PML in European drug dimethyl fumarate
 

The New England Journal of Medicine reports 2 cases of PML in the European Psoriasis drug that is the main ingredient in Tecfidera (BG-12).

Read here: http://www.foxbusiness.com/news/2013...ain-infection/

And here at Medline: http://www.medscape.com/viewarticle/803100

ANN :(

I started the paperwork ball rolling (actually running not rolling).. today!
I can't wait to give it a go. Hopefully mid next week!

EDIT - just tried your links for 1st time and they're gone. Hopefully it was b.s. like flashcrash. Either way, i'm in.

The PML risk is there per this excerpt from a report....

Sorry about the links, Eddie. Info was moved from "breaking news" to just news or, the one that angers me, "Business news."

This is an upsetting development as so many people wanted this drug or needed it as they have no where left to stick.:(
ANN

It's disappointing as my own Neuro mentioned it to me at my last appointment and wanted me to try it. Now......I don't think I'm willing to take the risk.

When I saw "PML" in the news report I'd read, I crossed that drug off my list:(

Just find a cure, already...

Here is a link to the story:

http://www.foxbusiness.com/news/2013...ain-infection/

I'm staying away from anything where PML is a risk. Nothing is 100%, even if my blood test says I am not at risk for that infection...yeah...

I have psoriasis, which isn't always in a flare. For that, I'll see my dermatologist for a topical ointment script, if need be...

I just came on Neurotalk to post something about BG-12 (Tecfidera) and PML but I see you already beat me to it! This is very sobering and scary news.

Here is another article on the issue which I think does a very good job of explaining the problem. There are a couple of neurologists in the article who state the risk of PML should be of concern.

http://www.everydayhealth.com/multip...6pLid%3D304022

Fact that it lowers white blood counts makes me & neuro more excited since i'm always 2x limit.
Anyone that gets scared off by a few cases of PML baffles me since it's been in use for a decade pre-modded version.

To each his own, I called Biogen again today to ask if my script got in system yet - nope. They have a mountin of faxes for new patients.

Only thing i'm not looking forward to is first month's side effects but i'll cope & try my hardest to keep swimming 20-30 laps/day throughout. 30 today.

I'll know if it's helping within 1st week which hopefully will be next Monday.
I need a Medrol dose pack in the worst way to stop this flair but i'll wait & hope to regain some of what i'm losing.

MRI of brain & cervical w/wo contrast set for Tuesday. Getting blood drawn tomorrow, i'll have baselines & yes i'll post my mri shots. I know this one will be ugly.

I guess no one read the article cause ...

"No cases of PML have been diagnosed in Tecfidera patients"

"Including the two case reports published Wednesday, a total of four patients have been diagnosed with PML since Fumaderm was approved in Germany in the mid-1990s for psoriasis, Biogen said. However, in two of the cases, patients had additional risk factors for developing the condition. Biogen has said in the past that the PML rate is consistent with what medical literature expects for patients with autoimmune diseases such as psoriasis"

Tecfidera is NOT Fumaderm.

I read the article.

It states that "The problem is that the studies with BG-12 covered a two-year period, but no longer periods," Schulz said, and he believes it may take prolonged treatment with the drug for PML to surface."

It also states that "The ingredient, dimethyl fumarate, is used in a drug called Fumaderm that was approved in Germany in 1994 to treat the skin condition psoriasis. It is also in a different but closely related medication called Tecfidera, which was just approved by the U.S. Food and Drug Administration in March for the treatment of multiple sclerosis (MS). It is known as a fumaric acid ester, which is commonly used as a food additive and has been used to treat psoriasis in Germany for 30 years."

It's going to take some time for any cases of PML to surface for patients who take Tecfidera. A two-year study just isn't, in my humble opinion, long enough to make an educated decision.

Each patient has to make their own decision and decide whether or not the risk versus the gain is something they're willing to take. There are no "wrong" decisions here.....just individual ones. :)

I'm still willing to try. I had to stop Ty because of JC+ and weird MRI but blood tests were normal. It's always something with these drugs. I should get my 1st delivery next week. My BC/BS rejected the drug so I had to use PA and it was pretty fast and not really complicated. I hate needles and being hooked up to an I.V. once a month was traumatic.

I'm ready for side effects and all. The manufacturer sent me a pill box already. I've tried 3 forms of treatment already and hopefully this will be my last.:D

Awesome reply Mocha thank you. Just got back from brain MRI w w/o contrast, thin slice.

I can't wait after using copaxone a few yrs- rebif a few months- tysabri 2.5 yrs.
All worked excellent 1st 2 yrs. Regained function lost. Well, i/m fading fast & next Ty is tuesday if i don't get Tecfidera by then. I'll wait a few more weeks to start if needed.

I'm still in! Waiting for someone to call me to set up a pharmacy. This report does not scare me. If you read it carefully, there were different situations with these two cases.

My doc is going to monitor my white cell count a little more often at first and that is fine with me.
Remember too....this drug has been fought against by the other major drug companies because they know its going to make many other drugs unpopular.

How will you know if it's working, Eddie? It is like all the other DMDs that supposedly merely slow down progression. Have you read something that says it calms a flare?

Sparky-

Do you have that backwards? Did you mean that DMD's reduce flares rather than progression or did my mind bend it??

ANN

I'll know because every morning i seem to lose a tad more sensory, and by the muscle jolts at night. Strength, less atrophy, many ways to tell.
btw all except Rebif worked wonders, for me. I shouldn't have included that one. Was the order of meds i've used.

Good deal Eddie; hope it stabilizes you!

ANN, I'm not sure who has what backwards! :confused: When I say DMD (Disease Modifying Drug), I'm using what I understand the definition is:
http://ms.about.com/od/glossary/g/modifying_drugs.htm.
"Definition: Disease modifying treatments are a group of drugs that impact the course of multiple sclerosis (MS) by slowing the progression of the disease and decreasing the number of relapses. The disease-modifying drugs are: Avonex, Betaseron, Copaxone, Novantrone, Rebif and Tysabri."

From my understanding DMDs (I'm assuming Tecfidera will be added to this list) are not for symptom management. I wouldn't surprised if I have this wrong! :D

DMD may reduce the amt. and length of exacerbations and thus
slow the progression of disability. Since you are not having as
many flares, you may notice that your MS symptoms seem to
improve, but DMDs are not cures or symptom relievers ..
per say.

They are meant to reduce flares, to possibly reduce disability
progression only. Any symptom relief is gravy...

I just heard that there is a washout period, in going from Tysabri
To BG12/Sofa pill, of 6 months!!!!:eek:

Maybe, baffling, to not want to take that risk, as minimal, as it appears, but, yeah..nothing is 100%. I'm young, active, and have young children. That miniscule risk, is too much risk for me.

{Edit to add}: Granted, a plane could fall from the sky, land on me, a car could drive into me, I could get cancer. But, you know, it just is what it is. My body, My choice, so to speak.

"I just heard that there is a washout period, in going from Tysabri
To BG12/Sofa pill, of 6 months"

Not true. Call Biogen. Neuro (and patient if lucky) make the decision since everyone's different. 3 weeks to 3 months.

Yes, to reduce the number of flares. And Sally, "gravy" as you use it is a favorite term of mine!

Saw my neuro today. He told me he and the other 6 neuros in his practice have not recommended it yet. He is more cautious than some doctors. He said they are taking a "wait and see" approach.

Interesting Barb. I saw my neuro this week too. I'm doing well on Tysabri but asked about Tecfidera. He said that he has patients that have gotten diarrhea on the drug - a couple of people have bad cases including one gentleman who stopped it because it was so severe and the anti-diarrheal meds weren't
helping even after 3 days off the drug.

He also said that Biogen's claim that the drop out rate from the clinical trials was low because side effect profile was low is a misleading statement. He said the side effects are so obvious (diarrhea and flushing) that people instantly knew they were on the drug. If this was their last chance for help or they wanted to get the drug in the trial, they would tough out the side effects to stay on it. I thought that made sense!

Anyhow, I'm just glad I don't have to contend with a possible new side effect profile!

Just saw my nero today and he suggested that I look into this new pill. I did shots for years when I was first DX but stopped because of injection site infection. I've been taking Copaxone for the past 2 months but I HATE the injections, even with the autoject. He said this is less expensive then a lot of the other drugs and he has several patients on it (of course not for that long), with good results. They are showing improvements in a very short time. I'm all for trying anything that will keep me moving longer. I've been off any type of meds for awhile (about 6 years), but having lots of increased problems. That's why I started with Gilenya (high blood pressure), then went to Copaxone and I think I'm going to try Trecfidera. I'll wait till next month when I'm off work for the summer. I don't like switching drugs all the time but did I mention that I HATE injections.

There's improvements with this MS, medication?

When I hear neuros use 100% and Improvements to MS, I see red flags and become a bit cynical.

((My neurologist mentioned that I was 100% certainly not ever going to develop PML. Of course, that was after, while in my last appointment, having another neurologist, a woman, interrupt my appoint to say, in a way I found giddy, Ahh, Dr.*insert name*, did you see that email, wasn't it sooo funny, hehehtehehe" Yeah, I walked out and never went back in..another story another thread))