Certolizumab Pegol (Cimzia)

What is certolizumab?

Certolizumab (brand name Cimzia) belongs to a new class of medicines called biological disease modifying antirheumatic drugs (biological DMARDs or bDMARDs).

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

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

The increased levels of cytokines 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 reduces inflammation, lessens the symptoms and helps stop further joint damage.

What benefit can you expect from your treatment?

Unlike standard antirheumatic drugs (DMARDs), certolizumab works relatively quickly. You may notice some relief of joint swelling, pain and stiffness within the first 4 weeks of treatment.

Stopping certolizumab

If certolizumab treatment is stopped for more than a few weeks there is a risk that your condition will get worse again. Continue with your treatment unless advised by your doctor or unless side effects develop (see Side effects).

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

How will your condition be monitored?

In view of the current prescribing restrictions for all bDMARDs:

Certolizumab will only be given if your disease is active and if standard treatments have been unsuccessful.
It will not be continued unless it helps your condition. This will be assessed at least 12 weeks after the start of treatment.
Blood tests will be required during your treatment to monitor your condition and to determine the effectiveness of treatment.
The frequency of blood tests will depend on what other medicines you are taking and what other illnesses you might have. Your rheumatologist will determine the frequency of tests required.

How is certolizumab given?

Certolizumab is injected under the skin of the abdomen or thigh.

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 the injection site each time.

What is the dosage?

The usual dose for adults with rheumatoid arthritis is 400 mg at weeks 0, 2 and 4, followed by a maintenance dose of 200 mg every two weeks. Alternatively it can be given as a dose of 400mg 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 doctor 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.
Headaches, cough and stomach and bowel discomfort may also occur.
As certolizumab affects the immune system, mild infections, particularly of the upper respiratory tract (e.g. colds, sinusitis) may occur more frequently than usual. Treatment with certolizumab may need to be temporarily stopped so contact your doctor 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 (see Precautions).
Rarely certolizumab may cause an allergic reaction with itchy, red skin or a rash or a feeling of tightness in the chest and difficulty 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.
It is still unclear from research if there is an increased risk of cancer due to certolizumab treatment (see Precautions).

What precautions are necessary?

Infections

If you have an active infection of any kind treatment with certolizumab will not be given until the infection is treated successfully.
Certolizumab will not be given if you have active untreated tuberculosis (TB) or HIV (AIDS) infection as it is likely to make these conditions worse.
If you have latent (inactive) TB preventative anti-TB treatment will be started at least 4 weeks before certolizumab. The anti-TB treatment will usually need to be taken for 9 months.
Hepatitis B or C infection may not necessarily exclude treatment.
Because of the risks associated with infection, the following tests may be conducted before commencing treatment with certolizumab:
- blood tests for hepatitis B and C
- chest x-ray and two step Tuberculin Skin Test (Mantoux) or QuantiFERON blood test for tuberculosis (TB)
- HIV tests are required for those who are at risk of this infection.

Precautions with other diseases

People with multiple sclerosis should not be treated with certolizumab due to the possible effects on the nerves.
People with moderate to severe heart failure may not be treated with certolizumab as the medicine can make heart failure worse.
People with systemic lupus erythematosus (lupus/SLE) are not usually given certolizumab but each case will be assessed individually.

Use with other medicines

Certolizumab can interact with other medicines. You should tell your doctor (including your general practitioner, rheumatologist and others) about all medicines you are taking or plan to take. This includes over the counter or herbal/naturopathic medicines.
You should also mention your treatment when you see other health professionals.
Certolizumab does not increase the risk of side effects from low dose aspirin (taken for prevention of heart attack and strokes).
The simple pain reliever paracetamol and combined pain medicines such as Panadeine and Panadeine Forte can be used while you are receiving certolizumab treatment provided you take them as directed.

Vaccines

If you are on certolizumab it is recommended you should not be immunised with ‘live’ vaccines such as MMR (measles, mumps and rubella), OPV (oral polio virus, BCG (Bacillus Calmette Guerin) or yellow fever.
Pneumovax and the combined yearly seasonal flu/swine flu vaccinations are safe and recommended to reduce your risk of those infections.

Surgery

If you require surgery for any reason, treatment with certolizumab will be stopped before surgery. It will be restarted again after the operation at a time determined by your surgeon and rheumatologist. Treatment will be restarted once the wound is healed and if there is no infection present.

Cancer risk

Lymphoma, a cancer of lymph glands, is found more commonly in patients with severe active rheumatoid arthritis than in the general population. Studies are in progress to see if treatment with certolizumab changes this. To date there is no evidence to suggest that this medicine increases lymphoma.
If cancer has been previously treated and cured it is unclear whether a TNF-bDMARD such as certolizumab can be used safely. Mounting data suggests it is probably safe. Discuss this with your Rheumatologist.
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. However, if you are also taking methotrexate you should be particularly cautious about your alcohol intake.
It is not known precisely what level of drinking is safe when on methotrexate, however there is general agreement that 1 to 2 standard drinks taken once or twice a week is unlikely to cause a problem.
Drinking more than 4 standard drinks on one occasion, even if infrequently, is strongly discouraged.

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, Certolizumab is minimally excreted into breast milk but data is limited.
More detailed information is available at https://rheumatology.org.au/gps/documents/ARAPregnancyPrescribingGuidanceupdateApr19.pdf

How to store certolizumab

Keep the medicine refrigerated, even when travelling.
Keep all medicines out of reach of children.

If you are taking certolizumab you should see your rheumatologist regularly to make sure the treatment is working and to minimise any possible side effects.