Characterizing the Journey of Early Alzheimer’s Disease in Patients Initiating Lecanemab Treatment in the United States: A Real-World Evidence Study

Abstract

Introduction: With the advent of disease-modifying therapies for early Alzheimer’s disease (AD), a comprehensive characterization of patients initiating lecanemab in the USA is needed to understand its use in real-world settings. Methods: This retrospective observational study used administrative claims from the Komodo Research Database (1/1/2023–6/30/2024). Eligible patients had ≥ 1 lecanemab administration (first claim defined the index date) and ≥ 12 months of clinical activity/insurance eligibility before the index date. Patient characteristics, diagnostic process, and AD-related medications were evaluated within 12 months before the index date (baseline), whereas lecanemab treatment patterns and concomitant medications were evaluated on or after the index date (follow-up). Outcomes were reported using descriptive statistics and persistence to lecanemab was evaluated using Kaplan–Meier analysis. Results: Of 3155 patients included in the study, mean age was 75.0 years, 55.8% were female, 44.2% were male, and most (93.3%) received their index lecanemab administration in an urban setting. Diagnoses of AD (83.8%) and mild cognitive impairment (60.8%) were common at baseline, and 67.6% of patients used AD symptomatic medications. Average time from earliest diagnosis to first lecanemab administration was 4.9 months among patients with a diagnosis in January 2023 (accelerated approval date) or onwards. Over a mean follow-up of 138.8 days, the monthly mean number of administrations of lecanemab was 1.9, with an average of 16.5 days between consecutive administrations and 47.4 days to the first follow-up head magnetic resonance imaging. Persistence to lecanemab was 87.6% at 4 months after treatment initiation. Conclusion: Lecanemab was utilized in appropriate patient populations according to the prescribing information approved by the US Food and Drug Administration. Findings from our study provide first insights into the real-world use of lecanemab in the USA and shed light on the need for increased and timely lecanemab initiation for the long-term management of early AD.