What is Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a chronic disease in which the body attacks the central nervous system (CNS), including the brain, spinal cord, and optic nerve. The body’s immune system attacks the CNS, causing symptoms such as numbness in the limbs, paralysis, or loss of vision. Disease progression is specific to the individual and many people can lead satisfying and productive lives with medication. MS is currently incurable but there are FDA-approved medications that help to “modify” and slow down the course of the disease. The National Multiple Sclerosis Society recommends patients with MS to consider treatment with an FDA-approved “disease-modifying” drug to lessen frequency and severity of MS attacks.
Multiple Sclerosis Facts
- Approximately 400,000 people have MS in the US
- Approximately 10,000 newly diagnosed case every year (almost 200 new cases per week)
- Most commonly diagnosed in people between the ages of 20-50 years
- Most common among Caucasians and people of Northern or Central Europe descent
List of FDA approved Disease-Modifying Agents for Multiple Sclerosis
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Copaxone (glatiramer acetate)
Extavia (interferon beta-1b)
Rebif (interferon beta-1a)
Tecfidera (dimethyl fumarate)
There are three FDA approved oral medications for MS
Aubagio (teriflunomide) was approved September 13, 2012. The specific mechanism of action for Aubagio is unknown. It may suppress the body’s immune system by reducing the production of white blood cells (T and B cells) which are involved in the MS disease process . It can help alleviate MS disease activity. In clinical trials 1,000 patients participated in a 2 year study of both strengths of Aubagio. The trial showed a reduction in relapses, disability progression, and brain lesions when compared to placebo. The most common side effects include diarrhea, abnormal liver tests, nausea, hair thinning or loss, flu-like symptoms, and paresthesia (sensation of tingling, tickling, prickling, or burning of a person’s skin). Serious side effects include reduced white blood cell count which may increase the risk of infections. Aubagio is available as 7 mg and 14 mg film-coated tablets and the dosing is 7 mg or 14 mg orally once daily with or without food. The cost of Aubagio is $148.35 per pill or $4,153.85 per month.
Tecfidera (dimethyl fumarate) was approved March 2013. Tecfidera is an oral prescription medicine with nervous system protective and anti-inflammatory properties. Although the exact mechanism of how it works is unknown, Tecfidera has been shown to activate the body’s response to cellular damage in patients with multiple sclerosis. It prevents immune cells from attacking the central nervous system. In clinical studies 1234 patients with relapsing forms of multiple sclerosis were studied for 2 years. Fewer patients in the Tecfidera 240 mg twice daily group had a relapse after 2 years of treatment compared to patients in the placebo (dummy pill) group. Fewer patients in the Tecfidera group developed new or newly enlarging lesions. Tecfidera 240 mg 3 times daily did not offer additional benefit over the 240 mg twice daily dose. Side effects include flushing, abdominal pain, diarrhea, nausea, vomiting, itching, and rash. More gastrointestinal (GI) events such as abdominal pain, diarrhea and vomiting occurred in the first month of therapy and decreased over time. Serious side effects include low white blood cell count that may increase the risk of infections. Tecfidera is available as 120 mg and 240 mg delayed-release capsules. The recommended dose is to start with 120 mg by mouth twice a day for 7 days. After 7 days, the dose should be increased to 240 mg twice a day. Tecfidera costs $5400 for a 30 day supply.
Gilenya (fingolimod) was approved October 2010. It may work by reducing the migration of white blood cells into the central nervous system. White blood cells cause inflammation and destruction of nerves in patients with MS. In a two-year study (FREEDOMS) that compared two doses of Gilenya to placebo, Gilenya (at the lower, 0.5 mg dose) reduced relapses by 54% and reduced the risk of disability progression by 30% compared to placebo. Gilenya also reduced brain lesion activity as measured by MRI. Common side effects include headache, flu, diarrhea, back pain, elevations of liver enzymes and cough. Serious side effects include low heartbeat, infections, visual problems, reduced number of white blood cells, and difficulty breathing. The recommended dose is one capsule (0.5 mg) orally once daily with or without food. Doses higher than 0.5 mg cause more adverse reactions without providing additional benefit. Gilenya costs $58,000 per year.
How are oral MS drugs used
Interferons and glatiramer acetate (Copaxone) are first-line therapies for MS due to long term use and studies of their safety. The new oral drugs offer the convenience of oral dosing and in short-term studies have been shown to be effective. Some patients may prefer the oral agents over injectable medications. More studies are required to observe the long-term effects of these 3 oral MS medications.
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