Real-World Effectiveness and Safety of Cladribine in Multiple Sclerosis: Longitudinal Data From the Nationwide Registry in Argentina.

OBJECTIVE: The aim was to evaluate patient profiles, effectiveness and safety of cladribine (CLAD) in patients with relapsing-remitting multiple sclerosis in Argentina. METHODS: This was a substudy included in RelevarEM (MS and neuromyelitis optica registry in Argentina, NCT03375177). Patients with MS who received CLAD tablets and were followed up for at least 24 months were included. Clinical evaluations every 3 months collect information about: a) clinical relapses; b) progression of physical disability, evaluated through Expanded Disability Status Scale, and c) new lesions found in the magnetic resonance imaging. Lymphopenia was evaluated during the follow-up and defined as grade 1: absolute lymphocyte count (ALC) 800-999/µL; grade 2: ALC 500-799/µL; grade 3: ALC 200-499/µL and grade 4: ALC <200/µL. RESULTS: A total of 240 patients were included from 19 centers from Argentina. The mean annualized relapse rate during the 12-month pre-CLAD initiation was 1.19 ± 0.56 versus 0.22 ± 0.18 at month 12 and 0.19 ± 0.15 at month 24 ( P < 0.001). A total of 142 (59.2%) fulfilled the criteria of disease activity during the 12 months before treatment initiation, whereas 27 (11.3%) fulfilled it at month 12 and 38 (15.8%) at month 24, P < 0.001. Regarding no evidence of disease activity (NEDA), 202 (84.2%) patients achieved NEDA status at month 12 and 185 (77%) at month 24. The most frequent incidence density of lymphopenia for course 2 observed was also for grade 1, 6.1 (95% confidence interval [CI] = 5.5-7.1). The overall incidence density of lymphopenia grade 4 was 0.1 (95% CI = 0.06-0.19). CONCLUSION: This information will help when choosing the best treatment option for Argentinean patients.

Selection of disease modifying therapies in multiple sclerosis based on patient's age and disease activity: Data from a nationwide registry.

BACKGROUND: Knowledge of the safety and efficacy of disease-modifying therapies (DMTs) in older patients with Multiple Sclerosis (pwMS) is limited due to their exclusion from clinical trials. Our purpose is to evaluate the choice of DMTs in pwMS older than 50 years old in a real-world setting. METHODS: Cross-sectional study of pwMS from the Argentine MS and NMOSD Registry. We included patients under 35 and above 50 years old prescribed DMTs. Disease activity was categorized as highly active (HA) or not highly active (NHA), and DMTs were classified as low efficacy therapies (LET) or high efficacy therapies (HET). RESULTS: 1460 patients (65% females) were enrolled. The HA group comprised 241 patients, 198 young (82.2%) and 43 older (17.8%). The NHA group included 1219 patients, 893 young (73%) and 326 older (27%). In the NHA group, older patients received LET more frequently than younger patients (66% versus 44%; p < 0.01). In the HA group, older patients received LET in 61% of cases, whereas younger patients received HET in 71% (p = 0.01). CONCLUSION: The study shows the preference of LET in older patients regardless of disease activity. However it does not demonstrate a difference in disability in older patients based on low vs high efficacy DMTs used, probably due to the design of the study. Further longitudinal studies are warranted to address this issue.

Clinical characterization of long-term multiple sclerosis (COLuMbus) patients in Argentina: A cross-sectional non-interventional study.

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.

Real-world effectiveness of natalizumab treatment in patients with relapsing multiple sclerosis in Argentina and Chile / Efectividad en el mundo real del tratamiento con Natalizumab para pacientes con esclerosis múltiple recurrente en Argentina y Chile

ABSTRACT Background: The real-world effectiveness of natalizumab in people with relapsing multiple sclerosis (PwRMS) in Argentina and Chile has not been reported. Objective: To evaluate the effectiveness of natalizumab treatment in PwRMS in Argentina and Chile, in clinical practice. Methods: We conducted a multicenter retrospective and observational study. We reviewed the medical records of PwRMS who had been treated with natalizumab for at least one year, without any interruption in MS treatment that lasted more than 12 weeks. We analyzed changes in annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score and magnetic resonance imaging (MRI). Results: We enrolled 117 PwRMS treated with natalizumab. Natalizumab treatment was associated with a significant reduction in ARR from baseline after one year and two years of treatment (from 1.97 to 0.06 and 0.09 respectively; p<0.01 at each time point). From baseline, EDSS scores were reduced by 0.71 and 0.73 points at one and two years, respectively (p<0.01). No worsening of disability was observed in 82.9 and 67.5% of PwRMS at one and two years, respectively. The improvement in disability was 44.4% at one year and 39.3% at two years. During natalizumab treatment, the number of relapse-related hospitalizations was significantly reduced (p<0.01). MRI lesions (new/enlarging T2 or gadolinium-enhancing) were significantly reduced, compared with baseline. No evidence of disease activity was observed in 65% at two years of natalizumab treatment. Conclusions: Natalizumab significantly reduced disease activity in PwRMS in Argentina and Chile, in clinical practice. Natalizumab also decreased the number of hospitalizations compared with pre-natalizumab treatment.

RESUMEN Antecedentes: La efectividad de Natalizumab en personas con esclerosis múltiple recurrente (PwRMS) en Argentina y Chile no se ha reportado. Objetivo: Evaluar la efectividad del tratamiento con Natalizumab en PwRMS en Argentina y Chile en la práctica clínica. Métodos: Estudio multicéntrico, retrospectivo y observacional. Revisamos los registros médicos de PwRMS que fueron tratados con Natalizumab al menos 1 año, sin interrupción de tratamiento para EM durante más de 12 semanas. Analizamos los cambios en la tasa anualizada de recaídas (ARR), escala de discapacidad expandida (EDSS) y resonancia magnética (MRI). Resultados: Se incluyeron 117 PwRMS. El tratamiento con Natalizumab se asoció con una reducción significativa de la tasa anualizada de recaídas (ARR) cada 1 y 2 años (de 1.97 a 0.06 y 0.09, respectivamente; p<0.01 en ambos casos). El EDSS se redujo 0,71 y 0,73 puntos al año 1 y 2, respectivamente (p<0,01). No se observó empeoramiento del EDSS en 82,9 y 67,5% de los PwRMS al año 1 y 2, respectivamente. La mejoría del EDSS fue 44,4 y 39,3% al año 1 y 2, respectivamente. El número de hospitalizaciones se redujo significativamente (p<0,01). Las lesiones en MRI (nuevas/agrandadas en T2 o con realce con gadolinio) se redujeron significativamente en comparación con el valor basal. No se observó evidencia de actividad de la enfermedad en el 65% de los PwRMS a 2 los años. Conclusiones: Natalizumab redujo significativamente la actividad de la enfermedad en PwRMS de Argentina y Chile en la práctica clínica. Además, disminuyó el número de hospitalizaciones comparado con el tratamiento previo.

Prevalencia de esclerosis múltiple en la Ciudad de Oliva, Provincia de Córdoba / Prevalence of multiple sclerosis in the city of Oliva, Córdoba Province

La Esclerosis Múltiple es una enfermedad desmielinizante del sistema nervioso central que afecta personas jóvenes, a predominio en mujeres. la prevalencia de la esclerosis múltiple está en relación a diferentes factores: genéticos, geográficos y ambientales. En Argentina los estudios de prevalencia realizados han determinado que nuestro país se encuentra en una zona de baja a modera prevalencia (entre 12 y 18 casos cada 100.000 habitantes). Este trabajo trata de una investigación epidemiológica a los fines de establecer la prevalencia de esclerosis múltiple en la ciudad de Oliva (provincia de Córdoba). Además se plantea como objetivo la búsqueda de factores que puedan estar relacionados con la prevalencia de la enfermedad. Se utilizó como metodología de obtención de datos un relevamiento puerta a puerta a través de un cuestionario que reveló la presencia de 11 pacientes con diagnóstico de esclerosis múltiple definida, lo cual demostró una prevalencia estimada de 88 casos cada 100.000 habitantes

Utilidad clínica del video-EEG prolongado en la epilapsia / Clinical utility of log-term video-EEG in the epilepsy

RESUMEN: Objetivo: Demostrar la utilidad del Video-EEG Prolongado (VEEG) en el estudio de pacientes con Epilepsia. Valorar la metodología, indicaciones y selección de pacientes. Metodo: Se realizó VEEG a 28 pacientes con probable diagnóstico de Epilepsia los cuales fueron estudiados en nuestra Unidad de Monitoreo Intensivo. Se plantearon 6 interrogantes clínicos de vital importancia para el diagnóstico y/o tratamiento. Los pacientes fueron registrados durante un periodo variable de 4 a 72 hs, de acuerdo al interrogante clínico a resolver. Resultados: La técnica de VEEG evidenció resultados satisfactorios en el 75 por ciento de los pacientes y pudo contestar al interrogante clínico planteado en el 72 por ciento. Conclusión: El VEEG Prolongado es un método de alta complejidad neurofisiológico, que junto a la clínica, EEG interictal, SPECT ictal, Resonancia Magnetica Nuclear y test neuropsicológicos, ayuda a identificar pacientes con Epilepsia de dificil diagnóstico y control terapéutico. Una buena selección de pacientes aportara beneficios en el 75 por ciento de los mismos.