Largest paediatric trial investigates treatments for severe atopic dermatitis

Posted on: 19 September 2023

Findings from a Trinity College/King’s College London clinical trial has recommended methotrexate for children with severe atopic dermatitis, a condition that affects 1 in 5 children in Ireland.

Largest paediatric trial investigates treatments for severe atopic dermatitis

Trinity researchers and collaborators in King’s College London have conducted the largest paediatric trial using conventional immuno-modulatory treatments in severe atopic dermatitis. The findings - published in the British Journal of Dermatology - are likely to change the treatment paradigm for the condition.

For children and young people with atopic dermatitis - the most common skin condition in children - the main first line conventional systemic treatments are methotrexate and ciclosporin, two immuno-modulatory drugs (drugs that modify the response of the immune system).

Until now there has been no adequately powered randomised clinical trial evidence in relation to their safety and treatment success for paediatric patients, and with new therapies being introduced at a high cost, establishing a gold standard for treatment with the conventional systemic therapies like methotrexate and ciclosporin is needed.

The team compared the safety and efficacy of ciclosporin with methotrexate in children and young people with this debilitating skin condition. They also examined whether the severity of the disease changed or returned after treatment ended.

The trial assessed 103 children with severe atopic dermatitis age 2-16 years across 13 centres in the UK and Ireland. The patients were given oral doses of methotrexate or ciclosporin and assessed over nine months of treatment and six months after the therapy ended.  

The study found that ciclosporin works faster and reduces disease severity more at 12 weeks but was more expensive, whereas methotrexate was significantly cheaper and led to better objective disease control after 12 weeks and off therapy, with fewer participant-reported flares of atopic dermatitis after treatment had stopped. There were also no concerning safety signals.

Based on the trial findings, methotrexate is a useful and safe treatment in paediatric patients with severe atopic dermatitis and a good alternative to ciclosporin, especially in settings where health care resources are limited.

Alan Irvine, Professor of Dermatology at the School of Medicine and our Lady’s Children’s Hospital, Dublin, said:

‘Atopic dermatitis is a common condition, affecting more than 1 in 5 Irish children. When severe it has an enormous impact on the quality of life of children and their families. At this stage treatment with creams is no longer effective. While innovative new therapies are now available, many European countries, including Ireland, require children to try unlicenced therapies first before they will pay for more advanced treatments. This is the first randomised trial to compare two of these commonly used therapies, methotrexate and ciclosporin, to assess safety and efficacy. We showed both treatments work well and are generally well tolerated, but methotrexate has more sustained benefit after discontinuing treatment.’

Professor Carsten Flohr, Chair in Dermatology and Population Health Sciences at King’s College London, and consultant dermatologist at St John’s Institute of Dermatology at Guy’s and St Thomas’ NHS Foundation Trust, said:

“This is the largest paediatric trial using conventional immuno-modulatory treatments in severe atopic dermatitis and was conducted across 13 centres in the UK and Ireland and is likely to change our treatment paradigm around this condition, not just for patients in the UK but also internationally.”

The paper, ‘Efficacy and safety of ciclosporin versus methotrexate in the treatment of severe atopic dermatitis in children and young people (TREAT): a multicentre, parallel group, assessor-blinded clinical trial’ is published in the British Journal of Dermatology and can be viewed here:

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