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Desarrollo de Fármacos

Steven Hersch1, Michelle Gee2, Thomas Doherty3

  • 1Eisai Inc., Nutley, NJ, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025

Ver abstracta en PubMed

Resumen
Este resumen es generado por máquina.

La lecanemab subcutánea para la enfermedad de Alzheimer (EA) muestra baja inmunogenicidad y una eficacia comparable a la administración intravenosa. Esta nueva formulación ofrece una alternativa conveniente y segura para los pacientes, con reacciones sistémicas reducidas.

Palabras clave:
lecanemab subcutáneoenfermedad de Alzheimerensayos clínicosfarmacocinéticafarmacodinámicainmunogenicidadanticuerpos monoclonales humanizadosinyecciones subcutáneas

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Área de la Ciencia:

  • Neurociencia; Farmacología; Ensayos Clínicos

Sus antecedentes:

  • Lecanemab (10 mg/kg IV Q2W) demostró eficacia en la ralentización de la progresión de la enfermedad de Alzheimer (EA) en el ensayo Clarity AD.; El modelado farmacocinético/farmacodinámico (PK/PD) relacionó las concentraciones de lecanemab con la reducción de la placa amiloide y ARIA-E.; Se desarrolló una formulación subcutánea para mejorar potencialmente la seguridad y reducir las reacciones sistémicas.

Objetivo del estudio:

  • Actualizar los resultados clínicos del programa de desarrollo de lecanemab subcutáneo.; Evaluar el perfil de seguridad, tolerabilidad y farmacodinámico de lecanemab subcutáneo.; Comparar lecanemab subcutáneo con la formulación intravenosa aprobada.

Principales métodos:

  • El estudio de Fase 3 Clarity AD incluyó pacientes con EA temprana aleatorizados a placebo o lecanemab (10 mg/kg cada dos semanas).; El desarrollo de la dosis subcutánea utilizó modelado PK/PD, datos de biodisponibilidad y un subestudio dentro de la extensión de etiqueta abierta de Clarity AD.; Se emplearon ensayos validados de anticuerpos anti-fármaco (ADA) y anticuerpos neutralizantes (Nab).

Principales resultados:

  • La lecanemab subcutánea de 360 mg semanal mostró bajas tasas de ADA (2%) y mantuvo biomarcadores plasmáticos consistentes con la inhibición de la patología de Alzheimer.; El modelado sugirió efectos comparables en PET amiloide y CDR-SB para la dosis de mantenimiento subcutánea semanal frente a la dosis intravenosa quincenal.; No se informaron ARIA-E, ARIA-H ni muertes con lecanemab subcutáneo; las reacciones en el lugar de la inyección fueron infrecuentes y leves/moderadas.

Conclusiones:

  • La lecanemab subcutánea demuestra un bajo riesgo de inmunogenicidad.; La formulación subcutánea ofrece un perfil de seguridad, tolerabilidad y farmacodinámico comparable a la dosis intravenosa.; La administración con autoinyector mejora la conveniencia del paciente para el tratamiento con lecanemab.