included in the primary analysis. Older age (hazard ratio (HR) = 1.02, p < 0.001), longer disease duration (HR = 1.01, p = 0.038), a higher Expanded Disability Status Scale score (HR = 1.30, p < 0.001), more rapid disability trajectory (HR = 2.82, p < 0.001) and greater number of relapses in the previous year (HR = 1.07, p = 0.010) were independently associated with an increased risk of secondary progressive multiple sclerosis. Improving disability (HR = 0.62, p = 0.039) and disease-modifying therapy exposure (HR = 0.71, p = 0.007) were associated with a lower risk. Recent cerebral magnetic resonance imaging activity, evidence of spinal cord lesions and oligoclonal bands in the cerebrospinal fluid were not associated with the risk of conversion. CONCLUSION: Risk of secondary progressive multiple sclerosis increases with age, duration of illness and worsening disability and decreases with improving disability. Therapy may delay the onset of secondary progression.


Assuntos
Progressão da Doença , Fatores Imunológicos/farmacologia , Esclerose Múltipla Crônica Progressiva/epidemiologia , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Índice de Gravidade de Doença , Adulto , Feminino , Humanos , Estudos Longitudinais , Masculino , Esclerose Múltipla Crônica Progressiva/tratamento farmacológico , Esclerose Múltipla Crônica Progressiva/fisiopatologia , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/fisiopatologia , Risco
16.
Mult Scler ; 26(1): 69-78, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30507345

RESUMO

BACKGROUND: Multiple sclerosis (MS) predominantly affects women of child-bearing potential. Pregnancy in MS is still a controversial issue lacking standardized treatment recommendations. OBJECTIVE: To examine the reciprocal effects of pregnancy, MS, and disease-modifying treatment (DMT). METHODS: We analyzed 387 pregnancies in 239 women with relapsing remitting multiple sclerosis (RRMS) and ⩾1 pregnancy, establishment of diagnosis >1 year before conception, and ⩾2 years of follow-up after delivery. Relapse rates and Expanded Disability Status Scale (EDSS) scores were compared in the year before conception, during pregnancy, and 2 years postpartum. Binary logistic regression was used to investigate predictors of risk for relapses and disability progression during pregnancy and postpartum. RESULTS: Risk of relapse and disability progression during pregnancy was predicted by pre-conception relapse activity, higher EDSS score at conception, use of highly effective disease-modifying treatment (H-DMT) pre-conception, and prolonged washout period. Postpartum relapse and disability progression was associated with relapse activity pre-conception and during pregnancy and use of H-DMT pre-conception. Early restart of DMT reduced the risk of postpartum relapse. CONCLUSION: A personalized approach in planning pregnancy in women with MS while on H-DMT needs to be adopted. It seems reasonable maintaining natalizumab closer to conception and restarting the drug early postpartum to reduce the considerable risk of disease reactivation during early pregnancy and after delivery.


Assuntos
Progressão da Doença , Fatores Imunológicos/administração & dosagem , Esclerose Múltipla Recidivante-Remitente , Período Pós-Parto , Complicações na Gravidez , Adulto , Áustria/epidemiologia , Feminino , Seguimentos , Humanos , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/fisiopatologia , Natalizumab/administração & dosagem , Gravidez , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/epidemiologia , Complicações na Gravidez/fisiopatologia , Transtornos Puerperais/tratamento farmacológico , Transtornos Puerperais/epidemiologia , Transtornos Puerperais/fisiopatologia
18.
NeuroRehabilitation ; 45(3): 349-358, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31796695

RESUMO

BACKGROUND: Memory impairments commonly afflict individuals with MS. While evidence-based cognitive rehabilitation treatments are available in English, the lack of such interventions in Spanish is an important barrier to care for Hispanics with MS. There is class I evidence that the modified Story Memory Technique (mSMT) improves learning in English. This intervention has been translated and adapted into Spanish. OBJECTIVE: To examine the preliminary efficacy of the Spanish mSMT to improve learning in Mexicans with MS. METHODS: Twenty individuals with relapsing-remitting MS were randomized to treatment (n = 10) or placebo control (n = 10) groups. The Spanish mSMT is a 10-session intervention that teaches imagery and context to facilitate learning. The control condition was matched to the treatment condition in treatment duration, and stimulus content and presentation. Participants completed baseline and post-treatment neuropsychological assessments. RESULTS: Individuals who received the Spanish mSMT showed significant improvements in learning and life satisfaction relative to the control group. Also observed were a near-moderate effect size on perceived memory complaints and a moderate-to-large effect size on the family's perception of the patient's competency. CONCLUSIONS: The Spanish mSMT showed preliminary efficacy in improving learning deficits in Mexicans with MS, and such improvements may extend to other domains.


Assuntos
Hispano-Americanos , Transtornos da Memória/epidemiologia , Transtornos da Memória/reabilitação , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/reabilitação , Adulto , Feminino , Hispano-Americanos/psicologia , Humanos , Masculino , Memória/fisiologia , Transtornos da Memória/psicologia , México/epidemiologia , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/psicologia , Testes Neuropsicológicos , Projetos Piloto , Resultado do Tratamento , Adulto Jovem
19.
J Neurol Sci ; 406: 116426, 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31629287

RESUMO

OBJECTIVE: To confirm anti-JC virus (JCV) antibody seroprevalence in Portuguese patients with relapsing-remitting multiple sclerosis (RRMS) and to determine their anti-JCV antibody index. METHODS: JUSTIFY was a retrospective, multicentre study that included 655 RRMS patients tested at least once with the anti-JCV antibody assay STRATIFY JCV DxSelect. Demographic data, multiple sclerosis history and results of the anti-JCV antibody test were collected, along with physicians' reasons for requesting the test and the impact of the results. RESULTS: Overall anti-JCV antibody seroprevalence was 60.8% (95% confidence interval, 56.9-64.5). Seroprevalence was associated with higher age (P = .030) and was lower in natalizumab-treated patients (P < .001). The mean anti-JCV antibody index of immunosuppressant-naive patients was 1.5 ±â€¯1.3 (n = 378). The main reasons for performing the test were clinical characterization (35.5%) and medication change (26.2%). In patients who switched treatments (n = 109), fingolimod (47.7%) and natalizumab (26.6%) were the most commonly chosen new treatments. CONCLUSIONS: The study confirmed the high anti-JCV antibody prevalence in Portuguese RRMS patients and its association with age. These data can be used to better understand the benefit-risk profile of natalizumab treatment in Portuguese patients and to support progressive multifocal leukoencephalopathy risk management strategies.


Assuntos
Anticorpos Antivirais/sangue , Vírus JC/metabolismo , Esclerose Múltipla Recidivante-Remitente/sangue , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Adolescente , Adulto , Idoso , Ensaio de Imunoadsorção Enzimática/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla Recidivante-Remitente/diagnóstico , Portugal/epidemiologia , Estudos Retrospectivos , Estudos Soroepidemiológicos , Adulto Jovem
20.
PLoS One ; 14(10): e0223863, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31647829

RESUMO

OBJECTIVE: The aim of the study was to assess the effectiveness of disease-modifying therapies (DMTs) in relapsing-remitting multiple sclerosis (RRMS) patients treated in MS centres in Poland. METHODS: Demographic and clinical data of all Polish RRMS patients receiving DMTs were prospectively collected from 2014 to 2018 in electronic files using the Therapeutic Program Monitoring System (SMPT). RESULTS: The study included 10,764 RRMS patients treated with DMTs in first-line and 1,042 in second-line programmes. IFNß more effectively lengthened the times to the first relapse, disability progression, and brain MRI activity than GA. After 2 and 4 years of follow-up, more patients on IFNß showed no evidence of disease activity (NEDA-3) in comparison to GA (66.3% and 44.3% vs 55.2% and 33.2%, respectively; p<0.001). NAT more effectively reduced brain MRI activity than FTY (p = 0.001). More patients under NAT had NEDA-3 after 2 and 4 years of follow-up compared to FTY (66.2% and 42.1% vs 52.1% and 29.5%, respectively; p = 0.03). In adjusted analysis, a higher baseline Expanded Disability Status Score (EDSS) was a predictor of relapse (p<0.001) and NEDA-3 failure (p = 0.003). CONCLUSION: IFNß compared to GA and NAT compared to FTY more effectively reduced disease activity in a Polish population of RRMS patients.


Assuntos
Cloridrato de Fingolimode/uso terapêutico , Acetato de Glatiramer/uso terapêutico , Interferon beta/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Natalizumab/uso terapêutico , Adulto , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Fatores Imunológicos/uso terapêutico , Imunossupressores/uso terapêutico , Masculino , Esclerose Múltipla Recidivante-Remitente/epidemiologia , Esclerose Múltipla Recidivante-Remitente/patologia , Polônia/epidemiologia , Prognóstico , Estudos Prospectivos , Taxa de Sobrevida
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