Evidence map›Paper›PMID 34426940›Full record

ArticleNeurology and therapy2021

Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer's Disease.

William L Herring, Ian Gopal Gould, Howard Fillit, Peter Lindgren, Fiona Forrestal, Robin Thompson, Peter Pemberton-Ross

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02484547 (A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02484547 phase3terminatednot on this map

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

TypeinterventionalSponsorBiogenRan2015 to 2019Enrolled1,643ConditionsAlzheimer's DiseaseArmsAducanumab (BIIB037), Placebo
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. cCOG Web-Based Cognitive Assessment Tool.Methods in molecular biology (Clifton, N.J.) · 2024
    Article
  11. Article
  12. Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024
    Review
  13. Article
  14. Observational
  15. Article
  16. Article
  17. Article
  18. Access to Disease-Modifying Alzheimer's Therapies: Addressing Possible Challenges Using Innovative Payment Models.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2022
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 3 countries.

William L HerringRTI Health Solutions, Research Triangle Park, NC, USA.
Ian Gopal GouldRTI Health Solutions, Research Triangle Park, NC, USA.
Howard FillitThe Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Peter LindgrenThe Swedish Institute for Health Economics, Stockholm, Sweden.
Fiona ForrestalBiogen International GmbH, Baar, Switzerland.
Robin ThompsonBiogen International GmbH, Baar, Switzerland.
Peter Pemberton-RossBiogen International GmbH, Neuhofstrasse 30, 6340, Baar, Switzerland. peter.pembertonross@biogen.com.
Biogen (Switzerland) · CHIcahn School of Medicine at Mount Sinai · USRTI Health Solutions · USSwedish Institute for Health Economics · SETriangle · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlzheimer's disease (AD) is a chronic and progressive neurodegenerative disease that places a substantial burden on patients and caregivers. Aducanumab is the first AD therapy approved by the US Food and Drug Administration to reduce a defining pathophysiological feature of the disease, brain amyloid plaques. In the phase 3 clinical trial EMERGE (NCT02484547), aducanumab reduced clinical decline in patients with mild cognitive impairment (MCI) due to AD and mild AD dementia and confirmed amyloid pathology.

methodsWe used a Markov modeling approach to predict the long-term clinical benefits of aducanumab for patients with early AD based on EMERGE efficacy data. In the model, patients could transition between AD severity levels (MCI due to AD; mild, moderate, and severe AD dementia) and care settings (community vs. institution) or transition to death. The intervention was aducanumab added to standard of care (SOC), and the comparator was SOC alone. Data sources for base-case and scenario analyses included EMERGE, published National Alzheimer's Coordinating Center analyses, and other published literature.

resultsPer patient over a lifetime horizon, aducanumab treatment corresponded to 0.65 incremental patient quality-adjusted life-years (QALYs) and 0.09 fewer caregiver QALYs lost compared with patients treated with SOC. Aducanumab treatment translated to a lower lifetime probability of transitioning to AD dementia, a lower lifetime probability of transitioning to institutionalization (25.2% vs. 29.4%), delays in the median time to transition to AD dementia (7.50 vs. 4.92 years from MCI to moderate AD dementia or worse), and an incremental median time in the community of 1.32 years compared with SOC.

conclusionThe model predicted long-term benefits of aducanumab treatment in patients with MCI due to AD and mild AD dementia and their caregivers. The predicted outcomes provide a foundation for healthcare decision-makers and policymakers to understand the potential clinical and socioeconomic value of aducanumab.

Indexed as

AducanumabAlzheimer’s dementiaAlzheimer’s diseaseAmyloid plaquesDisease-modifying therapyEconomic modelInstitutionalizationMarkov modelNatural historyProgression

Identifiers

PMID34426940
PMCPMC8571451
OpenAlexW3195630219

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.