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BACKGROUND: As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across observational data sources and scientific collaboration is limited. OBJECTIVES: To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts. METHODS: A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset. RESULTS: A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data). CONCLUSION: The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.
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Esclerosis Múltiple , Humanos , Sistema de RegistrosRESUMEN
Geographical variations in the incidence and prevalence of multiple sclerosis have been reported globally. Latitude as a surrogate for exposure to ultraviolet radiation but also other lifestyle and environmental factors are regarded as drivers of this variation. No previous studies evaluated geographical variation in the risk of secondary progressive multiple sclerosis, an advanced form of multiple sclerosis that is characterized by steady accrual of irreversible disability. We evaluated differences in the risk of secondary progressive multiple sclerosis in relation to latitude and country of residence, modified by high-to-moderate efficacy immunotherapy in a geographically diverse cohort of patients with relapsing-remitting multiple sclerosis. The study included relapsing-remitting multiple sclerosis patients from the global MSBase registry with at least one recorded assessment of disability. Secondary progressive multiple sclerosis was identified as per clinician diagnosis. Sensitivity analyses used the operationalized definition of secondary progressive multiple sclerosis and the Swedish decision tree algorithm. A proportional hazards model was used to estimate the cumulative risk of secondary progressive multiple sclerosis by country of residence (latitude), adjusted for sex, age at disease onset, time from onset to relapsing-remitting phase, disability (Multiple Sclerosis Severity Score) and relapse activity at study inclusion, national multiple sclerosis prevalence, government health expenditure, and proportion of time treated with high-to-moderate efficacy disease-modifying therapy. Geographical variation in time from relapsing-remitting phase to secondary progressive phase of multiple sclerosis was modelled through a proportional hazards model with spatially correlated frailties. We included 51 126 patients (72% female) from 27 countries. The median survival time from relapsing-remitting phase to secondary progressive multiple sclerosis among all patients was 39 (95% confidence interval: 37 to 43) years. Higher latitude [median hazard ratio = 1.21, 95% credible interval (1.16, 1.26)], higher national multiple sclerosis prevalence [1.07 (1.03, 1.11)], male sex [1.30 (1.22, 1.39)], older age at onset [1.35 (1.30, 1.39)], higher disability [2.40 (2.34, 2.47)] and frequent relapses [1.18 (1.15, 1.21)] at inclusion were associated with increased hazard of secondary progressive multiple sclerosis. Higher proportion of time on high-to-moderate efficacy therapy substantially reduced the hazard of secondary progressive multiple sclerosis [0.76 (0.73, 0.79)] and reduced the effect of latitude [interaction: 0.95 (0.92, 0.99)]. At the country-level, patients in Oman, Tunisia, Iran and Canada had higher risks of secondary progressive multiple sclerosis relative to the other studied regions. Higher latitude of residence is associated with a higher probability of developing secondary progressive multiple sclerosis. High-to-moderate efficacy immunotherapy can mitigate some of this geographically co-determined risk.
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Esclerosis Múltiple Crónica Progresiva , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Esclerosis Múltiple Crónica Progresiva/epidemiología , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple Recurrente-Remitente/epidemiología , Rayos Ultravioleta , Progresión de la Enfermedad , Recurrencia Local de NeoplasiaRESUMEN
BACKGROUND: Cerebral arterial stenosis (CAS), in the absence of a structural lesion, can result in cognitive impairment that represents an ongoing contention among studies. Accordingly, we investigated cognitive functions in asymptomatic patients with CAS, using P300 which is a neurophysiological tool. We also compared cognition in intracranial stenosis (ICS) and extracranial stenosis (ECS). METHODS: Asymptomatic patients with CAS (≥ 70%) in the absence of structural brain lesions were categorized into ICS and ECS groups of 15 patients each, in addition to 15 normal controls. MRI, MRA, CT angiography, P300 analysis, Mini-Mental State examination (MMSE), Wisconsin Card Sorting Test (WCST), and Wechsler Memory Scale Test-Revised (WMST) were performed to all patients. RESULTS: Impairment on all cognitive scales ranged from 70 up to 100% among CAS group. Prolonged p300 latency and reaction time correlated with worse performance on WMST (p = 0.02), while lower amplitude and decreased accuracy correlated with more errors on WCST (p = 0.01). ICS scores on WCTS were lower than those of ECS group (p = 0.001), while ECS had a longer reaction time (p = 0.02) and lower scores on MMS and WMST than those of ICS group (p = 0.03). CONCLUSION: Patients with asymptomatic CAS had a high prevalence of cognitive dysfunction which places them at risk of higher morbidity. ICS group showed impairment on executive functions, while the ECS group showed predilection to memory and information processing dysfunction.
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Estenosis Carotídea , Disfunción Cognitiva , Humanos , Constricción Patológica/diagnóstico por imagen , Estenosis Carotídea/diagnóstico , Pruebas Neuropsicológicas , Disfunción Cognitiva/diagnóstico por imagen , Disfunción Cognitiva/etiología , Función Ejecutiva , CogniciónRESUMEN
BACKGROUND: Leukoaraiosis (LA) is a finding in the elderly, that might be asymptomatic or can impact their motor and cognitive functions. We studied the presence of LA in the MRI of patients with AIS and its impact on functional outcome at 3 months. METHODS: 500 consecutive patients diagnosed as AIS were enrolled. Medical history included pre-medication by antiplatelets or statins, and vascular risk factors were reported by history and laboratory investigations. Severity of stroke was assessed by NIHSS and stroke outcome was evaluated on discharge and at 3 months by modified Rankin scale (mRS). LA was diagnosed by MRI-FLAIR sequence and delineated from acute infarction by diffusion-weighted image. And accordingly, patients were divided into group A (absent LA) and group B (present LA). RESULTS: 460 patients completed the study, with 53% of patients on antiplatelet therapy and 11.7% on statins prior to stroke. The percentage of patients with LA was significantly more than those without LA. Patients with LA showed a significantly higher age, more frequent and longer duration of diabetes and hypertension, ischemic heart disease, previous stroke/TIA and antiplatelet intake. Microbleeds were more and mRS was worse in LA group. CONCLUSION: The presence of LA in the background MRI of AIS patients is accompanied by the presence of more risk factors, and unfavorable outcome. Pre-medication with antiplatelets did not prevent the incidence of a new stroke especially in LA group. This might necessitate the identification of some medication for secondary prevention in patients with small vessel disease.
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Imagen de Difusión por Resonancia Magnética , Evaluación de la Discapacidad , Accidente Cerebrovascular Isquémico/diagnóstico , Leucoaraiosis/diagnóstico por imagen , Anciano , Estudios Transversales , Egipto/epidemiología , Femenino , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Incidencia , Hemorragias Intracraneales/etiología , Accidente Cerebrovascular Isquémico/epidemiología , Accidente Cerebrovascular Isquémico/fisiopatología , Accidente Cerebrovascular Isquémico/terapia , Leucoaraiosis/epidemiología , Leucoaraiosis/fisiopatología , Leucoaraiosis/terapia , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Valor Predictivo de las Pruebas , Pronóstico , Recurrencia , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: Time matters in multiple sclerosis (MS). Irreversible neural damage and cell loss occur from disease onset. The MS community has endorsed a management strategy of prompt diagnosis, timely intervention and regular proactive monitoring of treatment effectiveness and disease activity to improve outcomes in people with MS. OBJECTIVES: We sought to develop internationally applicable quality standards for timely, brain health-focused MS care. METHODS: A panel of MS specialist neurologists participated in an iterative, online, modified Delphi process to define 'core', 'achievable' and 'aspirational' time frames reflecting minimum, good and high care standards, respectively. A multidisciplinary Reviewing Group (MS nurses, people with MS, allied healthcare professionals) provided insights ensuring recommendations reflected perspectives from multiple stakeholders. RESULTS: Twenty-one MS neurologists from 19 countries reached consensus on most core (25/27), achievable (25/27) and aspirational (22/27) time frames at the end of five rounds. Agreed standards cover six aspects of the care pathway: symptom onset, referral and diagnosis, treatment decisions, lifestyle, disease monitoring and managing new symptoms. CONCLUSION: These quality standards for core, achievable and aspirational care provide MS teams with a three-level framework for service evaluation, benchmarking and improvement. They have the potential to produce a profound change in the care of people with MS.
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Encéfalo , Esclerosis Múltiple , Neurología/normas , Encéfalo/patología , Consenso , Técnica Delphi , Humanos , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/patología , Esclerosis Múltiple/terapiaRESUMEN
OBJECTIVES: In this research we wanted to highlight the importance of defining Borderzone infarctions (BZI) as a separate subtype in stroke classifications. We thus studied cases of isolated BZI, small vessel disease (SVD), and large vessel disease (LVD), to identify their points of similarities and difference in a sample of Egyptian patients. METHODS: This is a cross-sectional (observational) study. Consecutive 637 acute ischemic stroke patients were recruited over a 2 year period, from 2 stroke units of Ain Shams University hospitals in Egypt. Medical history and laboratory investigations were done to identify risk factors. National Institute of Health Stroke Scale (NIHSS) was performed on admission, and modified Rankin scale (mRS) on admission, and after 3 months. MRI brain was done to identify stroke subtype; MRA and carotid duplex were used to define vascular status. RESULTS: Among the studied group of patients, 72 (11.3%) had BZI, 145 (22.8%) had SVD, 165 (26%) had LVD, and 255 were excluded as they had either undetermined, or mixed etiology. BZI showed significantly older age, early confluent lesions, more disease severity by NIHSS, and worst outcome by mRS (P < 0.05). SVD had more microbleeds than BZI and LVD. LVD showed lower prevalence of hypertension and lower high-density lipoprotein levels. CONCLUSIONS: Isolated BZI, SVD, and LVD infarctions have characteristic risk factors and clinical patterns. Further studies are needed to identify if they are different from cases with mixed pathology. This could have an impact on the selection of primary and secondary preventive measures appropriate to each type.
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Infarto Encefálico/diagnóstico , Enfermedades de los Pequeños Vasos Cerebrales/diagnóstico , Leucoencefalopatías/diagnóstico , Anciano , Infarto Encefálico/epidemiología , Infarto Encefálico/fisiopatología , Infarto Encefálico/terapia , Angiografía Cerebral/métodos , Enfermedades de los Pequeños Vasos Cerebrales/epidemiología , Enfermedades de los Pequeños Vasos Cerebrales/fisiopatología , Enfermedades de los Pequeños Vasos Cerebrales/terapia , Estudios Transversales , Evaluación de la Discapacidad , Egipto/epidemiología , Femenino , Humanos , Leucoencefalopatías/epidemiología , Leucoencefalopatías/fisiopatología , Leucoencefalopatías/terapia , Angiografía por Resonancia Magnética , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Prevalencia , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía Doppler DúplexRESUMEN
Disease-modifying therapies (DMTs) delay or may prevent the progression of patients with high-risk clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (MS), and from relapsing-remitting MS to secondary progressive MS. Current evidence on the effects of DMT on disability in MS is supported by the use of the Expanded Disability Status Scale (EDSS), which is dominated by ambulation, and usually used as a secondary outcome measure. Less is known about the long-term effects of DMTs on other aspects of functional status, particularly cognition, which is a key determinant of ability to work. The time scale for measurements of disability is at most a few years, with scant data from more than 10 years of observation. Longer prospective follow-up of large numbers of patients with CIS is needed to determine whether early intervention with a DMT influences long-term disease progression. Finally, the emergence of the radiologically isolated syndrome (RIS) as a clinical entity has shifted the debate about when to intervene to an even earlier time frame. Balancing the significant side-effects associated with DMT in general and the expected outcome of pharmacologic intervention is increasingly problematic for managing patients with uncertain prognosis, as many patients may have low-risk CIS, benign MS or patients with RIS only. Preventing long-term disability in MS should be recognised more clearly as an important outcome in its own right, with disability measured more consistently with more sensitive instruments beyond the use of the EDSS.
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Inmunosupresores/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Evaluación de la Discapacidad , Progresión de la Enfermedad , HumanosRESUMEN
We have reviewed the clinical literature with reference to the local applicability of guidelines for the diagnosis and management of multiple sclerosis (MS) in the Middle East. There is a substantial burden of MS in the region: the prevalence of the disease appears to have increased markedly in recent decades, with a faster rate of increase in female vs. male patients. The aetiology and presentation of MS appears to be broadly similar in the Middle East to that in other regions. Interferon-ß is the most commonly used treatment for MS in the Middle East, as elsewhere, although it is unclear to what extent economic constraints act as a barrier to accessing this treatment. Similarly, limited available data suggest that the availability of MRI scanners appears to be lower in the Middle East than in more developed nations. Little is known concerning other potential barriers to treatment. There is a need for further research on aspects of management of MS beyond the pharmacological aspects of treatment to assess fully the potential barriers to the adoption of international guidelines for the diagnosis and management of the disease in the Middle East.
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Guías como Asunto , Cooperación Internacional , Esclerosis Múltiple , Bases de Datos Factuales/estadística & datos numéricos , Guías como Asunto/normas , Humanos , Medio Oriente/epidemiología , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/terapiaRESUMEN
Introduction and background: Adherence is a critical factor for optimal clinical outcomes in multiple sclerosis (MS) treatment. This study investigated the adherence and clinical outcomes of MS patients treated with subcutaneous (sc) interferon (IFN) (ß)-1a, an established immunomodulatory treatment for relapsing MS. The benefits of a patient support programme (PSP) were also studied. Methods: This phase-IV prospective, observational multicentre study enrolled patients with relapsing MS who were treated with sc IFN ß-1a for 24 months was conducted at 53 centres across 17 countries. The primary endpoint was adherence to sc IFN ß-1a treatment, as assessed using Morisky Green Levine Medication Adherence Scale (MGLS) scores at 24 months. The MGLS is a self-reported diagnostic tool to address medication non-adherence, with a score ranging from 0 to 4, with 0 representing high adherence, 1-2 representing medium adherence, and 3-4 representing low adherence. Other endpoints included time to study and treatment discontinuation over 24 months, the proportion of relapse-free patients, and Expanded Disability Status Scale (EDSS) progression (defined as ≥1.0 point increase sustained for 3 months) at 24 months. A subgroup analysis was performed for endpoints based on patients assigned to PSP (yes/no-PSP versus non-PSP subgroup). Results: Of the 577 patients enrolled, 408 had evaluable MGLS scores at 24 months. A total of 336 (58.2%; 95% confidence interval [CI]: 54.1-62.3%) patients reported high adherence, 57 (9.9%; 95% CIs: 7.6-12.7%) reported medium adherence, and 15 (2.6%; 95% CI: 1.5-4.3%) reported low adherence at 24 months. The PSP subgroup reported higher adherence (n = 206; 65.8%) than the non-PSP subgroup (n = 130; 56.5%). By 24 months, 52.2% of the patients were relapse-free and 17.2% patients experienced ≥1 relapse. Expanded Disability Status Scale progression was observed in 12.3% of patients. Over the 24-month period, 30.8% of the patients discontinued treatment, and the most common reasons for treatment discontinuation were adverse events (AEs, 10.4%), being lost to followup (7.1%), and a lack of efficacy (5.5%). Overall, 39.6% patients experienced ≥1 AE, which ranged from mild to moderate. Conclusion: The study demonstrated high adherence to sc IFN ß-1a treatment with an added benefit of PSP participation. More than half of the patients remained relapse-free over a 24-month period. No new safety concerns to sc IFN ß-1a treatment were observed. Clinical trial registration: https://clinicaltrials.gov/study/NCT02921035, NCT02921035.
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It has been over a year since people with multiple sclerosis (pwMS) have been receiving vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With a negligible number of cases in which vaccination led to a relapse or new onset MS, experts around the world agree that the potential consequences of COVID-19 in pwMS by far outweigh the risks of vaccination. This article reviews the currently available types of anti-SARS-CoV-2 vaccines and the immune responses they elicit in pwMS treated with different DMTs. Findings to date highlight the importance of vaccine timing in relation to DMT dosing to maximize protection, and of encouraging pwMS to get booster doses when offered.
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COVID-19 , Esclerosis Múltiple , Humanos , SARS-CoV-2 , COVID-19/prevención & control , Vacunas contra la COVID-19 , VacunaciónRESUMEN
Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths. In this article, we discuss how, through a corrective plan, we could change the landscape of stroke services in Egypt, in a relatively short time, raising thrombolysis rate from <1% to 12.3%, with shortening of door-to-needle time. We could build a database that now exceeds 5,000 patients, our centers received international accreditation and several awards, and we developed tele-stroke service.
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Isquemia Encefálica , Accidente Cerebrovascular , Isquemia Encefálica/tratamiento farmacológico , Egipto/epidemiología , Fibrinolíticos/uso terapéutico , Humanos , Prevalencia , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/terapia , Terapia Trombolítica , Activador de Tejido Plasminógeno/uso terapéutico , Resultado del TratamientoRESUMEN
Patients with multiple sclerosis (MS) should be vaccinated against COVID-19. All COVID-19 vaccines are effective and do not appear to carry any additional risk for patients with MS. Patients with MS should get a COVID-19 vaccine as soon as it becomes available. The risks of COVID-19 disease outweigh any potential risks from the vaccine. Even if vaccinated, patients with MS should continue to practice standard and recommended precautions against COVID-19, such as wearing a face mask, social distancing and washing hands. There is no evidence that patients with MS are at higher risk of complications from the mRNA, non-replicating viral vector, inactivated virus or protein COVID-19 vaccines, compared to the general population. COVID-19 Vaccines are safe to use in patients with MS treated with disease-modifying therapies (DMTs). The effectiveness of vaccination may be affected by few of the DMTs but yet some protection is still provided. For certain DMTs we may consider coordinating the timing of the vaccine with the timing of the DMT dose to increase vaccine efficacy.
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COVID-19 , Esclerosis Múltiple , Vacunas contra la COVID-19 , Humanos , Esclerosis Múltiple/terapia , SARS-CoV-2 , Vacunación , Eficacia de las VacunasRESUMEN
BACKGROUND: Assessment of multiple sclerosis (MS) patients during the era of the coronavirus disease 2019 (COVID-19) pandemic was confronted with the overwhelmed healthcare facilities in Egypt and fear of the patients to get infected while attending the follow-up visits. This study aimed to assess the value of telephone-based assessments in the follow-up of MS patients. It includes one hundred and five patients who participated in the study and completed 3 telephone-based assessments which are the Hauser Ambulation index, Multiple Sclerosis Neuropsychology Questionnaire (MSNQ), and Symptoms of Multiple Sclerosis Scale (SMSS). RESULTS: The Hauser Ambulation index was significantly correlated with the latest Expanded Disability Status Scale (EDSS) score done within 1 month from the telephone call (r=0.738, P<0.001). The analysis of MSNQ scores showed that one-third of the study population had evidence of cognitive and/or neuropsychological impairment. Post hoc analysis regarding the cognitive and psychological impairment component of SMSS revealed that the patients who answered "Never" had significantly lower MSNQ scores compared to those who answered "Sometimes" (P=0.016), "Often" (P=0.022), and "Always" (P=0.001). The comparison of the EDSS scores of the patients regarding the sensory-motor impairment component of SMSS showed a non-significant difference. CONCLUSION: The Hauser Ambulation index may be a reliable telephone-based tool for the assessment of physical disability. The MSNQ and the cognitive and psychological impairment component of SMSS can be used for the assessment of cognitive and psychological impairment among patients with MS.
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OBJECTIVES: Evidence on the effectiveness and safety of fingolimod in real-world clinical practice in the Middle East and North African (MENA) region is limited. This study aimed to evaluate the effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) in real-world setting in the MENA region. PATIENTS AND METHODS: RRMS patients who had been treated with fingolimod for at least 12 months were retrospectively identified from the databases of 34 centers across the MENA region. Study outcomes included the annualized relapse rate (ARR), relapse-free rate (RFR), time to first and second relapses, mean change in Expanded Disability Status Scale (EDSS), proportion of patients with Magnetic Resonance Imaging (MRI) activity and no evidence of disease activity (NEDA)-3, retention of patients on treatment, as well as all safety measures. RESULTS: A total of 806 patients were included: 66.34 % female; mean age 32.97 ± 9.62 years; mean disease duration 4.92 ± 4.66 years; mean fingolimod use 37.2 ± 16.7 months. Most patients had received previous disease-modifying therapy (79.65 %). Compared to the year preceding fingolimod initiation, RFR improved (33.00%-86.35%; p < 0.001), ARR decreased (0.84 ± 0.73 to 0.16 ± 0.45; p = 0.005), EDSS decreased (2.69 ± 1.74-2.01 ± 1.66; p < 0.001), and the proportion of patients with Gadolinium-enhancing T1 lesions decreased (57.84 % to 12.93 %; p < 0.001), after 12 months of fingolimod treatment. NEDA-3 was achieved in 41.3 % of patients. Median time to first and second relapses was not reached since 86.35 % and 98.39 % of patients had not experienced relapses for the first time and second time, respectively. Eight-hundred one (99.38 %) patients continued fingolimod treatment beyond 12 months. One-hundred thirty patients (16.13 %) experienced adverse events, mainly lymphopenia (5.46 %) and leukopenia (2.11 %), while 13 patients (1.61 %) experienced serious adverse events. CONCLUSION: This study confirms the effectiveness and safety profile of fingolimod in real-world setting in the Middle East and North African (MENA) region.
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Clorhidrato de Fingolimod/uso terapéutico , Inmunosupresores/uso terapéutico , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Adulto , África del Norte , Femenino , Humanos , Masculino , Medio Oriente , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: This study aimed to report the severity of COVID-19 in a cohort of Egyptian patients with multiple sclerosis (MS) with particular attention on the impact of disease modifying drugs (DMDs). METHODS AND STUDY POPULATION: We included 119 MS patients recruited from two centers, Ain-Shams university and Cairo university with confirmed or suspected COVID-19 during the period from May to September 2020 as a part of the MuSC-19 project. Univariate logistic regression was fitted to assess risk factors for severe COVID-19 (at least one outcome among hospitalization, ICU admission and death). RESULTS: Females were 77%, mean age was 34 years, mean duration of MS was 5.28 years, median EDSS was 3, most of the patients (83%) had RRMS, while 15% and 2% had respectively SPMS and PPMS. Only eleven patients (9% of study population) had a severe outcome and 3 patients (3%) died. Headache was the only symptom significantly associated with the severity of COVID-19 (OR=10.85, P = 0.001). There was no association between any of the DMDs and severe COVID-19 outcome. CONCLUSION: This study showed an acceptable safety profile of DMDs in Egyptian MS patients who developed COVID-19, as 91% of the cohort had a favorable outcome. Headache as a symptom associated with severe outcome in Egyptian patients' needs further validation.
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COVID-19 , Esclerosis Múltiple , Adulto , Estudios de Cohortes , Egipto/epidemiología , Femenino , Humanos , Esclerosis Múltiple/complicaciones , Esclerosis Múltiple/epidemiología , SARS-CoV-2RESUMEN
BACKGROUND: One of the major objectives of the Multiple Sclerosis Data Alliance (MSDA) is to enable better discovery of multiple sclerosis (MS) real-world data (RWD). METHODS: We implemented the MSDA Catalogue, which is available worldwide. The current version of the MSDA Catalogue collects descriptive information on governance, purpose, inclusion criteria, procedures for data quality control, and how and which data are collected, including the use of e-health technologies and data on collection of COVID-19 variables. The current cataloguing procedure is performed in several manual steps, securing an effective catalogue. RESULTS: Herein we summarize the status of the MSDA Catalogue as of January 6, 2021. To date, 38 data sources across five continents are included in the MSDA Catalogue. These data sources differ in purpose, maturity, and variables collected, but this landscaping effort shows that there is substantial alignment on some domains. The MSDA Catalogue shows that personal data and basic disease data are the most collected categories of variables, whereas data on fatigue measurements and cognition scales are the least collected in MS registries/cohorts. CONCLUSIONS: The Web-based MSDA Catalogue provides strategic overview and allows authorized end users to browse metadata profiles of data cohorts and data sources. There are many existing and arising RWD sources in MS. Detailed cataloguing of MS RWD is a first and useful step toward reducing the time needed to discover MS RWD sets and promoting collaboration.
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The majority of disease-modifying drugs (DMDs) available for the management of active relapsing-remitting multiple sclerosis (RMS) depend on continuous drug intake for maintained efficacy, with escalation to a more active drug when an unacceptable level of disease activity returns. Among continuously applied regimens, interferons and glatiramer acetate act as immunomodulators, while dimethyl fumarate, fingolimod, ocrelizumab, natalizumab and teriflunomide are associated with continuous immunosuppression. By contrast, immune reconstitution therapy (IRT) provides efficacy that outlasts a short course of treatment. Autologous hemopoietic stem cell transplantation is perhaps the classic example of IRT, but this invasive and intensive therapy has challenging side-effects. A short treatment course of a pharmacologic agent hypothesized to act as an IRT, such as Cladribine Tablets 3.5 mg/kg or alemtuzumab, can provide long-term suppression of MS disease activity, without need for continuous treatment (the anti-CD20 mechanism of ocrelizumab has the potential to act as an IRT, but is administered continuously, at 6-monthly intervals). Cladribine Tablets 3.5 mg/kg shows some selectivity in targeting adaptive immunity with a lesser effect on innate immunity. The introduction of IRT-like disease-modifying drugs (DMDs) challenges the traditional maintenance/escalation mode of treatment and raises new questions about how disease activity is measured. In this review, we consider a modern classification of DMDs for MS and its implications for the care of patients in the IRT era.
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BACKGROUND: Vitamin D deficiency and obesity may be related to the pathogenesis and disease activity of multiple sclerosis (MS). This study aimed to assess the correlation between the serum level of 25(OH) vitamin D, body mass index (BMI) and the Expanded Disability Status Scale (EDSS) in a sample of Egyptian MS patients. SUBJECTS AND METHODS: This was an observational study that included 130 MS patients who were recruited consecutively among the patients attending the MS unit of Ain Shams University Hospital, Cairo, in the period between December 2017 and March 2018. The serum level of 25(OH) D, BMI and EDSS were recorded. RESULTS: Females represented 77.7% of the study sample, the mean age was 32.4⯱â¯8.2 years. MS types were: RRMS 83.1%, SPMS 14.6% and PPMS in 2.3%. Serum level of 25(OH) vitamin D was deficient (less than 10â¯ng/ml) in 69.2% and insufficient (10-30â¯ng/ml) in 19.2% of the study population. The mean BMI was 25.5⯱â¯4.7â¯kg/m² (classified as overweight). The mean EDSS was 3.5⯱â¯1.9. The relationship between the EDSS score and 25(OH) D level was inversely correlated, all patients with EDSSâ¯≤â¯2 had sufficient levels while all patients with EDSSâ¯≥â¯4.5 had deficient levels. High EDSS scores were statistically correlated (pâ¯<â¯0.001) to high BMI and low Log 25(OH) D levels. An inverse correlation was found between the BMI and log 25(OH) D. CONCLUSION: Vitamin D deficiency and overweight are predominant among Egyptian MS patients. The EDSS was positively correlated to the BMI and negatively correlated to 25(OH) D. These factors may possibly play a role in the pathogeneses and progression of MS in Egypt.
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Índice de Masa Corporal , Esclerosis Múltiple/sangre , Esclerosis Múltiple/epidemiología , Sobrepeso/epidemiología , Deficiencia de Vitamina D/epidemiología , Vitamina D/sangre , Adulto , Biomarcadores/sangre , Estudios Transversales , Evaluación de la Discapacidad , Egipto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sobrepeso/sangre , Deficiencia de Vitamina D/sangre , Adulto JovenRESUMEN
BACKGROUND: The aim of this work was to identify the magnetic resonance imaging (MRI) markers of disability in Egyptian multiple sclerosis (MS) patients. SUBJECTS AND METHODS: This retrospective observational study included 673 patients recruited from the registry of the MS unit at Ain Shams University hospitals. At the time when the MRI scans of the brain and spinal cord were done (with and without gadolinium enhancement), clinical disability was rated using the Expanded Disability Status Scale (EDSS) during the patient's first visit. RESULTS: Females represented 72.5%, all types of MS were included, the mean age of onset was 26.1⯱â¯7.7(SD) years, mean duration of illness was 8.3⯱â¯5.5(SD) years. The mean EDSS of the patients was 3.5⯱â¯2.1. The study population was divided into three groups according to the EDSS score; mild from 0-3 (56.6%), moderate from 3.5-6 (34.9%) and severe more than 6 (8.5%). The number and types of MRI lesions (T2, T1 black holes, T1 contrast and confluent lesions) in the different anatomical locations (periventricular, juxtacortical, infratentorial and spinal) were correlated with the clinical and demographic data of the patients as well as with the EDSS score. The presence of confluent brain lesions (P Ë 0.001), brain T1 hypointense lesions (Pâ¯=â¯0.009), and infratentorial T2 lesions (from 1 to 3 lesions (Pâ¯=â¯0.04), from 4 to 10 (Pâ¯Ëâ¯0.001) and more than 10 (Pâ¯Ëâ¯0.001)), were significantly correlated to high EDSS scores after linear regression analysis. CONCLUSION: This is the first Egyptian study to show that infratentorial lesions, confluent brain lesions and T1 hypointense lesions are conventional MRI parameters that correlate with the degree of disability in Egyptian MS patients.
Asunto(s)
Esclerosis Múltiple/diagnóstico por imagen , Índice de Severidad de la Enfermedad , Adulto , Biomarcadores , Egipto , Femenino , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de TiempoRESUMEN
Background The rate of alteplase (tPA) thrombolysis utilization in acute stroke in Egypt is <1%. We report on the causes of this low rate of reperfusion therapies and take corrective action to improve it. Methods Two prospective observational studies were conducted at Ain Shams University hospitals. The first included 269 acute stroke patients admitted to the hospital over a six-month period. Obstacles to reperfusion therapy were identified, and based on the results, a corrective action plan was implemented including making alteplase(tPA) available, training, and establishing a standardized local protocol for reperfusion therapy. A second study was then conducted that included 284 acute ischemic stroke patients over another six-month period. Results In the first study, 53/269 patients (19.7%) arrived at hospital within 4.5 h and were eligible for reperfusion therapy. Of those, seven (13.2%) received alteplase(tPA), representing 2.6% of the total ischemic stroke patients admitted. The main causes for not giving thrombolytic therapy was unavailability of alteplase(tPA) (56.5%), wrong treatment decision (17.4%), missed window while performing brain imaging (15%), and unavailability of intermediate care bed (10.9%). The second study showed that out of 284 cases admitted with acute ischemic stroke, 37 were eligible for thrombolysis and 35 received alteplase(tPA) (94.3%), representing 12.3% of the total ischemic stroke admissions. Conclusion A comprehensive action plan that centers around making the drug available and training resulted in a significant improvement of reperfusion therapy utilization in Egypt.