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Immunoglobulin G4-related disease is a systemic immune-mediated disease with insidious evolution characterized by fibroinflammatory lesions over virtually any organ system. Despite the remarkable progression of knowledge, its etiology remains undefined. Due to its relapse-remitting pattern, it could accumulate irreversible damage, increasing comorbidities and mortality. This paper emphasizes key concepts for diagnosing and treating patients with this condition.
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Enfermedad Relacionada con Inmunoglobulina G4 , Humanos , Enfermedad Relacionada con Inmunoglobulina G4/diagnóstico , Enfermedad Relacionada con Inmunoglobulina G4/complicaciones , Enfermedades Raras , Inmunoglobulina G/sangreRESUMEN
BACKGROUND: Most Multiple Sclerosis (MS) clinical trials fail to assess the long-term effects of disease-modifying therapies (DMT) or disability. METHODS: COLuMbus was a single-visit, cross-sectional study in Argentina in adult patients with ≥10 years of MS since first diagnosis. The primary endpoint was to determine patient disability using the Expanded Disability Status Scale (EDSS). The secondary endpoints were to evaluate the distribution of diagnoses between relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS), patient demographics, disease history, and the risk of disability progression. The relationship between baseline characteristics and the current disability state and the risk of disability progression was assessed. RESULTS: Out of the 210 patients included, 76.7 % had a diagnosis of RRMS and 23.3 % had been diagnosed with SPMS, with a mean disease duration of 17.9 years and 20.5 years, respectively. The mean delay in the initial MS diagnosis was 2.6 years for the RRMS subgroup and 2.8 years for the SPMS subgroups. At the time of cut-off (28May2020), 90.1 % (RRMS) and 75.5 % (SPMS) of patients were receiving a DMT, with a mean of 1.5 and 2.0 prior DMTs, respectively. The median EDSS scores were 2.5 (RRMS) and 6.5 (SPMS). In the RRMS and SPMS subgroups, 23 % and 95.9 % of patients were at high risk of disability, respectively; the time since first diagnosis showed a significant correlation with the degree of disability. CONCLUSIONS: This is the first local real-world study in patients with long-term MS that highlights the importance of recognizing early disease progression to treat the disease on time and delay disability.
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Esclerosis Múltiple Crónica Progresiva , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Humanos , Esclerosis Múltiple/diagnóstico , Esclerosis Múltiple/epidemiología , Esclerosis Múltiple/terapia , Estudios Transversales , Argentina/epidemiología , Progresión de la Enfermedad , Esclerosis Múltiple Crónica Progresiva/diagnóstico , Esclerosis Múltiple Crónica Progresiva/epidemiología , Esclerosis Múltiple Crónica Progresiva/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/diagnóstico , Esclerosis Múltiple Recurrente-Remitente/epidemiología , Esclerosis Múltiple Recurrente-Remitente/terapiaRESUMEN
INTRODUCTION: Multiple Sclerosis (MS) is a chronic disease affecting around 2.8 million people worldwide. Two-thirds are women, and the mean age at diagnosis is about 30 years old. Social trends are moving towards older age at first pregnancy, both in women with and without MS. OBJECTIVES: To determine the frequency of diminished ovarian reserve (DOR) through anti-Mullerian Hormone (AMH) measurement in women with MS at fertile age and Healthy Females (HF) in Chile. METHODS: Case-control, multicentric, cross-sectional study including relapsing-remitting people with MS (pwMS) between 18 and 40 years and sex and age-matched HF. We obtained a blood sample to determine AMH levels. We defined DOR as AMH <1.5 ng/mL and very-low AMH levels as <0.5 ng/mL. Also, we performed questions regarding reproductive decision-making. RESULTS: We included 79 sex and age-matched HF and 92 pwMS, median age 32(19-40) years, median disease duration 6 (1-17)years, median EDSS 1.0 (0-6), 95% were receiving disease-modifying therapy (DMT), 70% high-efficacy DMT and 37% with a treatment that contraindicates pregnancy. DOR was observed in 24% (n = 22) of the pwMS, compared to 14% (n = 11) of the HF (p = 0.09), while very-low AMH levels were observed in 7.6% (n = 7) of pwMS and none of the HF (p = 0.0166). We observed an inverse correlation between age and AMH levels. Age was the only significant risk factor for low AMH levels in pwMS (OR 1.14 95%CI(1.00-1-31), p = 0.04), including smoking, body mass index (BMI), hormonal contraception, autoimmune comorbidity, high/low-moderate efficacy DMT, and active disease as covariables. We did not find statistically significant differences in age at diagnosis, BMI, disease duration, EDSS, autoimmune comorbidity, use of hormonal contraception, or percentage of active disease between MS women with normal vs DOR. Over 70% of pwMS desired to become pregnant in the future, while 60% considered that the diagnosis of MS was a limitation for pregnancy planning. CONCLUSIONS: No differences in DOR, measured by levels of AMH, were observed between pwMS MS and HF in Chile. As expected, AMH levels were correlated only with ageing. This information may be evaluated early during the disease course to help patients and neurologists with fertility counselling and family planning considerations regarding DMT use.
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Esclerosis Múltiple , Reserva Ovárica , Embarazo , Humanos , Femenino , Adulto , Masculino , Esclerosis Múltiple/epidemiología , Estudios Transversales , Chile/epidemiología , EnvejecimientoRESUMEN
BACKGROUND: Multiple sclerosis is a chronic, autoimmune, degenerative disease. Therapies targeting B-cells have been shown to be effective in its treatment; however, there are few studies evaluating their efficacy in the Mexican population. OBJECTIVE: To evaluate the clinical impact of rituximab in patients with newly-diagnosed relapsing-remitting multiple sclerosis (RRMS). MATERIAL AND METHODS: Real life, descriptive study, in which rituximab was evaluated as treatment for RRMS over a 24-month period. Pre- and post-treatment clinical variables were analyzed; a comparison was made between treatment-naïve and non-treatment-naïve patients. RESULTS: Twenty-eight patients with RRMS were included. Mean age at diagnosis was 30.7 years, and 22 patients were treatment-naïve (78.5 %). After 24 months, there was a mean reduction of 1.8 points in the EDSS scale and a decrease in the number of active lesions on magnetic resonance imaging; a significant difference in both variables could be established (p < 0.05). However, the logistic regression model did not show a relationship between the variables for achieving NEDA-3 criteria. No serious adverse events were observed. CONCLUSIONS: Treatment with rituximab resulted in significant clinical and radiological improvement in treatment-naïve and non-treatment-naïve Mexican patients with RRMS.
ANTECEDENTES: La esclerosis múltiple es una enfermedad crónica, autoinmune y degenerativa. Las terapias blanco contra los linfocitos B han probado ser efectivas en su tratamiento; sin embargo, existen pocos estudios que evalúen su eficacia en población mexicana. OBJETIVO: Evaluar el impacto clínico del rituximab en pacientes con esclerosis múltiple remitente recurrente (EMRR) de reciente diagnóstico. MATERIAL Y MÉTODOS: Estudio de vida real, descriptivo, en el que se evalúa rituximab como tratamiento de EMRR durante un periodo de 24 meses. Se analizaron variables clínicas pre y postratamiento; se realizó la comparación entre pacientes naïve y no naïve. RESULTADOS: Se incluyeron 28 pacientes con EMRR. La edad media al diagnóstico fue de 30.7 años y 22 pacientes fueron naïve (78.5 %). Después de 24 meses, se observó una reducción media de 1.8 puntos en EDSS y en el número de lesiones activas por resonancia magnética. Aunque se logró establecer una diferencia significativa en ambas variables con p < 0.05, el modelo de regresión logística no mostró una relación entre las variables para alcanzar un NEDA-3. No se observaron eventos adversos graves. CONCLUSIONES: El tratamiento con rituximab resultó en mejoría significativa clínica y radiológica en pacientes mexicanos con EMRR naïve y no-naïve.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Rituximab/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Factores Inmunológicos/uso terapéutico , México , Centros de Atención Terciaria , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/inducido químicamenteRESUMEN
Introducción: La esclerosis múltiple es una enfermedad autoinmune, inflamatoria, desmielinizante, crónica, del sistema nervioso central. Supone la primera causa de discapacidad no traumática en adultos jóvenes; afecta de forma significativa la calidad de vida de los pacientes, con alteraciones físicas, sociales y emocionales. Objetivo: Caracterizar desde el punto de vista clínico, a pacientes con diagnóstico de esclerosis múltiple. Método: Se realizó un estudio descriptivo transversal en una serie de casos de 40 pacientes, según las variables edad, sexo, comorbilidad, síntomas iniciales, formas clínicas y grado de discapacidad. Se realizó un análisis de frecuencias. Resultados: Predominaron los pacientes con edades comprendidas entre 30 y 39 años (57,5 %). Los pacientes del sexo femenino representaron el 58,8 % de los casos estudiados y el 85,5% presentó manifestaciones motoras, como síntomas iniciales de la enfermedad. La forma clínica de esclerosis múltiple más frecuente fue la recurrente remitente y el grado de discapacidad mínima. Conclusiones: Las manifestaciones motoras son los síntomas iniciales más frecuentes, así como la forma clínica recurrente remitente y el grado de discapacidad mínima. Los pacientes son fundamentalmente del sexo femenino, en la cuarta década de la vida.
Introduction: Multiple sclerosis is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. It is the first cause of non-traumatic disability in young adults, significantly affecting the quality of life, with physical, social and emotional alterations. Objective: To characterize from the clinical point of view, patients diagnosed with multiple sclerosis. Method: A descriptive and cross-sectional observational study was carried out in a case series of 40 patients, with variables age, sex, comorbidity, initial symptoms, clinical forms and degree of disability. A frequency analysis was carried out. Results: Patients aged between 30 and 39 years (57.5%) predominated. Female patients represented 58.8% of the cases studied and 85.5% presented motor manifestations, as initial symptoms of the disease. Motor symptoms were predominant during the onset of the disease. The most frequent clinical form of multiple sclerosis was relapsing-remitting and the degree of minimal disability. Conclusions: Motor manifestations are the most frequent initial symptoms, as well as the relapsing-remitting clinical form and the minimum degree of disability. The patients are fundamentally female, in the fourth decade of life.
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Resumen Antecedentes: La esclerosis múltiple es una enfermedad crónica, autoinmune y degenerativa. Las terapias blanco contra los linfocitos B han probado ser efectivas en su tratamiento; sin embargo, existen pocos estudios que evalúen su eficacia en población mexicana. Objetivo: Evaluar el impacto clínico del rituximab en pacientes con esclerosis múltiple remitente recurrente (EMRR) de reciente diagnóstico. Material y métodos: Estudio de vida real, descriptivo, en el que se evalúa rituximab como tratamiento de EMRR durante un periodo de 24 meses. Se analizaron variables clínicas pre y postratamiento; se realizó la comparación entre pacientes naïve y no naïve. Resultados: Se incluyeron 28 pacientes con EMRR. La edad media al diagnóstico fue de 30.7 años y 22 pacientes fueron naïve (78.5 %). Después de 24 meses, se observó una reducción media de 1.8 puntos en EDSS y en el número de lesiones activas por resonancia magnética. Aunque se logró establecer una diferencia significativa en ambas variables con p < 0.05, el modelo de regresión logística no mostró una relación entre las variables para alcanzar un NEDA-3. No se observaron eventos adversos graves. Conclusiones: El tratamiento con rituximab resultó en mejoría significativa clínica y radiológica en pacientes mexicanos con EMRR naïve y no-naïve.
Abstract Background: Multiple sclerosis is a chronic, autoimmune, degenerative disease. Therapies targeting B-cells have been shown to be effective in its treatment; however, there are few studies evaluating their efficacy in the Mexican population. Objective: To evaluate the clinical impact of rituximab in patients with newly-diagnosed relapsing-remitting multiple sclerosis (RRMS). Material and methods: Real life, descriptive study, in which rituximab was evaluated as treatment for RRMS over a 24-month period. Pre- and post-treatment clinical variables were analyzed; a comparison was made between treatment-naïve and non-treatment-naïve patients. Results: Twenty-eight patients with RRMS were included. Mean age at diagnosis was 30.7 years, and 22 patients were treatment-naïve (78.5 %). After 24 months, there was a mean reduction of 1.8 points in the EDSS scale and a decrease in the number of active lesions on magnetic resonance imaging; a significant difference in both variables could be established (p < 0.05). However, the logistic regression model did not show a relationship between the variables for achieving NEDA-3 criteria. No serious adverse events were observed. Conclusions: Treatment with rituximab resulted in significant clinical and radiological improvement in treatment-naïve and non-treatment-naïve Mexican patients with RRMS.
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The purpose of this study was to examine whether myeloid dendritic cells (mDCs) from patients with multiple sclerosis (MS) and healthy controls (HCs) become similarly tolerogenic when exposed to IL-27 as this may represent a potential mechanism of autoimmune dysregulation. Our study focused on natural mDCs that were isolated from HCs and MS patient peripheral blood mononuclear cells (PBMCs). After a 24-h treatment with IL-27 ± lipopolysaccharide (LPS), the mDCs were either harvested to identify IL-27-regulated gene expression or co-cultured with naive T-cells to measure how the treated DC affected T-cell proliferation and cytokine secretion. mDCs isolated from HCs but not untreated MS patients became functionally tolerogenic after IL-27 treatment. Although IL-27 induced both HC and untreated MS mDCs to produce similar amounts of IL-10, the tolerogenic HC mDCs expressed PD-L2, IDO1, and SOCS1, while the non-tolerogenic untreated MS mDCs expressed IDO1 and IL-6R. Cytokine and RNA analyses identified two signature blocks: the first identified genes associated with mDC tolerizing responses to IL-27, while the second was associated with the presence of MS. In contrast to mDCs from untreated MS patients, mDCs from HCs and IFNb-treated MS patients became tolerogenic in response to IL-27. The genes differentially expressed in the different donor IL-27-treated mDCs may contain targets that regulate mDC tolerogenic responses.
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Interleucina-27 , Esclerosis Múltiple , Humanos , Células Cultivadas , Citocinas/metabolismo , Células Dendríticas , Interleucina-27/metabolismo , Leucocitos Mononucleares/metabolismo , Esclerosis Múltiple/genética , Esclerosis Múltiple/metabolismo , Linfocitos T/metabolismoRESUMEN
OBJECTIVES: This study aimed to determine the cost-utility of ocrelizumab versus rituximab in patients with RRMS, from the perspective of the Colombian healthcare system. METHODOLOGY: Cost-utility study based on a Markov model, with a 50-year horizon and payer perspective. The currency was the US dollar for the year 2019, with a cost-effectiveness threshold of $5180 defined for Colombian health system. The model used annual cycles according to the health status determined by the disability scale. Direct costs were considered, and the incremental cost-effectiveness ratio per 1 quality-adjusted life-year (QALY) gained was used as the outcome measure. A discount rate of 5% was applied to costs and outcomes. Multiple one-way deterministic sensitivity analyses and 10 000 Monte Carlo simulation were conducted. RESULTS: For the treatment of patients with RRMS, ocrelizumab versus rituximab had an incremental cost-effectiveness ratio of $73 652 for each QALY gained. After 50 years, 1 subject treated with ocrelizumab earns 4.8 QALYs >1 subject treated with rituximab, but at a higher cost of $521 759 versus $168 752, respectively. Ocrelizumab becomes a cost-effective therapy if its price is discounted > 86% or if there is a high willingness to pay. CONCLUSIONS: Ocrelizumab was not a cost-effective drug as compared with rituximab in treating patients with RRMS in Colombia.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Análisis Costo-Beneficio , Inmunosupresores/uso terapéutico , Rituximab/uso terapéutico , Colombia , Esclerosis Múltiple/tratamiento farmacológicoRESUMEN
Abstract Introduction Postural instability is considered one of the most disabling symptoms of relapsing-remitting multiple sclerosis (RRMS). Objective To evaluate postural control in patients with RRMS. Method A total of 79 individuals between 18 and 65 years old, of both genders, were distributed into an experimental group composed of patients with RRMS (n = 51) and in a control group composed by healthy individuals (n = 28). The evaluation consisted of anamnesis, Dizziness Handicap Inventory (DHI), visual vertigo analog scale (WAS), and static posturography (Tetrax IBS). Results Patients with RRMS presented mild degree in the DHI and in the VVAS; in Tetrax IBS, they presented higher or lower values of the indices of general stability, weight distribution, synchronization of postural oscillation, fall risk, and frequency bands of postural oscillation in two, five or all eight sensory conditions, in relation to the control group. Vestibular, visual and/or somatosensory dysfunction of peripheral type (51.0%) prevailed over the central type. The RRMS group, with an expanded scale of disability status > 3 points, presented a higher fall risk than with a score ≤ 3 points (p = 0.003). There was a positive correlation of the Fall Risk Index with the total DHI Score (s = 0.380; p = 0.006) and with the VVAS score (s = 0.348; p = 0.012). Conclusion Patients with RRMS may present with inability to maintain postural control due to general instability, desynchronization and increased postural oscillation at frequencies that suggest deficiencies in the vestibular, visual, and somatosensory systems; as well as fall risk related to the state and intensity of functional disability and self-perception of the influence of dizziness on quality of life.
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Introduction Postural instability is considered one of the most disabling symptoms of relapsing-remitting multiple sclerosis (RRMS). Objective To evaluate postural control in patients with RRMS. Method A total of 79 individuals between 18 and 65 years old, of both genders, were distributed into an experimental group composed of patients with RRMS ( n = 51) and in a control group composed by healthy individuals ( n = 28). The evaluation consisted of anamnesis, Dizziness Handicap Inventory (DHI), visual vertigo analog scale (VVAS), and static posturography (Tetrax IBS). Results Patients with RRMS presented mild degree in the DHI and in the VVAS; in Tetrax IBS, they presented higher or lower values of the indices of general stability, weight distribution, synchronization of postural oscillation, fall risk, and frequency bands of postural oscillation in two, five or all eight sensory conditions, in relation to the control group. Vestibular, visual and/or somatosensory dysfunction of peripheral type (51.0%) prevailed over the central type. The RRMS group, with an expanded scale of disability status > 3 points, presented a higher fall risk than with a score ≤ 3 points ( p = 0.003). There was a positive correlation of the Fall Risk Index with the total DHI Score (s = 0.380; p = 0.006) and with the VVAS score (s = 0.348; p = 0.012). Conclusion Patients with RRMS may present with inability to maintain postural control due to general instability, desynchronization and increased postural oscillation at frequencies that suggest deficiencies in the vestibular, visual, and somatosensory systems; as well as fall risk related to the state and intensity of functional disability and self-perception of the influence of dizziness on quality of life.
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BACKGROUND: Multiple sclerosis has a great disability burden. Management of the disease is complex, and patients often seek new conservative approaches. OBJECTIVE: To investigate the effect of low-frequency pulsed electromagnetic field (PEMF) therapy, compared to placebo, on the level of fatigue, walking performance, symptoms of depression, and quality of life (QOL) in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: Forty-four adults with RRMS and minimal to significant disability were randomly assigned to a 4-week protocol using a PEMF or a placebo whole-body mat. The PEMF group were initially treated with 15Hz frequency, gradually increased to 30Hz (intensity between 25-35µT). The primary outcome was fatigue, assessed with the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). Secondary measures included walking function (GAITRite system and Timed 25-Foot Walk test), the Beck Depression Inventory-II, and the Multiple Sclerosis International Quality of Life Questionnaire. Data were collected at baseline, after intervention, and at 3-months post-intervention (follow-up). RESULTS: There were no differences between groups for changes in fatigue symptoms from baseline to end of intervention (mean and 95% confidence interval FSS: -0.6, 95%CI: -1.3, 0.1; MFIS: -5.4, 95% CI: -15.1, 4.4) or at follow-up (FSS: -0.6, 95% CI: -1.4, 0.2; MFIS: -2.1, 95% CI: -10.9, 6.8). Similarly, both groups did not differ for any of the secondary outcomes at post-intervention or follow-up. CONCLUSIONS: Low-frequency PEMF therapy is no more effective than placebo to produce changes in fatigue, gait performance, severity of depression, and QOL in people with RRMS and minimal to significant disability.
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Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Adulto , Humanos , Calidad de Vida , Esclerosis Múltiple/complicaciones , Campos Electromagnéticos , Depresión/terapia , Fatiga/terapia , Caminata , Esclerosis Múltiple Recurrente-Remitente/complicaciones , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológicoRESUMEN
RESUMEN Fundamento: los fármacos modificadores, en la esclerosis múltiple, tienen la finalidad de reducir la frecuencia de recaídas, retardar la progresión de la discapacidad, así como la aparición de nuevas lesiones en el Sistema Nervioso Central. Objetivo determinar los indicadores precoces de respuesta al tratamiento con IFNb-1ª en pacientes con esclerosis múltiple remitente-recurrente. Métodos: estudio observacional, analítico de cohorte con prospectiva longitudinal en los pacientes con diagnóstico de esclerosis múltiple. Se conformaron dos cohortes de estudio, cada una con 39 pacientes. Resultados: la media y desviación estándar de la escala ampliada del estado de discapacidad a los 36 meses fue de 2.37 ± 1.86 en el grupo estudio y en el control de 3.15 ± 2.1. En los brotes de .13 ± .33 en el grupo estudio y en el grupo control de .41 ± .59. Las lesiones nuevas en T2 tras los 12 primeros meses de tratamiento fue de 0.90 ± 1.16 para el grupo estudio y para el control de 1 ± 1.10. La progresión por escala ampliada del estado de discapacidad, la tasa anualizada de brotes antes del tratamiento, la edad de inicio de la enfermedad, tiempo de evolución de la enfermedad y lesiones que realzan gadolinio se asociaron de forma significativa con la razón de ventaja de mayor probabilidad de no progresión para el grupo estudio con respecto al grupo control por la variable combinada progresión por escala ampliada del estado de discapacidad y brotes. Conclusiones: se identificaron indicadores precoces de respuesta al tratamiento con el interferón beta-1a, que ayudan a valorar la respuesta al tratamiento de forma precoz, lo que repercute de forma positiva en la evolución de la enfermedad.
ABSTRACT Background: multiple sclerosis modifying drugs are intended to reduce the frequency of relapses, delay the progression of disability, as well as the appearance of new lesions in the Central Nervous System. Objective: to determine the early indicators of response to treatment with IFNb-1a. Methods: Observational, analytical longitudinal prospective cohort study in patients diagnosed with multiple sclerosis. Two study cohorts were formed, each with 39 patients. Results the mean and standard deviation of the expanded disability status scale at 36 months was 2.37 ± 1.86 in the study group and 3.15 ± 2.1 in the control group. In the outbreaks of .13 ± .33 in the study group and in the control group of .41 ± .59. New lesions in T2 after the first 12 months of treatment was 0.90 ± 1.16 for the study group and 1 ± 1.10 for the control. Extended-scale progression of disability status, pretreatment annualized relapse rate, age of disease onset, time since disease progression, and gadolinium-enhancing lesions were significantly associated with the odds ratio of older Probability of non-progression for the study group with respect to the control group for the combined variable progression by extended disability status scale and relapses. Conclusions: early indicators of response to treatment with interferon beta-1a were identified; that help assess the response to treatment early, which has a positive impact on the evolution of the disease.
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Introducción: La neurorrestauración integral en la esclerosis múltiple mejora los déficits funcionales. Dentro de la atención de las personas con la enfermedad, se ha incluido la valoración de la calidad de vida relacionada con la salud, que es un elemento clave para la evaluación subjetiva de las influencias del estado de salud actual. Objetivo: Determinar la influencia de la neurorrestauración integral en la calidad de vida relacionada con la salud de los pacientes con esclerosis múltiple remitente-recurrente. Material y Métodos: Se realizó un estudio cuasi-experimental en 78 pacientes con esclerosis múltiple remitente-recurrente, tratados en el Hospital Universitario Clínico-quirúrgico Arnaldo Milián Castro de Santa Clara, en el periodo comprendido entre enero de 2014 a diciembre de 2020. Los pacientes se distribuyeron aleatoriamente en un grupo estudio y un grupo control, asignados por sorteo. Resultados: En cuanto a las actividades de la vida diaria mostró una media al final de la intervención de 95,89 para el grupo estudio; y para el grupo control de 81,28. Posterior a la intervención se evidenció una mejoría del funcionamiento de la calidad de vida relacionada con la salud del grupo estudio en los componentes de la escala en comparación con los controles. Conclusiones: se determinó como el desarrollo de intervenciones promueven el mayor bienestar posible de los pacientes con esclerosis múltiple remitente-recurrente a través de la neurorrestauración integral(AU)
Introduction: Comprehensive neurorestoration in Multiple Sclerosis improves functional deficits. The assessment of health-related quality of life, which is a key element for the subjective evaluation of the influences of the current state of health, has been included in the care of people with the disease. Objective: To determine the influence of comprehensive neurorestoration on the health-related quality of life of patients with relapsing-remitting multiple sclerosis. Material and Methods: A quasi-experimental study was carried out in 78 patients with relapsing-remitting multiple sclerosis treated at the "Arnaldo Milián Castro" Clinical-Surgical University Hospital in Santa Clara, in the period between January 2014 and December 2020. The patients were randomly assigned to a study group and a control group. Results: Regarding activities of daily living, the study group showed a mean of 95.89 at the end of the intervention, while the control group showed a mean of 81.28. After the intervention, an improvement in the functioning of the health-related quality of life of the study group was evidenced in the components of the scale, compared with the controls. Conclusions: It was determined that the development of interventions through comprehensive neurorestoration promote the best possible well-being of patients with relapsing-remitting multiple sclerosis(AU)
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HumanosRESUMEN
The objective of this study was to evaluate the clinical files of patients with RRMS who started rituximab (RTX) compared with a second-line treatment (natalizumab (NTZ) or fingolimod (FTY)). This was a historical cohort study. We compared the effect according to the Expanded Disability Status Scale (EDSS) and the number of relapses in RRMS patients receiving these treatments after a mean period of 12 months. We found a statistically significant difference (p < 0.001) when comparing the EDSS scores and the annual relapse rates of patients receiving RTX with those receiving NTZ or FTY. This study is essential for our clinical practice, since patients with limited treatment options represent a challenge with regard to the management of their medical care. However, clinical trials and prospective studies with long follow-up periods are necessary to provide sufficient evidence on the efficacy of RTX and thus include this treatment in the therapeutic profile of patients with MS.
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RESUMEN Fundamento: las alternativas terapéuticas en pacientes con esclerosis múltiple no deben centrar sus esfuerzos en la rehabilitación de dominios cognitivos específicos, sino valorar el empleo de estrategias de intervención multimodal, con el propósito de minimizar los factores negativos que intervienen en la salud cognitiva de estos. Objetivo: determinar la efectividad del tratamiento neurorrehabilitador integral en la función cognitiva de los pacientes con esclerosis múltiple remitente recurrente. Métodos: se realizó un estudio cuasiexperimental con dos grupos (un grupo estudio y un grupo control) en pacientes con diagnóstico de esclerosis múltiple remitente recurrente. Cada grupo quedó conformado por 39 pacientes. Los métodos estadísticos exigieron la utilización de un estudio de pruebas repetidas, variante de ANOVA. Para las pruebas de dos momentos se utilizó el concepto de ANOVA de un factor. Resultados: después de la intervención se obtuvo en el grupo de estudio, un aumento de las puntuaciones en las pruebas de velocidad de procesamiento, memoria de trabajo-flexibilidad cognitiva, fluidez verbal y el control inhibitorio; así como disminución en los niveles de fatiga. Se comprobó una mejoría significativa en el estado emocional del grupo de estudio, pues hubo disminución del estado de ansiedad y depresión. Conclusiones: el proceso de neurorrehabilitación integral resultó efectivo al disminuir en los pacientes los niveles de depresión y ansiedad, además de mejorar el funcionamiento cognitivo en el grupo de pacientes que completó el proceso, lo que muestra la viabilidad de un enfoque de neurorrehabilitación integral y su utilidad para mejorar la calidad de vida en adultos con esclerosis múltiple.
ABSTRACT Background: Therapeutic alternatives should not focus their efforts on the rehabilitation of specific cognitive domains, but value the use of multimodal intervention strategies, with the purpose of minimizing the negative factors that intervene in the cognitive health of patients with multiple sclerosis. Objective: to determine the effectiveness of comprehensive neurorehabilitation treatment on the cognitive function of patients with relapsing-remitting multiple sclerosis. Methods: a quasi-experimental study was carried out with two groups (a study group and a control group) in patients diagnosed with relapsing-remitting multiple sclerosis. Each group was made up of 39 patients. Statistical methods required the use of a repeated test study, variant of ANOVA. For the two-moment tests, the one-way ANOVA concept was used. Results: after the intervention, in the study group, an increase in the scores in the tests of processing speed, working memory-cognitive flexibility, verbal fluency and inhibitory control was obtained; as well as decreased levels of fatigue. A significant improvement in the emotional state of the study group was verified, showing a decrease in the state of anxiety and depression. Conclusions: the comprehensive neurorehabilitation process was effective in reducing depression and anxiety levels in patients, in addition to improving cognitive functioning in the group of patients who completed the process, which shows the viability of a comprehensive neurorehabilitation approach and its effectiveness utility to improve quality of life in adults with multiple sclerosis.
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RESUMEN Introducción: El inicio de la terapia con interferón ha sido y es el primer paso en el tratamiento de muchos pacientes con esclerosis múltiple, con el propósito de retrasar la progresión de la enfermedad. Objetivo: Identificar los marcadores clínicos de respuesta al tratamiento con interferón beta-1a de pacientes con esclerosis múltiple remitente-recurrente. Métodos: Se realizó un estudio observacional, descriptivo, longitudinal, prospectivo, de una serie de casos de pacientes con diagnóstico de esclerosis múltiple remitente-recurrente, que recibían tratamiento con interferón beta-1a, en el periodo comprendido entre enero del 2014 a diciembre del 2020. Se incluyeron los 39 pacientes. Resultados: La media de edad fue de 34,54 años. La media del nivel de discapacidad en la línea base, 12, 24 y a los 36 meses fue de 1,76; 1,91; 2,1 y 2,37 respectivamente. La media de los brotes en la línea base, 12, 24 y a los 36 meses fue de 1,13; 0,26; 0,38 y 0,13 respectivamente. Se muestra la cifra de progresiones inferior en un 51 % a los 36 meses. La razón de ventajas (odds ratio) para la no presencia de brotes se muestra entre 2 y 4 veces en estos pacientes. Conclusiones: Se identifican marcadores clínicos de respuesta al tratamiento con interferón beta-1a que ayudan a valorar la respuesta al tratamiento, lo cual repercute de forma positiva en la evolución de la enfermedad.
ABSTRACT Introduction: The initiation of interferon therapy has been and is the first step in the treatment of many patients with multiple sclerosis, with the aim of delaying the progression of the disease. Objective: To identify the clinical markers of response to treatment with Interferon beta-1a in patients with relapsing-remitting multiple sclerosis. Methods: An observational, descriptive, longitudinal, prospective study was carried out of a series of cases of patients diagnosed with relapsing-remitting multiple sclerosis, who received treatment with interferon beta-1a, in the period between January 2014 and December 2020. All 39 patients were included. Results: The mean age was 34.54 years. The mean disability level at baseline, 12, 24, and 36 months was 1.76; 1.91; 2.1 and 2.37 respectively. The mean number of flares at baseline, 12, 24, and 36 months was 1.13; 0.26; 0.38 and 0.13 respectively. The number of progressions lower by 51% at 36 months is shown. The odds ratio for the absence of relapses is between 2 and 4 times in these patients. Conclusions: Clinical markers of response to treatment with Interferon beta-1a are identified that help assess the response to treatment, which has a positive impact on the evolution of the disease.
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OBJECTIVES: To study different components of social cognition and quality of life in patients with early multiple sclerosis and low Expanded Disability Status Scale and to test the influence of cognitive performance, fatigue and neuropsychiatric symptoms on social cognition performance. METHODS: Thirty-four patients with relapsing-remitting MS, with ≤2 years of disease duration and scores ≤2 on the EDSS and 30 healthy controls underwent neuropsychological assessment with the Brief Repeatable Neuropsychological Test Battery. Components of social cognition, such as emotion recognition, theory of mind, empathy, and emotional reactivity, were assessed with the Reading the Mind in the Eyes test, the Faux Pas task, the International Affective Imagery System, and the Empathy Quotient. Anxiety, depression, fatigue and quality of life were measured. RESULTS: Patients showed significant differences in verbal memory, executive functions and social cognition, especially emotion recognition and ToM. Regarding emotional reactivity, patients showed a positive bias in the interpretation of the valence of neutral images. CONCLUSIONS: Patients with early MS showed impairments in several components of social cognition independent of cognitive performance, neuropsychiatric symptoms and fatigue. Social cognition deficits may be present in MS even in the early stages.
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Background: Relapsing-remitting multiple sclerosis (RRMS) is a subtype of degenerative inflammatory demyelinating disease of multifactorial origin that affects the central nervous system and leads to multifocal neurological impairment. Objectives: To develop a clinical pathway (CP) for the management of Peruvian patients with RRMS. Methods: First, we performed a literature review using Medline, Embase, Cochrane, ProQuest, and Science direct. Then, we structured the information as an ordered and logical series of five topics in a defined timeline: (1) How should MS be diagnosed? (2) How should a relapse be treated? (3) How should a DMT be initiated? (4) How should each DMT be used? and (5) How should the patients be followed? Results: The personnel involved in the care of patients with RRMS can use a series of flowcharts and diagrams that summarize the topics in paper or electronic format. Conclusions: We propose the first CP for RRMS in Peru that shows the essential steps for diagnosing, treating, and monitoring RRMS patients based on an evidence-based medicine method and local expert opinions. This CP will allow directing relevant clinical actions to strengthen the multidisciplinary management of RRMS in Peru.
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ABSTRACT Background: Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system. The YKL-40 protein, which is secreted from various cells that contribute to inflammation and infection, plays a role in immune regulation. Objective: This study investigated the serum YKL-40 levels of patients with clinically isolated syndrome (CIS) and MS. Methods: The participants was divided into three groups: 1) patients with CIS (n = 20); 2) patients with relapsing-remitting MS (RRMS; n = 39); and 3) healthy individuals (n = 35). The YKL-40 levels in serum samples obtained from the participants were measured using enzyme-linked immunoassays. Results: The median serum YKL-40 level was 20.2 ng/mL (range 9.8-75.9 ng/mL) in the patients with CIS, 22.7 ng/mL (range 13.4-57.9 ng/mL) in the patients with RRMS and 11.0 ng/mL (range 10.0-17.3 ng/mL) in the control group (p < 0.001). The serum YKL-40 levels in the patients with RRMS were correlated with the patients' expanded disability status scale scores and ages (p < 0.05). No relationships were determined between the serum YKL-40 levels and the other variables (p > 0.05). The serum YKL-40 levels were higher in the CIS group than in the MS group. These findings show that the serum YKL-40 levels were high even at the beginning of the disease. The serum YKL-40 levels were also not involved in the progression to clinically definite MS. Conclusions: The findings from this study suggested that YKL-40 may be a useful marker for the inflammatory process of MS.
RESUMO Contexto: A Esclerose Múltipla (EM) é uma doença inflamatória crônica que afeta o sistema nervoso central. A proteína UKL-40, secretada de várias células que participam de processos inflamatórios e infecciosos, desempenha um importante papel na regulação imunológica. Objetivo: Este estudo investigou níveis séricos de YKL-40 em pacientes com Síndrome Clinicamente Isolada (SCI) e EM. Métodos: Os participantes foram divididos em três grupos: 1) pacientes com SCI (n = 20); 2) pacientes com EM recorrente-remitente (EMRR; n = 39); e 3) indivíduos saudáveis (n = 35). Os níveis de YKL-40 em amostras séricas obtidas dos participantes foram medidos usando-se imunoensaios ligados a enzimas. Resultados: O nível sérico médio de YKL-40 foi 20.2 ng/mL (range 9.8-75.9 ng/mL) em pacientes com CIS, 22.7 ng/mL (intervalo entre 13.4-57.9 ng/mL) em pacientes com EMRR e 11.0 ng/mL (intervalo entre 10.0-17.3 ng/mL) no grupo controle (p < 0.001). Os níveis séricos de YKL-40 em pacientes com EMRR estavam correlacionados às pontuações e idades dos pacientes na EDSS (p < 0.05). Não foram determinadas relações entre os níveis séricos de YKL-40 e outras variáveis (p > 0.05). Os níveis séricos de YKL-40 no grupo SCI estavam mais elevados do que no grupo EM. Estes resultados demonstram que os níveis séricos de YKL-40 estavam mais elevados até mesmo no início da doença. Os níveis séricos de YKL-40 também não estavam associados à progressão da EM clinicamente definida. Conclusões: A partir deste estudo, os resultados sugeriram que a proteína YKL-40 pode ser um indicador útil no processo inflamatório da EM.
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Humanos , Enfermedades Desmielinizantes , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Biomarcadores , Proteína 1 Similar a Quitinasa-3RESUMEN
Objetivo: Avaliar o impacto orçamentário da inclusão da cladribina oral no tratamento de esclerose múltipla remitente-recorrente em alta atividade da doença (EMRR HDA) no Sistema de Saúde Suplementar (SSS). Métodos: Foi conduzida uma análise de impacto orçamentário, sob a perspectiva do SSS, com horizonte temporal de quatro anos, considerando a abordagem de coorte aberta na qual o número de pacientes elegíveis para tratamento varia em cada ano com a introdução de novos pacientes diagnosticados de EMRR HDA e a retirada de indivíduos prevalentes devido a morte ou progressão secundária. Foram considerados custos médicos diretos, incluindo a aquisição e administração de medicamentos, monitoramento, eventos adversos e surtos. Os comparadores utilizados na análise foram: alentuzumabe, fingolimode, natalizumabe e ocrelizumabe. Os custos foram apresentados em real brasileiro (BRL). Resultados: O custo incremental da inclusão da cladribina oral para o SSS foi estimado em 463.265 BRL, 739.691 BRL, -1.414.963 BRL, -3.719.007 BRL, nos anos 1, 2, 3 e 4, respectivamente. Isso resultou em um custo incremental total de -3.931.015 BRL no período analisado, representando 1,5% da redução orçamentária total no tratamento de EMRR HDA. Conclusão: A inclusão da cladribina oral para o tratamento de pacientes com diagnóstico de EMRR HDA poderia gerar uma economia substancial para o sistema brasileiro de saúde suplementar, atingindo um valor de cerca de 3,9 milhões de BRL em um período de quatro anos
Objective: To evaluate the budget impact of adopting cladribine tablets as a treatment strategy for relapsing remitting multiple sclerosis with high disease activity (RRMS HDA), from the Brazilian private healthcare system perspective. Methods: A budget impact analysis, under private healthcare system perspective, with a 4-years time horizon was conducted, considering the open cohort approach in which the number of patients eligible for treatment varies each year with the introduction of newly diagnosed RRMS HDA patients and the drop out of prevalent individuals due to death or secondary progression. Direct medical costs, including acquisition, drug administration, monitoring, adverse events and relapses were considered. Comparators used in the analysis were: alentuzumab, fingolimod, natalizumab and ocrelizumab. Costs were presented in Brazilian real (BRL). Results: The incremental cost of incorporating cladribine tablets into the private healthcare system was estimated at 463,265BRL, 739,961BRL, -1,414,963 BRL, -3,716,007 BRL, in years 1, 2, 3 and 4, respectively. This resulted in a total incremental cost of -3,931,015 BRL over the period analyzed, representing 1.5% of the total budget reduction in the treatment of RRMS HDA. Conclusion: Incorporation of cladribine tablets for the management of RRMS HDA could generate substantial savings for the private healthcare system, reaching a value of approximately 3.9 million BRL in a 4-years period