18/8/2016
El estudio sobre el siponimod muestra una reducción de la actividad de la esclerosis múltiple y tasas de recidiva bajas sin nuevos problemas de seguridad.
Fingolimod es un comprimido oral aprobado por la Agencia para el Control de los Alimentos y Medicamentos (FDA) de Estados Unidos en 2010 para la Esclerosis Múltiple Remitente-Recidivante.
De manera similar al fingolimod, el siponimod funciona atrapando cierto tipo de células inmunitarias (linfocitos T) en los ganglios linfáticos del organismo. De esta forma, se evita que entren en el cerebro y la médula espinal, donde dañarían la mielina protectora que recubre los nervios. En comparación con el fingolimod, el siponimod funciona de manera más selectiva en los linfocitos T y, por lo tanto, puede dar lugar a menos efectos secundarios a la vez que mantiene efectos beneficiosos similares.
El estudio actual es una ampliación de un ensayo anterior sobre siponimod, llamado estudio BOLD. Investiga en mayor detalle si este comprimido oral es seguro y eficaz para personas con Esclerosis Múltiple Remitente-Recidivante.
En el estudio participaron 184 personas con Esclerosis Múltiple de 73 centros de Estados Unidos y nueve centros de Europa, Canadá y Rusia. Se las dividió en cinco grupos, a los cuales se administraron diferentes dosis de siponimod.
La actividad de la Esclerosis Múltiple, como se observó en las pruebas de RMN, disminuyó en todos los grupos. No obstante, no se observaron modificaciones en la discapacidad clínica medida usando la Escala Expandida del Estado de Discapacidad (EDSS). No hubo efectos en tasa de reducción de volumen cerebral, que es mayor en las personas con Esclerosis Múltiple que en las personas sanas. La tasa de recidivas se mantuvo baja en todos los grupos.
En los grupos, entre un 84 y un 96 % de las personas a las que se administró siponimod presentaron efectos secundarios, y nueve personas sufrieron efectos secundarios graves. Entre ellos se encontraron infecciones de garganta, dolor de cabeza y modificación de las enzimas hepáticas.
Según los autores, deberían continuarse los ensayos con siponimod en la siguiente fase del ensayo (fase 3), en la que habrá más participantes y podrá aportar respuestas más decisivas.
Lea el artículo completo (la página web externa se abre en una nueva ventana).
Fuente: www.msif.org
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