Since 2009, three new oral agents for relapsing forms of multiple sclerosis (MS) have been approved:
All three medicines are approved for the treatment of relapsing forms of MS. All three reduce the rate of relapses of MS, reduce new or enhancing MRI lesion formation, and may slow progression of MS. None of these are related to the older injectable agents for MS, and all have their own mechanism of action (how they work in MS).
All are approved as first-line treatments for relapsing forms of MS, but long-term use has not been extensively studied in these medicines due to their recent release on the market. Many insurance plans require that one or two injectable agents be tried before using one of the oral agents. We usually consider a standard injectable agent as a first choice unless there are specific reasons to begin with one of these oral agents. All of these medicines have their own mechanism of action, side effect profile, and monitoring protocol.
Fingolimod (Gilenya) is a medicine which acts by blocking the exit of lymphocytes (immune cells that the body forms which may cause injury in the brain and spinal cord in MS) from the lymph nodes.
Gilenya is administered as a once a day pill (0.5 mg) in a standard dose. Higher doses were not shown to work better than this dose. Fingolimod is generally safe and well tolerated but there are important safety issues that must be evaluated prior to and after starting the medicine.
Teriflunomide was approved in 2012 for relapsing forms of multiple sclerosis. There are two doses, a 7-mg and a 14-mg pill, both of which are given once a day orally. Teriflunomide reduced relapse rate and MRI lesion formation, and the higher dose reduced progression of disability.
The exact mechanism of teriflunomide is not known, but it may reduce the number of active immune cells (lymphocytes) in the brain and spinal cord. While teriflunomide is usually well- tolerated, there are some side effects which must be considered.
Dimethyl fumarate (DMF) (Tecfidera) was approved by the FDA in 2013 for relapsing forms of MS. This medicine also reduced the frequency of relapses of MS, as well as reduced MRI activity and progression of MS.
The exact mechanism of action is not known, but the medicine may inhibit some pathways which lead to more inflammation. DMF is an oral agent administered as a twice-a-day 240-mg dose pill. A seven-day starter pack of 120-mg pills is available and recommended to help improve tolerability. The medicine may be tolerated better if taken with food.
Dimethyl fumarate is generally safe and well tolerated. It can lower lymphocyte count, so a blood count (CBC and diff) before starting and a few months after starting is recommended to monitor this. Two main side effects may be seen with DMF:
Specific information on each of these medicines can be found at the following websites:
Fingolimod (Gilenya) www.gilenya.com
Teriflunomide (Aubagio) www.aubagio.com
Dimethyl fumarate (Tecfidera) www.tecfidera.com
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