Certolizumab

What is certolizumab pegol and how is it used?

In rheumatoid arthritis and some other 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 certolizumab pegol (trade name:Cimzia) block the action of TNF and so reduce this inflammation.

Certolizumab pegol isn’t a painkiller but can modify the disease and improve your symptoms over a period of 6–12 weeks.

Certolizumab pegol can be prescribed by a consultant rheumatologist for:

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

There are national and local guidelines that determine when it can be used, and these vary according to which condition you have. It’s usually prescribed along with methotrexate unless methotrexate isn’t suitable for you.

Certolizumab pegol won’t be started if:

• the disease isn’t active
• you have an infection
• you haven’t tried other treatments appropriate for your condition first.

Your doctor may decide not to prescribe certolizumab pegol if you’ve had:

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

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

You’ll need further blood tests while you’re on certolizumab pegol to monitor its effects.

When and how do I take certolizumab pegol?

Certolizumab pegol is taken as an injection under the skin (subcutaneous injection) using a pre-filled penlike syringe. You, your partner, or another family member can learn to give the injections at home.

Each pre-filled syringe contains 200 mg. Your doctor will advise on the correct dose – usually 400 mg (two syringes) once every two weeks for the first three doses, then 200 mg (one syringe) every two weeks.

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

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

If you forget a dose of certolizumab pegol, take the next dose as soon as you remember. Then continue according to your original schedule.

Possible risks and side-effects

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

Because certolizumab pegol 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, coughing up green phlegm, diarrhoea, or any other new symptoms that concern you. If any of these symptoms are severe, you should stop taking certolizumab pegol 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 certolizumab pegol. You may need antiviral treatment, and the drug may be stopped until you’re better.

Rarely, people may experience 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, certolizumab pegol 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 certolizumab pegol 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

Certolizumab pegol 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 certolizumab pegol if you’re treated by anyone other than your usual rheumatology team.

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

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

Vaccinations

It’s best to discuss vaccinations with your healthcare team before starting certolizumab pegol.

It’s usually recommended that people on certolizumab pegol 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 certolizumab pegol. Shingles vaccination isn’t recommended for people who are already on this medication.

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

Having an operation

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

Alcohol

There’s no known interaction between certolizumab pegol and alcohol. However, if you’re also taking methotrexate, you should keep well within the recommended limits of 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 plan to try for a baby, become pregnant, or are thinking of breastfeeding we suggest you discuss your medications with your rheumatologist.

Current guidelines state that certolizumab pegol can be used throughout pregnancy to help prevent a flare-up of your arthritis. With other anti-TNF drugs, if taken in the later stages of pregnancy, it’s recommended that your baby doesn’t have any live vaccines until they’re seven months old in case their immune system is affected. It’s not clear if this applies to certolizumab pegol as it appears that less of this drug reaches the baby than with other anti-TNFs. We suggest you discuss this with your healthcare team.

If you’re also taking methotrexate this drug should be stopped 3 months before you try for a baby.

There’s no evidence certolizumab pegol is harmful in men trying to father a child, and other anti-TNF drugs can be used in this situation. We suggest you discuss this with your rheumatologist. For men who are also taking methotrexate, guidelines
now state that methotrexate doesn’t need to be stopped when trying to father a child.
There’s only limited information about the use of certolizumab pegol while breastfeeding but research suggests it doesn’t pass into your breast milk, so it’s unlikely to be harmful. If you were also taking methotrexate before your pregnancy, this should not be re-started until you stop breastfeeding.