When headlines hit the news such as last week’s announcement that
cases of PML have occurred with a medication containing the same active
ingredient as Biogen Idec’s newly approved Tecfidera (BG12, oral dimethyl fumarate),
I have a need to know the whole story. Fortunately, I was able to
access the case studies and company’s response published in the New England Journal of Medicine (NEJM).
Only weeks following the approval of Tecfidera (oral dimethyl
fumarate), also known as BG-12, for the treatment of relapsing forms of
multiple sclerosis, the headlines have been scattered with mentions of
PML, or progressive multifocal leukoencephalopathy.
In the April 25, 2013 issue of the New England Journal of Medicine (NEJM),
two separate cases involving patients in Europe diagnosed with
psoriasis who developed PML while taking different forms of dimethyl
fumarate. Dimethyl fumarate is the active ingredient found in Fumaderm®
(fumaric acid esters) tablets and Tecfidera™ (dimethyl fumarate)
delayed release capsules made by Biogen Idec. The cases studies are
described in Letters to the Editor in NEJM with a response provided by Biogen.
Read this post in its entirety:
Tecfidera and PML: Is there a direct connection?
Just this morning I was enrolled in the Tecfidera program and hope to be starting treatment in the next month (after jumping through insurance hoops). I have read and read and read everything I can get my hands on and I have to say - I'm very comfortable starting Tecfidera... much more comfortable than I would have been with Tysarbi (which was never an option for me). BG-12 has been around for years and years and long term it has proven safe. From what I can gather, the cases of PML involved different compounds with dimethyl fumarate with fewer regulations/standards than the FDA has in place. I'm going to take a leap of faith and hope for the best LOL
ReplyDeleteHi Sheri,
DeleteHow are you doing so far on Tecfidera? And, what was insurance like for you? It'd be great to hear some stories.
Lisa
HI LISA . I WAS JUST DOING A GOGGLE SEARCH ON THIS AND CAUGHT YOUR BLOG. I HAVE MS/RA/AND SLE . TRIPLE THE FUN.LOL STARTING NEXT WEEK I'LL BE STARTING TECFIDERA FOR THE MS. THE REASON FOR MY GOOGLE SEARCH WAS MY CONCERNS OR HOPES THAT THIS DRUG MAY ALL HELP THE RA . MAYBE ITS WISHFUL THINKING AT THIS POINT. I'VE FOUND NOTHING TO SUPPORT MY HOPEFUL THINKING AS OF YET. I'M HOPEFUL THAT THE TECFIDERA WILL HELP THE MS . (PLEASE EXCUSE THE CAPS .I'M LEGALLY BLIND ) . (((HUGS)))
ReplyDeleteHi Dawn,
ReplyDeleteWow, triple whammy for you - MS, RA, lupus. Sorry to hear that. I wish I knew the answer about Tecfidera and the other diseases. I hope that you will let me know how it goes for you. I was on Copaxone for four years and it did okay for awhile. But when I switched to Rituxan, I noticed a real difference in both my MS and RA. I just hope that it continues to work well for me. I'm not sure what I would try next.
Please do let me know how this treatment seems to affect each of your diseases. Like you noticed, there isn't really any information to be found regarding this concern. I looked too!
Be well,
Lisa