Cimzia

certolizumab pegol

This is a summary of the European public assessment report (EPAR) for Cimzia. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cimzia.

What is Cimzia?

Cimzia is a solution for injection that contains the active substance certolizumab pegol. It is available in a prefilled syringe (200 mg/ml).

What is Cimzia used for?

Cimzia is used in combination with another medicine, methotrexate, to treat adults with moderate to severe, active rheumatoid arthritis (a disease causing inflammation of the joints). It is used when the disease has not responded adequately to other treatments such as methotrexate. Cimzia can also be given alone when treatment with methotrexate is not appropriate.

The medicine can only be obtained with a prescription.

How is Cimzia used?

Treatment with Cimzia should only be started by a specialist doctor who has experience in diagnosing and treating rheumatoid arthritis. Cimzia is given by injection under the skin, usually in the thigh or abdomen (tummy). The treatment starts with a 400-mg dose given as two injections. This is followed by a further 400-mg dose two and four weeks later. After this, the patient should be given a maintenance dose of 200 mg given as one injection, every two weeks. After training, patients may inject themselves with Cimzia if their doctor agrees.

Patients who are treated with Cimzia must be given a special alert card that summarises the safety information about the medicine. For more information, see the package leaflet.

How does Cimzia work?

The active substance in Cimzia, certolizumab pegol, is an immunosuppressant medicine, a medicine that reduces the activity of the immune system (the body’s natural defences). It is made up of a monoclonal antibody, certolizumab, which has been ‘pegylated’ (attached to a chemical called polyethylene glycol). A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body. Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha (TNF-alfa). This messenger is involved in causing inflammation and is found at high levels in patients with rheumatoid arthritis. By blocking TNF-alfa, certolizumab pegol reduces the inflammation and other symptoms of the disease.

Pegylation decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.

How has Cimzia been studied?

Cimzia was compared with placebo (a dummy treatment) in two main studies involving 1,601 adults with active rheumatoid arthritis who were receiving methotrexate treatment. An additional study compared Cimzia given alone with placebo in 218 patients whose response to other medicines such as methotrexate had been inadequate. However, the dose of Cimzia used in this study was higher than the normal dose.

The main measures of effectiveness were the number of patients who had 20% reductions in the number and severity of symptoms after 24 weeks and a reduction in the worsening of joint damage as seen on X-rays.

What benefit has Cimzia shown during the studies?

Cimzia with methotrexate was more effective than placebo with methotrexate at treating rheumatoid arthritis. In one main study, 57% of patients receiving Cimzia (141 out of 246) achieved 20% reductions compared with 9% of patients receiving placebo (11 out of 127).

In the other main study, the results were similar with 59% of patients who received Cimzia (228 out of 388) achieving 20% reductions compared with 14% of patients receiving placebo (27 out of 198). This study also showed that patients who received Cimzia had a greater reduction in the worsening of joint damage as seen on X-rays.

In the additional study of Cimzia used on its own, more patients who received Cimzia achieved 20% reductions compared with those who received placebo.

What is the risk associated with Cimzia?

The most common side effects with Cimzia (between 1 and 10 patients in 100) are bacterial infections including abscesses (cavities containing pus), viral infections (including herpes, papillomavirus and influenza), eosinophilic disorders (disorders of eosinophils, a type of white blood cell), leucopenia (low white-blood-cell counts including low levels of neutrophils and lymphocytes), nausea (feeling sick), headaches (including migraine), sensory abnormalities (such as numbness, tingling, burning sensation), hypertension (high blood pressure), hepatitis (liver inflammation) including increased levels of liver enzymes, rash, fever, pain, asthenia (weakness), pruritus (itching) and reactions at the injection site. For the full list of all side effects reported with Cimzia, see the package leaflet.

Cimzia must not be used in people who are hypersensitive (allergic) to certolizumab pegol or any of the other ingredients. It must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure (an inability of the heart to pump enough blood around the body).

Why has Cimzia been approved?

The CHMP decided that Cimzia’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Which measures are being taken to ensure the safe use of Cimzia?

The company that makes Cimzia will provide educational packs for doctors who will prescribe Cimzia. These packs will include information on the safety of the medicine.

Other information about Cimzia

The European Commission granted a marketing authorisation valid throughout the European Union for Cimzia on 1 October 2009.

For more information about treatment with Cimzia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 14/06/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

25/04/2013  Cimzia -EMEA/H/C/001037 -II/0031

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate.

Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents