This study was a double blind, randomized, placebo controlled study done in collaboration with the National Heart Lung and Blood Institute with findings showing that patients who had taken the drug ustekinumab had a 19% improvement in aortic inflammation that was measured and confirmed by advanced imaging.
It is estimated that psoriasis affects about 6.5 million Americans, it is a chronic inflammatory disease which causes skin cells to multiple quickly resulting in red raised patches than can be covered in silvery scales occurring typically on the scalp, elbows, and knees but can appear anywhere including the genitals, face, and nails, which in moderate to severe cases it can increase the risks of stroke, heart attack, and even premature death.
Ustekinumab was approved for sale by the FDA under the name of Stelara for the treatment of psoriasis, Crohn’s Disease, and psoriatic arthritis. Researchers began this study to see if the benefits of ustekinumab/Stelara could go beyond the skin.
43 psoriasis patients participated in this study and were divided into 2 groups at random, one group of 22 receiving the treatment, and the other of 21 given a placebo. Aortic inflammation was measured by 18-FDG-PET/CT scan, and was conducted before the onset of treatment and again at 12 weeks. Results were that the group that had received treatment had an 6.6% decrease in aortic inflammation with the placebo group having an increase of 12%, meaning that the drug was shown to be responsible for a 19% improvement, and also resulted in improvement is skin inflammation in 77% treated patients by a 75% or greater improvement, compared to 10.5% in the placebo group. Both of these findings are statistically significant and are consistent with previous studies, but are in contrast to 2 other trials using adalimumab sold as Humira.
This study shows promise of the potential Ustekinumab/Stelara to decrease the risks of stroke and heart attack in the future and is encouraging. This trial is ongoing to evaluate the longer term effects of Ustekinumab/Stelara on follow up to see if the results are sustainable and if there is continued improvements.