Cargando…
Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease
INTRODUCTION: Alzheimer’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...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571451/ https://www.ncbi.nlm.nih.gov/pubmed/34426940 http://dx.doi.org/10.1007/s40120-021-00273-0 |
_version_ | 1784595024368893952 |
---|---|
author | Herring, William L. Gould, Ian Gopal Fillit, Howard Lindgren, Peter Forrestal, Fiona Thompson, Robin Pemberton-Ross, Peter |
author_facet | Herring, William L. Gould, Ian Gopal Fillit, Howard Lindgren, Peter Forrestal, Fiona Thompson, Robin Pemberton-Ross, Peter |
author_sort | Herring, William L. |
collection | PubMed |
description | INTRODUCTION: Alzheimer’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. METHODS: We 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. RESULTS: Per 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. CONCLUSION: The 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40120-021-00273-0. |
format | Online Article Text |
id | pubmed-8571451 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-85714512021-11-15 Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease Herring, William L. Gould, Ian Gopal Fillit, Howard Lindgren, Peter Forrestal, Fiona Thompson, Robin Pemberton-Ross, Peter Neurol Ther Original Research INTRODUCTION: Alzheimer’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. METHODS: We 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. RESULTS: Per 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. CONCLUSION: The 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40120-021-00273-0. Springer Healthcare 2021-08-23 /pmc/articles/PMC8571451/ /pubmed/34426940 http://dx.doi.org/10.1007/s40120-021-00273-0 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Herring, William L. Gould, Ian Gopal Fillit, Howard Lindgren, Peter Forrestal, Fiona Thompson, Robin Pemberton-Ross, Peter Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title | Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title_full | Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title_fullStr | Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title_full_unstemmed | Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title_short | Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease |
title_sort | predicted lifetime health outcomes for aducanumab in patients with early alzheimer’s disease |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571451/ https://www.ncbi.nlm.nih.gov/pubmed/34426940 http://dx.doi.org/10.1007/s40120-021-00273-0 |
work_keys_str_mv | AT herringwilliaml predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT gouldiangopal predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT fillithoward predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT lindgrenpeter predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT forrestalfiona predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT thompsonrobin predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease AT pembertonrosspeter predictedlifetimehealthoutcomesforaducanumabinpatientswithearlyalzheimersdisease |