Certolizumab pegol (Cimzia)

What is certolizumab pegol?

Certolizumab pegol (Cimzia™) is an anti-TNF drug.

In rheumatoid arthritis and some other 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 certolizumab pegol 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.

Uses

Certolizumab pegol can be prescribed by a rheumatologist for:

There are national and local guidelines that determine when it can be used, and these vary depending on which condition you have. It's usually prescribed alongside methotrexate (unless methotrexate isn't suitable for you).

Are there any reasons I won't be prescribed certolizumab pegol?

Certolizumab pegol won't be started if:

  • the disease isn't active
  • you have an infection
  • you haven't tried other treatments suitable 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 cartolizumab 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 a course of 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.

How is it taken?

Certolizumab pegol is taken as an injection under the skin (subcutaneous injection) using a pre-filled pen-like 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.

How long does it take to work?

If certolizumab pegol works for you, you'll probably feel better in 2–12 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.

Side-effects and risks

The most common side-effects are reactions at the injection site such as 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 your 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
  • any other 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 immediately if you develop chickenpox or shingles or come into contact with someone who has chickenpox or shingles. These illnesses can be 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

Effects on other treatments

Certolizumab pegol may be prescribed alongside 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.

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 team.

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 vaccinations 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 this before starting certolizumab pegol. Shingles vaccination isn't recommended for people who are already on certolizumab pegol.

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

Having an operation

Talk this over with your specialists. It's likely you'll 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 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 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 shouldn't have any live vaccines until they're seven months old in case their immune system is affected. It's not clear if the same applies to certolizumab pegol as it appears that less of this drug reaches the unborn baby than with other anti-TNFs. We suggest you discuss this with your rheumatologist.

Women who are also on methotrexate should stop this drug at least three months before trying 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. The guidelines now 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 certolizumab pegol by women who are breastfeeding, but research suggests it doesn't pass into the breast milk so it's unlikely to be harmful. If you were also taking methotrexate before your pregnancy you should not re-start this until you stop breastfeeding.