For Patients on Discontinued Aduhelm, What Now?

In February, Biogen announced it was pulling Aduhelm off the market. The company will continue supplying the drug until November but stopped providing it to trial participants in May. 

Aduhelm was controversial from the start. Biogen almost gave up on the drug in March 2019, after an independent committee found the drug probably would not work. However, after a second clinical trial, the drug received accelerated approval in 2021. Less than a week later, three FDA advisors quit the panel, and a congressional investigation found that the drugmaker Biogen had held inappropriate closed-door meetings with FDA officials. 

Now, former trial participants and early adopters of the therapy are trying to figure out how to move forward. Since anti-amyloid drugs are so new, clinicians and those living with Alzheimer’s who want to make the switch must navigate several challenging questions to see if they can switch to an alternative like Leqembi or Kisunla. 

How long does it take for Aduhelm to leave the body? Should doctors measure whether there are any amyloid plaques left in the brain? Should patients without any plaques take Leqembi or Kisunla? The questions are numerous. It is also unclear whether the Centers for Medicare and Medicaid (CMS) will cover treatment for people whose plaques were removed via Aduhelm but want to continue taking Leqembi.

Here’s what three people taking Aduhelm are planning to do next.

Participating in the next disease-modifying drug trial

For clinical trial participants, this journey was “a rollercoaster ride”, according to Phil Gutis, a Being Patient contributor and board member of the patient-led advocacy group Voices of Alzheimer’s. Gutis, who lives with early-onset Alzheimer’s, joined the Aduhelm trial more than seven years ago and experienced all its starts and stops. 

“The thing I always felt so angry about was that they stopped testing us,” Gutis said, expressing frustration that after the drug was approved, Biogen stopped testing and tracking patients who had started taking the drug in clinical trials. “I never understood why you wouldn’t want to have a cohort of people who’ve been on this drug for eight years to see what it does long term.” 

Once Leqembi was approved, Gutis realized it was “almost inevitable” that Aduhelm would be taken off the market. He decided to stop taking the drug in March so that he’d be able to go through a six-month washout period and become eligible for participation in other clinical trials in September.

“It was really quite strange and very emotional to walk away from the treatment, but I felt it was the right thing to do,” Gutis said.

Now, he wants to participate in clinical trials that may help scientists find another new treatment for the disease. “For me, what’s always been important has been trying to be part of the solution,” Gutis said.

Switching to the newest Alzheimer’s drug, Kisunla

In 2021, Mike Zuendel was among the first to take Aduhelm once it was approved.

“My geriatrician told me that I had a miraculous recovery from the removal of beta-amyloid plaque in my brain [which he attributed to Aduhelm],” Zuendel told Being Patient, adding that he has less plaque in his brain than the average healthy person. His neuropsychological tests showed that he hadn’t experienced cognitive decline in the four years since his diagnosis.

Zuendel hasn’t experienced severe side effects from taking Aduhelm, even though he has two copies of the APOE4 risk genes, which put him at a higher risk of brain swelling or bleeding from this class of drugs. While he would have liked for the drug to stay on the market, he wasn’t surprised when Biogen withdrew it. 

Right now, Zuendel is speaking with his doctors to figure out whether it makes sense for him to switch to another anti-amyloid treatment. He’s hoping he’ll be eligible to try Kisunla since it appears to work better than Aduhelm. 

“I’m actually excited to hopefully be able to change drugs,” he said. “If I can’t change drugs for whatever reason, I’m going to be very, very disappointed to stay the least.”

Zuendel believes it is important for people experiencing symptoms of cognitive decline to advocate for themselves and ensure they’re getting the best care possible. 

“I would always encourage people to not be afraid to stand up to their physicians and ask them the hard questions,” he said. He suggests that if a doctor isn’t receptive to a patient’s concerns or doesn’t seem to know a lot about emerging treatments or trials for Alzheimer’s, the patient should feel empowered to do some research and find a physician who is better equipped to help.

Making a decision based on amyloid plaques

When Michelle Hall and her husband, Doug, found out that Aduhelm was being taken off the market in February, they weren’t surprised.

“Michelle started having problems when she was in her early 50s, and we looked around for a year and a half to try to get diagnosed but the local doctors just fumbled the ball,” Doug Hall told Being Patient. Hall’s doctors told her the symptoms were just stress but eventually, she visited doctors at the Mayo Clinic and got a diagnosis. 

Her doctor told her about Aduhelm — a drug that might be approved in the coming months. Once it received accelerated approval, she and Doug booked an appointment with a doctor to discuss the risks and benefits. Hall became one of the first people to receive Aduhelm and has been taking it for about three years. 

With the drug going off the market, she is considering switching to a new drug. “We decided we’re going to wait to see what my plaques look like and then go from there,” she told Being Patient.

Since Hall is enrolled in a study of people with early-onset Alzheimer’s, she receives regular monitoring and brain scans, and the researchers running the study are sharing some of the data with the Halls so that they can make an informed decision based on her amyloid status. 

While some doctors think a six-month washout period is necessary for Aduhelm to clear the system before starting on a new anti-amyloid medication, the Halls don’t want to wait that long. 

“There’s a subset of doctors and people in the research community that think you wait at least a month, maybe two months, and just clean out most of the other drug out and you’ll be OK,” said Doug Hall.