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Barts & the london pml risk education guide June 2013

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Understand your risk of PML with Tysabri Tysabri (Natalizumab) is a drug that has shown a reduction in relapses for multiple sclerosis patients. However, as with most drugs, there are risks linked to the long term use of Tysabri. The main risk is of a potentially fatal brain infection, called progressive multifocal leukoencephalopathy (PML). We need our white blood cells to fight off infections. Tysabri can suppress the immune system and blocks white blood cells from getting into the brain. That means if we get an infection which attacks the brain, like PML, our immune system can’t fight it. PML is caused by the JC virus, a common virus completely unrelated to MS. The virus has no symptoms, so we don’t know we’ve got it. You must have been infected with JC virus to be at risk of PML. What are the risks of Tysabri Treatment? What are the benefits of Tysabri treatment? What are the risks of PML? of these people have died. 83 81 reduction in relapse rate % 64 % >1 in 3 359 people have developed PML reported as of May 2013. reduction in disability progression PML may be fatal or result in severe disability. are free of disease activity What is Tysabri? What are the risks? How are Tysabri and PML linked?
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Page 1: Barts & the london pml risk education guide  June 2013

Understand your risk of PML with Tysabri

Tysabri (Natalizumab) is a drug that has shown a reduction in relapses for multiple sclerosis patients. However, as with most drugs, there are risks linked to the long term use of Tysabri.

The main risk is of a potentially fatal brain infection, called progressive multifocal leukoencephalopathy (PML).

We need our white blood cells to fight off infections. Tysabri can suppress the immune system and blocks white blood cells from getting into the brain. That means if we get an infection which attacks the brain, like PML, our immune system can’t fight it.

PML is caused by the JC virus, a common virus completely unrelated to MS. The virus has no symptoms, so we don’t know we’ve got it. You must have been infected with JC virus to be at risk of PML.

What are the risks of Tysabri Treatment?

What are the benefits of Tysabri treatment?

What are the risks of

PML?

of these people have died.83

81 reduction in relapse rate%

64%

>1 in 3 359 people have developed PML

reported as of May 2013.reduction in disability progression

PML may be fatal or result in severe disability.

are free of disease activity

What is Tysabri?

What are the risks?

How are Tysabri and PML linked?

Page 2: Barts & the london pml risk education guide  June 2013

Positive

Negative

No

Yes

No

No

Yes

Yes

Tysabri treatmentmore than 2 years

Have you previously taken Immunosuppressants?

Have you previously taken Immunosuppressants?

1 in 14286

1 in 1667

1 in 556

1 in 192

1 in 94

RISK FACTOR:Prior history of JC virus infection, as indicated by the presence of JCV antibodies. 

Almost half of the general UK population are infected with JC virus in childhood and adolescence. It is unknown how you catch the virus, but

you excrete it in your urine and we think it is found in the tonsils.

The JC virus test will detect if you have anti-JC virus antibodies, meaning you have been infected with the virus at some point.

RISK FACTOR:Previous treatment with immunosuppressive (IS) drugs.

These are drugs that reduce the activity of your body’s immune system.

What is your JC virus status?

RISK FACTOR:TYSABRI treatment duration, especially over 2 years.  

Highest PML risk

Lowest PML risk

Date of print: June 2013

What is your risk of developing PML?

Page 3: Barts & the london pml risk education guide  June 2013

Negative Positive

Understand your risk of PML with Natalizumab

46212

What is Natalizumab?

What are the risks?

How are Natalizumab and PML linked?

The most effective treatment of PML is to get Tysabri out of the body and let the immune system back in the brain to identify the infection and clear it.

This means stopping the drug and washing it out using a treatment called plasma exchange.

www.ms-res.org

Why do I need regular JC virus tests?

What happens if I get PML?Who can I contact to discuss this further?

JC virus Test date ..../..../....

Understand your risk of PML with Tysabri

What are the risks of Tysabri Treatment?

What are the risks of

PML?

of these people have died.83359 people have developed PML

reported as of May 2013.

PML may be fatal or result in severe disability.

This means that you have one of the three risk factors to developing PML. Now you are JC virus positive, you will not be retested.

You will not be taken off Tysabri.

If you are uncomfortable with the increased risk, there are alternative treatment options available. This should be discussed with your clinician or MS Nurse.

This means you have not been infected with the JC virus but every year 2% of the population become JC virus positive. It’s like catching a cold.

We will retest you every 6 months.

I am JC virus...

Understand your risk of PML with Tysabri

Tysabri (Natalizumab) is a drug that has shown a reduction in relapses for multiple sclerosis patients. However, as with most drugs, there are risks linked to the long term use of Tysabri.

The main risk is of a potentially fatal brain infection, called progressive multifocal leukoencephalopathy (PML).

We need our white blood cells to fight off infections. Tysabri can suppress the immune system and blocks white blood cells from getting into the brain. That means if we get an infection which attacks the brain, like PML, our immune system can’t fight it.

PML is caused by the JC virus, a common virus completely unrelated to MS. The virus has no symptoms, so we don’t know we’ve got it. You must have been infected with JC virus to be at risk of PML.

What are the benefits of Tysabri treatment?

What are the risks of

PML?

81 reduction in relapse rate%

64%

>1 in 3 reduction in disability progression

are free of disease activity

What is Tysabri?

What are the risks?

How are Tysabri and PML linked?

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