Affiliations: [a]
Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| [b] Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan
| [c]
Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| [d]
Department of Neurology, Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan
Correspondence:
[*]
Correspondence to: Takeshi Iwatsubo, Department of Neuropathology, Graduate School of Medicine, The University of Tokyo. Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-8655, Japan. Tel.: +81 03 3815 5411; E-mail: [email protected].
Abstract: Anti-amyloid drugs for early Alzheimer’s disease, including lecanemab, are associated with adverse events (AEs), such as amyloid-related imaging abnormalities (ARIA)-edema/effusion (E), ARIA-hemorrhage, and infusion-related reactions, which can indicate allocated arms in clinical trials. Herein, we evaluated the predictive value of AEs using a meta-analysis to estimate their incidence and simulated positive predictive value (PPV). The PPV for ARIA-E was high (0.915), but that for ARIA hemorrhage was low (0.630). Infusion-related reactions had a high PPV of 0.910, but with a wide confidence interval. Our results suggest the need to ameliorate the unblinding effects of AEs, particularly ARIA-E in trials.
