MSMonday: Treatment Options: Oral Medications
Last week we discussed inject-able medications. This week let’s discuss the oral medication options that are available. Oral medications didn’t hit the market until just recently. Before then, people with MS were stuck with injection only options, which was clearly not ideal. As patients, we would hear about oral medications being an option someday in the future, but we didn’t know when it would actually happen. Until it eventually did in 2010 when Gilenya was approved by the FDA. Currently there are only three oral medications on the market approved for relapsing remitting MS. Let’s take a closer look at each of these medications.
Gilenya is in a new class of medication called sphingosine 1-phosphate receptor modulator (that’s a mouthful). Scientist think that it works by keeping certain white blood cells in the lymph nodes, thereby making it impossible for them to cross the blood brain barrier and get into the central nervous system. Making it so the cells cannot get into the central nervous system, reduces inflammation and damage to nerve cells. In several studies done, Gilenya was shown to be effective. Gilenya cut relapses by 52% when compared to Avonex in a one year study. It also prevented relapses by 54% when compared to placebo over a two year period. The FDA approved the use of Gilenya in 2010 for relapsing remitting MS.
There are several side effects associated with Gilenya. Headache, slowed heart beat, weakness, fatigue, infection, elevated liver enzyme’s and diarrhea were noted. An uncommon side effect is macular edema, which is the swelling of an area of the retina which is responsible for central vision. Gilenya is also known to slow the heart rate significantly, especially in the first month of treatment. An individual also might feel really tired, have heart palpitations or chest pain or feel dizzy. Usually if someone experiences the symptoms, they will disappear within the first day or two of treatment.
In 2012 the FDA updated the regulations around a patient’s first dose of Gilenya. It is now required that an individual have an ECG before receiving the first dose and again six hours after the first dose. Is also recommended that the first dose be taken under medical observation. This is due to a patient unfortunately passing away in late 2011 after taking their first dose of Gilenya. As far as I know, the has not been definitively linked to Gilenya.
Tecfidera, also known as dimethyl fumarate, is an oral medication taken twice a day that was specifically developed for people with relapsing remitting MS. A similar chemical compound called Fumaderm, has been used in Germany for many years to treat flares of psoriasis. The specific way Tecfidera works is still unknown, but scientist think that it activates certain pathways in the body that help to protect nerve cells from damage and inflammation. In one study, in a two year period 27% of people who are taking Tecfidera experience a relapse compared to 46% of people in the placebo group. Tecfidera was approved by the FDA in 2014 for the use in relapsing remitting MS.
Common side effects of Tecfidera include flushing, stomach pain, nausea and diarrhea. Side effects seem to be present more so at the beginning of treatment, and then will dissipate as treatment progresses. There have been cases of PML reported in patients who are taking Tecfidera, 4 of them actually. PML is a rare and deadly brain disease that can happen when individual is taking an immuno-suppressant medication. In order to develop PML, individual must be positive for the JC virus first. Routine blood test to monitor JC virus status is recommended when taking most MS meds.
Aubagio, also known as teriflunomide, is a pyrimidine synthesis inhibitor. It works by reducing the number of white blood cells in the central nervous system, decreasing inflammation overall and protecting nerves in people with MS. In several studies, Aubagio was proven to be effective over placebo, reducing relapses by 31%, reducing disability progression by 30% and showing an 80% decrease in brain lesions. Aubagio was approved in 2012 by the FDA for use in relapsing remitting MS.
Common side effects of Aubagio include headache, nausea, hair loss, diarrhea, elevated liver tests, like symptoms and numbness or tingling in in the hands or feet. Less common but more serious side effects include elevated blood pressure, increased risk for infections and liver damage. While taking Aubagio you will need to have regular blood test to monitor liver function and blood cell counts. Aubagio is also associated with severe birth defects, and neither women nor man should be taking Aubagio if pregnancy as planned. Aubagio can remain in your body for up to two years after discontinuing the medication, so a special treatment may be needed to remove the drug from your system if you’re planning on becoming pregnant. Usually when taking the medication, it is required that an individual be on an effective birth control method.
I took Aubagio for about a year. Unfortunately I went into the treatment already in a “active disease state “, and had two relapses while taking the medication. I liked how I could just take a pill instead of the daily injections of my previous Copaxone, but I soon experienced side effects of (a lot of) hair loss and irregular blood cell counts. Due to the relapses, I eventually changed medications.
The arrival of oral medications has been a welcome relief for many MS patients. They represent the constant advancement of research and development. Hopefully the future will bring many more options to the table.