Cimzia - certolizumab pegol

What is Cimzia?

Cimzia is a solution for injection containing the active substance certolizumab pegol. it is available as a pre-filled syringe (200 mg / ml).

What is Cimzia used for?

Cimzia is used in combination with another medicine, metotrassato, to treat moderate to severe adults with active rheumatoid arthritis (a disease that causes 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 as monotherapy when methotrexate treatment 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 experienced in the diagnosis and treatment of rheumatoid arthritis. Cimzia is administered by subcutaneous injection, usually in the thigh or in the abdomen (belly). The initial treatment consists of a 400 mg dose in two injections, followed by another 400 mg dose two to four weeks apart. Thereafter, a 200 mg maintenance dose should be given to the patient in a single injection every two weeks. After receiving adequate instructions, patients can inject themselves with Cimzia if their doctor considers it appropriate. Patients treated with Cimzia must be given a special warning card that summarizes the information on the safety of the medicine. For more information, see the package leaflet.

How does Cimzia work?

The active substance in Cimzia, certolizumab pegol, is an immunosuppressive drug, which means that it reduces the activity of the immune system (the body's natural defenses). It is formed from an antibody monochlonal, certolizumab, which has been "pegylated" (attached to a chemical compound called polyethylene glycol). A monoclonal antibody is an antibody (a type of protein) created to recognize a specific structure (called an antigen) present in the body and bind to it. Certolizumab pegol was created to bind to a messenger protein present in the body and called tumor necrosis factor alpha (TNF-α). This messenger is involved in the inflammatory process and is found in high quantities in patients with rheumatoid arthritis. By blocking TNF-α, certolizumab pegol reduces inflammation and other symptoms of the disease. Pegylation reduces the speed at which the substance is eliminated from the body and allows the drug to be administered less frequently.

What studies have been carried out on Cimzia?

The effects of Cimzia were first tested in experimental models before being studied in humans. Cimzia has been compared with placebo (a dummy treatment) in two main studies that

involved 1 601 adults with active rheumatoid arthritis who were taking methotrexate.

Another study compared Cimzia administered alone with placebo in 218 patients whose response to other medicines such as methotrexate had been inadequate. The dose of Cimzia used in this study was, however, higher than the normal dose.

The main measure of effectiveness was the number of patients who had a 20% reduction in the number and severity of symptoms after 24 weeks and a reduction in the worsening of the joint lesion observed radiographically.

What benefit has Cimzia shown during the studies?

Cimzia associated with methotrexate was more effective than the placebo associated with methotrexate in the treatment of rheumatoid arthritis. In one of the main studies, 57% of patients taking Cimzia (141 out of 246) achieved a 20% reduction compared to 9% of patients taking placebo (11 of 127).

In the other main study the results were similar: 59% of the patients taking Cimzia (228 out of 388) achieved a 20% reduction compared to 14% of patients taking placebo (27 out of 198). This study also showed that patients taking Cimzia had a greater reduction in the worsening of the joint lesion observed radiographically.

In the additional study in which Cimzia was used alone, a higher number of patients taking Cimzia compared with those taking placebo reached 20% reduction.

What is the risk associated with Cimzia?

The most common side effects associated with taking 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 (eosinophil disorders, a type of white blood cell),

leukopenia (reduced number of white blood cells, including low levels of neutrophils and lymphocytes), headache (including migraine), sensory changes (such as numbness, tingling, burning sensation), hypertension (high blood pressure), hepatitis (inflammation of the liver), including high levels of liver enzymes, skin rashes, fever, pain, asthenia (weakness), itching and injection site reactions. Cimzia should not be used in people who may be hypersensitive (allergic) to certolizumab pegol or any of the other ingredients. It must not be used in patients with active tuberculosis, other serious infections or moderate to severe heart failure (inability of the heart to pump enough blood into the body).

Why has Cimzia been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Cimzia's benefits are greater than its risks for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs ( DMARD), including methotrexate, was found to be inadequate. The committee recommended that Cimzia be given marketing authorization.

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

The company that produces Cimzia will provide information packages to the doctors who will prescribe the medicine. These packages will include information on the security of the latter.