What is etanercept?

Etanercept (Enbrel™) is a type of drug known as anti-TNF. In rheumatoid arthritis and some other inflammatory conditions, too much of a protein called TNF (tumour necrosis factor) is produced in the body, causing inflammation, pain and damage to the bones and joints. Anti-TNF drugs such as etanercept block the action of TNF and so reduce this inflammation.

Etanercept isn't a painkiller, but can modify the disease and should start to improve your symptoms over a period of 2–12 weeks.

Uses

Etanercept can be prescribed by a consultant rheumatologist for:

There are national and local guidelines that determine when it can be prescribed, and these vary according to which condition you have. It's usually given along with other disease-modifying drugs – for example, methotrexate or sulfasalazine.

Before starting etanercept you'll have a chest x-ray and tests to check if you've ever been exposed to tuberculosis (TB). You may need treatment for latent (asymptomatic) TB before starting etanercept. You'll also be checked for previous hepatitis infection, as etanercept may increase the risk of hepatitis being reactivated.

You may have further blood tests while you're on etanercept to monitor its effects.

Are there any reasons I won't be prescribed etanercept?

Etanercept won't be started if:

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

Doctors sometimes use a score known as DAS28 to work out how active your arthritis is. This counts how many of 28 specific joints are tender and swollen, and looks at inflammation levels in a blood test. You'll also be asked to score how well you feel on a scale of 0 to 10.

Your doctor may decide not to prescribe etanercept if you've had:

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

How is it taken?

Etanercept is taken once or twice a week as an injection under the skin (subcutaneous injection) using a pre-filled pen-like syringe – these should be stored in the fridge. You, your partner, or another member of your family can learn to give these injections at home.

If etanercept works for you, your symptoms should start to improve over 2–12 weeks. Because it’s a long-term treatment, it's important to keep taking etanercept (unless you have severe side-effects):

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

Etanercept bio-similar

Etanercept was originally available only under the brand name Enbrel. More recently, a new version of etanercept with the brand name Benepali has become available.

This new drug is referred to as a 'bio-similar' because it's meant to act in the same way as the original drug. Because this drug is newer, we don't yet know as much about it in terms of safety and effectiveness in all the situations described in this leaflet.

Benepali is only licensed for adults aged 18 and over, whereas Enbrel can be prescribed to children from the age of 2 years old as well as to adults.

Some known risks associated with Enbrel are thought to apply to Benepali, for example, people taking Benepali are warned that they are more at risk of infectious diseases such as tuberculosis. If you are currently being treated with Enbrel and it is proposed that you change to Benepali, we strongly advise you discuss this with your rheumatology team before any change is made.

Side-effects and risks

The most common side-effects of etanercept are:

  • a blocked or runny nose
  • nausea (feeling sick)
  • a mild fever
  • headaches
  • dizziness
  • a rash
  • stomach pain or indigestion.

Some people may have reactions at the injection site such as redness, swelling or pain. Regularly changing the injection site will help reduce the chances of this irritation.

Because etanercept affects the immune system, it can make you more likely to pick up infections. It can also make them harder to spot. Tell your doctor or rheumatology nurse straight away if you develop any signs of infection such as:

  • a sore throat or fever
  • unexplained bruising, bleeding or paleness
  • any other new symptoms that concern you.

If any of these symptoms are severe, you should stop taking etanercept and see your doctor straight away.

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

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

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 confirmed an increased risk of other cancers.

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

Reducing the risk of infection

Effects on other treatments

Etanercept may be prescribed along with other drugs, including methotrexate. Check with your doctor before starting any new medications, and remember to mention you're on etanercept if you're treated by anyone other than your usual rheumatology team.

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

Vaccinations

It's best to discuss vaccinations with your healthcare team before starting etanercept. It's usually recommended that people on etanercept 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 if you can have this before starting etanercept. Shingles vaccination isn't recommended for people who are already on etanercept.

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

If possible, children should have the standard immunisations before starting etanercept. Measles, mumps and rubella (MMR) immunisation may need to be delayed in children being treated with etanercept.

Having an operation

Talk this over with your specialists. It's likely you'll be advised to stop etanercept for a time before and after surgery.

Alcohol

There's no known interaction between etanercept and alcohol. However, if you're also taking methotrexate, you should keep well within the recommended limits (no more than 14 units of alcohol per week for adults) because methotrexate and alcohol can interact and affect your liver. In some circumstances your doctor may advise lower limits.

Fertility, pregnancy and breastfeeding

If you're planning to try for a baby, if you become pregnant, or if you're thinking of breastfeeding we suggest you discuss your medications with your rheumatologist.

Current guidelines state that etanercept can be used during pregnancy and in men trying to father a child. If it's used during pregnancy it will usually be stopped after about six months. If it's used after this, then it's possible (though not proven) that it may increase the risk of infection in the newborn baby. However, if there's concern that your arthritis may flare up if etanercept is stopped then you can continue with it throughout your pregnancy – in this case, your baby should not have any live vaccines (such as BCG) until they're seven months old.

Women who are also on methotrexate should stop taking it and use contraception for at least three months before trying for a baby. Current guidelines state there's no need for men to stop methotrexate when trying to father a baby.

There's only limited information about the use of etanercept in breastfeeding mothers, but we have no evidence that it's harmful. If you were also taking methotrexate before your pregnancy this should not be re-started until you stop breastfeeding.