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Anyone part of BG12 drug trials?
Wondering if anyone was part of the BG12 drug trials and if so, could you share anecdotal stories about the side effects?
I read one story where the gastrointestinal problems last for the first few months. I work full time and cannot deal with a month or more of diarrhea and stomach cramps.
I'm also concerned with the suppressed immune system and the possible liver problems.
Injecting Copaxone daily isn't fun, but I don't have to deal with stuff like that.
I read one story where the gastrointestinal problems last for the first few months. I work full time and cannot deal with a month or more of diarrhea and stomach cramps.
I'm also concerned with the suppressed immune system and the possible liver problems.
Injecting Copaxone daily isn't fun, but I don't have to deal with stuff like that.
A great discussion! I have been waiting for BG-12 to come out in this its market iteration as Tecfidera for a couple years now as it seems to be the drug best suited to my medical history and needs.
However, as I am doing exceptionally well on IVIG infusion, now once every 6 weeks, I will wait and see what the reactions are to this new drug and should IVIG begin to lose its efficacy I will certainly consider making the switch to Tecfidera. :)
Be well, everyone
Cheers, Jessica
However, as I am doing exceptionally well on IVIG infusion, now once every 6 weeks, I will wait and see what the reactions are to this new drug and should IVIG begin to lose its efficacy I will certainly consider making the switch to Tecfidera. :)
Be well, everyone
Cheers, Jessica
Thank you all for responding to my question.
I have taken Copaxone for 10 years and my neurologist was involved somehow with Tecfidera and has suggested I think about switching after some time has passed.
My MS is mild and my major concern is not rocking my treatment boat.
I will watch future postings about Tecfidera with great interest.
Thank you again.
I have taken Copaxone for 10 years and my neurologist was involved somehow with Tecfidera and has suggested I think about switching after some time has passed.
My MS is mild and my major concern is not rocking my treatment boat.
I will watch future postings about Tecfidera with great interest.
Thank you again.
Good question Nancy -
Most all want to know experiences about a med when they are weighing thoughts of "to take, or not to take." Thoughts like, will it hurt me? Will I be like the animal toxicology and experience. Can def. be alarming to folks when taken out of context like Essdipity alludes to - as laypersons we must count on our sytems in place like the FDA. It's good you posted it MSinfl because if not, we'd not have the opportunity to include responses ref the same. I can honestly say I read that too a week or so ago and wondered what were the odds that would happen to me if I take it!
What a great discussion - To me, where disease modifiers are concerned (at least where our forum is concerned), there has been consistent comments and thoughts that they "suppress" the immune system, among other things. I'm not surprised Tecfidera will get the same wrap.
Sooooo, well done corrections Essdipity and Twopack, Sarah because of your energy and knowledge to correct the information your educating the masses.
I look forward to adding a new thread like our others in the near future ones that says DMD Users - Tecfidera Add your name here!
These are exciting times to me where treatment is concerned!
-Shell
Most all want to know experiences about a med when they are weighing thoughts of "to take, or not to take." Thoughts like, will it hurt me? Will I be like the animal toxicology and experience. Can def. be alarming to folks when taken out of context like Essdipity alludes to - as laypersons we must count on our sytems in place like the FDA. It's good you posted it MSinfl because if not, we'd not have the opportunity to include responses ref the same. I can honestly say I read that too a week or so ago and wondered what were the odds that would happen to me if I take it!
What a great discussion - To me, where disease modifiers are concerned (at least where our forum is concerned), there has been consistent comments and thoughts that they "suppress" the immune system, among other things. I'm not surprised Tecfidera will get the same wrap.
Sooooo, well done corrections Essdipity and Twopack, Sarah because of your energy and knowledge to correct the information your educating the masses.
I look forward to adding a new thread like our others in the near future ones that says DMD Users - Tecfidera Add your name here!
These are exciting times to me where treatment is concerned!
-Shell
the one used in europe for psoriasis is a sister drug or cousin drug, not the exact same make up, I read the detailed report "somewhere" but the side effects are supposed to be about the same.
Yes to trials. It has an established side-effect profile as it was used by a small company called Fumaderm (Am fairly certain that was the name) for the treatment of psoriasis in Europe. No GI events to speak of. A chance encounter between a dermatologist and a neurologist ultimately ended up in Biogen getting involved and buying the company.
For me it is occasional flushing. Totally random and not dosing related. Out of all the options it is by far the best in terms of efficacy and side-effect profile. Don't obsess over data-sheets and please, please, please read a bit of Ben Goldacre so you can learn rudimentary trails data interpretation and some of you do stop quoting numbers out of context. It amounts to scaremongering as you aren't properly interpreting what you pass on.
For me it is occasional flushing. Totally random and not dosing related. Out of all the options it is by far the best in terms of efficacy and side-effect profile. Don't obsess over data-sheets and please, please, please read a bit of Ben Goldacre so you can learn rudimentary trails data interpretation and some of you do stop quoting numbers out of context. It amounts to scaremongering as you aren't properly interpreting what you pass on.
Is this the drug that was used for Psoriasis? If so it is not a completely new drug like some that never have been on the market. This drug is not for those who do great on the CRABs it is for people who need more. I am sure the insurance companies are not going to pay for it if someone is showing stability on a CRAB. I think the price tag is $55,000 a year. It is all benefit/risk even with Asprin.
Alex
Alex
I certainly didn't say the FDA is perfect; in fact, I said the opposite.
The fact remains, though, that here in the US the FDA is the best we've got. To get to market, a drug must pass rigorous testing by those far more competent to judge than those of us in the general public. If we all were left to decide on every possible remedy based on our own instincts, what a mess we'd be in. Our tax dollars pay for oversight and scrutiny of every drug, from aspirin to chemotherapy. I for one have confidence in the ability of the experts to do their jobs, always keeping in mind that nothing is 100%.
ess
The fact remains, though, that here in the US the FDA is the best we've got. To get to market, a drug must pass rigorous testing by those far more competent to judge than those of us in the general public. If we all were left to decide on every possible remedy based on our own instincts, what a mess we'd be in. Our tax dollars pay for oversight and scrutiny of every drug, from aspirin to chemotherapy. I for one have confidence in the ability of the experts to do their jobs, always keeping in mind that nothing is 100%.
ess
I don’t remember hearing anyone here talk about being in these trials but I do hope someone will pop up and share. In the mean time, I found some info on the MSAA (MS Association of America) website. I would assume their information is as accurate as any that is presently available.
You can read the entire thing at http://mymsaa.org/news-msaa/840-tecfidera-approved but I’m highlighting a few of the side effect reports from the article in hopes of clarifying points that seem to be causing some dissention here.
“In the large studies leading up to the approval of Tecfidera, flushing and GASTROINTESTIONAL EVENTS, such as diarrhea, nausea and vomiting, and abdominal pain, were the MOST COMMONLY REPORTED side effects. Flushing and gastrointestinal events occurred in approximately 30 TO 40 PERCENT of patients and occurred more often at the beginning of treatment, DECREASING in frequency AFTER THE FIRST ONE OR TWO MONTHS on this medication.”
“In terms of long-term health risks, REDUCED WHITE BLOOD CELL (lymphocyte) COUNTS WERE SEEN DURING THE FIRST YEAR of treatment (lymphocytes are disease-fighting cells). HOWEVER, THE INCIDENCE OF INFECTION DID NOT DIFFER BETWEEN THE TREATED AND PLACEBO GROUPS during the studies. Because of the reduced white-blood cell counts, the FDA recommends that prior to starting Tecfidera, and annually thereafter while still on the treatment, patients be given a complete blood count to monitor their ability to fight infection.”
“During the first six months of therapy in the DEFINE study, LIVER ENZYMES WERE ELEVATED IN 6 PERCENT OF INDIVIDUALS taking Tecfidera, compared to 3 percent of the placebo group. NO CASES OF LIVER FAILURE WERE REPORTED in either study. EXCESS PROTEIN IN THE URINE (proteinuria) WAS OBSERVED SLIGHTLY MORE OFTEN in the treated groups versus the placebo group of the DEFINE study. NO CASES OF KIDNEY FAILURE WERE REPORTED in either study.”
The risks here don’t appear to be high but they do exist and there are PwMS who have refused the interferons citing similar concerns over a likewise unlikely possibility. Each person is entitled to set the personal risk level they are most comfortable accepting.
For what it’s worth, the FDA isn’t perfect and drugs don’t come with guaranteed safety ratings even under the best of circumstances. This drug may have a history of use in other markets for other conditions but the fact remains FDA approval comes after testing is completed in various phases of strictly controlled research settings. The final test phase for any new drug application BEGINS when the first patients outside the research setting fill scripts and begins their therapy.
All of us will need to ask our neuro to find out if they believe Tecfidera is a good fit for us. Hopefully they will help us but how many of us have been handed literature (or not) with no instruction other than, “Get back to me when you decide which one you want to try.” I believe it is entirely appropriate to be asking questions and sharing information. Please just make sure your information is fact based and as accurate as possible.
You can read the entire thing at http://mymsaa.org/news-msaa/840-tecfidera-approved but I’m highlighting a few of the side effect reports from the article in hopes of clarifying points that seem to be causing some dissention here.
“In the large studies leading up to the approval of Tecfidera, flushing and GASTROINTESTIONAL EVENTS, such as diarrhea, nausea and vomiting, and abdominal pain, were the MOST COMMONLY REPORTED side effects. Flushing and gastrointestinal events occurred in approximately 30 TO 40 PERCENT of patients and occurred more often at the beginning of treatment, DECREASING in frequency AFTER THE FIRST ONE OR TWO MONTHS on this medication.”
“In terms of long-term health risks, REDUCED WHITE BLOOD CELL (lymphocyte) COUNTS WERE SEEN DURING THE FIRST YEAR of treatment (lymphocytes are disease-fighting cells). HOWEVER, THE INCIDENCE OF INFECTION DID NOT DIFFER BETWEEN THE TREATED AND PLACEBO GROUPS during the studies. Because of the reduced white-blood cell counts, the FDA recommends that prior to starting Tecfidera, and annually thereafter while still on the treatment, patients be given a complete blood count to monitor their ability to fight infection.”
“During the first six months of therapy in the DEFINE study, LIVER ENZYMES WERE ELEVATED IN 6 PERCENT OF INDIVIDUALS taking Tecfidera, compared to 3 percent of the placebo group. NO CASES OF LIVER FAILURE WERE REPORTED in either study. EXCESS PROTEIN IN THE URINE (proteinuria) WAS OBSERVED SLIGHTLY MORE OFTEN in the treated groups versus the placebo group of the DEFINE study. NO CASES OF KIDNEY FAILURE WERE REPORTED in either study.”
The risks here don’t appear to be high but they do exist and there are PwMS who have refused the interferons citing similar concerns over a likewise unlikely possibility. Each person is entitled to set the personal risk level they are most comfortable accepting.
For what it’s worth, the FDA isn’t perfect and drugs don’t come with guaranteed safety ratings even under the best of circumstances. This drug may have a history of use in other markets for other conditions but the fact remains FDA approval comes after testing is completed in various phases of strictly controlled research settings. The final test phase for any new drug application BEGINS when the first patients outside the research setting fill scripts and begins their therapy.
All of us will need to ask our neuro to find out if they believe Tecfidera is a good fit for us. Hopefully they will help us but how many of us have been handed literature (or not) with no instruction other than, “Get back to me when you decide which one you want to try.” I believe it is entirely appropriate to be asking questions and sharing information. Please just make sure your information is fact based and as accurate as possible.
Like you, I'm not endorsing or condemning either --
Just responding to the post asking where there was data re kidney issues etc.
I did preface the data by saying it's available on the Tecfidera website, in case anyone wants to read the entire pdf.
Sorry if it causes more confusion for anyone -- this is a great group, and we're all lucky to be a part of it.
Just responding to the post asking where there was data re kidney issues etc.
I did preface the data by saying it's available on the Tecfidera website, in case anyone wants to read the entire pdf.
Sorry if it causes more confusion for anyone -- this is a great group, and we're all lucky to be a part of it.
This is in response to the above, and is meant neither to endorse nor condemn Tecfidera as an MS treatment.
I just want it noted that scientific data has to be put in context. It is misleading to cite reports that can be alarming to us laypersons who are not familiar with overall testing procedures, dosage relative to size of subject, differences between animal and human reactions, and so on. If we were all scientifically knowledgeable we could evaluate for ourselves the risk/benefit ratio of all drugs, but the fact is, very few of us are capable of doing this.
That is why we have the FDA, with its very rigorous procedures, reporting requirements and phases of testing. Occasionally a drug turns out to be 'bad' despite all of this, but the huge majority of drugs approved by the FDA are safe to use.
ess
I just want it noted that scientific data has to be put in context. It is misleading to cite reports that can be alarming to us laypersons who are not familiar with overall testing procedures, dosage relative to size of subject, differences between animal and human reactions, and so on. If we were all scientifically knowledgeable we could evaluate for ourselves the risk/benefit ratio of all drugs, but the fact is, very few of us are capable of doing this.
That is why we have the FDA, with its very rigorous procedures, reporting requirements and phases of testing. Occasionally a drug turns out to be 'bad' despite all of this, but the huge majority of drugs approved by the FDA are safe to use.
ess
This is from the Tecfidera Website, a pdf called "Prescriber Information":
Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors:
squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day; leiomyosarcomas ofthe forestomach at 400 mg/kg/day in males and females; renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males;
and renal tubule adenomas at 400 mg/kg/day in females. Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of 480 mg/day.
In rats, oral administration of DMF (25, 50, 100, and 150 mg/kg/day) for up to two years resulted in increases in squamous cell carcinomas and papillomas of the forestomach at all doses tested in males and females, and in testicular interstitial (Leydig) cell adenomas at 100 and 150 mg/kg/day.
.
13.2 Animal Toxicology and/or Pharmacology:
Kidney toxicity was observed after repeated oral administration of dimethyl fumarate (DMF) in mice, rats, dogs, and monkeys.
Renal tubule epithelia regeneration, suggestive of tubule epithelial injury, was observed in all species. Renal tubular hyperplasia was observed in rats with dosing for up to two years.
Cortical atrophy and interstitial fibrosis were observed in dogs and monkeys at doses above 5 mg/kg/day. In monkeys, the highest dose tested (75 mg/kg/day) was associated with single cell necrosis and multifocal and
diffuse interstitial fibrosis, indicating irreversible loss of renal tissue and function.
In dogs and monkeys, the 5 mg/kg/day dose was
associated with plasma MMF exposures less than or similar to that in humans at the recommended human dose (RHD).
Carcinogenicity studies of dimethyl fumarate (DMF) were conducted in mice and rats. In mice, oral administration of DMF (25, 75, 200, and 400 mg/kg/day) for up to two years resulted in an increase in nonglandular stomach (forestomach) and kidney tumors:
squamous cell carcinomas and papillomas of the forestomach in males and females at 200 and 400 mg/kg/day; leiomyosarcomas ofthe forestomach at 400 mg/kg/day in males and females; renal tubular adenomas and carcinomas at 200 and 400 mg/kg/day in males;
and renal tubule adenomas at 400 mg/kg/day in females. Plasma MMF exposure (AUC) at the highest dose not associated with tumors in mice (75 mg/kg/day) was similar to that in humans at the recommended human dose (RHD) of 480 mg/day.
In rats, oral administration of DMF (25, 50, 100, and 150 mg/kg/day) for up to two years resulted in increases in squamous cell carcinomas and papillomas of the forestomach at all doses tested in males and females, and in testicular interstitial (Leydig) cell adenomas at 100 and 150 mg/kg/day.
.
13.2 Animal Toxicology and/or Pharmacology:
Kidney toxicity was observed after repeated oral administration of dimethyl fumarate (DMF) in mice, rats, dogs, and monkeys.
Renal tubule epithelia regeneration, suggestive of tubule epithelial injury, was observed in all species. Renal tubular hyperplasia was observed in rats with dosing for up to two years.
Cortical atrophy and interstitial fibrosis were observed in dogs and monkeys at doses above 5 mg/kg/day. In monkeys, the highest dose tested (75 mg/kg/day) was associated with single cell necrosis and multifocal and
diffuse interstitial fibrosis, indicating irreversible loss of renal tissue and function.
In dogs and monkeys, the 5 mg/kg/day dose was
associated with plasma MMF exposures less than or similar to that in humans at the recommended human dose (RHD).
I am not sure, someone correct me if I am wrong, that the participants in the trial programs are free to discuss it. If there is anyone, will you let us know. I did have a friend on a trial program and she refused to discuss it.
ess is right, there is NO evidence that BG-12, now known by its name Tecfidera, (Tec fi dera) causes "suppressed immune system and possible liver problems" In fact, the prescribing literature given to doctors (yep read that one too) states that the lymphocyte counts did go down in some clinical trial participants and then stabilized after about 6 months. A CBC is needed within the last 6 months before starting it.
lymphocyte counts, to my nursing brain, deal with the WBC in the immune system but there is NO evidence that Tecfidera suppresses the immune system.
I researched this drug VERY THOROUGHLY and then discussed it for over an hour with my caseworker (Tysabri and Tecfidera are now patents held by Biogen) and they answered all of my questions.
I currently take Tysabri and due to my gypsy road status find it difficult to keep arranging infusion sites and welcome a drug where the side effects will probably go away after about 6 months.
Now, that said, I suffer now from the same side effects listed in Tecfidera, and I HAD them from Tysabri until they were worked out with a very patient neuro and a knowledgeable pharmacist and talks with Biogen and with the drug "cocktail" I now have, I no longer have any of the side effects and often forget I am on it until I see it marked on my calendar.
ALL DMD drugs carry some sort of "trade off". It's the price of them. Even my cardiac and urology drugs carry side effects and potential harm, its their trade of,f but the benefits outweigh them.
I am happy that you like your Copaxone but know many who suffer with it, having the side effects that are listed, and some will never get their perfect skin back, as an example. I have a friend who went off of it after 5 years and her thigh looks like nauga hide upholstery (am sure I spelled that wrong) and has no feeling there. Interferon patients are at risk of flu like symptoms for about 1-2 days, I have a friend who takes one and we leave him alone on week-ends, as he takes it on Friday night, hoping to be back to par for work on Monday.........and the list goes on!
My only problem with your post and if admin wants to slap my hand, so be it, is that some people will read it, accept it as gospel and not only believe it but will tell others word for word and the fear grows...........many of us understand the risks of what we take and when new things come out, we tend to really look into it, read, watch, wait, and some, like Kyle and I are waiting eagerly for it. Also this drug was used in Europe for a number of years for another disease before it was put up to FDA for approval for MS
I, for one, am glad its here. I turned down the other oral drug, Gylenia, due to the cardiac risk (I have a long cardiac history) but only because I felt it clashed with a problem that has already brought me face to face with death once and I thought long and hard before starting Tysabri but after much research, went with it and I have already notified Tecfidera thru my current caseworker to send my neuro a notice that I want to start this as soon as they determine if I can afford it.......for those who missed the earlier post, the $10 copay does NOT apply to anyone on Federal programs (VA, Medicare, etc) but am sure it won't be a problem, I already had qualified for free Tysabri before finding insurance to cover what Medicare would not.
ess is right, there is NO evidence that BG-12, now known by its name Tecfidera, (Tec fi dera) causes "suppressed immune system and possible liver problems" In fact, the prescribing literature given to doctors (yep read that one too) states that the lymphocyte counts did go down in some clinical trial participants and then stabilized after about 6 months. A CBC is needed within the last 6 months before starting it.
lymphocyte counts, to my nursing brain, deal with the WBC in the immune system but there is NO evidence that Tecfidera suppresses the immune system.
I researched this drug VERY THOROUGHLY and then discussed it for over an hour with my caseworker (Tysabri and Tecfidera are now patents held by Biogen) and they answered all of my questions.
I currently take Tysabri and due to my gypsy road status find it difficult to keep arranging infusion sites and welcome a drug where the side effects will probably go away after about 6 months.
Now, that said, I suffer now from the same side effects listed in Tecfidera, and I HAD them from Tysabri until they were worked out with a very patient neuro and a knowledgeable pharmacist and talks with Biogen and with the drug "cocktail" I now have, I no longer have any of the side effects and often forget I am on it until I see it marked on my calendar.
ALL DMD drugs carry some sort of "trade off". It's the price of them. Even my cardiac and urology drugs carry side effects and potential harm, its their trade of,f but the benefits outweigh them.
I am happy that you like your Copaxone but know many who suffer with it, having the side effects that are listed, and some will never get their perfect skin back, as an example. I have a friend who went off of it after 5 years and her thigh looks like nauga hide upholstery (am sure I spelled that wrong) and has no feeling there. Interferon patients are at risk of flu like symptoms for about 1-2 days, I have a friend who takes one and we leave him alone on week-ends, as he takes it on Friday night, hoping to be back to par for work on Monday.........and the list goes on!
My only problem with your post and if admin wants to slap my hand, so be it, is that some people will read it, accept it as gospel and not only believe it but will tell others word for word and the fear grows...........many of us understand the risks of what we take and when new things come out, we tend to really look into it, read, watch, wait, and some, like Kyle and I are waiting eagerly for it. Also this drug was used in Europe for a number of years for another disease before it was put up to FDA for approval for MS
I, for one, am glad its here. I turned down the other oral drug, Gylenia, due to the cardiac risk (I have a long cardiac history) but only because I felt it clashed with a problem that has already brought me face to face with death once and I thought long and hard before starting Tysabri but after much research, went with it and I have already notified Tecfidera thru my current caseworker to send my neuro a notice that I want to start this as soon as they determine if I can afford it.......for those who missed the earlier post, the $10 copay does NOT apply to anyone on Federal programs (VA, Medicare, etc) but am sure it won't be a problem, I already had qualified for free Tysabri before finding insurance to cover what Medicare would not.
I was not in a trial so I can't answer that part of your post.
However, I'd like to know where you learned that this drug can cause liver problems. I've read a lot on the subject and have never come across this effect. The interferons can cause elevated liver enzymes, but this isn't an interferon.
Also, there is no evidence that the immune system is suppressed by Tecfidera. Please give us your info.
In general, people doing well with their current treatments and without problem side effects probably should continue as at present, in my view, at least for now. Those with injection issues or hard-to-tolerate effects might look at things differently.
ess
However, I'd like to know where you learned that this drug can cause liver problems. I've read a lot on the subject and have never come across this effect. The interferons can cause elevated liver enzymes, but this isn't an interferon.
Also, there is no evidence that the immune system is suppressed by Tecfidera. Please give us your info.
In general, people doing well with their current treatments and without problem side effects probably should continue as at present, in my view, at least for now. Those with injection issues or hard-to-tolerate effects might look at things differently.
ess
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