Radiologists should be aware of amyloid-related imaging abnormalities for patients taking Alzheimer's drug

Safety information for patients taking a drug meant to treat Alzheimer’s has been updated to include the addition of two MRI scans during the first year of treatment. 

Biogen announced the U.S. Food and Drug Administration’s update to their label in a release on April 29. The safety update pertains to Biogen’s Alzheimer’s drug, aducanumab (Aduhelm). With the most recent addition of the two MRIs, patients seeking treatment using the drug are now recommended to receive a total of five scans—four during the first year of treatment and one which should be completed a year before initiating treatment to confirm the presence of amyloid beta pathology. 

In a release addressing the label changes, the Biogen statement reads: 

Informed by insights from the company’s ongoing pharmacovigilance, a group of medical experts and the updated Appropriate Use Guidelines, certain label changes aim to further help doctors in identifying and managing patients, and aid in the earlier detection and management of amyloid-related imaging abnormalities (ARIA), an adverse event observed in clinical trials and in real world use of ADUHELM. These updates provide more precise guidance that can help physicians and patients make informed treatment decisions.” 

On imaging, ARIA might show up as swelling or small spots of bleeding on the surface of the brain, according to the statement. Although ARIA is listed as a possible side effect and does not usually cause symptoms, in rare cases patients can experience serious adverse events, such as seizures. In these cases, Biogen recommends that providers temporarily discontinue treatment depending on symptom severity and resolution.