Study Documents Real-World, Long-Term Safety and Efficacy Findings in Individuals Receiving Leqembi to Treat Alzheimer Disease

According to a real-world retrospective case series investigation conducted at the Alzheimer’s Research and Treatment Center in Wellington, FL, treatment experience with Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) for Alzheimer disease (AD) in the clinical setting was consistent with experiences found in previous clinical trials in terms of safety and efficacy. The findings of this study, which were presented at the 17th annual Clinical Trials on Alzheimer’s Disease (CTAD) conference, suggest that Leqembi treatment for AD is effective in the real-world setting. 

The single-center retrospective study included 136 patients with AD who participated in the phase 3 Clarity AD clinical trial (NCT03887455) or the phase 2 Study 201 (NCT01767311). Participants were randomized to receive either Leqembi (Clarity AD, n=37; Study 201, n=53) or placebo (Clarity AD, n=30; Study 201, n=16). After completion of both studies, patients had the option to enroll in an open-label extension (OLE) study to continue treatment with Leqembi. Patient data were recorded, including demographic characteristics, clinical history, Leqembi treatment exposure, and safety, and clinician and patient perspectives were collected.

A total of 66 patients from the double-blind core phases of the 2 studies continued treatment with Leqembi (Clarity AD, n=44; Study 201, n=22) at the Alzheimer’s Research and Treatment Center. In addition to the 18 months included in the double-blind core phases of the clinical trials:

• 40 patients had >3 years of Leqembi treatment exposure.
• 24 patients had >4 years of exposure.
• 13 patients had >5 years of exposure.

Patients at the Center had a mean age of 74.7 years, 48.5% were female, 67.6% had mild cognitive impairment (MCI), 56.6% were apolipoprotein E ε4 (APOE ε4) carriers, and there was a mean Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) score of 2.64 at baseline. The study authors observed no long-term safety signals and no discontinuations due to adverse events (AEs). They also report that AEs were consistent with the previously published safety profile for Leqembi.