Real-world data from 178 early Alzheimer’s disease (AD) patients treated with lecanemab show an 87.4% treatment continuation rate at an average of 375.4 days. Clinical stability or improvement was observed in 83.6% of this cohort. Of patients receiving 40 or more doses over 18 months, 86.7% remained stable or improved. This interim analysis, presented at AAIC 2025, offers a preliminary glimpse into lecanemab’s performance outside the controlled setting of pivotal trials.
Eisai and Biogen are leveraging these real-world findings to bolster lecanemab’s position in the nascent AD treatment market. The data, while encouraging, represent an interim snapshot from a limited sample, lacking a control group. Nevertheless, the high continuation rate and observed clinical stability suggest a manageable safety profile and potential real-world benefit. This becomes crucial in the context of payer scrutiny and patient access challenges that have plagued AD therapies.
The study also provides insight into amyloid-related imaging abnormalities (ARIA), a key safety concern with lecanemab. The 12.9% ARIA incidence (7.9% ARIA-E, 6.2% ARIA-H) aligns with the FDA-approved label range. Importantly, most ARIA cases were asymptomatic, potentially easing physician and patient apprehension. This real-world ARIA data will be crucial as clinicians navigate risk-benefit assessments in diverse patient populations.
The integration of blood-based biomarkers (BBMs) in diagnostic pathways is highlighted, with 27.5% of study participants utilizing BBMs. This reflects the increasing adoption of BBMs in clinical practice, streamlining patient identification and potentially expanding the addressable market for AD treatments. The rapid growth in p-tau217 testing specifically underscores the evolving diagnostic landscape.
Looking ahead, the final real-world data readout (expected late Q3 2026 for Eisai’s fiscal year) will be critical in solidifying lecanemab’s long-term effectiveness and safety profile. Continued monitoring of ARIA incidence, patient-reported outcomes, and the impact of APOE4 status on treatment response and ARIA risk remains essential. These data points will inform treatment guidelines, payer coverage decisions, and ultimately, patient access. The longer-term strategic question remains whether real-world performance can translate into sustained commercial uptake given the complexities of AD diagnosis and treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
