Lots of people are benefiting from Tecfidera; many do very, very well on it w/o major problems. 2% to 5% (depending on who you read) of the people on Tecfidera experience lymphopenia; that means 95% to 98% don’t. As RingpOP mentioned there are few meds without risks.
Unfortunately, Biogen doesn’t exactly instill confidence when they put out a statement like: “It is not yet clear whether dimethyl fumarate was directly responsible or whether other factors caused this case of PML.” Pretty weak reasoning, IMO.
PML is caused by the JC virus. Period. PML isn’t caused by Tecfidera any more than PML is caused by Tysabri. The article linked by RingpOP states, “PML is a known side effect of another disease modifying treatment, natalizumab (Tysabri).”
Tysabri diminishes immune surveillance blocking white blood cells from crossing the blood brain barrier. White blood cells patrolling the brain normally keep JC virus from becoming a problem. But if enough aren't getting in there JCV can become a problem.
Tecfidera diminishes white blood cells; in the brain and in the blood outside the brain. The recent patient taking Tecfidera got PML and died from pneumonia, Biogen said. Evidently, this person had insufficient white blood cells in the brain to prevent JCV from causing PML and insufficient white blood cells to prevent or recover from pneumonia. Indeed, Biogen has already stated the patient had lymphopenia (low white blood cells).
If PML is a known side effect of Tysabri it’s difficult to believe it is not a side effect of Tecfidera. Neither medicine directly causes PML. JCV directly causes PML. But both meds deplete white blood cells and that depletion allows the mutation of JC virus into a harmful form causing PML.
The argument of whether Tecfidera causes PML directly is a spurious one, IMO. Does a particular medicine, in this case Tecfidera, allow JCV to cause PML? That is the real question. It will be tough for Biogen to argue it didn’t.
It appears this particular medicine allowed JCV to cause PML in one person.
IMO, it is pound your head on the wall stupid for anyone to discontinue Tecfidera based on one person out of 100,000.
MS is a terrible disease. Please don’t stop treatment w/o consulting your doctor. I know people on Tysabri who accept a 1 in 87 risk of PML because they know what MS does to them. A 1 in 100,000 risk certainly ought to be tolerable. Don’t allow fear to take advantage of you by discontinuing Tecfidera because of one case.
Overall, Tecfidera has a good safety profile. It is a very valuable medicine for MS.
Pipes, Agate is spot on with the immunosuppressant info. It is correct that steroids for flares are not considered (in the risk for PML) as prior use of immunosuppressants.
Best.
Unfortunately, Biogen doesn’t exactly instill confidence when they put out a statement like: “It is not yet clear whether dimethyl fumarate was directly responsible or whether other factors caused this case of PML.” Pretty weak reasoning, IMO.
PML is caused by the JC virus. Period. PML isn’t caused by Tecfidera any more than PML is caused by Tysabri. The article linked by RingpOP states, “PML is a known side effect of another disease modifying treatment, natalizumab (Tysabri).”
Tysabri diminishes immune surveillance blocking white blood cells from crossing the blood brain barrier. White blood cells patrolling the brain normally keep JC virus from becoming a problem. But if enough aren't getting in there JCV can become a problem.
Tecfidera diminishes white blood cells; in the brain and in the blood outside the brain. The recent patient taking Tecfidera got PML and died from pneumonia, Biogen said. Evidently, this person had insufficient white blood cells in the brain to prevent JCV from causing PML and insufficient white blood cells to prevent or recover from pneumonia. Indeed, Biogen has already stated the patient had lymphopenia (low white blood cells).
If PML is a known side effect of Tysabri it’s difficult to believe it is not a side effect of Tecfidera. Neither medicine directly causes PML. JCV directly causes PML. But both meds deplete white blood cells and that depletion allows the mutation of JC virus into a harmful form causing PML.
The argument of whether Tecfidera causes PML directly is a spurious one, IMO. Does a particular medicine, in this case Tecfidera, allow JCV to cause PML? That is the real question. It will be tough for Biogen to argue it didn’t.
It appears this particular medicine allowed JCV to cause PML in one person.
IMO, it is pound your head on the wall stupid for anyone to discontinue Tecfidera based on one person out of 100,000.
MS is a terrible disease. Please don’t stop treatment w/o consulting your doctor. I know people on Tysabri who accept a 1 in 87 risk of PML because they know what MS does to them. A 1 in 100,000 risk certainly ought to be tolerable. Don’t allow fear to take advantage of you by discontinuing Tecfidera because of one case.
Overall, Tecfidera has a good safety profile. It is a very valuable medicine for MS.
Pipes, Agate is spot on with the immunosuppressant info. It is correct that steroids for flares are not considered (in the risk for PML) as prior use of immunosuppressants.
Best.
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