Safety, short-term clinical outcomes, and associated factors of lecanemab: a multicenter real-world study from the Korean Joint Registry for Alzheimer’s Treatment and Diagnostics (JOY-ALZ)

Identifying patient characteristics and treatment strategies associated with better outcomes of lecanemab is important in clinical practice. We evaluated the real-world safety and short-term outcomes of lecanemab and factors associated with these outcomes using the Korean Joint Registry for Alzheimer’s Treatment and Diagnostics (JOY-ALZ). We analyzed data from 663 participants with Alzheimer’s disease (AD) who received at least one lecanemab infusion at 32 hospitals nationwide. Amyloid-related imaging abnormality (ARIA) analyses included 657 patients who underwent at least one monitoring MRI. Dose titration was used at the clinician’s discretion in 74.7% of APOE ε4 homozygotes, 50.5% of heterozygotes, and 32.7% of noncarriers. ARIA occurred in 106 patients (16.1%): ARIA with edema/effusion (ARIA-E) with or without ARIA with hemorrhage/hemosiderin deposition (ARIA-H) in 27 (4.1%) and isolated ARIA-H in 79 (12.0%). Symptomatic ARIA occurred in four patients (0.6%) with ARIA-E. APOE ε4 homozygosity (hazard ratio [HR] 2.81; 95% confidence interval [CI] 1.06–7.46), higher Clinical Dementia Rating-Sum of Boxes score (HR 1.18; 95% CI 1.04–1.35), greater number of baseline microhemorrhages (HR 1.69; 95% CI 1.32–2.16), and baseline superficial siderosis (HR 7.45; 95% CI 1.50–37.12) were independently associated with ARIA-E. The incidences of ARIA-E and ARIA-H did not differ between standard-dose and titration-dose groups within each APOE ε4 genotype group. Infusion-related reactions occurred in 26.7% and were less frequent with dose titration. Mini-Mental State Examination (MMSE) scores declined over time (β = −0.15 points/month, 95% CI − 0.21 to − 0.08; P < 0.001), with less decline in patients with mild cognitive impairment and late-onset AD. Higher baseline plasma p-tau217 levels were associated with greater worsening in functional activities. Amyloid PET negativity was achieved in 23.4% (15/64) at 3–9 months and 27.6% (8/29) at 10–12 months and was independently associated with lower baseline Centiloid values (OR 0.92; 95% CI 0.88–0.96) and higher baseline MMSE scores (OR 1.23; 95% CI 1.04–1.45). Lecanemab showed favorable real-world safety and short-term clinical outcomes. These findings may inform patient selection, ARIA risk stratification, treatment optimization, and biomarker-informed treatment strategies in clinical practice.

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Journal
Alzheimer s Research & Therapy
Published
2026-10-19
DOI
https://doi.org/10.1186/s13195-026-02232-z
Primary Topic
Alzheimer's disease research and treatments
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article
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article

Safety, short-term clinical outcomes, and associated factors of lecanemab: a multicenter real-world study from the Korean Joint Registry for Alzheimer’s Treatment and Diagnostics (JOY-ALZ)

Seunghee Na, Yeshin Kim, YongSoo Shim, Eun Ah Lee et al.
Alzheimer s Research & Therapy
Alzheimer's disease research and treatments
article

Safety, short-term clinical outcomes, and associated factors of lecanemab: a multicenter real-world study from the Korean Joint Registry for Alzheimer’s Treatment and Diagnostics (JOY-ALZ)

Seunghee Na, Yeshin Kim, YongSoo Shim, Eun Ah Lee, Jee Hyang Jeong, Eun Ye Lim, Eun Joo Chung, Seong‐Ho Koh, 최호진, So Young Moon, Jung‐Min Pyun, Hae Ri Na, Kee Hyung Park, Yeonsil Moon, Young‐gun Lee, Won‐Jin Moon, Young Ho Park, Jay Cheol Kwon, Heeyoung Kang, Yun Jeong Hong, Han-Kyeol Kim, Jae-Sung Lim, Byeong C. Kim, Hanna Cho, Seong Hye Choi, Sung Hoon Kang, Eun-Joo Kim, Danbee Kang, Geon Ha Kim, Sujung Oh, Young Hee Jung, Dong Won Yang, Jong Hun Kim, Hee-Jin Kim, Hyun Sook Kim, Jae Seung Kim, Si Eun Kim, Jaeho Kim
article en

Abstract

Identifying patient characteristics and treatment strategies associated with better outcomes of lecanemab is important in clinical practice. We evaluated the real-world safety and short-term outcomes of lecanemab and factors associated with these outcomes using the Korean Joint Registry for Alzheimer’s Treatment and Diagnostics (JOY-ALZ). We analyzed data from 663 participants with Alzheimer’s disease (AD) who received at least one lecanemab infusion at 32 hospitals nationwide. Amyloid-related imaging abnormality (ARIA) analyses included 657 patients who underwent at least one monitoring MRI. Dose titration was used at the clinician’s discretion in 74.7% of APOE ε4 homozygotes, 50.5% of heterozygotes, and 32.7% of noncarriers. ARIA occurred in 106 patients (16.1%): ARIA with edema/effusion (ARIA-E) with or without ARIA with hemorrhage/hemosiderin deposition (ARIA-H) in 27 (4.1%) and isolated ARIA-H in 79 (12.0%). Symptomatic ARIA occurred in four patients (0.6%) with ARIA-E. APOE ε4 homozygosity (hazard ratio [HR] 2.81; 95% confidence interval [CI] 1.06–7.46), higher Clinical Dementia Rating-Sum of Boxes score (HR 1.18; 95% CI 1.04–1.35), greater number of baseline microhemorrhages (HR 1.69; 95% CI 1.32–2.16), and baseline superficial siderosis (HR 7.45; 95% CI 1.50–37.12) were independently associated with ARIA-E. The incidences of ARIA-E and ARIA-H did not differ between standard-dose and titration-dose groups within each APOE ε4 genotype group. Infusion-related reactions occurred in 26.7% and were less frequent with dose titration. Mini-Mental State Examination (MMSE) scores declined over time (β = −0.15 points/month, 95% CI − 0.21 to − 0.08; P < 0.001), with less decline in patients with mild cognitive impairment and late-onset AD. Higher baseline plasma p-tau217 levels were associated with greater worsening in functional activities. Amyloid PET negativity was achieved in 23.4% (15/64) at 3–9 months and 27.6% (8/29) at 10–12 months and was independently associated with lower baseline Centiloid values (OR 0.92; 95% CI 0.88–0.96) and higher baseline MMSE scores (OR 1.23; 95% CI 1.04–1.45). Lecanemab showed favorable real-world safety and short-term clinical outcomes. These findings may inform patient selection, ARIA risk stratification, treatment optimization, and biomarker-informed treatment strategies in clinical practice.

Alzheimer s Research & Therapy
Inje University (KR), Chonnam National University (KR), Gachon University (KR), Ewha Womans University (KR), Changwon National University (KR), Gyeongsang National University (KR), Inha University (KR), Yonsei University (KR), Konkuk University (KR), Korea University Medical Center (KR), Asan Medical Center (KR), Seoul National University Bundang Hospital (KR), Ansan University (KR), University of Ulsan (KR), Sacred Heart Hospital (NG), Sacred Heart Hospital (US), Konkuk University Medical Center (KR), St. Mary's Hospital (US), The Catholic University of Korea St. Vincent's Hospital (KR), Yang Hospital (KR), The Catholic University of Korea Incheon St. Mary's Hospital (KR), Inje University Haeundae Paik Hospital (KR), Wonju Severance Christian Hospital (KR), The Catholic University of Korea Uijeongbu St. Mary's Hospital (KR), Korea Institute of Materials Science (KR), Inje University Ilsan Paik Hospital (KR), Inje University Busan Paik Hospital (KR), Pusan National University Hospital (KR), Bobath memorial hospital (KR), Hanyang University Guri Hospital (KR), Ewha Womans University Medical Center (KR), CHA University Bundang Medical Center (KR), Myongji Hospital (KR), Gangnam Severance Hospital (KR), Sacred Heart Hospital (US), Hallym University Dongtan Sacred Heart Hospital (KR), Hallym University Sacred Heart Hospital (KR), The Catholic University of Korea Seoul St. Mary's Hospital (KR), Korea University (JP), Hanyang University (KR), Ajou University (KR), Sungkyunkwan University (KR)
Openalex Percentile: Top 13%
Alzheimer's disease research and treatments
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