What is Remsima - infliximab and what is it used for?
Remsima is an anti-inflammatory medicine that contains the active substance infliximab . It is usually used, when other medicines or treatments are not effective, in adults suffering from the following diseases:
- rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). Remsima is used with methotrexate (a medicine that acts on the immune system);
- Crohn's disease (a disease that causes inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with formation of fistulas, abnormal passages between the intestine and other organs);
- ulcerative colitis (a disease that causes inflammation and ulcers in the lining of the intestine);
- ankylosing spondylitis (a disease that causes inflammation and pain in the joints of the spine);
- psoriatic arthritis (a disease that causes the formation of red scaly spots on the skin and inflammation of the joints);
- psoriasis (a disease that causes the formation of red scaly spots on the skin).
Remsima is also used to treat severe active Crohn's disease or severe active ulcerative colitis in patients aged between six and 17 who have not responded or cannot be treated with other medicines or therapies. For complete details, see the summary of product characteristics (included with EPAR). Remsima is a "biosimilar" medicine. This means that Remsima is similar to a biological medicine (the "reference medicine") already authorized in the European Union (EU) and that Remsima and the reference medicine contain the same active substance. The reference medicine for Remsima is Remicade. For more information on biosimilar medicines, see the question and answer document here.
How is Remsima used - infliximab?
Remsima is available as a powder to be made up into a solution for infusion (drip) into a vein. The medicine can only be obtained with a prescription and treatment must be started and supervised by a specialist doctor experienced in the diagnosis and treatment of diseases for which Remsima is indicated. Remsima is usually given at a dose of 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary. For other diseases, the dose is 5 mg per kilogram. The frequency of repetition of the treatment depends on the disease treated and the patient's response to the medicine. Remsima is given as an infusion lasting one or two hours. All patients are monitored, to check for possible reactions, during the infusion and for at least one or two hours later. To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Remsima, or the infusion rate may be slowed. For more information, see the package leaflet. Patients treated with Remsima must receive a special alert card, which summarizes the information regarding the safety of the medicine.
How does Remsima - infliximab work?
The active ingredient in Remsima, infliximab, is a monoclonal antibody, which is an antibody (a type of protein) designed to recognize a specific structure (called an antigen) present in the body and bind to it. Infliximab was designed to bind to a chemical messenger in the body, called tumor necrosis factor alpha (TNF-alpha). This messenger is involved in the inflammatory process and is found at high levels in patients suffering from the diseases for which Remsima is indicated. By blocking TNF-alpha, infliximab improves inflammation and other disease symptoms. Remsima is produced by a method known as "recombinant DNA technology". Infliximab is composed of cells that have received a gene (DNA), which makes them able to produce it
What benefit has Remsima - infliximab shown during the studies?
Remsima has been studied to demonstrate its comparability to the reference medicine, Remicade. Remsima was compared with Remicade in one main study involving 606 adults with rheumatoid arthritis. Patients were treated with Remsima or Remicade in addition to methotrexate for 30 weeks. The main measure of effectiveness was the change in symptoms. After 30 weeks of treatment, Remsima was effective as Remicade, with approximately 60% of patients responding to treatment with either medicine.
A further study was performed on 250 patients with ankylosing spondylitis to show that Remsima produces levels of the active substance in the body comparable to those of the reference medicine, Remicade.
What is the risk associated with Remsima - infliximab?
The most common side effects with Remsima (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory tract infection (colds), sinusitis (inflammation of the sinuses), nausea, abdominal pain (stomach ache), infusion-related reactions and pain. Some side effects, including infections, may be more common in children than in adults. For the full list of all side effects reported with Remsima, see the package leaflet. Remsima must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past or who are hypersensitive (allergic) to mouse proteins or to any of the other components of Remsima. Remsima should not be used in patients with tuberculosis, other serious infections or moderate or severe heart failure (inability of the heart to pump enough blood into the body).
Why has Remsima - infliximab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that, in accordance with EU requirements, Remsima has shown that it has a comparable quality, safety and efficacy profile to Remicade. Therefore, the CHMP considered that, as in the case of Remicade, the benefits outweigh the identified risks and recommended the approval of the use of Remsima in the EU.
What measures are being taken to ensure the safe and effective use of Remsima - infliximab?
A risk management plan has been developed to ensure that Remsima is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Remsima, including the appropriate precautions to be followed by healthcare professionals and patients. Furthermore, the company that markets Remsima will provide information material to doctors who will prescribe the medicine to adults and children, including information on the safety of the medicine and an alert card to be delivered to patients. The company will also perform studies to confirm the long-term safety of the medicine.
More information on Remsima - infliximab
On 10 September 2013, the European Commission issued a marketing authorization for Remsima, valid throughout the European Union. The full EPAR for Remsima can be found on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Remsima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09/2013
