The use of adalimumab therapy in patients with psoriasis was associated with reduced key markers of inflammation, including glycoprotein acetylation, compared with the use of phototherapy, according to the results of a multicenter, randomized controlled trial (ClinicalTrials.gov identifier: NCT01553058) and a 52-week, open-label extension study (ClinicalTrials.gov identifier: NCT01866592) that were published in Circulation: Cardiovascular Imaging.
The investigators sought to assess and compare the effect of treatment with adalimumab or phototherapy on vascular inflammation and cardiovascular biomarkers in patients with moderate to severe psoriasis.
They conducted a randomized, double-blind trial of adalimumab, phototherapy, or placebo, assigned to participants in a 1:1:1 ratio for 12 weeks.
After this, there was a crossover to adalimumab for a total of 52 weeks. Study outcomes included vascular inflammation, based on 18F-fluorodeoxyglucose positron emission tomography/computed tomography and cardiovascular biomarkers of inflammation, insulin resistance, and lipoproteins.
Overall, 97 patients were randomly assigned to initial treatment, with 92 completing the randomized controlled portion of the study. A total of 81 patients then entered the adalimumab extension phase of the study, with 61 participants completing 52 weeks of treatment with adalimumab.
No difference was reported at week 12 regarding change in vascular inflammation in the adalimumab group (change compared with placebo, 0.64%; 95% CI, −5.84% to 7.12%) or the phototherapy group (−1.60%; 95% CI, −6.78% to 3.59%) or after 52 weeks of adalimumab therapy (0.02% compared with study initiation; 95% CI, −2.85% to 2.90%).
Both adalimumab and phototherapy reduced inflammation by serum C-reactive protein and interleukin 6. Only adalimumab therapy, however, was associated with reduced tumor necrosis factor and glycoprotein acetylation at both 12 and 52 weeks. Moreover, neither adalimumab nor phototherapy had an effect on such metabolic markers as insulin, adiponectin, and leptin. Only phototherapy increased levels of high-density lipoprotein particles at 12 weeks. Furthermore, at 52 weeks of adalimumab treatment, cholesterol efflux and high-density lipoprotein particles were reduced.
The investigators concluded that the use of anti-tumor necrosis factor therapy has strong and consistent anti-inflammatory effects in the skin and blood of patients with psoriasis compared with phototherapy. Larger studies with more detailed phenotyping of vascular disease are warranted to evaluate the comparative differences in the effects of adalimumab and phototherapy that were observed in the current study.
Mehta NN, Shin DB, Joshi AA, et al. Effect of 2 psoriasis treatments on vascular inflammation and novel inflammatory cardiovascular biomarkers: a randomized placebo-controlled trial. Circ Cardiovasc Imaging. 2018;11(6):e007394.