Active Substance: anakinra
Common Name: anakinra
ATC Code: L04AA14
Marketing Authorisation Holder: Biovitrum AB (publ)
Active Substance: anakinra
Authorisation Date: 2002-03-08
Therapeutic Area: Arthritis, Rheumatoid
Pharmacotherapeutic Group: Immunosuppressants
Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in adults with an inadequate response to methotrexate alone.
What is Kineret?
Kineret is a solution for injection in a vial or a prefilled syringe. It contains the active substance anakinra (100 mg).
What is Kineret used for?
Kineret is used to treat of the signs and symptoms of rheumatoid arthritis (an immune-system disease causing inflammation of the joints). It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients who have not responded adequately to methotrexate alone.
How is Kineret used?
Kineret treatment should be started and supervised by a doctor who has experience in the treatment of rheumatoid arthritis.
The recommended dose of Kineret is 100 mg once a day, given by injection under the skin at around the same time each day. The injection site should be varied with each dose to avoid discomfort. Kineret should be used with caution in patients who have moderate problems with their kidneys, and should not be used in patients with severe kidney problems.
How does Kineret work?
The active substance in Kineret, anakinra, is an immunosuppressive medicine. It blocks the receptors for a chemical messenger in the body called interleukin-1. This messenger is produced in high levels in patients with rheumatoid arthritis, causing inflammation of the joints and joint damage. By attaching to the receptors that interleukin-1 would normally attach itself to, anakinra blocks the activity of interleukin-1, helping to relieve the symptoms of the disease.
The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘human interleukin-1-receptor antagonist’. It is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce anakinra. The replacement anakinra acts in same way as the natural protein.
How has Kineret been studied?
Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis. All three studies compared the effectiveness of Kineret with that of placebo (a dummy treatment). The first study included 468 patients, some of whom had taken other medicines for their disease in the past, and who were given either Kineret on its own or placebo. In the other two studies, the medicines were used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient’s weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day. In all three studies, the main measure of effectiveness was the number of patients with an improvement in symptoms of at least 20% after six months. Symptoms were measured by the doctor and the patient using the ‘American College of Rheumatology’ score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C-reactive protein in the blood (a marker of inflammation).
What benefit has Kineret shown during the studies?
The first study showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of rheumatoid arthritis. However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
The other two studies showed that Kineret was more effective than placebo when used as an add-on to methotrexate. In the study using a fixed dose of Kineret, 38% of the patients adding Kineret had at least a 20% reduction in symptoms after six months, compared with 22% of those adding placebo.
What is the risk associated with Kineret?
The most common side effects with Kineret (seen in more than 1 patient in 10) are headache and injection site reactions (redness, bruising, pain and inflammation). For the full list of all side effects reported with Kineret, see the package leaflet.
Kineret should not be used in people who may be hypersensitive (allergic) to anakinra, to any of the other ingredients or to proteins produced by Escherichia coli (a type of bacterium). Kineret should not be used in patients who have severe problems with their kidneys. The use of Kineret with tumour-necrosis-factor (TNF) antagonists (other medicines used in rheumatoid arthritis) is not recommended.
Why has Kineret been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Kineret’s benefits are greater than its risks for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone. The Committee recommended that Kineret be given marketing authorisation.
Other information about Kineret
The European Commission granted a marketing authorisation valid throughout the European Union for Kineret on 8 March 2002. The marketing authorisation was renewed on 8 March 2007. The marketing authorisation holder is Biovitrum AB (publ).
Source: European Medicines Agency
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