Enthusiasm for a new medication to treat multiple sclerosis was tempered this week by news that a patient in Germany contracted a potentially deadly brain infection after switching to the drug Ocrevus.
The German patient contracted progressive multifocal leukoencephalopathy (PML) after switching from the MS medication Tysabri to Ocrevus in April, Reuters reported.
It’s unclear whether the PML stemmed from use of Ocrevus or from Tysabri, which has been linked to dozens of cases of the disease, the news agency reported. The European manufacturer, Roche Pharmaceuticals, is investigating the source of the infection.
In March, the Food and Drug Administration approved the use of Ocrevus for treating multiple sclerosis and primary progressive multiple sclerosis, by the Roche subsidiary, Genentech Pharmaceuticals.
Genentech said it is investigating the case but that the instance of PML is seen as a “carry-over from natalizumab [Tysabri] by the treating physician.”
“Patient safety is Roche and Genentech’s highest priority and we are gathering more details about the case and the patient’s history,” a Genentech spokesman said in an email to The Washington Times. “We will continue to share information with healthcare providers and global health authorities as we know more.”
The National Multiple Sclerosis Society estimates that 400,000 people in the U.S. and 2.3 million worldwide are affected by the autoimmune and inflammatory disease of the central nervous system, which affects the spine and brain.
It’s a debilitating disorder affecting a person’s motor skills, sensation of feeling, speech and thinking. It usually appears between the ages of 20 and 50 and is known to be at least three times as prevalent in women than men.
Epidemiologists list a number of factors that contribute to the disease including genetics, age, ethnicity and geography — with the disease more prevalent in northern areas, like North America, Europe and Scandinavian countries.
The approval of Ocrevus — an intravenous infusion that targets and kills a specific type of immune cell central to the disease — was seen as a promising addition to the repertoire of drugs already used to manage the disease.
While the immunosuppressive properties of the medication make patients more susceptible to other diseases, studies evaluating the safety of Ocrevus found side effects minimal compared to its benefits.
“So far, thankfully, the safety profile of Ocrevus looks very good,” Dr. Jeffrey Cohen, director of Mellen Center for Multiple Sclerosis at Cleveland Clinic, said in an interview with The Times.
He also said that the occurrence of PML has a higher likelihood of being linked to Tysabri instead of Ocrevus.
“It’s only a recently approved medication, so we don’t have very much experience with it and all of us are a little bit wary that over time some safety issues may emerge, but so far it’s looked very good,” Dr. Cohen said.
In addition to medical therapies, maintaining a healthy lifestyle, diet and exercise are important to managing the disease, he said.
“We think that slows down the worsening of the disease and allows the body to attempt to repair the damage itself,” he said. “Avoiding smoking, having adequate levels of vitamin D, getting exercise, eating correctly with good nutrition, we think all those things are very important too.”
The results of the final phase III trials of Ocrevus — which were used in the FDA determination — were published in the New England Journal of Medicine in January. The researchers highlighted the efficacy of the drug in patients with PPMS but added in their conclusion that additional, long-term safety and efficacy evaluations are needed.
“So that’s always the crux of this decision, is weighing the risk of someone’s MS getting worse versus the risk of the medication itself,” Dr. Cohen said, although he was not involved in the study.
There are 14 approved therapies in the U.S. for treating MS, with the disease typically defined by periods of remittance and relapse.
Primary progressive multiple sclerosis, however, is characterized by a patients’s rapid and sudden deterioration. Ocrevus is the first drug to show any improvement in quality of life for those patients.
“It’s very scary for patients to hear the diagnosis of multiple sclerosis because it’s often disabling,” Dr. Cohen said. “It’s also a very unpredictable disease and typically presents when people are in young adulthood, when they’re just starting their career, just starting a family.”
Also difficult for patients to deal with is the affordability of treating their disease. A 2015 study published in the American Academy of Neurology found that drug prices had risen exorbitantly for 12 Disease-Modifying Therapies (DMT) over the course of 20 years, between 1993 and 2013.
“MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class,” the authors wrote in their conclusion, highlighting that first-generation DMT’s originally had cost between $8,000 and $11,000 but then rose to $60,000.
“There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs.”
In addition to rising medication costs, Dr. Cohen pointed out that the crippling nature of the disease could cause patients to lose or leave their jobs and any health coverage tied to employment.
“It sort of illustrates many of the issues with healthcare currently,” Dr. Cohen said, “because it’s a relatively common disease, we have effective therapies for it but they’re extremely expensive and the price is going up, so it costs the healthcare system quite a lot of money.”
For Malia Litman, who was diagnosed 18 years ago with MS, failures of medications to offer any relief from her disease in the U.S. led her to try experimental therapies being developed abroad.
Around four years ago she flew to Israel to be part of an experimental treatment with stem-cell therapy being performed at Hadassah Medical Center in Jerusalem.
While her insurance covered a lot of the cost of her different treatments in the U.S., Ms. Litman decided to pay out of pocket expenses over $10,000 to receive stem-cell treatment in Israel.
She’s an advocate for the treatment, despite it still being in preliminary and experimental phases.
“After the first treatment, the effects were dramatic and immediate,” she said. “… my husband said ’Oh my God, you sound totally different,’ so my speech improved immediately.”
Last month, Ms. Litman regaled members of the Women’s Health Empowerment Summit in the District of Columbia that the week before she was able to climb 68 stairs — albeit hobbling, she said — to see her son graduate from Berkeley University. Five years earlier she had sat at another graduation as a wheelchair user.
“What an amazing event this was for me to be able to have gotten up the stairs and in a walker and not in a wheelchair,” she said.
• Laura Kelly can be reached at lkelly@washingtontimes.com.
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