What is certolizumab pegol and how is it used?

Certolizumab pegol is an anti-TNF drug. It blocks the action of chemicals in the body that can cause pain and swelling in joints.

In autoimmune conditions the immune system, which normally protects us from infection and illness, starts to attack healthy parts of the body.

Within the immune system, a number of chemicals act as messengers between cells in the body. One of these chemicals is called tumour necrosis factor (TNF). TNF can cause inflammation in the body, including in joints. Inflammation is usually an important tool of the immune system. It occurs when extra fluid is sent to a part of the body to fight an infection.

In an autoimmune condition, such as rheumatoid arthritis, inflammation can be caused when it’s not needed. This can lead to problems, such as swelling, pain and damage inside joints.

Anti-TNF drugs such as certolizumab pegol, which is also known by the trade name Cimzia, block the action of TNF. This can reduce inflammation and improve your symptoms over a period of 6–12 weeks.

Certolizumab pegol can be prescribed by a consultant rheumatologist for:

There are guidelines to help doctors decide who the drug is suitable for, depending on what condition people have and how serious it is. Certolizumab pegol is often prescribed alongside another drug used to treat some autoimmune conditions, called methotrexate.

Certolizumab pegol won’t be prescribed until you’ve tried other treatments 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
  • a serious lung condition.

Before starting certolizumab pegol you’ll have a chest x-ray and blood tests to check if you’ve ever been exposed to the condition tuberculosis (ter-ber-cue-low-sis) (TB).

Even if you don’t have symptoms, the bacteria that cause tuberculosis may still be present in the body and you may need treatment for this before starting certolizumab pegol. If you‘ve had tuberculosis in the past, you may need treatment with anti-tuberculosis drugs to reduce the risk of the infection coming back.

If you have HIV, this should be well controlled before starting certolizumab pegol. Your HIV specialist should be involved in discussions about whether you should have this drug. Some rheumatology clinics routinely test all patients for HIV before starting certolizumab pegol while other clinics only test people who may be at higher risk of HIV infection.

You’ll also be checked for previous hepatitis infection, as certolizumab pegol may increase the risk of hepatitis becoming active again.

You’ll need further blood tests while you’re on certolizumab pegol to check how well it’s treating your condition.

When and how do I take certolizumab pegol?

Certolizumab pegol is taken as an injection under the skin, this is known as a subcutaneous (sub-cue-tay-nee-us) injection. The drug will be in a pre-filled syringe or pen. You, your partner, or another family member can learn to give the injections at home.

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 such as redness, swelling or pain, but these aren’t usually serious. Regularly changing the injection site will help reduce the chances of this.

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.

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 to certolizumab pegol. 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. However, the link between the two is unclear. Skin cancers can often be treated successfully when diagnosed early. To be on the safe side, make sure to wear sun screen and regularly check your skin for any new spots or changes to your freckles or moles.

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.

It’s important not to stop taking certolizumab pegol or change your dose without talking to your doctor.

Reducing the risk of infection

  • Try to avoid close contact with people you know have an infection.
  • Wash your hands regularly and carry around a small bottle of antibacterial hand gel.
  • Keep your mouth clean by brushing your teeth regularly.
  • Stop smoking if you’re a smoker.
  • Make sure your food is stored and prepared properly.
  • Try to keep your house clean and hygienic, especially the kitchen, bathrooms and toilets.

Taking other medicines

Certolizumab pegol may be prescribed along with other drugs, including the disease-modifying anti-rheumatic drug (DMARD) 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 shouldn’t take the biological therapy anakinra at the same time as certolizumab pegol. Anakinra is very occasionally used to treat rheumatoid arthritis, but it must not be taken at the same time as an anti-TNF drug, because this could leave you at risk of serious infections.

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.

If you’re on certolizumab pegol as a rule you should avoid live vaccines, such as yellow fever.

However, in certain situations it might be important for some people to have a live vaccine. You should speak to your doctor about this first.

Before starting on certolizumab pegol treatment, people at risk of hepatitis infections might need to have a vaccination to protect them. These aren’t live vaccines, but they may be less effective once you’ve started certolizumab pegol.

If you’re offered shingles vaccination, known as Zostavax, it’s best if you can have this at least two weeks before starting certolizumab pegol. Shingles vaccination isn’t recommended for people who are already on this medication.

If you haven’t had chicken pox, it’s recommended you have the chicken pox vaccine before starting certolizumab pegol. Talk to your doctor about this, as you might not be able to have this vaccine if you’re already on a different drug that reduces the effect of your immune system.

It may also be recommended that people you live with, and therefore who you have close contact with, should have the chicken pox vaccine if they haven’t yet had chicken pox. They will need to have this vaccine before you start taking certolizumab pegol.

Pneumococcal vaccine (new-mo-cok-al vak-seen), which gives protection against the most common cause of pneumonia, and yearly flu vaccines are safe and recommended.

Having an operation

If you’re due to have an operation, talk to your surgeon and rheumatology team about taking your certolizumab pegol. 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. Guidelines state that adults shouldn’t have more than 14 units of alcohol per week, and that they should spread them out over the course of the week. 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 during pregnancy.

Research suggests that either no amount of this drug or only a very small amount of it, can pass from mother to baby during pregnancy, and so it can be taken during pregnancy if needed. It’s not known what effects, if any, very small amounts of this drug may have upon your baby. Therefore, if you do take this drug, your baby should not be given any live vaccines until at least five months after you received your last dose during pregnancy.

If you’re also taking methotrexate this drug should be stopped three months before you try for a baby. You must not take methotrexate if you’re pregnant.

There’s no evidence that 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 the current guidelines now state that methotrexate does not need to be stopped when trying to father a child.

Research suggests that only a minimal amount of certolizumab pegol passes into breast milk, so it can be used while breastfeeding. If you were also taking methotrexate before your pregnancy, this should not be re-started until you stop breastfeeding.