TB risk with TNF-alpa inhibitors

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What are TNF-alpha inhibitors?

Tumour necrosis factor alpha (TNF-alpha) inhibitors are a type of medicine used to treat conditions that involve inflammation and problems with the immune system. This includes psoriasis and psoriatic arthritis. TNF-alpha inhibitors are given as an injection every few weeks. When used to treat psoriasis or psoriatic arthritis they are prescribed by rheumatologists or dermatologists, usually after other medicines have been tried and have not worked well enough.

There are five TNF-alpha inhibitors licensed in the UK. These are adalimumab, certolizumab pegol, etanercept, golimumab and infliximab. Read more about use in psoriasis or psoriatic arthritis.

What are the risks of treatment with TNF-alpha inhibitors?

TNF-alpha inhibitors are effective treatments for the symptoms of psoriasis and psoriatic arthritis, but as with all medicines it is possible that there may be unwanted side effects, although not everybody gets them. One of the important risks associated with TNF-alpha inhibitors is that you may get infections more easily. This includes common infections like coughs and colds, as well as more serious infections. The full list of possible side effects can be found in the Patient Information Leaflet (PIL) supplied with the medicine. Copies of the Patient Information Leaflets are also available online: http://www.medicines.org.uk/emc/

TNF-alpha inhibitors and the risk of tuberculosis

One of the serious infections that people taking a TNF-alpha inhibitor are more likely to get is tuberculosis (TB). If you have been exposed to TB in the past it can remain in the body in an inactive state, not causing any symptoms. Being treated with a TNF-alpha inhibitor also increases the risk of inactive TB becoming active again and making you ill.

Although the chance of getting TB is higher in people who are treated with TNF-alpha inhibitors, TB is not common in the UK. The World Health Organisation estimated that 15 out of every 100,000 people developed TB in the UK in 2012. TB can be treated with antibiotics, but it is still a serious illness and can even be life-threatening, especially if it is not treated.

What can be done to reduce the risk of tuberculosis?

The following steps help to reduce the risk of developing an active TB infection when you are treated with a TNF-alpha inhibitor:

  • Before starting treatment you should tell your doctor if you have ever had TB, or have been in close contact with someone else who has.
  • Your doctor should test you for TB to make sure that you are not infected before you start treatment.
     

Patient alert cards for TNF-alpha inhibitors

You should be given a credit card-sized alert card when you start treatment with a TNF-alpha inhibitor. The Alert card has information about some of the risks associated with TNF-alpha inhibitor treatment. The card can be used to record the results of your tests for TB. You should show the card when you visit a GP or other healthcare professional, so that he or she knows that you are using a TNF-alpha inhibitor.

  • You should seek medical advice if you get symptoms of TB during or after treatment with a TNF-alpha inhibitor. Symptoms of TB can include persistent coughing, shortness of breath, flu-like symptoms, weight loss, persistent tiredness, fever, and night sweats.
     

Reporting side effects

If you have any concerns about your treatment, or notice any symptoms which you think may be a side effect, you should talk to your doctor, pharmacist or nurse.

You can report side effects directly to the Yellow Card Scheme. This helps to provide more information on the safety of medicines. Please note the Yellow Card Scheme does not provide medical advice in individual cases.

You can report by using the online Yellow Card form at: www.mhra.gov.uk/yellowcard

Paper Yellow Card forms can be obtained by calling the Yellow Card hotline on freephone 0808 100 3352 (available weekdays 10:00 and 14:00), and can also be found at some pharmacies and GP surgeries. Forms can also be downloaded (the form should be returned to the address on the bottom of the form - no stamp is needed). You can also make a report by telephone to the Yellow Card hotline.

Article supplied by:
The Medicines and Healthcare Products Regulatory Agency (MHRA)
25/11/14