What is Cimzia?
Cimzia is a solution for injection that contains 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, metotrassate, to treat adults with moderate to severe 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 treatment with methotrexate is inappropriate.
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 the diagnosis and treatment of rheumatoid arthritis. Cimzia is given by injection under the skin, usually in the thigh or abdomen (belly). Initial treatment consists of a 400 mg dose in two injections, followed by a "further 400 mg dose two and four weeks apart. Thereafter, the patient should be given a 200 mg maintenance dose in a single" injection every two weeks. After receiving appropriate instructions, patients can self-inject Cimzia if their doctor deems it appropriate. Patients treated with Cimzia must be given a special alert card summarizing the safety information 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 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) created to recognize a specific structure (called an antigen) in the body and attach itself to it. Certolizumab pegol was created to attach to a messenger protein in the body called an antigen. tumor necrosis 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 rate at which the substance is eliminated from the body and allows the medicine to be administered less frequently.
How has Cimzia been studied?
The effects of Cimzia were first tested in experimental models before being studied in humans. Cimzia was 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 given 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 joint injury worsening seen radiographically.
What benefit has Cimzia shown during the studies?
Cimzia combined with methotrexate was more effective than placebo combined 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 with 9% of patients taking Cimzia. patients taking placebo (11 out of 127).
In the other main study, the results were similar: 59% of patients taking Cimzia (228 out of 388) achieved 20% reduction compared with 14% of patients taking placebo (27 out of 198). It was also shown that patients taking Cimzia had a greater reduction in the worsening of joint damage seen on radiographs.
In the additional study where Cimzia was used alone, more patients taking Cimzia achieved 20% reduction than those taking placebo.
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 (pus-containing cavities), 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, rash, fever, pain, asthenia (weakness), itching and injection site reactions. Cimzia must 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 severe infections or moderate to severe heart failure (inability of the heart to pump enough blood around 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 granted a marketing authorization.
What measures are being taken to ensure the safe use of Cimzia?
The manufacturing company of Cimzia will provide information packs to doctors who will prescribe the medicine. These packages will include information on the security of the latter.
Other information about Cimzia:
On 1 October 2009, the European Commission granted UCB Pharma SA a "marketing authorization" for Cimzia, valid throughout the European Union.
For the complete version of Cimzia's EPAR click here.
Last update of this summary: 07-2009
The information on Cimzia - certolizumab pegol published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
