New Drugs to Treat Multiple Sclerosis

Las Vegas—In the past 3 years, the FDA has approved 3 oral drugs to treat multiple sclerosis (MS): fingolimod in 2010, teriflunomide in 2012, and dimethyl fumarate in 2013. Still, the first-line treatment for the disease older therapies, such as interferon beta-1b, interferon beta-1a, and glatiramer acetate.

John R. Corboy, MD, professor of neurology at the University of Colorado School of Medicine, said those therapies were approved in the 1990s, are cheaper, and are at lower risk of side effects. However, they are associated with poor tolerance and compliance because they are injectable medications administered intravenously or subcutaneously.

Dr. Corboy recommended that healthcare professionals use newer oral therapies or natalizumab (an injectable drug approved in 2004) as first-line therapies because the medications are more effective, particularly in the first few years of the disease. He said that treating MS early is crucial to lowering disability, but he added, “we are not doing that as a rule.”

“It is completely backwards the way we are doing things,” said Dr. Corboy, who spoke at the fall managed care forum during a session titled Changing Paradigms in MS Therapies. “Efficacy needs to go to the top of the list because that is the only thing that will alter disability over time.”

MS, an autoimmune disease affecting the central nervous system, is a complex disorder. It is the most common cause of disability in young women and the second most common cause of disability in young men. Approximately 85% of people with MS have relapsing-remitting disease.

Before prescribing disease modifying therapies, Dr. Corboy suggested that healthcare professionals convince patients to exercise, take vitamin D, do not smoke, and increase salt intake; treat acute attacks with high-dose oral or intravenous steroids; and use symptomatic therapies such as dalfampridine. Disease modifying therapies are only effective when used early in the disease and when patients have evidence of inflammation, according to Dr. Corboy. The drugs alter the natural history of the disease and are used for relapsing forms of multiple sclerosis.

Teriflunomide is administered once daily at doses of 7 mg or 14 mg and is generally well tolerated, according to Dr. Corboy. However, it is not as effective as fingolimod or dimethyl fumarate. Patients take 240 mg of dimethyl fumarate twice daily. The drug reduces relapses by 50%, but it is associated with gastrointestinal issues and is less effective at slowing disability or brain atrophy.

When determining the best treatment to use, Dr. Corboy said there are numerous issues, including patient issues such as efficacy, ease of use, mode of administration, side effects, and costs. Doctors are most concerned with their familiarity with medications as well as the efficacy and risks associated with the various options. Meanwhile, insurance companies typically require that patients fail with first-line therapies before they will pay for other treatments.

Of the drugs approved in the past decade, Dr. Corboy said natalizumab is the most effective, although it has not been tested in comparison trials. He added that the FDA has closely monitored the side effects of natalizumab and found the most significant risk is progressive multifocal leukoencephalopathy (PML). As of October 2013, more than 400 people treated with natalizumab had PML. The risk of patients taking natalizumab to develop PML is 1 in 300 patients, according to Dr. Corboy.

Despite the risk of PML, Dr. Corboy recommended that natalizumab as first-line therapy option along with fingolimod, teriflunomide, and dimethyl fumarate.

“I think it is time to flip the process [of first-line therapies] completely,” he said.