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Warning and Precautions It is vital to obtain a brain MRI before starting aducanumab, as ARIA may develop with treatment. In cases where baseline MRI showed evidence of hemorrhage (including cerebral microbleeds), superficial siderosis, stroke, or diffuse leukoaraiosis, treatment with aducanumab should not be offered. During the placebo-controlled period of the clinical trials, ARIA occurred in just over 41% of participants, with ARIA-E arising in 35% and ARIA-H occurring in fewer than 20%. ARIA-E can be visualized as brain edema or sulcal effusions, and ARIA-H can be observed as microhemorrhage and superficial siderosis on MRI. Symptoms can include but are not limited to headache, confusion, delirium, altered mental status, disorientation, dizziness, vision abnormality, and nausea. When data from the two clinical trials were combined into an integrated safety data set, ARIA-E occurred in just over 35% of patients receiving the 10 mg/kg dose; 26% of these patients experienced symptoms, most commonly headache, which occurred in 46%.[22] Most ARIA resolves without the need to discontinue treatment. Recurrent cases of ARIA-E may necessitate re-evaluation, and permanent discontinuation is recommended should a third episode of ARIA-E occur. Severe manifestations of ARIA require immediate and permanent cessation of therapy, with likely hospital admission and care for by clinicians—such as vascular neurologists—experienced in the sequelae of ARIA. These recommendations may be updated as the real-world experience with aducanumab accumulates. Hypersensitivity Hypersensitivity reactions (eg, angioedema, urticaria) may occur during an aducanumab infusion. In such an occurrence, the infusion must be stopped promptly, and appropriate management should be initiated.

Aducanumab was fast-tracked to FDA approval in 2021 and is indicated for use in patients with MCI-AD or the mild dementia stage of AD. The care of patients with AD requires management and supervision from an interprofessional healthcare team. The healthcare team should include a neurologist experienced in the diagnosis and management of dementia, working in close collaboration with the patient's primary care clinician and with access to vascular neurology and neuroradiologists experienced in evaluating amyloid PET and recognizing ARIA. Social work and pharmacy can provide useful support.  Routine care and follow-up for patients with AD by the interprofessional healthcare team promote efficient clinical evaluations and facilitate precise management plans and more reliable patient outcomes. Infusion suite staff should be familiar with the particular needs of patients with cognitive impairment; elopements were reported during some of the clinical trials in monoclonal antibodies. Infusion suites should be prepared with training and equipment to manage hypersensitivity reactions, should they occur. All members of the treating team must be aware of the potential adverse effects of ARIA and its asymptomatic or clinical manifestations. The prescribing neurologist should obtain informed consent and should fully advise patients of the warning signs of ARIA and the need for close clinical monitoring by brain MRI.  The interprofessional healthcare team should routinely follow up with patients receiving aducanumab and thoroughly inquire about any new-onset symptoms indicative of ARIA. Such symptoms can include headache, confusion, delirium, altered mental status, disorientation, dizziness, vision abnormality, and nausea.