What is Kineret?
Kineret is a solution for injection in a vial or pre-filled syringe. It contains the active ingredient anakinra (100 mg).
What is Kineret used for?
Kineret is used to treat the signs and symptoms of rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). It is used in combination with methotrexate (a medicine used to reduce inflammation) in patients with an inadequate response to methotrexate alone.
How is Kineret used?
Kineret therapy should be started and supervised by a doctor experienced in the treatment of rheumatoid arthritis.
The recommended dose of Kineret is 100 mg once a day, given by injection under the skin around the same time each day. Alternate at each dose the point where the injection is performed to avoid discomfort at the puncture site. Kineret should be used with caution in patients with moderate kidney problems and should not be used in patients with severe kidney problems.
How does Kineret work?
The active substance in Kineret, anakinra, is an immunosuppressive drug. It blocks the receptors of a chemical messenger in the body called interleukin-1. This messenger is produced at high concentrations in patients with rheumatoid arthritis causing inflammation of the joints and joint damage. By attaching to the receptors to which interleukin-1 would normally bind, anakinra blocks the activity of interleukin-1, helping to alleviate 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 called 'recombinant DNA technology': it is produced by a bacterium that has received a gene (DNA) that makes it capable of producing anakinra. The replacement anakinra acts in the 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 a placebo (a dummy treatment). The first study included 468 patients, some of whom had taken other medicines for their disease in the past and were given Kineret alone or placebo. In the other two studies, medicines were used as an adjunct to existing methotrexate therapy: a study that included 419 patients used a range of Kineret dosages depending on patient weight and the other study, which included 501 patients, used Kineret to a fixed dose of 100 g once a day. In all three studies, the main measure of effectiveness was the number of patients with an improvement of at least 20% after six months. The symptoms were measured by the doctor and the patient by means of the scale of the 'American College of Rheumatology' which is based on the measurement of the number of painful or aching joints, the activity of the disease, pain, disability and protein levels C-reactive in blood (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, due to the way the study was designed, the results were considered insufficient to justify the use of the medicine alone.
The other two studies showed that Kineret was more effective than placebo when used in addition to methotrexate: 38% of patients adding Kineret in the study using a fixed Kineret dose had at least a 20% reduction in symptoms after six months, compared to 22% of those adding placebo.
What is the risk associated with Kineret?
The most common side effects of Kineret (seen in more than 1 patient in 10) are headache and injection site reactions (redness, hematoma, 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 components or to proteins produced by Escherichia coli (a type of bacterium). Kineret should not be used in patients with severe kidney problems. The use of Kineret together with antagonists of tumor necrosis factor (TNF - other medicines used for rheumatoid arthritis) is not recommended.
Why has Kineret been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined 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 authorization.
More information on Kineret:
On 8 March 2002, the European Commission issued a marketing authorization valid for Kineret throughout the European Union. The marketing authorization was renewed on 8 March 2007. The marketing authorization holder is Biovitrum AB (publ).
The full EPAR for Kineret can be found here.
Last update of this summary: 12-2008.
