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ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease
Honig LS, Barakos J, Dhadda S, Kanekiyo M, Reyderman L, Irizarry M, Kramer LD, Swanson CJ et al.. Alzheimer's & dementia (New York, N. Y.), 2023-01-01
Topic: Plasma and spinal-fluid biomarkers
Introduction Lecanemab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that preferentially targets soluble aggregated Aβ species (protofibrils) with activity at amyloid plaques. Amyloid-related imaging abnormalities (ARIA) profiles appear to differ for various anti-amyloid antibodies. Here, we present ARIA data from a large phase 2 lecanemab trial (Study 201) in early Alzheimer's disease. Methods Study 201 trial was double-blind, placebo-controlled (core) with an open-label extension (OLE). Observed ARIA events were summarized and modeled via Kaplan-Meier graphs. An exposure response model was developed. Results In the phase 2 core and OLE, there was a low incidence of ARIA-E (<10%), with <3% symptomatic cases. ARIA-E was generally asymptomatic, mild-to-moderate in severity, and occurred early (<3 months). ARIA-E was correlated with maximum lecanemab serum concentration and incidence was higher in apolipoprotein E4 (ApoE4) homozygous carriers. ARIA-H and ARIA-E occurred with similar frequency in core and OLE. Discussion Lecanemab can be administered without titration with modest incidence of ARIA.
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APA 7th
Honig, L. S., Barakos, J., Dhadda, S., Kanekiyo, M., Reyderman, L., Irizarry, M., et al. (2023). ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease. Alzheimer's & dementia (New York, N. Y.). https://doi.org/10.1002/trc2.12377
Vancouver
Honig LS, Barakos J, Dhadda S, Kanekiyo M, Reyderman L, Irizarry M, et al. ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease. Alzheimer's & dementia (New York, N. Y.). 2023. doi:10.1002/trc2.12377. PMID: 36949897.
BibTeX
@article{honig2023-36949897,
author = {Honig, L. S. and Barakos, J. and Dhadda, S. and Kanekiyo, M. and Reyderman, L. and Irizarry, M. and Kramer, L. D. and Swanson, C. J. and others},
title = {{ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease}},
journal = {Alzheimer's \& dementia (New York, N. Y.)},
year = {2023},
doi = {10.1002/trc2.12377},
pmid = {36949897},
url = {https://doi.org/10.1002/trc2.12377}
}
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Key findings
- Results In the phase 2 core and OLE, there was a low incidence of ARIA-E (<10%), with <3% symptomatic cases.
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Study details
- Study designclinical trial
- Evidence strengthLow
How this study scored 47/100
Published in a leading specialty journal. Scored zero for study design, sample size, effect reported, studied in people and randomized / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record and multicenter collaboration, so those were left out: it earned 27 of the 58 points we could judge it on, which is 47 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Alzheimer's & dementia (New York, N. Y.)) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2023 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 36949897) |
| Free to read | 2 / 2 | Free to read |
| Points | 27 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 27 of the 58 points we could judge it on is 47 out of 100. |
| Total | 47 / 100 | — |
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