Resultados clínicos longitudinais após depuração amilóide em estudos de fase 3 com aducanumab

O que aconteceu

Anti-amyloid antibody clinical trials with a high proportion of participants reaching treatment-related amyloid clearance (TRAC) had positive clinical outcomes. We evaluated the aducanumab phase 3 program to determine whether TRAC during the double-blind period was likewise associated with clinical benefit. We pooled ENGAGE and EMERGE (E/E) aducanumab-treated participants in the amyloid positron emission tomography substudy who continued into the long-term extension ≤ 134 weeks (continuously treated population) and/or returned to the EMBARK redosing study 0.7 to 2.5 years after termination of E/E (treatment gap population). Clinical outcomes were stratified by week 78 TRAC status. In these exploratory analyses, week 78 TRAC status was associated with better clinical outcomes. NCT02484547, NCT02477800, NCT04241068.

Trecho mantido em inglês: a tradução automática não passou na conferência de números.

O que encontraram

Os participantes do TRAC apresentaram menor declínio clínico na semana 78, semana 134 e na linha de base do EMBARK do que os não participantes do TRAC. O declínio clínico pós-TRAC foi heterogêneo; aproximadamente dois terços dos participantes do TRAC apresentaram declínio anual < 1 ponto na Clinical Dementia Rating Sum of Boxes.