AI Article Synopsis
- Anti-amyloid drugs like lecanemab used for early Alzheimer's disease can cause adverse events (AEs), including specific brain imaging abnormalities and infusion reactions.
- A meta-analysis was conducted to assess the predictive value of these adverse events, revealing that ARIA-E has a high positive predictive value (PPV) of 0.915, while ARIA hemorrhage has a low PPV of 0.630.
- The findings indicate that the impact of AEs, especially ARIA-E, can influence the results of clinical trials and emphasize the need to reduce potential biases stemming from these events.
Article 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.
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| http://dx.doi.org/10.3233/JAD-240623 | DOI Listing |
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