Polish specialists to conduct world's first trials in children with AD
Specialists from the Medical University of Lodz will help children with atopic dermatitis thanks to the support of the Medical Research Agency.
The PLN 16 million grant will help launch the world's first clinical trials in patients from two years of age with moderate and severe atopic dermatitis (AD).
Atopic dermatitis is a severe inflammatory disease that mainly affects children. In Poland, it affects approx. 8 percent of children, in the vast majority of cases developing by the age of five.
Specialists from the Medical University of Lodz emphasise that this disease is characterized by inflammatory changes on the skin. In the most severe cases, the lesions cover as much as 80-90 percent of the surface, with the skin becoming dry and patients feeling severe, persistent itching.
Skin changes cause many problems in AD patients, including sleep disorders because of itching, behavioural disorders, anxiety, and even sub-depressive states. Some patients develop depression and have suicidal thoughts.
About 30-40 percent of patients also suffer from other atopic diseases, such as food intolerance or allergies, allergic rhinitis or asthma. Atopic dermatitis is a disease with a very complex and still not fully understood pathogenesis. Genetic, immunological and environmental factors contribute to its development.
Despite ongoing research, there are currently no satisfactory therapeutic methods, especially for children; their effectiveness and safety have not been confirmed by clinical trials. The only drug approved for the population (dupilumab) is a biological preparation that the European Medicines Agency (EMA) has approved for use in Europe for patients with moderate and severe AD from the age of six.
This drug is not reimbursed in Poland, in addition it does not protect younger children. Clinical experience and practice is to treat the youngest patients with immunosuppressive drugs, including methotrexate and cyclosporine, but this treatment is not reimbursed.
Project coordinator, Professor Joanna Narbutt from the Medical University of Lodz said: “Therefore, the goal of our project is to conduct the world's first randomised, double-blind and placebo-controlled clinical trial in patients with moderate and severe AD, from the age of two.”
The study co-financed by the Medical Research Agency is designed to determine the effectiveness and safety of cyclosporine and methotrexate in children, with particular emphasis on the youngest patients. Numerous studies and consultations are planned to cover patients with holistic care in order to learn more about their physical and mental health problems. The project is unique and the results obtained will have very important clinical implications, specialists say.
Professor Narbutt said that the project involves the world's first clinical trial in a group of paediatric AD patients from the age of two, aimed at determining the safety and effectiveness of cyclosporine and methotrexate therapy.
She said: “Extensive research and consultations will contribute to a better understanding of the essence of the disease and enable clinicians to conduct a safe and effective therapy based on the objective results of the study.” (PAP)
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