Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 170 mg/1.7 mL [100 mg/mL], 300 mg/3 mL [100 mg/mL]) |
| Drug Class | Amyloid beta-directed antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Alzheimers disease
- Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials
- This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM
- Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s)
Latest News
Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Aducanumab demonstrated a modest improvement in slowing cognitive decline in patients with Alzheimer’s disease, as evidenced by small but statistically significant reductions in amyloid-beta plaques and improvements in cognitive scales like standardized mean difference = -0.07; 95% confidence interval (CI), -0.10 to -0.04 the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) and P = 0.01 (the Clinical Dementia Rating Scale (CDR))-P = 0.01 (Sum of Boxes (SB)), compared to placebo.
- In comparative analyses, aducanumab showed similar efficacy to other anti-amyloid monoclonal antibodies like lecanemab and donanemab. However, these improvements did not exceed the minimum clinically important difference, indicating limited clinical significance.
- The studies did not highlight significant differences in effectiveness across population subgroups or specific genetic profiles.
- Aducanumab was associated with an increased risk of amyloid-related imaging abnormalities (relative risk (RR) = 10.29; number needed to harm (NNH) = 9 (ARIA)), including Amyloid Related Imaging Abnormalities (ARIA)-edema and ARIA-hemorrhage, with more profound serious adverse events observed in high-dose treated groups.
- Compared to placebo and other anti-amyloid monoclonal antibodies, aducanumab had a higher incidence of ARIA, similar to lecanemab and donanemab, while solanezumab did not show an increased risk of ARIA.
- The study populations included 33,864 participants with early Alzheimer’s disease across 58 trials. There was no significant evidence of differences in aducanumab's effectiveness across population subgroups based on demographics. However, genetic status, such as the presence of the APOE4 (apolipoprotein E4) allele, may influence treatment outcomes and risk of adverse effects like ARIA in patients treated with aducanumab, lecanemab, or donanemab.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Aduhelm (aducanumab-avwa) Prescribing Information. | 2023 | Biogen Inc., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for pharmacotherapy in Alzheimer's disease - A primer on FDA-approved drugs. | 2023 | Journal of Neurosciences in Rural Practice |
| Aducanumab Use in Symptomatic Alzheimer Disease Evidence in Focus: A Report of the AAN Guidelines Subcommittee. | 2022 | Neurology |
| Aducanumab: Appropriate Use Recommendations. | 2021 | The Journal of Prevention of Alzheimer's Disease |