- Limited Clinical Benefit: Monoclonal antibodies targeting amyloid in Alzheimer patients offer only marginal benefits on cognitive and functional scales. These benefits fall below the minimal clinically important difference (MCID), indicating a lack of substantial clinical impact.
- Significant Harms and Risks: The use of monoclonal antibodies for Alzheimer treatment is associated with serious risks, including cerebral edema, hemorrhage, and other adverse events. The potential harms may outweigh the perceived benefits, raising concerns about the overall safety of these treatments.
- High Financial Costs: Monoclonal antibody treatments for Alzheimer come with a hefty price tag, ranging from $26,500 to $28,000 per year. The study questions the cost-effectiveness of these treatments, especially considering the limited clinical benefits and potential risks involved.
- FDA Approval Based on Intermediate Markers: The article criticizes the FDA's approval process for monoclonal antibodies like lecanemab and aducanumab. These approvals were primarily based on improvements in medical imaging and biomarkers, without demonstrating substantial improvements in clinical outcomes. This approach is deemed inappropriate and may set a concerning precedent for drug approvals.
- Meta-analysis Findings: The meta-analysis, involving data from 23,202 participants across 24 studies, revealed no quantitative evidence supporting significant improvement in cognitive or daily functional abilities beyond the MCID. The lack of robust clinical efficacy across multiple studies raises questions about the overall effectiveness of monoclonal antibodies for Alzheimer treatment.