A drug that is currently used for the treatment of psoriasis has been found to be effective in treating the early stages of type 1 diabetes in children and adolescents according to a new clinical trial led by Cardiff University with the assistance of Swansea Trials Unit (STU) and the Diabetes Research Group Laboratory at Swansea University.

Swansea University reports the study, which has been funded by a National Institute for Health and Care Research and Medical Research Council partnership, suggests that ustekinumab, a drug used to treat psoriasis since 2009, is effective in preserving the body’s ability to produce insulin in recently diagnosed type 1 diabetes patients, bringing the goal of managing this form of diabetes without insulin a step closer.

Dr Danijela Tatovic, Clinical Senior Lecturer at Cardiff University School of Medicine, said “Type-1 diabetes occurs when the body’s immune system attacks and destroys the cells of the body that produce insulin. This eventually leaves the person dependent on insulin injections. Researchers are now developing ways to slow or halt the immune system attack. If such treatments can be started early, before all the insulin making cells are lost, this could prevent or reduce the need for insulin.

“Ustekinumab is an injection treatment which patients give themselves at home once every 2 months. It has been used effectively in the treatment of more than 100,000 patients with immune conditions ranging from arthritis to inflammation of the bowel as well as psoriasis and shown to have very few side-effects. This is the first time it has been tested in a controlled clinical trial in type 1 diabetes.”

Professor Tim Tree, King’s College London, said “We have found that Ustekinumab reduces the level of a tiny group of immune cells in the blood called Th17 cells. Th17 cells make up only 1 in 1000 of blood immune cells, but they seem to cause most of the problem in type 1 diabetes. This explains why Ustekinumab has so few side-effects. It targets the trouble-making cells, while leaving 99% of the immune system intact – a great example of precision medicine.”

The study was by Cardiff University, Swansea University, King’s College London, and the University of Calgary. STU and the Diabetes Research Group Laboratory at Swansea University helped design the original study, with STU having responsibility for managing the trial, data, statistical and governance elements of the trial while the Diabetes Research Group Laboratory undertook laboratory analysis of screening samples and primary outcome measures.

The study tested the psoriasis treatment in seventy two adolescents between the ages of twelve and eighteen treated within a hundred days of being diagnosed with type 1 diabetes. The findings from the study have been published in Nature Medicine. After twelve months of using Ustekinumab, the researchers found that C-peptide levels, a measure of the body’s ability to make insulin, were 49% higher compared to those taking a dummy injection (placebo). The treatment was found to be very safe, with no more side effects than the placebo injections.

Professor Colin Dayan, Clinical Professor at Cardiff University’s School of Medicine, said “We tested this treatment in children and adolescents who already needed insulin treatment. It would be better if we could treat at an earlier stage, while the children are still well and prevent them needing insulin. Thankfully, Ustekinumab has a good enough safety record to be considered for use in children at this early stage.”

Dr Peter Taylor, Cardiff University’s Systems Immunity Research Institute, said “It is now possible with a simple finger-prick antibody test to detect children who will develop type 1 diabetes years before they need insulin. Combining screening in this way with early treatment with Ustekinumab seems a very promising approach to preventing the need for insulin. Further trials will be needed to confirm this.”

Dr Kym Carter, Senior Trial Manager at Swansea University, said “STU are delighted to have been part of the ground-breaking work and to have coordinated and analysed the trial results in collaboration with Professor Dayan. The findings make an important contribution to the field of diabetes management.”

The research, Targeted reduction of a proinflammatory subset of Th17 T-cells by Ustekinumab is associated with C-peptide preservation in Type 1 diabetes, was published in Nature Medicine.