Tecfidera and Brain Infections

[Lia]

Hi everyone. I went to visit my 6th neurologist. Long story maybe for another time. This new MS neurologist wanted to conduct all his own investigations so since last December until this February I will have undergone a ton of blood work, a lumbar puncture, salivary glands testing, nerve conduction studies, evoked potential studies, and an MRI of my brain and spinal cord. Then in late February my new MS neurologist will review the results of all the above investigations. He also has my previous history which includes many reports from previous neurologists and specialists and MRI reports to review. I have been taking Tecfidera for the last 2 years since I was diagnosed just over 2 years ago. The concern that my new MS neurologist has is that he want to be certain that I do in fact have MS because so far reports seem to be inconclusive. My new MS neurologist also stated that a complication from using Tefidera may be a brain infection to which no treatment currently exists. Has anyone else heard this same concern about using Tecfidera to treat RRMS? Please let me know if you have any further information. Thanks so much!

[jreagan70]

The concern that my new MS neurologist has is that he want to be certain that I do in fact have MS because so far reports seem to be inconclusive.

I guess that explains the long story about why you're seeing your 6th neuro.

My new MS neurologist also stated that a complication from using Tefidera may be a brain infection to which no treatment currently exists. Has anyone else heard this same concern about using Tecfidera to treat RRMS?

The concern about infections doesn't apply only to Tecfidera. ANY medication that can suppress the immune system leaves the body open to infections of all kinds. The drug's mechanism of action and a person's own susceptibility determines how likely those infections are to happen and how likely they are to recover from them.

The specific brain infection your neuro was referring to is called progressive multifocal leukoencephalopathy, or PML for short. Tecfidera isn't a medication that is believed to have a high chance of leading to PML, but there has been at least one case of it in a person taking Tecfidera. A warning about it has been added to the prescribing information, which is on that large piece of paper that comes with your prescription.

PML is rare, but rare doesn't mean nonexistent. On the other hand, rare does mean that a decision about whether to take a medicine should keep in mind how rare the chances of developing PML truly are -- it has to be kept in perspective.

Your neuro was also speaking in generalities. It is no longer true that there are no treatments for PML. When recognized early -- which is the key -- there are steps that can be taken to reduce the likelihood of death and disability. There isn't any guarantee that the treatment will be effective, but the death rate in MS patients who develop PML while taking other medications seems to have been reduced by early treatment.

Again, keep in mind that there has been only one occurrence of PML attributable to Tecfidera (more for other medications). That doesn't mean that people on Tecfidera aren't developing other kinds of infections, but even those don't seem to be common.

[Marco]

Hi Lia!
Prior to diagnosing MS, all other possibilities be explored and excluded so it's not a bad thing to be tested. There have been a number of patients misdiagnosed with MS so it's not bad that a neurologist wants to be thorough. In your case it can serve as a 2nd or even 6th opinion.

The brain infection your neurologist is talking about is called Progressive multifocal leukoencephalopathy (PML). There have been a handful of Tecidera, and also on its predecessor Fumaderm, that have contracted PML. By design, Tecfidera modulates down the number of available lymphocytes you have -and- this is a GOOD thing for MS patients. The problem can occur when your lymphocyte drops to an unsafe level. This is largely mitigated by having regular blood work to determine if your lymphocyte counts remain in a safe range. A significant PML risk factor is whether or not you test positive for the John Cunningham virus (JC or JCV). JCV is very common and testing positive does not preclude you from taking Tecfidera or any other MS medication. The other thing to consider is that the majority of our more potent medications also have higher risk profiles. Only you can decide what an acceptable risk vs side effect ratio for you.

There's a ton of information on PML, Tecfidera and PML and Tecfidera. The current treatment for PML is plasmapheresis or plasma exchange. If you look at PML mortality rates you need to exclude HIV and organ recipients from the rates. Death in their population groups is much higher than PML-related deaths in the MS community. Also remember that a number of our medications have some risk of developing PML.

I personally have no PML reservations about treating RRMS with Tecfidera, but that's just my opinion, Please ask if you have any other questions. I wish you well!

[Lia]

Thanks so much for the information and clarifying my inquiry.

It's so ironic that following my post I saw the first commercial advertising Tecfidera to treat MS and in the list of side effects is PML which can be fatal. This frightens the heck out of me.

I will have to wait until the end of February to discuss diagnosis and treatment options with my MS Neurologist. I will give you an update following this appointment.