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TREAT

A Randomised Controlled Trial Assessing the Effectiveness, Safety and Cost-effectiveness of Methotrexate versus Ciclosporin in C

TREAT

A Randomised Controlled Trial Assessing the Effectiveness, Safety and Cost-effectiveness of Methotrexate versus Ciclosporin in C
Funding EME
Portfolio Paediatric, foetal and maternal health
Interventions Medicine
Randomised Yes
Status In follow-up
Start Date 11-May-2016

The TREAT study aims to compare the effectiveness and safety of two immunosuppressive (drug which works against the body's immune (protective) response) medicines, methotrexate (MTX) and ciclosporin (CyA), in the treatment of severe, difficult to manage eczema in children, aged 2 -16 years. Eczema affects 1 in 4 children in the UK. It causes inflamed, itchy skin and typically affects the folds of the body such as behind the knees, inside the elbows as well as the neck. Flare ups are common and the impact on health service costs and patients' and families' quality of life is similar to diabetes or asthma. Eczema treatment aims to reduce the skin inflammation (swelling), relieve itching and prevent flare-ups. Usually, this can be achieved with regular application of emollients and steroid creams and the majority of children grow out of their eczema over time. However, in a small group of patients the disease is so severe that immuno-suppressive medication is required. So far, there has been very limited research into this area in children, and clinical management is therefore primarily guided by studies performed in adults. We will also study how well the two medications control flares and their safety and tolerability (adverse reactions). Although MTX has been extensively used in a number of diseases, such as rheumatoid arthritis, we do not know how it works, and this will also be examined in our trial. For this, blood tests will be required but not more frequently than during routine NHS clinical care. We will also use a special sticky tape to collect samples from the skin of participating children. This is not traumatic and will allow us to study the immune response in the skin. Patients will be recruited through the main paediatric dermatology departments. Patients (102) will be allocated at random to receive either methotrexate or ciclosporin for 9 months and then followed up for another 6 months to assess short- and long-term effectiveness and the safety of both drugs.

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  • Irvine, A. D., et al. (2018). "A randomized controlled trial protocol assessing the effectiveness, safety and cost-effectiveness of methotrexate vs. ciclosporin in the treatment of severe atopic eczema in children: the TREatment of severe Atopic eczema Trial (TREAT)." British Journal of Dermatology 179(6): 1297-1306.
    1. https://doi.org/10.1111/bjd.16717