What is Erelzi - Etanercept used for?
Erelzi is an anti-inflammatory medicine for the treatment of the following diseases:
- rheumatoid arthritis (a disease that causes inflammation of the joints) in adults, in combination with methotrexate or as a single agent;
- certain forms of juvenile hydipoatic arthritis (diseases that cause inflammation of the joints, with first appearance during childhood or adolescence);
- plaque psoriasis (a disease that causes red and scaly patches on the skin) in adults and children;
- psoriatic arthritis (psoriasis with inflammation of the joints) in adults and adolescents;
- ankylosing spondylitis (a disease that causes inflammation of the joints of the spine) in adults;
- axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when no X-ray abnormalities are present.
Erelzi is used especially when these conditions are severe or moderately severe, or when other treatments have not been sufficiently effective or cannot be used. For detailed information on the use of Erelzi in all conditions, see the summary of product characteristics (included with EPAR).
Erelzi contains the active ingredient etanercept and is a "biosimilar medicine". This means that Erelzi is very similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine of Erelzi is Enbrel. For more information on biosimilar medicines, see the following page by clicking here.
How is Erelzi - Etanercept used?
Erelzi is available as syringes and pre-filled pens containing a solution for injection. The injection is administered under the skin and the patient or caregiver can perform it after receiving appropriate instructions. In adults the usual recommended dose is 25 mg twice a week or 50 mg once a week. Treatment with 50 mg twice a week is also possible during the first 12 weeks of treatment of plaque psoriasis. In children, the dosage depends on body weight. Erelzi is not indicated in children who require doses other than 25 or 50 mg (eg children weighing less than 62.5 kg), because the medicine is only available in these dosages; for these children an alternative product must be used. For more information, see the package leaflet.
The medicine can only be obtained with a prescription. Treatment is initiated and supervised by medical specialists with experience in the diagnosis and treatment of diseases for which Erelzi is employed.
How does Erelzi - Etanercept work?
The active ingredient in Erelzi, etanercept, is a protein designed to block the activity of a substance called tumor necrosis factor alpha (TNF). This substance helps cause inflammation and is found in high concentrations in patients suffering from the diseases for which Erelzi is indicated. By blocking TNF, etanercept reduces inflammation and other symptoms of these diseases.
What benefit has Erelzi - Etanercept shown during the studies?
Laboratory studies that compared Erelzi and Enbrel have shown that the active ingredient of Erelzi is very similar to that of Enbrel in terms of structure, purity and biological activity.
Because Erelzi is a biosimilar medicine, studies performed with Enbrel regarding the efficacy and safety of etanercept should not be repeated for Erelzi. Studies have been conducted that show that Erelzi produces levels of active ingredient in the body similar to those produced with Enbrel.
Erelzi has also been shown to be as effective as Enbrel in a main study involving 531 adults with plaque psoriasis. For over 70% of patients treated with Erelzi (186 of 264 patients) and about 72% of those treated with Enbrel (191 of 267) a reduction of at least 75% in the level of symptoms was observed after 12 weeks of treatment . This figure represented the main measure of effectiveness.
What are the risks associated with Erelzi - Etanercept?
The most common side effects with etanercept (seen in more than 1 patient in 10) are reactions at the injection site (including bleeding, redness, itching, pain and swelling) and infections (including colds, infections of the lungs, of the bladder and skin). Patients who develop a serious infection should stop treatment with Erelzi. For the full list of all side effects reported with Erelzi, see the package leaflet.
Erelzi should not be used in patients who present or are at risk of sepsis (when bacteria and toxins circulate in the blood and begin to damage organs) or in patients with active infections. For the full list of limitations, see the package leaflet.
Why has Erelzi - Etanercept been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that, in accordance with EU requirements for biosimilar medicines, Erelzi has shown that it has a comparable quality, safety and efficacy profile to Enbrel. Therefore, the CHMP considered that, as in the case of Enbrel, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Erelzi.
What measures are being taken to ensure the safe and effective use of Erelzi - Etanercept?
The company that markets Erelzi will provide training material for doctors who should prescribe the product to teach patients how to properly use the pre-filled pen and a special patient alert card so that they can recognize any serious side effects and know when to contact a doctor urgently. The training material also includes a reminder that Erelzi is not intended for use in children and adolescents weighing less than 62.5 kg.
The recommendations and precautions to be followed by healthcare professionals and patients for Erelzi to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Erelzi - Etanercept
For the full EPAR for Erelzi, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Erelzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
