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Sunday, April 28, 2013

How Does Tecfidera (BG-12) Compare With Other MS Drugs?

WebMD Health News
Reviewed by Brunilda Nazario, MD

three prescription bottles with pills

April 25, 2013 - With the arrival of Tecfidera this spring, people withmultiple sclerosis now have three oral drugs to choose from to treat the relapsing form of the disease.
Tecfidera (dimethyl fumarate) joins two other oral MS drugs. Aubagio (teriflunomide) was approved in 2012, and Gilenya (fingolimod) was approved in 2010.
For the 350,000 people in the U.S. who have MS, these drugs represent a treatment breakthrough. Other MS drugs used to treat the relapsing form are injected or given through an IV.
All three oral MS drugs are expensive. Tecfidera's wholesale cost is nearly $55,000 a year. Gilenya and Aubagio cost $60,000 and $45,000 a year.
All three drugs also have side effects. The active ingredient in Tecfidera has been linked to four cases of a rare but sometimes fatal brain disease, progressive multifocal leukoencephalopathy (PML). That side effect was not seen in patients taking Tecfidera during clinical trials, the company making the MS drug says.
With three similar drugs, what do patients need to know? 
For answers, WebMD turned to Barbara Giesser, MD, professor of neurology and clinical director of the University of California Los Angeles Multiple Sclerosis Program. She was not involved in the clinical trials for any of the three drugs.

How does Tecfidera work?

It appears to have anti-inflammatory actions and brain-protective actions. The main problem in MS is that immune cells are getting into the brain and the spinal cord and they are attacking the nerves. One of the main ways they cause damage is by inflammation, particularly in relapsing-remitting MS.
So Tecfidera does a number of different things to lower inflammation and lower the ability of the immune cells to get in and attack the central nervous system. Additionally, it may protect nerves from damage.

How do Gilenya and Aubagio work?

Gilenya prevents the T-cells, the immune cells, from getting out of the lymph nodes. I tell my patients it's like the "roach motel" model of immunity. They can check in, but they can't check out.
The T-cells can't get out of lymph nodes and into the blood. If they can't get into the blood, they can't get into the nervous system.
Gilenya also may protect the brain.
Aubagio basically decreases production of T-cells and B-cells, which are also immune system cells.

Has there been a head-to-head comparison of the three oral MS drugs?

No, as far as I know they have not been compared to each other.
The thing is, if you are going to tell a patient about a new drug, the first thing they are going to ask you is, 'Is it better than the old drug?' And what you have to say is these drugs have not been compared against every single one of our older drugs.
You can't compare across [different] trials because there are different patient populations, different conditions, and so on.
For example, Copaxone and most of the interferons reduce relapses by around a third, compared to placebo.
If you look at the three newer drugs, Gilenya vs. placebo reduces relapses by around 54%. Aubagio vs. placebo reduces relapse by around 30%. Tecfidera reduces relapses in the neighborhood of 50%.
It suggests that some of the newer drugs are more effective than our older drugs, but only relatively, because there hasn't been a head-to-head comparison.

What are the major side effects for each of these drugs?

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steve s said...

"Treatment breakthrough " because they are oral? They should focus more on efficacy than on route of administration. Breakthrough should be used when disease process is totally halted.

Cherie said...

In my opinion, Barbara Geisser, MD did us a great favor in this article by telling us how each of the drugs (oral and injectible) is thought to work. Since there are no comparison studies available, this is perhaps the most helpful writing to date on this topic. Thank you.

Cherie C. Binns RN BS MSCN