Certolizumab Pegol

What is certolizumab?

Certolizumab belongs to a class of medicines called biological disease modifying antirheumatic drugs (biological DMARDs or bDMARDs). Specifically, it is a TNF inhibitor.

bDMARDs have now been given to over a million people worldwide since their first use in the late 1990s.

These medicines block substances, produced by arthritic tissues, called cytokines. These cytokines are found in excessive amounts in the blood and joints of people with rheumatoid arthritis, psoriatic arthritis, juvenile arthritis and ankylosing spondylitis.

They cause inflammation, which results in symptoms of pain, joint swelling and stiffness, and can lead to joint damage.

By blocking the cytokine called Tumour Necrosis Factor (TNF), certolizumab lessens inflammation, pain symptoms and helps stop further joint damage.

What benefit can you expect from your treatment?

You may notice lessening of joint swelling, pain and stiffness, often within the first 8 weeks of starting.

Stopping certolizumab

If you stop or delay your certolizumab treatment, you may worsen again. Keep on your treatment, unless told by your rheumatologist to stop or unless side effects occur (see Side effects).

If you stop certolizumab for any reason, you must contact your rheumatologist. Failure to do so may mean that your treatment may no longer be subsidised.

How will your condition be monitored?

• Medicines like certolizumab are very expensive and highly funded by Medicare. Certain conditions must be met to receive it.
• Certolizumab will only be given if your disease is active and if standard treatments have not worked.
• It will only be kept going if it helps your condition. This must be checked between 12 and 16 weeks after the start of treatment.
• Blood tests are needed during your treatment to watch for side effects and decide if the treatment is working.
• How often you have blood tests will depend on what other medicines you are taking and what other illnesses you might have. Your rheumatologist will advise on this.

How is certolizumab given?

• Certolizumab is injected under the skin of the abdomen or thigh. It comes in a pen or a syringe injection.
• It can be injected by your doctor, nurse, carer or by you. If injecting yourself, be sure to follow the detailed instructions carefully to ensure the best response. It is particularly important to change where you inject each time.

What is the dosage?

The usual dose for adults with arthritis is 400mg given in two injections on the same day every two weeks for the first 3 doses. Then either a 200mg injection may be given every two weeks or two 200mg injections every 4 weeks.

Can other medicines be taken with certolizumab?

Certolizumab may be used with other arthritis medicines including:

• other DMARDs such as methotrexate
• steroid medicines such as prednisolone or cortisone injections into the joint
• anti-inflammatory medicines (NSAIDs) such as naproxen (Naprosyn) or ibuprofen (Brufen, Nurofen)
• simple pain medicines such as paracetamol.

Certolizumab cannot be used with other bDMARDs.

There are separate information sheets for the medicines mentioned above.

Are there any side effects?

You might experience side effects with your treatment. Contact your rheumatologist if you have any concerns about possible side effects. Many side effects disappear when certolizumab treatment is stopped.

Most common possible side effects

• Mild pain, swelling or itching at the site of the injection are very common (up to 20% of patients) but can be reduced by applying ice and antihistamine/steroid creams to the injection site and/or leaving it out of the refrigerator for 30 minutes before injecting.
• Headaches, cough, stomach and bowel discomfort may also occur.
• As certolizumab affects the immune system, mild infections, mainly the upper respiratory tract (e.g. colds, sinusitis) may occur more often. Treatment with certolizumab may need to be briefly stopped for a serious infection so contact your rheumatologist for advice.

Less common or rare possible side effects

• Serious infections such as tuberculosis (TB) are seen rarely, and screening for TB is needed before treatment begins.
• Rarely, certolizumab may cause an allergic reaction with itchy, red skin or a rash or a feeling of tightness in the chest and trouble breathing.
• Side effects involving the nerves such as inflammation of the nerve to the eye, may also occur rarely, causing changes in vision or sensation.
• Very rarely ‘drug-induced lupus’ has occurred with symptoms of rash, fever and increased joint pain.
• Annual skin checks are suggested with any medications that can suppress the immune system as there is a slight increase in risk in skin cancers. To date research and use over 20 years, have not shown an increase in risk of other cancers.

What precautions are necessary?

Infections

• If you have a current infection of any kind treatment with certolizumab should not be given until the infection is treated.
• You will need some blood tests and a chest x-ray to exclude some chronic infections before your first bDMARD.

Precautions with other diseases
Worsening may occur of the following conditions:

• multiple sclerosis
• moderate to severe heart failure.
• systemic lupus erythematosus (lupus/SLE) People with SLE are not often given certolizumab but each case will be assessed whether safe by your rheumatologist

Use with other medicines

• Certolizumab can interact with other medicines. You should tell all your doctors about all medicines you are taking or plan to take. This includes over the counter or herbal/naturopathic medicines.

Vaccines

• If you are taking certolizumab you should not be immunised with ‘live’ vaccines such as MMR (measles, mumps and rubella), Varicella vaccine (Chicken pox) or Zostavax (Varicella Zoster or Shingles), OPV (oral polio virus), BCG (Bacillus Calmette Guerin), Japanese Encephalitis or Yellow Fever. Talk with your rheumatologist before receiving any vaccines.
• Pneumococcal vaccines and the yearly seasonal flu vaccinations are safe and encouraged.

More information is available here Vaccinations in Rheumatology and COVID-19 vaccination.

Surgery

• If you need surgery for any reason, certolizumab should be stopped before surgery. It can start again after the operation at a time decided by your surgeon and rheumatologist, (often once the wound has healed and there is no infection).

Cancer risk

• Lymphoma, a cancer of lymph glands, is found more commonly in patients with severe active rheumatoid arthritis than in the general population. To date there is no evidence to suggest that certolizumab increases lymphoma.
• If cancer has been previously treated and cured it may be possible for certolizumab to be used safely.
• For general cancer prevention, stopping smoking and taking skin cancer prevention measures are recommended. It is important to use sunscreen and avoid prolonged sun exposure. A yearly skin check is recommended.
• Talk to your doctor if you have any concerns about issues relating to cancer risk.

Use with alcohol

• You may drink alcohol while taking certolizumab. If you are also taking methotrexate you should be cautious about how much alcohol you drink.

Use in pregnancy and when breastfeeding

• If you plan to become pregnant it is important to discuss this with your doctor as each case is different. Certolizumab is not actively transferred across the placenta in the third trimester, therefore there is minimal placental transfer to the infant. Recent data suggests it can be used through conception and continued throughout pregnancy until delivery.
• You should discuss with your rheumatologist regarding breastfeeding. In a study of lactating mothers, minimal transfer of certolizumab from plasma to breast milk was observed. Certolizumab can be used during breastfeeding. You should be supported by your healthcare team if you wish to breastfeed.
• If certolizumab is continued later in pregnancy, the theoretical risk of administration of live or live-attenuated vaccines to infants exposed in utero to certolizumab should be weighed against the benefits of vaccinations and live vaccines (e.g. Rotavirus) should be avoided in the first 6 months. Discussion with a neonatologist/paediatrician is recommended. Note: due to lower rates of transfer with certolizumab, this decision may be revised in the future with more data.
• More detailed information can be found here.

How to store certolizumab

• Certolizumab should normally be kept refrigerated. If needed for example when travelling, it may be stored below 25°C for up to 7 days and then used or discarded.
• Keep all medicines out of reach of children

Important things to remember

• You must see your rheumatologist regularly to make sure the treatment is working and check for possible side effects.
• You should have regular blood tests as suggested by your rheumatologist
• It is important to tell your rheumatologist if you have a new serious illness such as a serious infection, cancer, heart failure etc.
• If you are worried about any side effects, you should contact your rheumatologist as soon as possible.
• If you stop certolizumab for any reason, you must contact your rheumatologist. Failure to do so may mean that your treatment may no longer be funded.
• If you plan to become pregnant, you must discuss the timing with your rheumatologist.

For more information see the Certolizumab_ printable information sheet