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IL17A/ F soneloquimab en pacientes con psoriasis en placas: estudio multicéntrico, aleatorizado, controlado con
Kim A Papp1, Mark A Weinberg2, Alun Morris3
1Probity Medical Research, Waterloo, ON, Canada.
Lancet (London, England)
|April 25, 2021
Resumen
Sonelokimab demostró beneficios clínicos significativos en pacientes con psoriasis en placas en comparación con el placebo, mostrando mejoras rápidas y duraderas con un perfil de seguridad aceptable. Las dosis más altas de sonelokimab (60 mg y 120 mg) resultaron particularmente efectivas para lograr una piel clara o casi clara.
Área de la Ciencia:
- Inmunodermatología
- Biológicos y proteínas terapéuticas
- Investigación en ensayos clínicos
Sus antecedentes:
- Sonelokimab es un nuevo nanobody trivalente dirigido a IL-17A, IL-17F y albúmina sérica humana.
- Los nanobodies son una nueva clase de proteínas terapéuticas derivadas de los anticuerpos de cadena pesada de los camélidos.
- La psoriasis en placas es una afección inflamatoria crónica de la piel que a menudo requiere terapia sistémica.
Objetivo del estudio:
- Evaluar la eficacia, seguridad y tolerabilidad de sonelokimab en pacientes con psoriasis tipo placa.
- Para comparar sonelokimab en cuatro regímenes de dosificación con el placebo.
- Utilizar el secukinumab como control activo para el análisis comparativo.
Principales métodos:
- Un ensayo multicéntrico, aleatorizado, controlado con placebo, de fase 2b en el que participaron 313 pacientes adultos con psoriasis en placas de moderada a grave.
- Los participantes fueron asignados al azar en seis grupos: placebo, sonelokimab (30 mg, 60 mg, 120 mg de carga normal, 120 mg de carga aumentada) y secukinumab (300 mg).
- El resultado primario fue la proporción de pacientes que obtuvieron una puntuación de evaluación global del investigador (IGA) de 0 o 1 en la semana 12.
Principales resultados:
- En la semana 12, se observaron mejoras significativas en las puntuaciones de IGA (0 o 1) en todos los grupos de sonelokimab en comparación con el placebo (p< 0, 0001).
- Las dosis más altas de sonelokimab (60 mg y 120 mg) mostraron altas tasas de eficacia, con un 84,6% y hasta un 88,2% logrando IGA 0/ 1.
- Las reacciones adversas fueron en su mayoría leves a moderadas; sonelokimab mostró un perfil de seguridad similar al secukinumab durante 52 semanas, con un ligero aumento en las infecciones manejables por Candida.
Conclusiones:
- Sonelokimab demostró un beneficio clínico significativo con respecto al placebo en el tratamiento de la psoriasis en placas.
- El tratamiento mostró un inicio de acción rápido, mejoras duraderas y un perfil de seguridad aceptable.
- Sonelokimab, especialmente en dosis de 120 mg o menos, representa una opción terapéutica prometedora para la psoriasis en placas.
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