Aducanumab: What a Difference 1 Year Makes—Not
The peer-reviewed results of the aducanumab phase 1B study in prodromal and mild AD are now available in Nature. And while some media outlets are touting this amyloid-targeting MAb as “revolutionary” on the basis of the newly published article, the 1-year results are absolutely no different than what was reported by the development company, Biogen, 1 year ago. Take a look at the article’s supplementary data tables here and here and compare them with what I tabulated in July of 2015. The values are exactly the same with no changes in statistical differences.
That said, I think we can all agree that the evidence for aducanumab’s ability to reduce brain amyloid is there. However, that benefit—if it is a benefit—is associated with a significant risk of ARIA-E, particularly in APOE ε4 carriers (55% at 10 mg/kg dosage). The risk of ARIA-E leading to drug
continuation discontinuation is 35% (still). Perhaps more important, the evidence for cognitive benefits—meaning the CDR-SB and MMSE score changes—is marginal and not reliably dose-dependent.
It therefore remains my impression (for what that’s worth) that aducanumab is bapineuzumab redux.