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Abatacept en niños con artritis idiopática juvenil: un ensayo de abstinencia aleatorizado, doble ciego y controlado
Nicolino Ruperto1, Daniel J Lovell, Pierre Quartier
1IRCCS G Gaslini, PRINTO, Genoa, Italy. nicolaruperto@ospedale-gaslini.ge.it
Lancet (London, England)
|July 18, 2008
Resumen
Abatacept redujo significativamente los brotes de artritis en niños con artritis idiopática juvenil (AJI) que no respondieron a otros tratamientos. Este modulador de costimulación selectiva de células T ofrece una alternativa segura y efectiva para el manejo de la JIA refractaria.
Área de la Ciencia:
- Reumatología Pediátrica.
- Inmunología Inmunología.
- Los ensayos clínicos son ensayos clínicos.
Sus antecedentes:
- La artritis idiopática juvenil (IAJ) plantea desafíos de tratamiento, ya que algunos niños no responden o son intolerantes a los medicamentos antirreumáticos convencionales modificadores de la enfermedad (DMARD), incluidos los agentes del factor de necrosis antitumoral (TNF).
- Abatacept, un modulador selectivo de la costimulación de células T, presenta una opción terapéutica potencial para estos casos difíciles de tratar.
Objetivo del estudio:
- Para evaluar la seguridad y eficacia de abatacept en pacientes pediátricos diagnosticados con IAI que habían fallado previamente otros tratamientos.
- Para determinar si abatacept puede prevenir o retrasar los brotes de artritis en esta población específica de pacientes.
Principales métodos:
- Un ensayo doble ciego, aleatorizado y controlado de abstinencia que involucró a 190 niños (de 6 a 17 años) con AJI activa y respuesta inadecuada a DMARDs anteriores.
- Los pacientes recibieron abatacept abierto durante 4 meses, seguido de una aleatorización para continuar con abatacept o recibir placebo durante 6 meses, con el tiempo hasta el brote como punto final primario.
Principales resultados:
- Se produjeron significativamente menos brotes de artritis en el grupo de abatacept (20%) en comparación con el placebo (53%) durante la fase doble ciego (p = 0.0003).
- El riesgo de exacerbación se redujo en más de dos tercios para los pacientes que continuaron con abatacept (razón de riesgo 0,31).
- Las frecuencias de eventos adversos fueron similares entre los grupos, sin diferencias significativas en los eventos adversos graves.
Conclusiones:
- La modulación selectiva de la costimulación de las células T con abatacept es un tratamiento alternativo viable y eficaz para los niños con IAI.
- Abatacept demuestra un perfil de seguridad y eficacia favorables en una población pediátrica con JIA refractaria.
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