A study led by King’s College London compared the safety and efficacy of cyclosporine 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.
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 cyclosporine, two immunomodulatory drugs.
However, until now there has been no adequately powered randomized clinical trial evidence in relation to their safety and treatment success for pediatric patients with this condition. With new therapies being introduced at a high cost, establishing a gold standard for treatment with conventional systemic therapies like methotrexate and cyclosporine is needed.
The TREAT trial
The TREAT clinical trial assessed 103 children, aged 2–16 years, with severe atopic dermatitis across 13 centers in the UK and Ireland. The patients were given oral doses of methotrexate or cyclosporine and assessed over nine months of treatment and six months after the therapy ended.
The study found that cyclosporin works faster and reduces disease severity more at 12 weeks but was expensive. Methotrexate, on the other hand, 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 TREAT trial findings, methotrexate is a useful and safe treatment in pediatric patients with severe atopic dermatitis and a good alternative to cyclosporine, especially in settings where healthcare resources are limited.
Professor Carsten Flohr, PhD, chair in dermatology and population health sciences at King’s College London, and consultant dermatologist at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, said, “This is the largest pediatric trial using conventional immunomodulatory treatments in severe atopic dermatitis and was conducted across 13 centers 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.”
- This press release was originally published on the King’s College London website