12 more cases of brain infection, 5 more deaths in Tysabri

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

12 more cases of brain infection, 5 more deaths in Tysabri

Postby MSUK » Fri Jul 15, 2011 10:54 am

12 more cases of brain infection, 5 more deaths in Tysabri MS patients

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Biogen Idec Inc. reported 12 more cases of a rare brain infection occurring in multiple-sclerosis patients taking the drug Tysabri, sold with Elan Corp, bringing the affected patients to 145 as of July 5.

The Weston, Mass., biotech company said there was five more deaths among those patients, bringing total deaths to 29, and provided updated data on its effort to develop a risk-assessment test for the infection. The incidence of the infection -- progressive multifocal leukoencephalopathy, or PML -- is updated monthly and is closely watched.

The drug is considered to be highly effective, but it is mostly reserved for patients that stop responding to other MS drugs or have an aggressive case of the debilitating disease.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905
MS-UK - http://www.ms-uk.org/
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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby HarryZ » Fri Jul 15, 2011 3:32 pm

squiffy2 wrote:12 more cases of brain infection, 5 more deaths in Tysabri MS patients


That's one of the largest monthly increases I've seen, both in new cases and related deaths. You would think that these numbers would start to stabilize a bit but instead, they are getting worse.

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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby RuSmolikova » Fri Jul 15, 2011 10:04 pm

HarryZ wrote:
squiffy2 wrote:12 more cases of brain infection, 5 more deaths in Tysabri MS patients


That's one of the largest monthly increases I've seen, both in new cases and related deaths. You would think that these numbers would start to stabilize a bit but instead, they are getting worse.

Harry


In my opinion, it must be worse. After all the number of patients treated for more than two years is constantly increasing.
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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby NHE » Sat Jul 16, 2011 12:53 am

squiffy2 wrote:12 more cases of brain infection, 5 more deaths in Tysabri MS patients

Image

Biogen Idec Inc. reported 12 more cases of a rare brain infection occurring in multiple-sclerosis patients taking the drug Tysabri, sold with Elan Corp, bringing the affected patients to 145 as of July 5.

The Weston, Mass., biotech company said there was five more deaths among those patients, bringing total deaths to 29, and provided updated data on its effort to develop a risk-assessment test for the infection.


What I would like to know is how many of the 145 people with PML have experienced an increase in disability as a direct result of the PML? So far, I have only read about one or two cases, but I suspect that there are many more.

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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby RuSmolikova » Sat Jul 16, 2011 1:37 am

NHE wrote:What I would like to know is how many of the 145 people with PML have experienced an increase in disability as a direct result of the PML? So far, I have only read about one or two cases, but I suspect that there are many more. NHE

"The study he reported here was a follow up to an analysis by the same group of researchers, published last month in Neurology, covering the first 35 PML patients.
The same general patterns were generally seen with the addition of more patients but, not surprisingly, the specific numbers differed somewhat.
Foley and colleagues obtained patient information from the treating physicians as well as from Biogen Idec's registry, comparing characteristics of survivors with those of fatal cases.
Median duration of follow up for the survivors was 9.6 months (range 1.2 to 29.1 months). Among the fatal cases, the median time from PML diagnosis to death was 2.1 months.
Most of the deaths and much of the morbidity in the PML cases were actually attributable to immune reconstitution inflammatory syndrome (IRIS) following withdrawal of natalizumab, Foley indicated.
Comparisons of survivors with fatal cases revealed the following differences:
Median age: 43 in survivors, 53 in fatalities
Median time from symptom onset to PML diagnosis: 27 days in survivors, 41 days in fatalities
Median JC virus loads in cerebrospinal fluid (CSF) at diagnosis: 132,000 copies/mL in survivors, 287,000 copies/mL in fatalities
Moreover, while patients in the U.S. represented 43% of the worldwide PML total, they accounted for 81% of the fatalities.
The survival rate in the U.S. was 62% versus 93% in Europe, Foley said.
Differences in practice patterns
Foley said the reasons for the disparity were uncertain, but he speculated that several differences between the U.S. and Europe in practice patterns may help explain it.
He said that U.S. patients receiving natalizumab were older and had more widespread disease than their European counterparts. Also, physicians in the U.S. may be more reluctant to treat aggressively with steroids when IRIS develops, he said.
"A lot of the U.S. cases probably are dying more during the IRIS phase when there is a lot of cell necrosis," he said. He also indicated that U.S. physicians may have been slower to diagnose PML after symptoms develop.
It is possible that more virulent JC virus strains are endemic in the U.S., he said, although much remains to be learned about the virology of JC virus.
Foley also identified several factors that were virtually identical in the survivors and fatal cases. These included the gender balance, median duration of natalizumab treatment, and prior immunosuppressant therapy.
The latter two have been found in Biogen Idec's analyses to be powerful predictors of PML development, along with JC virus infection status.
Another finding in the new study was that most patients surviving PML appear to need a long time to recover. Among 38 patients with Karnofsky performance ratings by their physicians at least six months after PML diagnosis, only five were in the "mild" disability category.
Half were rated as moderately impaired, and 37% were severely disabled and required custodial care.
One implication of the study, Foley said, is that it may be advisable to begin natalizumab treatment earlier in the disease in patients negative for JC virus. That may improve the survival chances in those extremely rare patients who still go on to develop PML.
At this point, according to Biogen Idec's data, no patient shown to be seronegative for JC virus exposure has developed PML.
But Robert Fox, MD, of the Cleveland Clinic, told MedPage Today that there is some risk that a seronegative patient will become infected during natalizumab treatment. Early data appear to indicate that the annual risk is on the order of 1% to 2% annually, he said.
The serological test now being studied for assessing JC virus status in MS patients also seems to have a false-negative rate of about 2.5%, he said.
Consequently, Fox said, it is likely that patients on natalizumab will need regular retesting every six months to confirm their continued negativity.
The study was supported by Biogen Idec."
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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby NHE » Sun Aug 14, 2011 12:04 am

RuSmolikova wrote:
NHE wrote:What I would like to know is how many of the 145 people with PML have experienced an increase in disability as a direct result of the PML? So far, I have only read about one or two cases, but I suspect that there are many more. NHE

Among 38 patients with Karnofsky performance ratings by their physicians at least six months after PML diagnosis, only five were in the "mild" disability category. Half were rated as moderately impaired, and 37% were severely disabled and required custodial care.


Thank you for posting this information. This is exactly the type of information that I was looking for. It seems that if you're on Tysabri and develop PML, then the chances of escaping unscathed are indeed slim.


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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby RuSmolikova » Sun Aug 14, 2011 8:42 am

NHE wrote:Thank you for posting this information. This is exactly the type of information that I was looking for. It seems that if you're on Tysabri and develop PML, then the chances of escaping unscathed are indeed slim.NHE

That´s it!
If the survivors had the opportunity, perhaps the majority would rather die than vegetated.
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Re: 12 more cases of brain infection, 5 more deaths in Tysab

Postby HarryZ » Fri Sep 02, 2011 5:51 am

Just saw that the August figures show an increase of 12 more cases of PML bringing the total to 157. No info as to any increase in deaths.

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