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Passive Alzheimer's immunotherapy: A promising or uncertain option?
Poul F Høilund-Carlsen, Mona-Elisabeth Revheim, Tommaso Costa, Abass Alavi, Kasper P Kepp, Stefano L Sensi, George Perry, Nikolaos K Robakis et al.. Ageing research reviews, 2023-07-05
Topic: Drug trials: efficacy and safety
The US Food and Drug Administration (FDA)'s recent accelerated approval of two anti-amyloid antibodies for treatment of Alzheimer's disease (AD), aducanumab and lecanemab, has caused substantial debate. To inform this debate, we reviewed the literature on randomized clinical trials conducted with eight such antibodies focusing on clinical efficacy, cerebral amyloid removal, amyloid-related imaging abnormalities (ARIAs) and cerebral volumes to the extent such measurements have been reported. Two antibodies, donanemab and lecanemab, have demonstrated clinical efficacy, but these results remain uncertain. We further argue that the decreased amyloid PET signal in these trials is unlikely to be a one-to-one reflection of amyloid removal, but rather a reflection of increased therapy-related brain damage, as supported by the increased incidence of ARIAs and reported loss of brain volume. Due to these uncertainties of benefit and risk, we recommend that the FDA pauses existing approvals and approval of new antibodies until results of phase 4 studies with these drugs are available to inform on these risk-benefit uncertainties. We recommend that the FDA prioritize FDG PET and detection of ARIAs and accelerated brain volume loss with MRI in all trial patients, and neuropathological examination of all patients who die in these phase 4 trials.
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APA 7th
Høilund-Carlsen, P. F., Revheim, M.-E., Costa, T., Alavi, A., Kepp, K. P., Sensi, S. L., et al. (2023). Passive Alzheimer's immunotherapy: A promising or uncertain option? Ageing research reviews. https://doi.org/10.1016/j.arr.2023.101996
Vancouver
Høilund-Carlsen PF, Revheim M.-E, Costa T, Alavi A, Kepp KP, Sensi SL, et al. Passive Alzheimer's immunotherapy: A promising or uncertain option? Ageing research reviews. 2023. doi:10.1016/j.arr.2023.101996. PMID: 37414156.
BibTeX
@article{hoilundcarlsen2023-37414156,
author = {Høilund-Carlsen, Poul F and Revheim, Mona-Elisabeth and Costa, Tommaso and Alavi, Abass and Kepp, Kasper P and Sensi, Stefano L and Perry, George and Robakis, Nikolaos K and others},
title = {{Passive Alzheimer's immunotherapy: A promising or uncertain option?}},
journal = {Ageing research reviews},
year = {2023},
doi = {10.1016/j.arr.2023.101996},
pmid = {37414156},
url = {https://doi.org/10.1016/j.arr.2023.101996}
}
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Key findings
- Two antibodies, donanemab and lecanemab, have demonstrated clinical efficacy, but these results remain uncertain.
- Due to these uncertainties of benefit and risk, we recommend that the FDA pauses existing approvals and approval of new antibodies until results of phase 4 studies with these drugs are available to inform on these risk-benefit uncertainties.
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Study details
- Evidence strengthHigh
How this study scored 48/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / 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, multi-centre collaboration and free to read, so those were left out: it earned 27 of the 56 points we could judge it on, which is 48 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Ageing research reviews) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” 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) |
| Randomised / blinded | 0 / 2 | No randomisation 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 |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 37414156) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 27 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 27 of the 56 points we could judge it on is 48 out of 100. |
| Total | 48 / 100 | — |
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