drugs

Lifmior - Etanercept

What is Lifmior - Etanercept and what is it used for?

Lifmior is an anti-inflammatory drug for the treatment of the following diseases:

  • rheumatoid arthritis (a disease that causes inflammation of the joints) as monotherapy or in combination with methotrexate in adults;
  • some forms of juvenile idiopathic arthritis (inflammation of the joints in children and adolescents);
  • 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;
  • 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 identified x-ray abnormalities are present.

Lifmior is used especially when these conditions are severe or moderately severe, or when other treatments have not been sufficiently effective. For detailed information on the use of Lifmior in all conditions, see the summary of product characteristics (included with EPAR).

Lifmior is identical to Enbrel, authorized in the EU since 3 February 2000. It contains the active substance etanercept.

How is Lifmior - Etanercept used?

Lifmior is given by subcutaneous injection. In adults the usual recommended dose is 25 mg twice a week or 50 mg once a week. In children, the dosage depends on body weight. The injection can be made by the patient himself or by his assistant, provided they are properly instructed. 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 Lifmior is employed.

How does Lifmior - Etanercept work?

The active substance in Lifmior, etanercept, is a protein designed to block the activity of a substance called tumor necrosis factor (TNF). This substance helps cause inflammation and is found in high concentrations in patients with diseases for which Lifmior is indicated. By blocking TNF, etanercept reduces inflammation and other symptoms of these diseases.

What benefit has Lifmior - Etanercept shown during the studies?

Several studies have indicated that Lifmior is more effective in reducing symptoms of inflammatory conditions than placebo (a dummy treatment) or a comparator.

In rheumatoid arthritis, five studies were performed on approximately 2, 200 patients. Three of these studies in patients who had taken medications for arthritis in the past showed that about two-thirds of patients who received Lifmior experienced a reduction in symptoms of 20% or more after three months, based on a score of one standard evaluation (ACR 20), compared to a quarter of patients treated with placebo.

In a fourth study conducted on patients with rheumatoid arthritis who had never previously been treated with methotrexate, subjects treated with Lifmior at a dose of 25 mg twice a week showed less joint damage than those treated with methotrexate as monotherapy after 12 and 24 months. A fifth study showed that Lifmior alone or in combination with methotrexate was more effective than methotrexate alone.

Further studies were performed in over 2, 300 patients suffering from other inflammatory diseases (juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and axial spondyloarthritis). Using scores from various standard assessments such as ACR, ASAS and PASI, these studies also showed that Lifmior induced a greater attenuation of symptoms than placebo after three or four months.

What are the risks associated with Lifmior - Etanercept?

The most common side effects with Lifmior (seen in more than 1 patient in 10) are reactions at the injection site (including bleeding, ecchymosis, redness, itching, pain and swelling) and infections (including colds, lung infections, bladder and skin infections). Patients who develop a serious infection should stop using Lifmior. For the full list of all side effects reported with Lifmior, see the package leaflet.

Lifmior should not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and begin to damage organs) or in patients with infections. For the full list of limitations, see the package leaflet

Why has Lifmior - Etanercept been approved?

Lifmior is effective in reducing symptoms in various inflammatory conditions and its side effects are considered manageable. The CHMP therefore considered that the benefits outweigh the identified risks and recommended that Lifmior be given marketing authorization.

What measures are being taken to ensure the safe and effective use of Lifmior - Etanercept?

The company that markets Lifmior will provide instructions for doctors who should prescribe the medicine (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).

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lifmior have also been reported in the summary of product characteristics and the package leaflet.

More information on Lifmior - Etanercept

For the full EPAR version of Lifmior, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Lifmior therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.