Disease Modifying Agents

Since the first FDA approved medication became available in 1993, a total of seven medications have been FDA approved for use in multiple sclerosis (MS).

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Each of the approved medications in some way alters the course of MS. Each medication is available in injection form only. In general the medications reduce the frequency of exacerbations of MS, reduce the amount of activity seen on MRI scanning, and may slow the progression of MS.

Each medication has its own side effects and risks. All of the approved medications have information materials to guide patient education provided by the manufacturer. In addition, the National Multiple Sclerosis Society provides information on all of these medications:

In general, one of four medications is used as a first choice medication for MS:

  • Interferon-beta-1a (either in an intramuscular once a week dosing or in a subcutaneous three times a week dosing)
  • Interferon-beta-1b (every other day subcutaneous dosing)
  • And copolymer (daily subcutaneous dosing)

In large research trials in patients with relapsing MS, each of these medications showed a similar reduction of attack frequency which was the primary measure of effect in these trials.

Each differs in the frequency and route of administration, as well as in the side effect profile.

For example, the interferons in general may cause flu-like symptoms (fever, chills, muscle aches, fatigue) after each injection. This side effect may be treated with medications such as acetaminophen or ibuprofen, and in general tends to become less over time.

Copolymer tends to give injection site reactions such as swelling, redness, itching, and occasionally an atrophy of the tissues under the skin at the injection site causing indentation of the skin.

The interferon medications require monitoring of blood work every 3-6 months to ensure that liver function and blood counts do not change significantly. Interferon-beta-1b may rarely cause a breakdown of the skin at the injection site which requires the medication to be stopped. All of these medications have been used in thousands of patients over years and have a good safety record.

Rare side effects of the interferons include immune inflammation of the liver, altered kidney function, and occasionally an increase in symptoms of depression. In general, copolymer does not have major risks other than skin reactions.

Fingolimod (Gilenya) is a new oral medication for relapsing forms of MS. It is a once-a-day pill in a fixed dose. Before starting this, patients must have:

  • lab work done (blood count, liver function tests, and other standard labs)
  • be asked if they have had chicken pox. If not they may need a vaccination before starting the medicine.
  • need an electrocardiogram (EKG)
  • an eye exam to make sure that they do not have swelling at the back of the eye (macular edema)

Significant heart, liver, or other major organ disease may be a contraindication to this medicine. Patients must be monitored for six hours during their first dose to make sure they do not have a significant drop in pulse or altered heart rhythm. There is a chance that infections will be more likely with this medicine. Fingolimod effectively reduces relapses and new MRI changes in patients with relapsing forms of MS.

Mitoxantrone and natalizumab are powerful medications which are usually reserved for patients with more severe MS or MS that does not respond to standard front line agents. Both have significant side effect profiles.

Other medications have been used in MS that are not FDA approved at this time. For example, sometimes medications that alter the immune system are added to one of the standard agents.

Azathioprine, methotrexate, mycophenolate mofetil, and other agents have all been used either alone or in combination with standard injectable agents. These are usually used when the injectable agent alone does not seem to be effective. Choosing to do this is complex and should be done by a physician experienced in treating MS.

There are other medications which have been used from time to time in MS, usually after other standard agents have failed. IVIG is a blood product that in some studies was shown to be helpful in relapsing MS. Cyclophosphamide is a chemotherapy which has been used on and off in MS for many years and which may be used in difficult to treat MS. Rituximab is an antibody treatment that recently has been shown to have a powerful effect in multiple sclerosis, but with a risk of causing infections due to suppression of the immune system.

All three of these medications are used under the guidance of a physician experienced in the care of patients with multiple sclerosis.

Plasmapheresis is a technique of cleaning antibodies out of the blood stream. It has been used in a number of neurological and immunological diseases. A recent study showed that plasmapheresis is helpful for patients with a severe attack of MS not responding to standard steroid therapy. It requires specialized equipment and is not generally used as a long term treatment.

References:

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This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. This document was last reviewed on: 10/31/2011...#9065

Dimethyl fumarate (also called Tecfidera, or BG-12) is an oral MS therapy approved in March 2013 for treatment of relapsing forms of MS.

Dimethyl fumarate was evaluated in two large, two-year clinical trials and found to decrease the frequency of clinical relapses, reduce new lesions on MRI, and (in one study) slow the progression of disability. The main side-effects of dimethyl fumarate are skin flushing (redness, warmth, and sometimes itching) and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea). Typically, the gastrointestinal symptoms improve within a month of treatment. Dimethyl fumarate has not be evaluated in either secondary progressive MS or primary progressive MS, so is generally not recommended in those patients without evidence for active inflammation.

Who should use this new treatment?

Mellen Center for Multiple Sclerosis physicians feel that dimethyl fumarate can be an appropriate treatment option for first-line treatment of relapsing forms of MS and an alternative treatment to other MS therapies. In general, patients who are stable on their current MS therapy, who tolerate it well, and don’t have significant risks of complications will be recommended to continue that treatment and not change to dimethyl fumarate. Current MS Patients at the Mellen Center who are interested in exploring whether dimethyl fumarate may be appropriate to them should contact their clinical team for further guidance. In most cases, they will need a clinical visit to the center to discuss the therapy, its risks and benefits, and whether it might be appropriate for an individual patient. Please view the video on this page for further information.

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