Golimumab

What is golimumab and how is it used?

In rheumatoid arthritis and some other inflammatory conditions, too much of a protein called TNF is produced in the body, causing inflammation, pain and damage to the bones and joints. Anti-TNF drugs such as golimumab (trade name: Simponi) block the action of TNF and so reduce this inflammation.

They’re not painkillers, but they can modify the disease and should start to improve your symptoms after about 12–14 weeks (after three or four doses).

Golimumab can be prescribed by a consultant rheumatologist for:

• rheumatoid arthritis
• psoriatic arthritis
• axial spondyloarthritis (including ankylosing spondylitis)

There are national and local guidelines that determine when golimumab can be used and these vary depending on the condition.

Golimumab won’t be prescribed if:

• your arthritis isn’t active
• you haven’t tried standard treatments appropriate for your condition first
• you have an infection.

You may not be prescribed golimumab if you’ve had or have:

• repeated infections
• multiple sclerosis (MS)
• cancer
• a serious heart condition
• scarring of lung tissue (lung fibrosis).

You’ll have a chest x-ray and a test to check whether you’ve ever been exposed to tuberculosis (TB). You may need treatment for latent (asymptomatic) TB before starting golimumab.

You may also be checked for previous hepatitis infection, as golimumab may increase the risk of hepatitis being reactivated.

You’ll probably have further checks while you’re on golimumab to monitor its effects.

If golimumab isn’t suitable for you your doctor will discuss other treatment options with you.

When and how do I take golimumab?

Golimumab is given once a month by injection under the skin (subcutaneous injection), usually into your thigh, tummy or upper arm. It comes in a 50mg ‘pen-like’ device or a syringe which you or a relative can learn to use.

If you forget a dose, you should take it as soon as you remember. If it’s more than two weeks late, you should start a new schedule from the date you take the delayed dose. Otherwise, you can keep to your original schedule. NEVER inject a double dose to make up for a forgotten dose.

If you weigh more than 100 kg (approximately 15 stone 10 lb) and you’ve not responded to golimumab after three or four doses, your doctor may increase your dose to 100 mg per month for three or four injections.

Because it’s a long-term treatment it’s important to keep taking golimumab (unless you have severe side-effects):

• even if it doesn’t seem to be working at first
• even when your symptoms start to improve (to help keep the disease under control).

Possible risks and side-effects

The most common side-effects are reactions at the injection site, such as redness, swelling or pain. These reactions aren’t usually serious. Regularly changing the injection site will help reduce
the chances of this irritation.

Golimumab affects your immune system, so you may be more likely to develop infections. You should tell your doctor or rheumatology nurse straight away if you develop a sore throat, fever or other signs of infection, or if you have any other new symptoms that concern you. You should see your doctor straight away if any of your symptoms are severe.

You should also see your doctor if you develop chickenpox or shingles or come into contact with someone who has chickenpox or shingles. These infections can be severe if you’re on golimumab. You may need antiviral treatment, and your golimumab may be stopped until you’re better.

Rarely, people may experience an allergic reaction. Contact your healthcare team if you think you may be having an allergic reaction. If the reaction is severe the drug will have to be stopped.

The long-term side-effects of golimumab aren’t yet fully understood because it’s a
relatively new drug.

Anti-TNF drugs have been associated with some types of skin cancer – these can be readily treated when diagnosed early. Research so far hasn’t shown an increased risk of other cancers.

Very rarely, golimumab can cause a condition called drug-induced lupus, which can be diagnosed with a blood test. The symptoms include a rash, fever and increased joint pain. If you develop these symptoms you should contact your rheumatology team. This is usually mild and clears up if golimumab is stopped.

Reducing the risk of infection

• Try to avoid close contact with people with severe active infections.
• For advice on avoiding infection from food, visit: http://www.nhs.uk/Conditions/Food-poisoning/Pages/Prevention.aspx

Taking other medicines

Golimumab is often prescribed along with other drugs, including methotrexate. Check with your doctor before starting any new medications, and mention you’re on golimumab if you’re treated by anyone other than your usual rheumatology team.

• You can carry on taking a non-steroidal anti-inflammatory drug (NSAIDs) or painkillers if needed, unless your doctor advises otherwise.
• Don’t take over-the-counter or herbal remedies without discussing this first with your healthcare team.

It’s recommended you carry a biological therapy alert card so anyone treating you will know that you’re on golimumab – you can get a card from your rheumatology department.

Vaccinations

It’s usually recommended that people on golimumab avoid live vaccines such as yellow fever. However, sometimes a live vaccine may be necessary – for example rubella immunisation in women of childbearing age.

If you’re offered shingles vaccination (Zostavax) it’s best to have it before starting golimumab. Shingles vaccination isn’t recommended for people who are already on golimumab.

Pneumococcal vaccine (which gives protection against the most common cause of pneumonia) and yearly flu vaccines are safe with golimumab and recommended.

Having an operation

Talk this over with your specialists. It’s likely you will be advised to stop golimumab for a time before and after surgery.

Alcohol

There’s no known interaction between golimumab and alcohol.If you’re also taking methotrexate, you should stay well within government guidelines for adults of no more than 14 units of alcohol per week. Your doctor may advise lower limits. Methotrexate and alcohol can interact and damage your liver.

Fertility, pregnancy and breastfeeding

If you’re planning to try for a baby, if you become pregnant, or if you’re thinking of breastfeeding talk to your rheumatologist.

Guidelines state that most anti-TNF drugs can be taken in pregnancy. There is, however, no evidence on which to advise about the use of golimumab during pregnancy. Since it is very similar to other anti-TNF drugs it is unlikely to be harmful if taken in the first three months of pregnancy as it does not cross to the baby.

If you were to take it throughout pregnancy, particularly in the last three months, then your baby should not have a live vaccine until they are at least seven months of age.

If you are also taking methotrexate this drug should be stopped three months before trying for a baby.Guidelines now state that men don’t need to stop taking methotrexate when trying to father a child.

We don’t know how golimumab might affect men trying to father a baby, though other anti-TNF drugs can be used in this situation. Talk to your rheumatologist.

It’s not known whether golimumab may pass into your breast milk. Other anti-TNF drugs may be used with caution in breastfeeding so you should talk with your doctor whether to use golimumab while breastfeeding.