New MS Drug: Q&A
How Does Tecfidera Compare With Other MS Drugs?
Has there been a head-to-head comparison of the three oral MS drugs?
Giesser: 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?
Giesser: Gilenya has known side effects of liver enzyme elevations [potentially causing liver disease], lowering of the white blood cell count [reducing infection-fighting ability], and slowing the heart rate.
A year or so after it came out, there were sudden deaths. These were people who had pre-existing heart problems or were on heart medication. So they had to change the labeling. Now, if someone has certain types of heart conditions or is on certain types of heart medication, Gilenya is not prescribed.
For Aubagio, you have to watch out for white blood cell counts, liver function, infections, and hair loss. I'm told the hair loss is fairly mild. The main issue with Aubagio is it's known to cause birth defects and affects the sperm as well. The effects can persist after you stop taking it for up to two years. People have to be absolutely very meticulous about practicing contraception while on Aubagio.
For Tecfidera, the common side effects are abdominal pain, diarrhea, and some bloating. And it causes flushing. You also have to watch the white blood cell count and the liver enzymes.
I'm told most of the flushing and the digestive effects only happen over the first month or two. After that, it decreases. If you take it with food, that is supposed to diminish the side effects.
The potential advantage that Tecfidera has over the other two drugs is that its active ingredient has been used in Germany for almost 20 years to treat psoriasis. But as with any drug, we have to see what happens when it's out in the real world [for treating MS].
Editor's note: An active ingredient similar to the one in Tecfidera has been linked to four cases of a rare but sometimes fatal
, progressive multifocal leukoencephalopathy (PML). That side effect has not been seen in patients taking Tecfidera, the manufacturer says. The four patients diagnosed with PML had additional risk factors. They include taking drugs that suppress your immune system or having prolonged periods of low white blood cell counts. In August 2013, the FDA said it was investigating a man in Europe who developed PML while taking Gilenya.