What is Remicade?
Remicade is a powder for the preparation of a solution for infusion (drip into a vein) and contains the active ingredient infliximab.
What is Remicade used for?
Remicade is an anti-inflammatory medicine. It is usually used in cases where other medicines or treatments have not given an adequate response in adults with the following diseases:
- rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). Remicade is used in combination with methotrexate (a medicine that acts on the immune system);
- Crohn's disease (a disease that causes inflammation of the digestive tract) severe or fistulising (with formation of fistulas, abnormal communications between the intestine and other organs);
- ulcerative colitis (a disease that causes inflammation and ulceration of the intestinal mucosa);
- ankylosing spondylitis (a disease that causes inflammation and pain in the joints of the spine);
- psoriatic arthritis (a disease that causes red and scaly patches on the skin and inflammation of the joints);
- psoriasis (a disease that causes red and scaly patches on the skin).
Remicade is also given to patients aged between six and 17 years with severe active Crohn's disease, when they have not responded or cannot take other medicines or cannot be treated with other therapies.
For more information read the summary of product characteristics (included with EPAR).
The medicine can only be obtained with a prescription.
How is Remicade used?
Remicade must be administered under the strict supervision and control of a doctor experienced in the diagnosis and treatment of diseases for which the use of Remicade may be indicated.
The dose of Remicade for rheumatoid arthritis is usually 3 mg per kilogram of body weight, although this dose can be increased if necessary. For other diseases, the dose is 5 mg per kilogram. The frequency of treatment depends on the disease being treated and the individual response of the patient to the medicine.
Remicade is given as an infusion lasting one to two hours. All patients are checked for reactions during the infusion and for at least one to two hours later. Before or during treatment with Remicade, patients may be given other medicines to reduce the risk of infusion-related reactions. For more information, see the package leaflet.
Patients receiving Remicade must be equipped with the special alert card that summarizes all the safety information on the medicine.
How does Remicade work?
The active substance in Remicade, infliximab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) developed to recognize and bind to a specific structure (called an antigen) present in the body. Infliximab was developed to bind to a chemical messenger present in the body called tumor necrosis factor alpha (TNF-alpha). This messenger helps cause inflammation and is found in large quantities in patients suffering from diseases to treat which is indicated Remicade. By blocking TNF-alpha, infliximab relieves inflammation and other disease symptoms.
How has Remicade been studied?
Remicade has been studied in a total of 1, 432 patients in two studies for the treatment of rheumatoid arthritis. Remicade was given in combination with methotrexate and was then compared with methotrexate monotherapy (alone). The main measure of effectiveness was the change in symptoms, injuries to the joints and physical functions for up to 54 weeks.
For Crohn's disease, Remicade has been compared with placebo (a dummy therapy) on 1, 090 adults in four studies. The main measures of effectiveness of the product were the improvement of symptom severity or the healing of fistulas. The effects of adding Remicade to an existing therapy were also studied in 103 children and adolescents with Crohn's disease aged between six and 17 years.
For ulcerative colitis (728 patients), ankylosing spondylitis (70 patients), psoriatic arthritis (104 patients) and psoriasis (627 patients), Remicade was compared with placebo. In all these studies the main measure of effectiveness was the improvement of symptoms up to 16 weeks.
What benefit has Remicade shown during the studies?
In all the studies, Remicade was more effective than comparator medicines:
- with regard to rheumatoid arthritis, a greater number of patients treated with Remicade associated with methotrexate experienced a decrease in symptoms compared to patients treated with methotrexate alone, as well as fewer lesions of the joints and greater improvement in physical function ;
- in adults with Crohn's disease, Remicade, compared to placebo, produced a more marked improvement in symptoms, led to the healing of fistulas in more patients and lengthened patients' response time to treatment. Most children and adolescents with Crohn's disease also showed a reduction in symptoms after adding Remicade to the previous treatment;
- in the study on ulcerative colitis, ankylosing spondylitis and psoriatic arthritis, more patients treated with Remicade also showed a reduction in symptoms greater than that observed with placebo;
- in psoriasis, Remicade produced a more marked improvement in symptoms than observed with placebo.
What is the risk associated with Remicade?
Most of the side effects seen in patients treated with Remicade are related to the infusion and not to the medicine itself. Such effects include dyspnoea (difficulty breathing), urticaria (erythema pruritus) and headache. Some patients may experience an anaphylactic shock (a severe allergic reaction) during the infusion or delayed hypersensitivity (an allergic reaction that occurs after the first exposure to the medicine). In patients experiencing these symptoms it is necessary to slow down the infusion of the medicine or to stop treatment.
The most frequent side effects of Remicade (seen in a number of patients between 1 and 10 out of 100) are viral infections (eg flu or febrile herpes), reactions similar to serum sickness (including skin rash, joint pain or fever), headache, dizziness (dizziness), hot flushes, infections of the upper respiratory tract (cold), infections of the deep respiratory tract (such as bronchitis or pneumonia), dyspnoea, sinusitis (inflammation of the sinuses), nausea, diarrhea, abdominal pain (stomach ache), dyspepsia (heartburn), erythema, itching, hives, increased sweating, dry skin, exhaustion (feeling tired), chest pain, fever and an increase in enzyme values Hepatic in the blood. Some side effects including infections may be more common in children than in adults. For a complete list of all side effects reported with Remicade, see the Package Leaflet.
Remicade should not be used in patients who have previously experienced hypersensitivity (allergy) to infliximab, or who are hypersensitive (allergic) to mouse proteins or to any of the substances of Remicade. Remicade should not be used in patients suffering from tuberculosis, other serious infections or heart failure (inability of the heart to pump enough blood into the body) of moderate or severe grade.
Why has Remicade been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Remicade outweigh its risks for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis in patients who have not responded adequately or cannot be treated with other therapies and has therefore recommended the granting of the marketing authorization for the product.
Originally, Remicade was authorized in "exceptional circumstances" because, for scientific reasons, limited information on the medicine was available at the time of product approval. As the company presented the additional information requested, the condition referring to "exceptional circumstances" was removed on 8 March 2004.
What measures are being taken to ensure the safe use of Remicade?
The company that makes Remicade will organize an information program for doctors who intend to prescribe the medicine to children with Crohn's disease, in order to illustrate the risks of the therapy.
More information on Remicade:
On 13 August 1999, the European Commission granted a marketing authorization for Remicade to Centocor BV, valid throughout the European Union. The marketing authorization was renewed on 13 August 2004 and 13 August 2009.
For the full EPAR of Remicade, click here.
Last update of this summary: 08-2009.
