What is Enbrel?
Enbrel is a medicine containing the active substance etanercept. It is available in vials containing a powder to be reconstituted to obtain a solution for injection and in pre-filled syringes and pens containing a solution for injection. Each vial or syringe contains 25 or 50 mg of etanercept. The pens contain 50 mg of etanercept.
What is Enbrel used for?
Enbrel is an anti-inflammatory drug. It is used in the treatment of the following diseases:
- moderate to severe rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints) in adults. Enbrel is used with methotrexate (a drug that acts on the immune system) in adults with moderate to severe disease who have not responded adequately to other treatments or alone in patients in whom the use of methotrexate is not adequate. Enbrel can also be used in patients with severe rheumatoid arthritis who have not previously been treated with methotrexate;
- polyarticular juvenile idiopathic arthritis (rare disease affecting children and causing inflammation of many joints) in children and adolescents aged between four and 17 years, who have not responded adequately to methotrexate or who cannot take it;
- psoriatic arthritis (a disease that causes the formation of red and scaly plaques on the skin and inflammation of the joints) in adults who did not respond adequately to other treatments;
- severe ankylosing spondylitis (a disease that causes inflammation of the joints of the spine) in adults who have not responded adequately to other treatments;
- plaque psoriasis (a disease that causes the formation of red and scaly plaques on the skin) in moderate to severe adults and in children from eight years of age with severe chronic disease. Enbrel is used in patients who have not responded to or cannot take other treatments for this disease.
For more information, see the summary of product characteristics (also part of the EPAR).
The medicine can only be obtained with a prescription.
How is Enbrel used?
Treatment with Enbrel should be started and supervised by a specialized doctor, experienced in diagnosing and treating the diseases that Enbrel is used for.
Enbrel is given by subcutaneous injection. In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week. In cases of psoriasis, treatment with 50 mg twice a week may also be given during the first 12 weeks of treatment. In children the dose depends on body weight. The injection can be given by the patient or caregiver if properly prepared. For more information, see the package leaflet.
Patients taking Enbrel must be given a special alert card that summarizes important information on the safety of the medicine.
How does Enbrel work?
The active ingredient in Enbrel, etanercept, is a protein designed to block the activity of a chemical messenger present in the body, called tumor necrosis factor (TNF). This messenger is present in high concentrations in patients suffering from the diseases with which Enbrel is treated. By blocking TNF, etanercept reduces inflammation and other disease symptoms. Etanercept is produced by a method known as "recombinant DNA technology": that is, it is derived from a cell that has received a gene (DNA), which makes it able to produce etanercept.
How has Enbrel been studied?
Enbrel has been studied in five main studies on rheumatoid arthritis, which involved about 2 200 patients and lasted from three months to two years. Three studies compared the use of Enbrel to a placebo (a dummy treatment) in patients who had previously taken anti-arthritis medications. One of these studies looked at the effects of Enbrel as an adjunct to methotrexate in 89 patients. In the fourth study, Enbrel was compared with methotrexate in 632 patients who had not previously received methotrexate. The fifth study compared the effectiveness of Enbrel, methotrexate and a combination of the two in 686 patients.
Enbrel has also been compared with placebo in 51 children with juvenile polyarticular idiopathic arthritis, 205 adults with psoriatic arthritis, 357 adults with ankylosing spondylitis, 1 263 adults and 211 children with plaque psoriasis.
In all the studies, the change in symptoms was the main measure of effectiveness.
What benefit has Enbrel shown during the studies?
Overall, in the studies conducted on rheumatoid arthritis, about two thirds of patients treated with Enbrel showed a reduction in symptoms of 20% or more after three months, compared with about a quarter of patients treated with placebo. In the study conducted on patients never previously treated with methotrexate, subjects treated with Enbrel at a dose of 25 mg twice a week had lower joint damage than those treated with methotrexate alone after a period of 12 and 24 months. In the fifth study, Enbrel alone or in combination with methotrexate was shown to be more effective than methotrexate alone.
For all other diseases studied, Enbrel resulted in a more marked improvement in symptoms than placebo after three or four months.
What is the risk associated with Enbrel?
The most common side effects associated with Enbrel (seen in more than 1 patient in 10) are injection-site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including a cold, lung infection, bladder and skin infections). Patients who develop severe infections should stop treatment with Enbrel. Similar side effects are observed in adults and children. For the full list of all side effects reported with Enbrel, see the Package Leaflet.
Enbrel should not be used in people who may be hypersensitive (allergic) to etanercept or any of the other ingredients of the medicine. Enbrel should not be used in patients who suffer or are at risk of sepsis (a serious blood infection) or in patients with
infections. Before using Enbrel, doctors must ensure that the patient is free of infections, including tuberculosis.
Why has Enbrel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Enbrel's benefits are greater than its risks for the treatment of rheumatoid arthritis, juvenile polyarticular idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. The Committee therefore recommended that it grant marketing authorization to Enbrel.
More information about Enbrel:
On 3 February 2000, the European Commission granted a marketing authorization valid throughout the European Union for Enbrel to Wyeth Europa Ltd. The marketing authorization was renewed on 3 February 2005.
The full EPAR for Enbrel can be found here.
Last update of this summary: 06-2009
