Gut Microbiota as a Potential Predictive Biomarker in Relapsing-Remitting Multiple Sclerosis.

BACKGROUND: The influence of the microbiome on neurological diseases has been studied for years. Recent findings have shown a different composition of gut microbiota detected in patients with multiple sclerosis (MS). The role of this dysbiosis is still unknown. OBJECTIVE: We analyzed the gut microbiota of 15 patients with active relapsing-remitting multiple sclerosis (RRMS), comparing with diet-matched healthy controls. METHOD: To determine the composition of the gut microbiota, we performed high-throughput sequencing of the 16S ribosomal RNA gene. The specific amplified sequences were in the V3 and V4 regions of the 16S ribosomal RNA gene. RESULTS: The gut microbiota of RRMS patients differed from healthy controls in the levels of the Lachnospiraceae, Ezakiella, Ruminococcaceae, Hungatella, Roseburia, Clostridium, Shuttleworthia, Poephyromonas, and Bilophila genera. All these genera were included in a logistic regression analysis to determine the sensitivity and the specificity of the test. Finally, the ROC (receiver operating characteristic) and AUC with a 95% CI were calculated and best-matched for Ezakiella (AUC of 75.0 and CI from 60.6 to 89.4) and Bilophila (AUC of 70.2 and CI from 50.1 to 90.4). CONCLUSIONS: There is a dysbiosis in the gut microbiota of RRMS patients. An analysis of the components of the microbiota suggests the role of some genera as a predictive factor of RRMS prognosis and diagnosis.

Fingolimod: efectividad y seguridad en la práctica clínica habitual. Estudio observacional, retrospectivo y multicéntrico en la provincia de Alicante / Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in the province of Alicante

INTRODUCCIÓN: Los estudios postautorización son importantes para confirmar si los resultados de los ensayos clínicos se reproducen en la práctica clínica habitual. OBJETIVO: Evaluar la efectividad y seguridad del fingolimod en la práctica clínica en la provincia de Alicante. PACIENTES Y MÉTODOS: Estudio multicéntrico retrospectivo de pacientes con esclerosis múltiple remitente tratados con fingolimod. Se recogen las características demográficas, clínicas y farmacológicas. Se describe la efectividad del fármaco -tasa anualizada de brotes (TAB) y porcentaje de pacientes libres de brotes- al año y a los dos años de tratamiento en relación con el año previo y datos de efectos secundarios. RESULTADOS: Se incluyó a 89 pacientes. El tratamiento previo fue inmunomodulador (interferón beta o acetato de glatiramero) en 54 pacientes y natalizumab en 32. Cincuenta pacientes cambiaron por fracaso con el inmunomodulador y 31 por serología positiva del virus JC (VJC+). La TAB global disminuyó el 67,3% el primer año (p < 0,0001) y el 84,1% el segundo (p = 0,0078). Disminuyó en los pacientes con fracaso del inmunomodulador (el 85,6% el primer año, p < 0,0001; el 88,9% el segundo año, p = 0,0039) y aumentó de forma no significativa en los pacientes VJC+ en el primer año. El porcentaje de pacientes libres de brotes en la población global aumentó del 32,6 al 68,1% en el primer año (p < 0,0019) y al 82,6% en el segundo (p = 0,0215). Este aumento no se observó en los pacientes VJC+. Trece pacientes tuvieron efectos secundarios, que obligaron a la retirada del fármaco en dos de ellos. CONCLUSIÓN: En la práctica clínica de la provincia de Alicante, el fingolimod mostró una efectividad y una seguridad ligeramente superiores a las de los ensayos clínicos

INTRODUCTION: Post-authorisation studies are important to confirm whether the outcomes of clinical trials are reproduced in usual clinical practice. AIMS: To evaluate the effectiveness and safety of fingolimod in clinical practice in the province of Alicante. PATIENTS AND METHODS: A retrospective multi-centre study was conducted with remitting multiple sclerosis patients treated with fingolimod. Demographic, clinical and pharmacological data were collected. We report on the effectiveness of the drug -annualised relapse rate (ARR) and percentage of patients free from attacks- at one and at two years after treatment in relation to the previous year, and data concerning side effects are also provided. RESULTS: The sample consisted of 89 PATIENTS: Previous treatment was with immunomodulators (interferon beta or glatiramer acetate) in 54 patients and natalizumab in 32. Fifty patients changed due to failure with the immunomodulator and 31 owing to positive serology for JC virus (JCV+). Overall ARR decreased by 67.3% the first year (p < 0.0001) and by 84.1% the second (p = 0.0078). It diminished in patients with immunomodulator failure (85.6% the first year, p < 0.0001; 88.9% the second year, p = 0.0039) and increased in a non-significant manner in JCV+ patients in the first year. The percentage of patients free from relapses in the overall population increased from 32.6% to 68.1% in the first year (p < 0.0019) and to 82.6% in the second (p = 0.0215). This increase was not observed in JCV+ PATIENTS: Side effects were reported by 13 patients, which led to the drug being withdrawn in two of them. CONCLUSIONS: In clinical practice in the province of Alicante, levels of effectiveness and safety of fingolimod proved to be slightly higher than those found in clinical trials (AU)

Meningitis subaguda e hipoglucorraquia persistente. Relación con la aparición de síndrome de reconstitución inmunitaria / Subacute meningitis and persistent hypoglucorrachia. Its relationship with the onset of immune reconstitution inflammatory syndrome

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