With a promising new oral medication recently made available, multiple sclerosis (MS) is now more than ever a treatable condition.
MS is a lifelong disease of the brain and spinal cord that begins in early adulthood and afflicts women two times as often as men. Treatments have typically included either injections or infusions for the patient's lifetime. Injections are painful, cause flu-like symptoms and focal disfigurement, and are a psychological reminder of the lifelong illness. Infusions, although less frequent, require traveling to infusion centers.
That is why there is such great excitement about Gilenya, the first oral drug approved by the FDA for treating MS.
Gilenya was first studied as a way to prevent rejection in kidney transplant patients; the dose used to treat MS is much lower than the lowest dose tested in transplant studies. Clinical studies showed that Gilenya significantly decreased the number of MS attacks, and MRI (magnetic resonance imaging) tests demonstrated lack of disease progression. But long-term side effects are still unknown. As long as no new serious side effects occur, Gilenya will likely become a first-line treatment option.
The medication is an oral once-daily treatment, with the first dose taken at your physician's office so that your vital signs can be monitored every hour for six hours. A few other tests may be needed, such as a baseline EKG and an eye exam, based on your risk factors. After that, if you feel well, you will be discharged.
If you stop taking this medication for two weeks or longer, you must return to the neurologist's office for re-dosing and another six-hour monitoring session. Live or attenuated vaccinations are not allowed when undergoing treatment. If a vaccine is necessary, it must be given one month before starting the medication or two months after stopping.
MS affects as many as 500,000 people in the United States and 2.5 million worldwide. The course of the disease varies, making it impossible to predict its severity or progression.
There are four MS classifications:
Relapsing remitting (the most common form): clearly defined attacks lasting from days to weeks with full recovery between.
Secondary progressive: begins initially with a relapsing-remitting course, but disability doesn't fade away between cycles, progressively worsens until a steady progression of disability replaces the cycle of attacks.
Primary progressive: progresses slowly and steadily from onset. There are no periods of remission and symptoms generally do not decrease in intensity. Temporary, minor improvements may be experienced.
Progressive relapsing (relatively rare): clear progression with steadily worsening symptoms and attacks during periods of remission.
The first treatment for relapsing remitting MS, interferon beta 1b, was not available until 1996. Interferon beta 1a and the drug glatiramer acetate were considered "platform therapies" or first-line treatments. Then a more aggressive treatment, mitoxantrone (an intravenous chemotherapeutic agent), was approved in 2000 for both relapsing remitting and secondary progressive forms of multiple sclerosis. In 2004, the once-a-month IV infusion natalizumab was approved.
All physicians who treat patients with multiple sclerosis have been repeatedly asked "Is the pill coming out soon?" Now, for the first time, we can answer a resounding "Yes!"
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