Cladribina es un tratamiento nuevo para la esclerosis múltiple (EM) con brotes. Ha sido aprobado en agosto de 2017 por la Agencia Europea del Medicamento para todos los pacientes con EM con brotes muy activa definida por características clínicas o de imagen. Quiere decir que está indicada para pacientes que hayan tenido un brote en el año previo, o un aumento de lesiones en resonancia magnética mientras estaban tratados con otro tratamiento modificador de la enfermedad para la EM, o para pacientes al inicio de la enfermedad con una EM muy activa.

Cladribina es un antimetabolito que actúa sobre los linfocitos. Se sabe que actúa sobre la respuesta inmune adaptativa y que actúa de forma selectiva en los linfocitos T y B más agresivos, a los que destruye. Posteriormente, se produce una reconstitución paulatina de la inmunidad del paciente, sería como una especie de reseteo del sistema inmune. Aumenta la secreción de citoquinas antiinflamatorias que son beneficiosas para la EM y disminuye los niveles de las citoquinas proinflamatorias dañinas para la EM.

Se han hecho varios ensayos clínicos con este producto, entre ellos los más importantes son el CLARITY y el ORACLE. En el estudio Clarity se comparaba cladribina contra placebo y se demostró que tenía un efecto positivo en el índice de recaída anual (el número de recaídas por año), reduciendo los brotes un 58% comparándolo con Avonex (eficacia similar al fingolimod), reduciendo las lesiones activas en un 86% y una reducción del 33% en la progresión de la discapacidad. El estudio oracle se hizo en pacientes con el primer brote de la enfermedad y mostró resultados similares.

Se administra en pastillas de 10 mg y la cantidad de pastillas a tomar depende del peso corporal del paciente, siendo el mínimo 4 pastillas en una semana y el máximo 10 pastillas en una semana.

Las pastillas sólo se toman dos semanas al año separadas por un mes, durante cinco días de tratamiento, lo que supone que el tratamiento sólo se va a tomar 10 días en todo un año, pero el efecto dura todo el año. En el segundo año se repite el mismo procedimiento que en el primer año, y en el tercero y cuarto año no se da el tratamiento.

Se dice que el tratamiento es duradero porque se hace durante dos años pero el beneficio se mantiene durante 4 años, lo que significa que el paciente toma la cladribina el primer y el segundo año y no toma tratamiento el tercero y cuarto años pero sigue protegido.

En cuanto a los efectos secundarios, los más comunes son disminución moderada de los linfocitos de la sangre y aumento de algunas infecciones, entre ellas las infecciones por herpes zóster. No presenta efectos secundarios inmediatos después de tomarse las pastillas.

En la práctica clínica la monitorización es muy sencilla y solo supone una resonancia magnética antes de iniciar el tratamiento y tres analíticas de sangre al año, una antes de empezar el tratamiento, otra dos meses después del inicio y la siguiente a los seis meses de iniciado el tratamiento. No se requieren más pruebas. El uso de cladribina está contraindicado durante el embarazo. Las mujeres y los hombres que tomen este tratamiento tienen que usar anticonceptivos durante todo el tratamiento y hasta 6 meses después del último ciclo.

En resumen, la cladribina tiene una eficacia muy elevada, una seguridad más que aceptable y una duración del efecto muy importante. Además, parece que puede modificar de forma positiva el sistema inmune y la reconstitución del mismo. Con pocas pastillas (de 8 a 20), divididas en 2 ciclos, se consigue mantener a los pacientes libres de actividad de enfermedad durante 4 años.

Dra. Celia Oreja-Guevara
Jefe de Sección de Neurología
Directora de la Unidad de Esclerosis Múltiple
Profesor Asociado de la Universidad Complutense
Hospital Clínico San Carlos, Madrid.

 

 

Categoría: Noticias AEDEM

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