The FDA has just approved BG-12 (Tecfidera). In spite of all my efforts to remain dispassionate about the news, I will admit to a brief surge of joy. Very brief, because now I have to review my options yet again, in advance of my appointment with the neurologist next week. I had in fact just determined — tentatively — to start on Aubagio (teriflunomide) regardless of whether BG-12 came out. And I may still do that, if the wait for Tecfidera is as long as I suspect it will be. Right now, getting off Avonex is my first priority.
So I’ve been doing some research. Ultimately it came down to this: fun as it is to call my blog “Needle Fatigue”, it really is no joke. The average time for someone with MS to just give up on injectable therapies is about 2 years, and I know why (I’m about 2.5 years in now). So right now it’s a pill or it’s nothing. Gilenya has been 90% ruled out because of potential heart problems and a risk of macular edema. So at this point, this leaves Aubagio and Tecfidera. How to decide?
If you have MS and are researching your options, the first thing I will say is: beware the MS forums. I’m not saying don’t participate in discussions or see what other people have to say; both the NMSS’ MS Connection and MSWorld have a lot of wonderful people with both harrowing and uplifting stories to share on just the subject of DMTs alone. But, be zen about it. Be aware that if you go there looking for others who have been on the therapy you’re considering, you will find 50 different people who’ve had 50 different reactions to it. That’s MS. My personal opinion is that, interesting as it is to see all the possible ways you might possibly deal with a given drug, it’s not terribly constructive. You’ll find message boards most helpful, I think, when you’re looking for advice on things like traveling with syringes, or book suggestions, or thoughts on who has the best cooling vests — or just basic moral support — but for making decisions about therapies, I recommend looking elsewhere.
I think the first place all of us go when we’re first diagnosed is the webpage of the National MS Society. It’s high visibility, and they are committed to publishing the latest news; the FDA decision today was up there right away — and they went farther and published a helpful FAQ on the drug as well. They have a lot of general information on most of the therapies available currently; definitely look at their “Treatments” page to see all of the FDA-approved options out there. After you’re done there, head to the website of the Multiple Sclerosis Association of America, and download a copy of the latest MS Research Update. It’s 50 pages and will make your head swim, but it’s definitely the place to go to get a thorough picture of all of the treatments both approved and in trials. Knowing the potential side effects is only part of the picture; what you really want to know before committing to a new therapy is if it’s worth it. Has it been shown to slow progression, and how much? How about reducing new lesions? And how does it work? Maybe not everybody is interested in that, but I am. I particularly like to know if my immune system is going to be suppressed or not.
So with the help of the March 2013 MS Research Update, I was able to find out that Aubagio:
“…is an immunomodulator that affects the production of T and B cells. It inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. Unlike some drugs that modulate the immune system, Aubagio is thought to leave the immune system’s response to infection intact, so it may still fight against infection while a patient is taking this drug. It may also inhibit nerve degeneration by reducing the production of free radicals. (Free radicals are unstable molecules [or atoms] produced in the body that can damage cells in the brain and other organs.)”
How Tecfidera works, however, is less clear:
“The mechanism of action in MS is still under investigation, however, Tecfidera may have a distinct dual mechanism of action. First, it is an immunomodulator with anti-inflammatory properties. This induces anti-inflammatory cytokines (small proteins that may stimulate or inhibit the function of other cells) and appears to suppress damaging macrophage cell activity. Second, Tecfidera may also have neuroprotective effects. This is due to its activation of a substance that is critical for resistance to cellular damage (from what is termed “oxidative stress”) as well as for normal immune function.”
Hmm. Cytokines. Wasn’t I just reading about the connection between depression and elevated cytokine levels? Better ask the neurologist about that.
As for reducing progression to disability, it seems that Aubagio has not performed as well (29.8% as opposed to 34-38% for Tecfidera). What is not so obvious is how they compare in the reduction of new lesions; Aubagio had a 67.4% reduction at the 14 mg dose; 39.4% at the 7 mg dose. The MSAA report doesn’t include this information for Tecfidera, but here’s where my old library school training comes in handy: PubMed to the rescue!
Unhelpfully, this article has some information that doesn’t exactly gibe with the MSAA report. First of all, it states the rate of progression reduction for Aubagio as 31.5% (14 mg/day), and Tecfidera as 44%–53% — but at least there’s a consensus on which one is more effective. Interestingly it’s just as difficult to determine whether there were fewer new lesions with one or the other, but both did show a “significant reduction of the MRI disease burden” when compared to the placebo.
At this point in your searching, if you’re not satisfied with the first article you find, it’s pretty easy to hunt down related articles (see the “Related Citations” on the right hand side of the abstract page). And if PubMed lets you down, it’s always worth doing a search on Google Scholar. If you encounter an article that looks promising, but has no free text or PDF, go to your library! Or your library’s website — there’s a whole world of virtual reference now that means you might not even have to set foot in a real library (though I recommend that you do!)
As for me, I figure I’ve done as much homework as I really want to do, without further discussion with the neurologist. I’m now reasonably sure that if I go on Aubagio, it will only be until Tecfidera becomes available, but we’ll see what he says about that next week. Doing this kind of research can be exhausting (though yes, we’re easily exhausted) and you may think there’s not much reason to do it. After all, this is why your neurologist is the big high-paid expert. But you need to do it, if only to show this disease that you’re paying attention; you are vigilant, and even through all the trial and error, you’re diligently studying how to beat it. Here’s to the day we finally do!