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Aducanumab for Alzheimer's Disease: Summarized Data From EMERGE, ENGAGE, and PRIME Studies
Yuksel JM, Noviasky J, Britton S.. The Senior care pharmacist, 2022-08-01
Topic: Drug trials: efficacy and safety
Objective To review the data informing the US Food and Drug Administration (FDA) approval for aducanumab for mild cognitive impairment (MCI) and mild Alzheimer's disease (AD). Data Sources At the time of writing there were no peer-reviewed published studies on aducanumab. All data presented are derived directly from the material Biogen submitted to the FDA for approval. The three studies that will be reviewed are: Multiple Dose Study of Aducanumab in Participants With Prodromal or Mild AD (PRIME), 221AD302 Phase 3 Study of Aducanumab in Early AD (EMERGE), 221AD301 Phase 3 Study of Aducanumab in Early AD (ENGAGE). Data Synthesis PRIME, which was a phase 1 study, demonstrated the most common adverse drug reactions were amyloid-related imaging abnormalities (ARIA), which occurred at rates up to 47% (10 mg/kg group), headache (25%), urinary tract infection (16%), and upper respiratory tract infection (19%). EMERGE demonstrated that high-dose aducanumab was clinically significant at slowing down clinical decline. However, ENGAGE was terminated early based on a futility analysis. Prior to termination ENGAGE demonstrated no clinical difference between treatment and placebo regarding the primary endpoint of slowing clinical decline. Conclusion Based on the data to date, it is difficult to accurately assess the role of aducanumab in patients with MCI or mild AD. EMERGE showed benefit with high-dose aducanumab slowing clinical decline. However, ENGAGE did not duplicate this benefit. With conflicting evidence of positive outcomes, future phase III studies are needed to confirm efficacy.
Key findings
- Data Synthesis PRIME, which was a phase 1 study, demonstrated the most common adverse drug reactions were amyloid-related imaging abnormalities (ARIA), which occurred at rates up to 47% (10 mg/kg group), headache (25%), urinary tract infection (16%), and upper respiratory tract infection (19%).
- EMERGE demonstrated that high-dose aducanumab was clinically significant at slowing down clinical decline.
- Prior to termination ENGAGE demonstrated no clinical difference between treatment and placebo regarding the primary endpoint of slowing clinical decline.
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Study details
- Study designclinical trial
- Evidence strengthLow
How this study scored 40/100
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 and multi-centre collaboration, so those were left out: it earned 23 of the 58 points we could judge it on, which is 40 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The Senior care pharmacist) |
| 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 | 2022 — 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 35879846) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 23 / 58 | Scored on 11 of 20 parts. We have no data for the rest, so they are left out: 23 of the 58 points we could judge it on is 40 out of 100. |
| Total | 40 / 100 | — |
What each of these 20 components measures, and what this score is not →
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Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Yuksel, J. M., Noviasky, J., & Britton, S. (2022). Aducanumab for Alzheimer's Disease: Summarized Data From EMERGE, ENGAGE, and PRIME Studies. The Senior care pharmacist. https://doi.org/10.4140/tcp.n.2022.329
Vancouver
Yuksel JM, Noviasky J, Britton S. Aducanumab for Alzheimer's Disease: Summarized Data From EMERGE, ENGAGE, and PRIME Studies. The Senior care pharmacist. 2022. doi:10.4140/tcp.n.2022.329. PMID: 35879846.
BibTeX
@article{yuksel2022-35879846,
author = {Yuksel, J. M. and Noviasky, J. and Britton, S.},
title = {{Aducanumab for Alzheimer's Disease: Summarized Data From EMERGE, ENGAGE, and PRIME Studies}},
journal = {The Senior care pharmacist},
year = {2022},
doi = {10.4140/tcp.n.2022.329},
pmid = {35879846},
url = {https://doi.org/10.4140/tcp.n.2022.329}
}
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