In collaboration with the National Heart, Lung, and Blood Institute, researchers from the Perelman School of Medicine at the University of Pennsylvania led a multicenter, randomized, double-blind, placebo-controlled study that compared the effect of adalimumab treatment of moderate to severe psoriasis or phototherapy on vascular inflammation and cardiovascular biomarkers.
In collaboration with the National Heart, Lung, and Blood Institute, researchers from the Perelman School of Medicine at the University of Pennsylvania led a multicenter, randomized, double-blind, placebo-controlled study that compared the effect of adalimumab to treat moderate to severe psoriasis with phototherapy on vascular inflammation and cardiovascular biomarkers.
Psoriasis is a common chronic inflammatory skin disease that affects more than 125 million people worldwide. Similar to other inflammatory diseases, psoriasis has been associated with increased risk of adverse cardiovascular events, dyslipidemia, and mortality.
Adalimumab is a monoclonal antibody that blocks anti—tumor necrosis factor (anti-TNF) and is the current standard of care biological therapy for the treatment of moderate to severe psoriasis. The therapy has also been suggested to reduce cardiovascular events. In addition, narrowband ultraviolet B phototherapy is also highly effective in the treatment of psoriasis but has not been associated with clinically significant changes in systemic immune function.
The study was a randomized controlled trial that enrolled 97 patients across 8 health centers in the United States with a 1:1:1 match to subcutaneous adalimumab injections every 2 weeks, narrowband ultraviolet B phototherapy at baseline, or placebo. In total, 92 patients (95%) completed the 12-week controlled portion of the study, after which, 81 patients entered into an open-label extension.
During this phase, study participants were treated with adalimumab for 52 weeks (if initially assigned to placebo or phototherapy) or an additional 40 weeks if originally assigned to the adalimumab arm, so that all patients received a total of 52 consecutive weeks of adalimumab therapy. In total, 9 patients (11%) discontinued the study, resulting in 67 patients included in the analysis.
Researchers found that both adalimumab and phototherapy resulted in substantial improvements in psoriasis severity compared with placebo. Patients evaluated during the open-label extension period achieved a high skin clearance rate, with 53% of patients presenting with either clear or almost clear skin.
“These results are similar to prior clinical trials which showed adalimumab did not reduce aortic inflammation in patients with psoriasis. They are, however, in contrast to a previous study which showed an improvement in aortic vascular inflammation at 12 weeks in patients taking ustekinumab— a biologic that targets a different aspect of the immune system,” study author Joel Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, said in a statement.
Overall, adalimumab reduced key markers of inflammation including glycoprotein acetylation compared with phototherapy. However, larger studies with more detailed phenotyping of vascular disease should be conducted to assess the differences in the effects of adalimumab and phototherapy demonstrated in this trial.
Mehta N, Shin D, Joshi A, et al. Effect of 2 psoriasis treatments on vascular inflammation and novel inflammatory cardiovascular biomarkers. Circ Cardiovasc Imaging. 2018;11(6):e007394. circimaging.ahajournals.org/content/11/6/e007394#sec-9 Accessed May 29, 2018.