Critical questions raised for evaluation of anti-amyloid immunotherapies in Alzheimer's treatment Alzheimers Treatment Immunotherapy Efficacy PatientCare MedicalResearch braincomms
By Tarun Sai LomteJul 4 2023Reviewed by Benedette Cuffari, M.Sc. A recent study published in Brain Communications discusses critical questions regarding the evaluation of anti-amyloid immunotherapies for the treatment of Alzheimer’s disease.
The decision by the U.S. Centers for Medicare and Medicaid Services to limit coverage of FDA-approved anti-amyloid immunotherapies suggests that their path to market might not be straightforward. In the present study, the authors discuss three central questions in evaluating the clinical safety and potential benefit of BLAs for anti-amyloid antibodies.
The extent to which ARIAs result in functional unblinding and differences in loss to follow-up should be assessed. Recent phase II or III trial publications on amyloid-lowering antibodies included little details of the statistical analyses that were used to address the potential confounding due to functional unblinding. In phase III trials on aducanumab, around 41% of patients in one of the dosage groups exhibited ARIAs.
Do treatment effects outweigh safety concerns? ARIAs are clinically benign, as they typically resolve spontaneously or after a brief suspension of the treatment. Nevertheless, some individuals develop symptoms, whereas others may experience serious complications, particularly with high therapeutic doses, which could be associated with long-term outcomes. Regulators must review ARIA-associated clinical outcomes and clinical/radiologic severity data for comprehensive safety assessment.
Brain volume changes due to aducanumab were first reported nine months after approval. Similarly, phase IIb lecanemab trial data reveals accelerated loss of brain volume relative to placebo. A reversible symptomatic effect might appear to delay or slow cognitive decline, thereby resulting in a difference in time-to-event. However, assumptions of disease modification should not invalidate the relevance of minimal clinically important differences .
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