Golimumab is a new anti TNF (anti-tumour necrosis factor) drug which has been approved by NICE for AS.
NICE has approved the use of the anti TNF therapy golimumab (Simponi) in AS. It will be used in the same way as adalimumab (Humira) and entanercept (Enbrel).
Golimumab is given by once monthly subcutaneous injection (an injection under the skin) using a pre-filled 'pen' device. You, your partner, or another member of your family can learn to give the injections. If this is not possible, the injections can be given by your rheumatology specialist nurse or a district nurse. The injections usually go under the skin of the thigh or the tummy.
If you are being prescribed golimumab, it is recommended that you carry a biological therapy alert card, which you can obtain from your doctor or rheumatology nurse. Then if you become unwell, anyone treating you will know that you are on golimumab and that you are therefore at risk of its side-effects, including infections.
Time golimumab takes to work
If you respond to golimumab, you will probably feel better in 12-14 weeks; that is after 3-4 doses. If you weigh more than 100 kg (approx 15 stone 10 lb) and you have not responded to golimumab, your doctor may consider increasing the dose of golimumab to 100 mg per month for 3 or 4 more injections.
Possible risks or side-effects?
Reactions at the injection site (e.g. redness, swelling or pain) may occur. These reactions are usually not serious.
Golimumab has effects on the body's own defence system (the immune system), and therefore may make you more likely to develop infections. You should tell your doctor or rheumatology nurse straight away if you develop any of the following after starting golimumab:
- a sore throat
- a fever
- any other symptoms of infection
- any other new symptoms or anything that concerns you.
You should see your doctor immediately if:
- if you have never had chickenpox and you come into contact with someone who has chickenpox or shingles
- you develop chickenpox or shingles. Chickenpox and shingles can be severe in people who are on treatments such as golimumab which affect the immune system. Therefore you may need antiviral treatment which your doctor will be able to prescribe.
Rarely people may experience an allergic reaction to golimumab. If the reaction is severe the drug will have to be stopped.
Rarely, people taking golimumab may develop a condition called ‘drug-induced lupus', which is usually mild. The symptoms are a rash, fever and increased joint pain. Your doctor will check for this with a blood test. If you develop drug-induced lupus, golimumab will be stopped and the condition usually then disappears.
It is possible that there may be a slightly increased risk of certain types of cancer in patients using anti-TNF drugs. Such a link has not been proven but is the subject of current research. Please discuss this with your doctor if you are concerned. Anti-TNF drugs have been associated with certain types of skin cancer - these can be readily treated when diagnosed early.
As yet, the long-term side-effects of golimumab are not fully understood because it is a relatively new drug.
Reduce the risk of infection
Because of its effects on the immune system, golimumab may make you more susceptible to food-borne infections such as salmonella and listeria, which may result in food poisoning and other serious illnesses. You can minimise this risk by avoiding foods such as:
- raw eggs or products made from raw eggs (such as mayonnaise, although many commercially available products are safe)
- unpasteurised milk
- mould-ripened soft cheeses (e.g. Brie and Camembert) and blue cheeses (whether pasteurised or unpasteurised), feta and goat's cheese
- undercooked meat and poultry
- all types of pâté.
You should also wash all raw fruit and vegetables and ensure that chilled ready meals are thoroughly cooked before eating. For further advice see the NHS Choices web page on food safey.
Checks needed while on golimumab
You will have a chest x-ray and blood tests before starting treatment. You may also have further blood tests while you are on golimumab to monitor its effects.
You will be assessed a few weeks after starting the drug in order to see that it is helping to treat your condition.
Golimumab may increase the risk of hepatitis B infection being reactivated in people who carry the virus. If your doctor considers that you may be at risk from a previous hepatitis B infection, he or she may test your blood for the presence of hepatitis B.
Taking other medicines along with golimumab
Golimumab may be prescribed along with other medications. You should discuss any new medications with your doctor before starting them, and you should always tell any other doctor treating you that you are taking golimumab.
Golimumab is not a painkiller. If you are already on a non-steroidal anti-inflammatory drug (NSAID) or painkillers you can carry on taking these as well as golimumab, unless your doctor advises otherwise.
Do not take over-the-counter preparations (other than paracetamol) or herbal remedies without discussing this first with your doctor, rheumatology nurse or pharmacist.
If you are on golimumab it is recommended that you should not be immunised with ‘live' vaccines such as yellow fever. However, in certain situations a live vaccine may be necessary (for example rubella immunisation in women of childbearing age), in which case your doctor will discuss the possible risks and benefits of the immunisation with you.
Pneumovax (which gives protection against the commonest cause of pneumonia) and yearly flu vaccines are safe and recommended.
Golimumab and surgery
If you are going to have an operation please inform your doctor, as you may be advised to stop golimumab temporarily before and after surgery.
Golimumab may take up to 5 months to be eliminated from the body; therefore even if you stop taking golimumab your immune system may be impaired for several weeks. This may be relevant if you are about to have surgery.
Golimumab and fertility or pregnancy
No-one knows the risk of golimumab to an unborn baby. Women of child-bearing age therefore must use contraception while on golimumab. If you are planning to become pregnant, you should continue to use contraception for 6 months after stopping golimumab.
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Last reviewed: March 2012