What is Solymbic and what is it used for - Adalimumab?
Solymbic is a medicine that acts on the immune system and 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);
- active arthritis associated with enthesitis (a rare disease that involves inflammation of the joints); suppurative hydrosadenitis (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).
Solymbic is mainly used in adults in the presence of serious, moderately severe or worsening conditions or if patients cannot be subjected to other treatments. For more information on the use of Solymbic in all conditions, including those in which it can be used in children, see the summary of product characteristics (included with EPAR).
Solymbic 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 Solymbic is Humira. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Solymbic used - Adalimumab?
Solymbic can only be obtained with a prescription; the treatment must be started and supervised by medical specialists experienced in the diagnosis and treatment of the conditions for which it is authorized. Doctors who prescribe a treatment for uveitis must also consult doctors who are experienced in the use of Solymbic.
The medicine is available as a solution for injection under the skin in a pre-filled syringe or pen. 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, Solymbic is more often given every two weeks; however, it can be administered weekly in certain situations. If your doctor thinks it is appropriate, the injection of Solymbic can be given by the patients or their carers after receiving the instructions. During treatment with Solymbic, patients may be given other medicines, such as methotrexate or corticosteroids (other anti-inflammatory medicines).
For information on the doses to be used for the various conditions and the use of Solymbic, see the package leaflet.
How does Solymbic - Adalimumab work?
The active substance in Solymbic, 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). This messenger is responsible for inflammation and is found in high concentrations in patients with diseases that can be treated with Solymbic. By binding to TNF, adalimumab blocks its activity, thus reducing inflammation and other disease symptoms.
What benefit has Solymbic - Adalimumab shown during the studies?
Large-scale laboratory studies comparing Solymbic and Humira have shown that adalimumab in Solymbic is highly similar to adalimumab in Humira in terms of chemical structure, purity and biological activity.
Because Solymbic is a biosimilar medicine, studies on Humira with regard to efficacy and safety should not all be repeated for Solymbic.
The medicine has been shown to have similar effects to Humira in one main study involving 526 patients with moderate to severe rheumatoid arthritis who had not responded adequately to methotrexate and in another study of 350 patients with moderate to severe psoriasis.
In the rheumatoid arthritis study, the response was quantified with a relief of 20% or more in the symptom score after 24 weeks of treatment: 75% of patients treated with Solymbic had responded compared to 72% of those treated with Humira . In the psoriasis study, which looked at the degree of improvement after 16 weeks, an 81% alleviation in the symptom score with Solymbic was found compared with an 83% alleviation with Humira.
What are the risks associated with Solymbic - Adalimumab?
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections of the nose and throat, sinuses and upper respiratory tract, injection site reactions (redness, itching, bleeding, pain or swelling ), headache and musculoskeletal pain.
Solymbic and other medicines of the same class can also affect the immune system's ability to fight infections and cancer, and there have been cases of severe infections and blood cancer in patients taking adalimumab.
Other rare serious side effects (observed between 1 in 10 000 patients and 1 in 1 000 patients) are the inability of the bone marrow to produce blood cells, nervous system disorders, lupus and lupus-like diseases (in which the immune system attacks the tissues of the patient causing inflammation and organ damage) and Stevens-Johnson syndrome (a serious skin condition).
Solymbic should not be used in patients with active tuberculosis and other serious infections or in patients with heart failure (inability of the heart to pump enough blood into the body) moderate to severe. For the full list of Solymbic restrictions, see the package leaflet.
Why has Solymbic - Adalimumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that, in accordance with EU requirements for biosimilar medicines, Solymbic has structure, purity and biological activity highly similar to Humira and is distributed in the body in the same way .
Furthermore, studies of rheumatoid arthritis and psoriasis have shown that the effects of the medicine are equivalent to those of Humira in such conditions. All these data were considered sufficient to conclude that Solymbic will behave in the same way as Humira in terms of efficacy and safety in the approved indications. Therefore, the CHMP considered that, as in the case of Humira, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Solymbic.
What measures are being taken to ensure the safe and effective use of Solymbic - Adalimumab?
The company that markets Solymbic must provide information packages to the doctors who prescribe the medicine. These packages contain information on the safety of the medicine and an alert card to be delivered to patients
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Solymbic have also been reported in the summary of product characteristics and the package leaflet.
More information on Solymbic - Adalimumab
For the full version of the EPAR and the summary of the Solymbic risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Solymbic therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
