Study is the first randomised trial to compare safety and efficacy of two commonly used therapies among paediatric patients
A new study involving researchers from Trinity College Dublin is likely to change the way children are treated for atopic dermatitis.
Along with collaborators in King’s College London, the researchers conducted the largest ever paediatric trial using conventional immuno-modulatory treatments in severe atopic dermatitis.
The study found that of the two conventional treatments currently available – methotrexate and ciclosporin – methotrexate proved to be a useful and safe treatment in paediatric patients with severe atopic dermatitis, and a good alternative to ciclosporin, especially in settings where healthcare resources are limited.
More than one-in-five children in Ireland are diagnosed with atopic dermatitis, with symptoms including severe itching and raised bumps that may become crusty and leak fluid, if scratched.
Until now there has been no adequately powered randomised clinical trial evidence in relation to the safety and treatment success of methotrexate and ciclosporin among children.
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 between the ages of two and 16 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.
Alan Irvine, professor of dermatology at the TCD School of Medicine and consultant dermatologist in Our Lady’s Children’s Hospital, Dublin, said that severe atopic dermatitis 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 un-licenced 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 that the trial ‘is likely to change our treatment paradigm around this condition, not just for patients in the UK but also internationally’.
The research was published in the British Journal of Dermatology.