In December 3, 2019, the Health Insurance Institute of Slovenia (ZZZS) put the first biological medication for patients with atopic dermatitis on its list of drugs, coming into effect on Wednesday, December 18, 2019. This means that the biological medication now classifies as a prescription drug and is available to adult and adolescent patients with moderate-to-severe atopic dermatitis who qualify for systemic treatment.
What is biological medication for atopic dermatitis?
The biological medication for atopic dermatitis is the first of its kind, designed for adult and adolescent patients with moderate-to-severe forms of atopic dermatitis, which was approved by FDA at the beginning of 2017 for adults and in 2019 for adolescents. The European Medicines Agency (EMA) approved the medicine for use in adolescents this August (2019). The biological medication is currently not indicated for the treatment of children with atopic dermatitis. The medication represents a breakthrough in the treatment of atopic dermatitis and works in completely different ways than any other currently available drug.
What is biological medicine?
Biological medicines are genetically designed from proteins gathered from live cells or tissues. They are designed to target very specific parts of the immune system that contribute to the development of chronic inflammatory illnesses such as atopic dermatitis. They work in a much more specific and selective manner in comparison to other systemic drugs that are used for atopic dermatitis. Because the biological medicine is made from live cells, its production is much more expensive than the production of non-biological drugs. Biological medicines have been in use for a very long time for illnesses such as psoriasis, asthma and rheumatoid arthritis. Currently, many different biological medicines are being developed for people with atopic dermatitis.
- The Medicinal Products Act defines biological medicines as drugs that contain biological substances or substances produced in processes that involve biological systems. A biological substance is a substance obtained from or through the use of a biological source and needs a combination of physiochemical and biological testing in order to determine its quality, together with the production procedure and its supervision. Biological medications are thus medicines produced in biological or biotechnical processes such as cell cultures and recombinant DNA technology, medicines produced from blood or plasma, immunosuppressant drugs and similar.
How does biological medicine work?
The immune system in our bodies uses intercellular mediators – interlukines (IL) – to communicate between cells. Interleukines play a role in protecting our body from pathogen microorganisms. The immune system of patients with atopic dermatitis overreacts to numerous allergens (antigens that encourage type 1 allergic reactions). The result is the overproduction of interleukines that are responsible for systemic inflammations in atopic dermatitis. The biological medication works by inhibiting the binding of neuroleukines to cell receptors.
The medicine contains monoclonal antibodies derived in an ethical manner from human cells. The antibodies bind to the alpha subunit of IL-4 receptors and thus prevent the binding of interleukines IL-4 and IL-13 to the cell receptors, a process that would otherwise help sustain the immune response of Th2 cells.
By inhibiting the binding to cell receptors, the medicine drastically reduces the itching sensation in many patients with atopic dermatitis. Due to the way it works, the medicine revolutionises our understanding of atopic dermatitis and the itch present in the illness. Its development was based on the concept that the rash in atopic dermatitis doesn’t cause the itch in patients. Rather, the itchy sensation is a result of the inflammation due to a hyperactive immune system and can’t be soothed with topical medication in patients with moderate-to-severe atopic dermatitis.
How effective is the biological medicine?
In the clinical trials, more than half of the patients reported a 75% relief from atopic dermatitis symptoms. The medicine significantly reduced itching in many patients, improving the quality of their sleep.
Do I qualify for the use of the biological medicine?
The biological medicine is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 or more, who are candidates for the systemic treatment of atopic dermatitis and who haven’t responded well to any other treatment courses. If you think that you qualify for the treatment given the criteria above, talk to your dermatologist. The dermatologist will evaluate your medical state and put your case up for approval with the committee for biological treatment at UKC Maribor or UKC Ljubljana.
How is the biological medication administrated? Does it come in the form of a cream or tablets?
The biological medicine for atopic dermatitis is given as an injection into the fatty area beneath the skin. The patients or their guardians can apply the injections themselves after they have been shown how by a qualified health worker.
The recommended dose for adults and adolescents (weighing more than 60 kg) is the starting dose of 600 mg (administered in two 300-mg injections) followed by a 300-mg subcutaneous injection every other week. Adolescents weighing less than 60 kg are given 200 mg injections.
What happens if the medication has no effect on me after a few weeks?
The doctors will consider stopping the treatment if there is no improvement after 16 weeks.
What are the side effects of the biological medication?
The biological medication has possible side effects like any other drug. Before using the medication, thoroughly consult with your doctor, read the instructions, communicate your fears and be an active participant in your treatment. Keep track of your medical reports, gather new information on the biological medication that you’re using and cooperate with your doctor.
The most common side effects of the medicine are:
- Irritation at the site of the injection.
- Inflammation of the conjunctiva (conjunctivitis or pink eye).
- Inflammation of the eyelids (blepharitis).
- Oral herpes.
As long as we have our health, we have it all. Become an active participant in your treatment course. Read, monitor and ask questions.