The accelerated approval of Biogen’s Alzheimer’s drug, Aduhelm®, has been controversial, in part due to its significant side effects. Aduhelm was proven to significantly increase the incidence of cerebral edema (ARIA), cerebral microhemorrhages, headache, and mental disorientation.
What Are ARIAs and How Do They Relate to Aduhelm ®?
Among the observed side effects, the most common include amyloid-related imaging abnormalities (ARIAs)—also known as cerebral edemas and microhemorrhages which are often painful.
According to Biogen’s clinical trial, 35 percent of the clinical trial patients that were administered Aduhelm® experienced ARIA-E (cerebral edema), whereas 3 percent of those who received the placebo had ARIA-E. Furthermore, among participants that had the active Aduhelm® treatment, 19 percent experienced ARIA-H (cerebral micro-bleeding), compared to only 7 percent among placebo patients.
Moreover, an Aduhelm® study published by a Dutch Alzheimer’s & Dementia journal concluded that while ARIA-E resolved over 6 months, ARIA-H persisted as a chronic condition. The same study also found that “in two Phase 3 clinical trials of aducanumab, some form of ARIA occurred in 40% of patients in the highest dose (10 mg/kg) treatment arm, and was symptomatic in 10%,” which is a higher incidence of ARIA than Biogen’s study.
Clinical trial participants that carry the genetic variant ApoE4𑁋which increases Alzheimer’s risk, were more likely to develop ARIAs. These side effects can be detected by MRI scans and often resolve over time.
Why Should the Public Be Concerned About Aduhelm® & Its Side Effects?
An increase of amyloid-beta plaques are a fundamental pathophysiological characteristic of Alzheimer’s disease–a condition that causes dementia, which leads to a progressive onset of cognitive decline.
Aduhelm® aims to reduce amyloid-beta plaques in order to alleviate cognitive decline. However, Aduhelm® has not yet proven significant clinical benefits in its earlier trials. Its first study concluded that “differences from placebo observed in the ADUHELM low dose group numerically favored ADUHELM but were not statistically significant.” Its second study concluded that “No statistically significant differences were observed between the ADUHELM-treated and placebo-treated patients on the primary efficacy endpoint.
For a drug with statistically insignificant improvement for patients, painful side effects, and a high price tag ($56,000 annually), it is important to analyze its costs with its benefits when deciding whether to take it or not.
Furthermore, since Aduhelm® can cause as many as 40% of patients to have ARIAs, it poses an additional risk to an already susceptible Alzheimer’s population.
Biogen must conduct a Phase 4 confirmatory trial to prove the drug’s benefits, and the drug will still remain on the market in the meantime for qualified patients with mild Alzheimer’s disease. As the Phase 4 confirmatory trial is underway, we will wait to see if Biogen’s hopes or the public’s fears are supported.
Contact Us Today
At Rheingold, Giuffra, Ruffo & Plotkin LLP, we aggressively represent our clients and have recovered billions in medical malpractice, mass tort, personal injury, and product liability cases. If you or a loved one have used Aduhelm and experienced side effects, please contact our office for a free, confidential evaluation of a potential claim. Please call (888) 260 – 0473 to speak with us directly and receive a free consultation.