tysabri pml progressive multifocal leukoencephalopathy

Genentech withdrew its psoriasis drug Raptiva from the market yesterday, citing the risk of developing progressive multifocal leukoencephalopathy (PML), a rare, often fatal brain infection. The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA)." http://www.the-scientist.com/templates/trackable/display/blog.jsp?

There are apparently two new cases of people on Tysabri with progressive multifocal leukoencephalopathy (PML). See http://www.bloomberg.com/apps/news?

Since the re-launch of Tysabri in July 2006, no new cases of progressive multifocal leukoencephalopathy (PML) have been reported. PML is an often-fatal viral infection of the brain. Data from the PLEX study suggest that plasma exchange may be an effective procedure for accelerating the removal of Tysabri from the blood if PML infection is suspected.

PHILADELPHIA, Pennsylvania — A new study shows that combining 2 markers for risk for progressive multifocal leukoencephalopathy (PML) during long-term therapy for relapsing-remitting multiple sclerosis (RRMS) with natalizumab (Tysabri, Biogen Idec) may expand the population of patients at risk compared with using the traditional single parameter of positivity for JC virus (JCV) antibody alone. "Patients that had high antibody titers had lower expression of CD62L.

The medication was taken off the market several years ago due to three people dying of PML- Progressive Multifocal Leukoencephalopathy. They found out the reason people contracted PML was because they were taking Avonex/and the other MS medications with Tysabri. I think the Tysabri has given me a second chance at helping slow my disease progress, but with out it I would be on no MS medications to slow the disease.

In Oct 2008 Health Canada fast-tracked Biogen Idec’s Tysabri, despite concerns it can cause a rare fatal brain infection called progressive multifocal leukoencephalopathy (PML). (The total worldwide total reported cases of Tysabri-linked PML stands at 181; the death count at 38.) This month, the FDA fast-tracked Tovaxin, a drug developed to treat secondary progressive MS on the grounds that no other therapies were available for this group.

s Committee for Medicinal Products for Human Use, known as CHMP, reported 23 cases of progressive multifocal leukoencephalopathy, or PML, a number that the Food and Drug Administration later confirmed, adding that those cases were after Tysabri returned to the market in 2006. The FDA said it is continuing to assess the situation. A Biogen spokeswoman, citing company policy, declined to comment on the number of PML cases.

t changed, and the agency stressed that the overall rate of patients developing progressive multifocal leukoencephalopathy, or PML, remains below the one-in-1,000 rate implied on the label. Another article said that as of Sept. 22, 2009, there have been 13 cases of PML worldwide, and that it became evident between 12 - 35 injections.

Other demyelinating disease are, leukodystrophies, central pontine myelinosis and progressive multifocal leukoencephalopathy. hope this helps. Consult a neurologist for evaluation. Take care.

s scared of the big guns (what I consider Tysabri) and risk of PML (progressive multifocal leukoencephalopathy) then he should definitely bring this concern to the Dr. for more insight. His doc may have good reasons to steer him this direction. We have Tysabri users on the forum and I'm hoping they see this post so you can get some 1st hand user experiences. Because of the above risk, there are checks inplace and monitoring while on it.

However, we have some good evidence that the TOUCH surveillance program is learning to pick out at least some of the people who may be at higher risk for PML, stopping the Tysabri and trying preemptive measures to get the Tysabri out of the system. Okay then. What is the worst thing that could happen if you don't do anything - except steroids - and what is the risk that it would happen?

005 TYSABRI Updated Incidence of Progressive Multifocal Leukoencephalopathy in Natalizumab-Treated Multiple Sclerosis Patients Stratified by Established Risk Factors – Platform S41.001 Anti-JCV Antibody Prevalence in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Natalizumab: Baseline Results of STRATIFY-2 – Platform S41.

Differential considerations include acute disseminated encephalomyelitis as well as progressive multifocal leukoencephalopathy. Also included in the differential would be chronic white matter small vessel ischemic change or demyelinating process such as multiple sclerosis. Further evaluation with dedicated MR imaging of the brain with intravenous contrast is recommended.

However since you say it is a big name, it could be Progressive Multifocal Leukoencephalopathy, posterior reversible encephalopathy syndrome (PRES), or Central pontine myelinolysis. It is really difficult to say what it was. Maybe one of this will sound familiar to you. Hope this helps. Please let me know if there is any thing else and do keep me posted. Take care!

We have a great concern about the use of Tysabri, the non-CRAB drug that is used as a last resort for MS patients who haven’t responded to other treatment, because of the possibility of PML , Progressive Multifocal Leukoencephalopathy. There have been a handful of PML cases reported among Tysabri users. PML is also listed as a possible side effect of many of the oral meds that are in the FDA pipeline for approval.

The thought at the time was that if patients took Tysabri alone, PML would not be an issue. Tysabri was re-released to the market, but with strict conditions and monitoring requirements, known as the TOUCH program. Unfortunately, that has not proven to be true. There have since been cases of PML as well as some deaths in patients who were taking only Tysabri at the time. When I started Tysabri in 2008, the estimated risk of PML was 1 in 1000.

If there are white spots on MRI, it is difficult to say whether they are due to MS or due to PML. However, PML Disease (Progressive Multifocal Leukoencephalopath) is more common in patients with suppressed immune systems like transplant recipients, cancer and HIV sufferers. On the other hand MS is more common in general population. Hence since other parts of the brain are normal, the diagnosis will depend on clinical findings.

There is an alogirthm for the chances of contracting PML while on tysabri. I believe it is on the tysabri website among other places. I will see if I can find it for you and report back.

• Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the U.S. FDA and the company have released data suggesting that the risk increases with increasing time on therapy. • The company changed the label of Tysabri to indicate that the risk of PML is increased in patients who have been treated with an immunosuppressant (such as mitoxantrone, and less commonly, azathioprine and methotrexate) prior to receiving Tysabri.

Plasmorephis, blood filtering is already standard treatment to get Tysabri out of the body quickly if PML happens. I saw that a trial had been registered with the US FDA in clinicaltrials.gov when Tysabri was returned to market a trial was registered for Plasmorephis blood filtering to remove Trysabri from the body quickly whren it needed to be removed quickly. I was proud of myself for noticing when that trial was registed with the gov & watched it's successful completion.

I read about this yesterday. While it is not godd to hear that PML is occurring with Tecfidera use, it is good to see that PML is no longer 100% fatal.

Tysabri pml progressive multifocal leukoencephalopathy

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