What is Benlysta - belimumab?
Benlysta is a powder that is made up into a solution for infusion (drip into a vein) that contains the active substance belimumab.
What is Benlysta used for?
Benlysta is indicated as add-on therapy in adults with autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.
The medicine can only be obtained with a prescription.
How is Benlysta used - belimumab?
Treatment with Benlysta should be initiated and supervised by a physician experienced in the diagnosis and treatment of SLE.
Benlysta is given as an intravenous infusion over "one" hour. The recommended dose is 10 mg per kilogram of body weight. The first three doses are given at two-week intervals. Thereafter, Benlysta is taken at four-week intervals.
The physician may need to consider interrupting or discontinuing treatment if the patient develops infusion reactions (including erythema, itching and difficulty breathing) or hypersensitivity (allergic) reactions. Benlysta should therefore only be administered in an environment where any such reactions can be dealt with immediately.
How does Benlysta work - belimumab?
SLE is a disease in which the immune system (the body's natural defenses) attacks the patient's cells and tissues causing inflammation and damage to various organs. It can affect almost any organ and is thought to involve a type of white blood cell called B lymphocytes. B lymphocytes generally produce antibodies (proteins) that help fight infections. In SLE, some of these antibodies attack the body's cells and organs (autoantibodies).
The active substance in Benlysta, belimumab, is a monoclonal antibody. A monoclonal antibody is an antibody developed to recognize and attach to a specific structure (the antigen) present in the body. Belimumab was designed to bind and block a protein called BLyS, which helps B lymphocytes live longer. By blocking the action of BLyS, belimumab shortens the lifespan of B lymphocytes, thereby reducing the inflammation and organ damage seen in SLE.
How has Benlysta - belimumab been studied?
Benlysta's effects were first tested in experimental models before being studied in humans.
Benlysta (given at doses of 1 and 10 mg / kg body weight) has been compared with placebo (a dummy treatment) in two main studies involving 1,693 adult patients with active SLE. Patients continued to receive standard SLE therapy throughout the studies. In both studies, the main measure of effectiveness was the number of patients in whom disease activity decreased to a certain level after 12 months.
What benefit has Benlysta - belimumab shown during the studies?
Benlysta was shown to be more effective than placebo in reducing disease activity when used as an adjunct therapy for SLE. In the first study, Benlysta's 10 mg / kg dose was effective in 43% of patients compared to 34. % of subjects treated with placebo. In the second study, the 10 mg / kg dose of Benlysta was effective in 58% of the patients compared to 44% of the subjects treated with placebo. In both studies, the 10 mg / kg dose of Benlysta was more effective than the 1 mg / kg dose.
What is the risk associated with Benlysta - belimumab?
The most common side effects with Benlysta (seen in more than 1 in 10 patients) are diarrhea and nausea. For the full list of side effects reported with Benlysta, see the package leaflet.
Benlysta must not be used in people who may be hypersensitive (allergic) to belimumab or any of the other substances.
Why has Benlysta - belimumab been approved?
The CHMP considered that Benlysta, used as add-on therapy in SLE patients, reduces the activity of the disease without serious risk for the patient. The medicine can cause hypersensitivity and infusion reactions as well as infections, but is generally well tolerated. The CHMP also noted that there are no effective alternative therapies for patients who have already received standard treatments. The Committee decided that Benlysta's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Benlysta - belimumab
On 13 July 2011, the European Commission issued a "Marketing Authorization" for Benlysta, valid throughout the European Union.
For more information about Benlysta therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2011.
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