2
Positive Negative Yes <=0.9 <=1.1 <=1.3 <=1.5 >1.5 49-72 months titre level 1-24 months No Have you previously taken Immunosuppressants? How long have you been on Tysabri? How long have you been on Tysabri? 25-48 months 1-24 months <=0.9 <=1.1 <=1.3 <=1.5 >1.5 <=0.9 <=1.1 <=1.3 <=1.5 >1.5 titre level titre level 49-72 months 25-48 months Insufficient data Low PML risk High PML risk 1 in 10,000 1 in 1,429 1 in 833 1 in 769 1 in 118 1 in 2,500 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. What is your JC virus status? 1 in 3,333 Date: 19th May 2014 What is your risk of developing PML? 1 in 1,429 1 in 1,000 1 in 833 1 in 123 1 in 89 1 in 556 1 in 1,000 1 in 10,000 RISK FACTOR: Previous treatment with immunosuppressive (IS) drugs. These are drugs that reduce the activity of your body’s immune system. RISK FACTOR: TYSABRI treatment duration, especially over 2 years.  RISK FACTOR: Titre level is the level of antibodies in your blood.

Barts MSer PML Risk Guide May 2014

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Page 1: Barts MSer PML Risk Guide May 2014

Positive

Negative

Yes

<=0.9

<=1.1

<=1.3

<=1.5

>1.5

49-72 months titre level

1-24 months

No

Have you previously taken Immunosuppressants?

How long have you been on Tysabri?

How long have you been on Tysabri?

25-48 months

1-24 months

<=0.9

<=1.1

<=1.3

<=1.5

>1.5<=0.9

<=1.1

<=1.3

<=1.5

>1.5

titre level

titre level

49-72 months

25-48 months

Insufficient data

Low PML risk High PML risk

1 in 10,000

1 in 1,429

1 in 833

1 in 7691 in 118

1 in 2,500

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.

What is your JC virus status?

1 in 3,333

Date: 19th May 2014

What is your risk of developing PML?

1 in 1,429

1 in 1,0001 in 833

1 in 123

1 in 89

1 in 556

1 in 1,000

1 in 10,000

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

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

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

RISK FACTOR:Titre level is the level of antibodies in your blood.

Page 2: Barts MSer PML Risk Guide May 2014

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.108448 people have developed PML

reported as of 6th March 2014.

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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