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Risankizumab para la colitis ulcerosa: dos ensayos clínicos aleatorizados

Edouard Louis1, Stefan Schreiber2, Remo Panaccione3

  • 1Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Liège, Liège, Belgium.

JAMA
|July 22, 2024
PubMed
Resumen
Este resumen es generado por máquina.

Risankizumab mejoró significativamente las tasas de remisión clínica en pacientes con colitis ulcerosa tanto en los ensayos de terapia de inducción como de mantenimiento en comparación con el placebo. Se necesitan más investigaciones para evaluar los beneficios a largo plazo más allá de las 52 semanas.

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Área de la Ciencia:

  • Gastroenterología
  • Inmunología
  • Farmacología

Sus antecedentes:

  • La colitis ulcerosa (UC) es una enfermedad inflamatoria intestinal crónica con opciones de tratamiento limitadas.
  • Risankizumab, un inhibidor selectivo de la IL-23, ha mostrado potencial en el tratamiento de enfermedades inflamatorias.

Objetivo del estudio:

  • Evaluar la eficacia y seguridad de risankizumab como tratamiento de inducción y mantenimiento para la colitis ulcerosa moderada a grave.
  • Determinar las tasas de remisión clínica a las 12 semanas (inducción) y a las 52 semanas (mantenimiento).

Principales métodos:

  • Dos ensayos clínicos aleatorizados de fase 3 (inducción y mantenimiento) con pacientes con UC moderadamente o severamente activa.
  • Los pacientes recibieron risankizumab intravenoso o placebo para la inducción, seguido de risankizumab subcutáneo o placebo para el mantenimiento.
  • El resultado primario fue la remisión clínica, definida por la frecuencia específica de las heces, el sangrado rectal y los criterios endoscópicos.

Principales resultados:

  • En el ensayo de inducción, el 20,3% de los pacientes que recibieron risankizumab lograron una remisión clínica frente al 6,2% de los que recibieron placebo a las 12 semanas.
  • En el ensayo de mantenimiento, las tasas de remisión clínica a las 52 semanas fueron del 40,2% (180 mg) y 37,6% (360 mg) para el risankizumab, frente al 25,1% para el placebo.
  • No se identificaron nuevos riesgos de seguridad con el tratamiento con risankizumab.

Conclusiones:

  • Risankizumab demostró una eficacia significativa en el logro de la remisión clínica en pacientes con colitis ulcerosa de moderada a grave.
  • El fármaco fue bien tolerado y no se identificaron nuevos problemas de seguridad durante el período de estudio.
  • Se requiere una investigación adicional para comprender el perfil de eficacia y seguridad a largo plazo de risankizumab en UC más allá de las 52 semanas.