What is Imraldi and what is Adalimumab used for?
Imraldi is a medicine that acts on the immune system. It is used in the treatment of the following diseases:
- plaque psoriasis (a disease that causes the appearance of red and scaly patches on the skin);
- psoriatic arthritis (a disease that causes the appearance of red and scaly patches on the skin with inflammation of the joints);
- rheumatoid arthritis (a disease that causes inflammation of the joints);
- axial spondyloarthritis (inflammation of the spine that causes back pain), including ankylosing spondylitis, even without radiographic findings but with clear signs of inflammation;
- Crohn's disease (a disease that causes inflammation of the intestine);
- ulcerative colitis (a disease that causes inflammation and ulcers of the intestinal mucosa);
- polyarticular juvenile idiopathic arthritis and active arthritis associated with enthesitis (both rare diseases that cause inflammation of the joints);
- hidradenitis suppurativa (reverse acne), a chronic skin disease that causes the appearance of nodules, abscesses (accumulations of pus) and scars on the skin;
- non-infectious uveitis (inflammation of the layer below the white of the eyeball).
Imraldi is mainly used in adults in the presence of serious, moderately severe or worsening conditions or when patients cannot be subjected to other treatments. For more information on the use of Imraldi in all conditions, including those in which it can be used in children, see the summary of product characteristics (included with EPAR).
Imraldi contains the active substance adalimumab and is a "biosimilar medicine". This means that it is very similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Imraldi is Humira. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Imraldi - Adalimumab used?
Imraldi can only be obtained with a prescription. Treatment must be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which it is authorized. The ophthalmologists who prescribe it as a treatment for uveitis must also consult doctors experienced in the use of Imraldi.
The medicine is available as a solution for injection under the skin in a pre-filled syringe. The dose depends on the condition to be treated and in children it is usually calculated based on body weight and height. After the initial dose, Imraldi is mostly given every two weeks; however, in certain situations it can be administered weekly. If the doctor considers it appropriate, the injection of Imraldi can be given by the patients themselves or by the people who care for them, after having received the relative instructions. During treatment with Imraldi, patients may be given other medicines, such as methotrexate or corticosteroids (other anti-inflammatory medicines).
For information on the doses to be administered for various diseases and the use of Imraldi, see the package leaflet.
How does Imraldi - Adalimumab work?
The active substance in Imraldi, adalimumab, is a monoclonal antibody (a type of protein) designed to recognize and bind to a chemical messenger present in the body, called tumor necrosis factor (TNF). TNF helps cause inflammation and is found in high concentrations in patients with diseases that can be treated with Imraldi. By binding to TNF, adalimumab blocks its activity, thus reducing inflammation and other disease symptoms.
What benefit has Imraldi - Adalimumab shown during the studies?
Laboratory studies that compared Imraldi and Humira have shown that the active ingredient of Imraldi is very similar to that of Humira in terms of structure, purity and biological activity. Some studies have also shown that the administration of Imraldi produces levels of active ingredient in the body similar to those obtained with Humira.
Furthermore, a main study of 544 patients with moderate to severe rheumatoid arthritis showed that despite treatment with methotrexate, Imraldi and Humira had similar efficacy. The response was quantified as an attenuation of 20% or more in the symptom score after 24 weeks of treatment: there was a response in 68% of the patients who received Imraldi (183 out of 269), compared to 67% of those who had taken Humira (184 out of 273). Long-term treatment continued to have benefits for a year.
Because Imraldi is a biosimilar medicine, it is not necessary that all studies performed on the efficacy and safety of adalimumab for Humira be repeated for Imraldi.
What are the risks associated with Imraldi - Adalimumab?
The most common side effects with adalimumab (seen in more than 1 patient in 10) are nose, throat and sinus infections, injection site reactions (redness, itching, bleeding, pain or swelling), headache and pain musculoskeletal.
Imaldi and other medicines of the same class can also affect the immune system's ability to fight infections and cancer: cases of serious infections and blood cancer have occurred in patients taking adalimumab.
Other rare serious side effects (which may affect up to 1 in 1, 000 people) are the inability of the bone marrow to produce blood cells, nervous disorders, lupus and lupus-like diseases (in which the immune system attacks the patient's own tissues causing inflammation and organ damage) and Stevens-Johnson syndrome (a serious skin condition).
Imraldi should not be used in patients with active tuberculosis or other serious infections or in patients with heart failure (inability of the heart to pump enough blood to various parts of the body) from moderate to severe. For the full list of restrictions and side effects reported with Imraldi, see the package leaflet.
Why has Imraldi - Adalimumab been approved?
The European Medicines Agency has decided that, in accordance with EU requirements for biosimilar medicines, Imraldi has structure, purity and biological activity very similar to Humira and is distributed in the body in the same way.
Furthermore, a study on rheumatoid arthritis showed that, in this condition, the effects of the medicine are equivalent to those of Humira. All these data were considered sufficient to conclude that Imraldi will behave in the same way as Humira in terms of efficacy and safety in the approved indications. Therefore, the Agency considered that, as in the case of Humira, the benefits outweigh the identified risks and recommended that Imraldi be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Imraldi - Adalimumab?
The company that markets it must provide information packages containing information on the safety of the medicine to the doctors who prescribe Imraldi. In addition, patients will receive an alert card.
Recommendations and precautions to be followed by healthcare professionals and patients for Imraldi to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Imraldi - Adalimumab
The full EPAR for Imraldi can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Imraldi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
