BG-12/Tecfidera Approved, and some Advice on Researching Options

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.

MSAA cover

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!

PubMed is a major online database for medical research information, and it is the publicly accessible cousin of MEDLINE (which is often accessible through your local library’s online database collection.)  All of the major (and many minor) medical journals are represented here.  Not every article you will find here is viewable; the ones that have free PDFs (or HTML versions) will say “Free PMC article” or “Free article”, and many of them do. One tip if you’re disappointed with your search results: find out the generic name of the drug and search on that, not the trade name (i.e. look for “teriflunomide”, not “Aubagio”).
Here is the first article returned by PubMed on that search:

Oral available agents in the treatment of relapsing remitting multiple sclerosis: an overview of merits and culprits

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!

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9 thoughts on “BG-12/Tecfidera Approved, and some Advice on Researching Options

  1. Great information and research!!! I’m excited to take some time and read through your blog entries. I’ll be interested to see what medication you end up picking after your next neurology appointment. Good luck & take care!!!

  2. Thank you Ashley! I was pretty surprised that Tecfidera was available so quickly; the neurologist didn’t think it was even worth starting on Aubagio in light of that. Sounds like you’re on that road too, so, BG-12 FTW… hopefully! ~ Sunshine

  3. I’m so happy to have found ya! I’ve been on Tec for the past 5 months. I am calling in on Mon. to ask how to wean off. The side effects for me are not worth it. I just had an endoscopy and have had major issues with my stomach( a side effect of the drug that may or may not go away in 3-6months of use). have diverticulitis, which for a vegetarian is puzzling, which may be from my liver having problems now. Hair loss and rashes every other day that takes Benedryl to get through. so i can say a big no to this. i won’t do shots. so i’m heading back to diet as a weapon. how are you doing on the drug?

  4. oh…I read that you learned of the 10/copay. It’s actually that the company will pay for HALF of your doses/year. the rest is up to you. you get on their program,which the girl on the other end said she didn’t know if they were going to do the program next year or not. Crazy

    • Sorry to hear you’ve had such a miserable time with the drug! Believe me I was pretty close to turning my back on it when the worst stuff hit in weeks 2-3, but I didn’t have nearly as many other side effects as you have… To be honest this is the last med I will try; if it starts to mess with my liver or kidneys, I’m doing the same as you, strictly diet based therapy. My next MRI and blood test will be late next month, so we’ll see. Ah yes and that $10 copay, I’m paying that now but won’t be surprised at all when/if the deal goes away. Sounds like my insurance will offer a $30-50 copay, which is better than $5000. It is all completely crazy, Kym. I wish you the best of luck with your next avenue of attack. If you’re on Twitter, look me up @SunJansen and keep me posted!

  5. Glad that you are doing better with it. I will not do shots. There is another drug that is in the pipeline that seems to be without alot of side effects. can’t remember what it is though. That’s awesome that your insurance is going to pay that. We are suppose to have incredible insurance, but they won’t cover till 3,000. is paid in deduct. My MRI’s have been the same, 24 lesions on my brain. but paper work was miscommunicated and they didn’t do my spine last month, which was where my new lesion was. And it’s been stable for the brain for 2 years…from the time that it was discovered. I went on the MS Recovery diet when I was high suspect for a year. Went on alot of supplements, so I’m guessing that, excersize and caring for so many creatures and a 10yr. old is helping to. The thing that’s hard to give up is icecream and my Kifer! I’m experimenting with almond milk to make my own as the stores are so expensive. maybe i can make kifer with almond milk too? who knows till ya try! B12 is a big problem for me too, so working on getting that under control. Just remember, if you start pooping like a bunny(in pellets) your liver is screaming at you! lol! I don’t twitter though! Just on FB!

  6. oh! Watch out for the Zolfran, I love it. took it when i was pregnant with my son, the whole time, and take it now, but you have to be careful as it will cause bad constipation. Phinergan(sp) will now do that, but I can’t take that due to it making me extremely ill. just a heads up! Getting 4 new added supplements to my arsenal today, here’s hoping! Good luck!

    • Yeah that Zolfran killed me — horrible headache (and the neurologist prescribed it even knowing I was prone to migraines…) In the end I just struggled through with mint tea and fennel and yoga… Good luck with your supplements!

      • one thing that I take that helps a bit with the Tec is black seed oil along with milk thistle caps, take the black seed as an oil and not the capsules. you get used to the taste. i chase it with juice. my digestion issues didn’t arise until 3months into taking Tec. the first month was a breeze, and the first 3 weeks of full dose was easy too, then came the huge bouts with hives! so i’m sure that adding benedryl on top of everything else i take, yikes. my neuro doesn’t want me off of it, so I’m doubling my black seed and we will see how that goes. one more month!

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