BG-12 Summary

[NYJenn]

Thanks for an excellent summary!

[hunterd]

My dr also wants me on this! Hope it does me good!

[daisy.girl]

Anyone know if BG12 can be taken with LDN?

I thought I read that this drug is available right now as a psoriasis treatment? If that is true....then why is it not being prescribed off label for MS?

Seems if it has been used since the 50's....it should be okay to prescribe to us. Is this just a money thing??

Thanks so much )

[Myoak]

Hello Marco,

Thank you for an excellent summary posting on BG-12. However, I noticed that you mentioned both the Define and the Confirm trials but only posted the Define results. The Confirm numbers were generally not quite as good as those of Define.

The Confirm results were:

Taken twice daily (BID)
44% annual reduction in relapse rate
34% relapse rate reduction at 24 months
21% reduction in disability progression
71% reduction in the mean number of new
or newly enlarging T2 hyperintense lesions
74% reduction in gadolinium enhancing lesions
57% reduction in T1 hypointense lesions

Taken thrice daily (TID)
51% annual reduction in relapse rate
45% relapse rate reduction at 24 months
24% reduction in disability progression
73% reduction in the mean number of new
or newly enlarging T2 hyperintense lesions
65% reduction in gadolinium enhancing lesions
65% reduction in T1 hypointense lesions


BG-12 compared favorably to Tysabri in Define but
less so in the Confirm Trial, it appears.

Tysabri results in Phase 3 Affirm Trial:

68% annual reduction in relapse rate
81% relapse rate reduction at 24 months
42% reduction in disability progression
83% reduction in the mean number of new
or newly enlarging T2 hyperintense lesions
92% reduction in gadolinium enhancing lesions
76% reduction in T1 hypointense lesions

Hopefully, I have made no mistakes in posting
any of these #'s. If so, please point out any
mistakes to correct, won't you?

[sammielizabeth]

BY GOING OVER THE SIDE EFFECTS OF FUMADERM (BG12), WHICH IS USED IN GERMANY TO TREAT PSORIASIS, IT DOESN'T SOUND VERY SAFE TO ME. LOWERS WHITE BLOOD CELLS SIMILIAR TO THOSE THAT HAVE HIV...DON'T THINK I LIKE THE SOUND OF THAT!! I WISH I COULD FIND WHERE I READ THIS..BUT I CAN'T FIND IT RIGHT NOW. I'LL KEEP LOOKING.

[KateA2]

Anyone know how many milligrams were taken each day? I am curious...looks like people max at 700mg/day for severe psoriasis.

Also wondering how much they changed the molecule between BG12 and Fumaderm. Still, when it becomes available I'm all for trying it out!

[Echo2099]

I'm waiting in line with you, Kate. Here's hoping it's available soon. Hot flashes, tummy troubles, etc., sounds like menopause and I've been there, done that.

I understand the symptoms may be more intense than menopause, but for me, and it my doc agrees, it's a risk I'm willing to take.

[klb]

I have been on BG-12 for 3 years. The side effects aren't that bad. I haven't reached menapause yet, but I think the flushing is similar. For me, it happens about once a day maybe 4 days out of 7 in a week. Lasts about 10 minutes at most.

The stomach trouble was only at initial dosing. I started out at half dose for two weeks then went to full dose....had some vomitting....so went back down to half dose for another two weeks (a total of four), then on to full dose. If taken with a meal (even a light one) no more stomach problems!

Other than the two mentioned above...I have not had any additional side effects.

[Myoak]

Hi Kate,

During the 2-year Confirm trial of BG-12, 240mg of the drug were given twice a day in one group and 240mg were given three times a day in another group. The results are listed in my previous post in this thread.


Sammielizabeth,

The possible side effects of so many meds are downright scary when you read through them. But actually the safety profile of BG-12 compares pretty favorably with other MS meds. Balancing safety and effectiveness and choosing between meds is always difficult. I suppose better assessments can only be made a couple of years after approval and in a larger patient population but doesn’t it seem that people often take a med with a long list of possible side effects and get none of them?

I will say the introduction of a new MS drug is often accompanied by an initial euphoria which usually wears off. It just seems to take a little while to gain a clear view of a drug’s performance. Time will prove what BG-12 does, the good and the bad. Never easy choices in MS.

Kind Regards.

[stazmatic]

Originally Posted by klb

I have been on BG-12 for 3 years. The side effects aren't that bad. I haven't reached menapause yet, but I think the flushing is similar. For me, it happens about once a day maybe 4 days out of 7 in a week. Lasts about 10 minutes at most.

The stomach trouble was only at initial dosing. I started out at half dose for two weeks then went to full dose....had some vomitting....so went back down to half dose for another two weeks (a total of four), then on to full dose. If taken with a meal (even a light one) no more stomach problems!

Other than the two mentioned above...I have not had any additional side effects.

How have you been on BG12 for 3 years? Do you have psoriasis along with MS? What dose are you on? Do you think it has helped your MS? I was just diagnosed with MS recently. My neuro wants me to pick an injectible drug but I want to hold out for BG12. Please tell us how you got on this drug. Thanks!

[klb]

HI, I was diagnosed July 2008 had another relapse March 2009. Finally the Neuro I found said yes get on a medication right away. She mentioned the BG-12 trial study to me along with all the ups and downs. I fit the right profile, age, length of diagnosis, etc. I chose to go into the trial study right away. This is how I have been on BG-12 for three years. The study closed to new participants not long after I came on board. So no I don't have Psoriasis, but lots of other health issues.

I do believe it has helped me with my MS. From July 2008 when diagnosed by my primary Physician until March 2009 with a huge relapse. I was on track to relapse about every six months. I felt horrible over that 8 month period. Lots of fatigue, vertigo, opti-neuritis, poor balance. Truly with every year I feel sooo good. My MRI come back NO progression. I know MS differs for everyone but I my experience has been positive.

I don't know my dosage because we are to be blinded by that. But I do take 2 pills three times a day. I went from no meds in my life to a whole host of them. But my thought is, remembering to take my pills everyday is a small inconvenience compared to the life I had before going on an MS medication!!!!

I was overwhelmed at first as to what meds, if any...but my neuro showed me studies of people who wait versus people who get on right away. The people who get on meds early have a longer time span of physical mobility as compared to people who wait or never go on meds.

I know I'm long winded, but in the beginning I didn't have anyone to ask questions or any direction with MS. It is easy to feel all alone. So if I can help by sharing my experiences I am willing! Take Care...

[Paisleyprk]

WHEN will this become available?? I can't tell you how sick and tired of jabbing myself with a needle EVERY DAMN DAY!!!
My doctor has been telling me. . "about 6 months" for the past 5 freaken YEARS!!!!

[Angeldifferent]

Wonderful news (I hope) geez! I am seeing my neuro on Wed, hopefully she'll have a note on it as well. I'm opting out of shots. And anxious about all of this

[ijustcallit]

Is BG-12 for secondary progressive MS?

[KateA2]

Myoak:
Thank you for answering my milligram question...*ponders* so looks like the max-dose in the trials about matches the high-dose used for psoriasis treatment. Hmm!

Either way, it's sort of ridiculous how interested I am in when this stuff hits the market...sheesh!

perhaps it's a bit of needle fatigue and the idea that it will work better (hopefully) than what I'm currently on? *rubs hands together mad-scientist-style*