Benepali - Etanercept

What is Benepali and what is it used for?

Benepali is an anti-inflammatory medicine, used in adults for the treatment of the following diseases:

moderate to severe rheumatoid arthritis (a disease of the immune system that causes inflammation of the joints). Benepali is used in combination with methotrexate (a medicine that acts on the immune system) in adults with a moderate or severe form of the disease in which the response to other treatments is inadequate, or as monotherapy if the methotrexate is not suitable for the patient. Benepali is also indicated for the treatment of severe rheumatoid arthritis in patients not previously treated with methotrexate;
psoriatic arthritis (inflammation of the joints that occurs in some psoriasis patients) in adults in which the response to other treatments is inadequate;
severe ankylosing spondylitis (a disease that causes inflammation of the joints of the spine) in adults in which the response to other treatments is inadequate;
non-radiographic axial spondyloarthritis severe (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities are detected by radiographic means;
plaque psoriasis (a disease that causes red and scaly patches on the skin) from moderate to severe. Benepali is used in patients who have not responded to other treatments for this disease or who cannot undergo it.

Benepali contains the active substance etanercept and is a "biosimilar medicine". This means that it should have been similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Benepali is Enbrel. For more information on biosimilar medicines, see the questions and answers by clicking here.

How is Benepali - Etanercept used?

Treatment with Benepali should be started and followed by a specialist who has experience in the diagnosis and treatment of diseases for which Benepali is indicated. The medicine can only be obtained with a prescription.

Benepali is available as pre-filled syringes or pens containing a solution for subcutaneous injection. The usual recommended dose is 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. After adequate training, the patient or caregiver can inject. For more information, see the package leaflet.

Benepali is not intended for use in children as there are no low dose formulations

How does Benepali - Etanercept work?

The active ingredient in Benepali, etanercept, is a protein designed to block the activity of a protein in the body, called tumor necrosis factor (TNF). This protein is present in high concentrations in patients with diseases for which treatment with Benepali is planned. By blocking TNF, etanercept reduces inflammation and other symptoms of these diseases.

What benefits of Benepali - Etanercept have been shown in studies?

A study was conducted that shows that Benepali produces levels of the active substance in the body similar to Enbrel.

Benepali has also been compared with Enbrel in a main study involving 596 patients with moderate to severe rheumatoid arthritis, despite treatment with methotrexate. The main measure of effectiveness was the proportion of patients who had a reduction of at least 20% in ACR scores (a measure of pain and swelling of joints, as well as other symptoms) after 24 weeks of treatment. The results of this study showed that Benepali is as effective as Enbrel in reducing symptoms of rheumatoid arthritis: 78% of patients treated with Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared to 80% of patients treated with Enbrel (188 of 234).

What are the risks associated with Benepali - Etanercept?

The most common side effects of Benepali are reactions at the injection site (including bleeding, redness, itching, pain and swelling) and infections (including colds, lung infections, bladder and skin infections). Patients who develop a severe infection should stop treatment with Benepali. For the full list of all side effects reported with Benepali, see the package leaflet.

Benepali 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 infections. For the full list of limitations, see the package leaflet.

Why has Benepali - Etanercept been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has been shown to have 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 that Benepali be given marketing authorization.

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

A risk management plan has been developed to ensure that Benepali is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Benepali, including the appropriate precautions to be followed by healthcare professionals and patients.

The company that makes Benepali will provide training material for doctors who could prescribe the product (in order to instruct patients on the correct use of the pre-filled syringe / pen). The training material also includes a reminder to remind you that Benepali is not intended for use in children. Patients taking Benepali should be given a special alert card that summarizes important safety information regarding the medicine, so that they can recognize any serious side effects and know when to seek medical help promptly.

Further information is available in the summary of the risk management plan.