The Influence of Adalimumab on Cardiovascular and Metabolic Risk in Psoriasis
Status:
Unknown status
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Psoriasis vulgaris is no longer considered as a chronic inflammatory disease restricted to
the skin. Evidence has accumulated in the past that psoriasis is a chronic inflammatory
systemic disease. As in rheumatoid arthritis, the chronic inflammatory process plays a
central role in the pathogenesis of associated comorbidities such as diabetes and
cardiovascular disease. Since several years the armamentarium of psoriasis treatment has been
broadened by the availability of TNF alpha blockers. These neutralize systemic TNF alpha
which not only plays a central role in the pathogenesis of psoriasis but has also been linked
to inflammatory pathways in diabetes and cardiovascular disease. While a few studies have
investigated the positive effects of TNF alpha blockers on associated cardiovascular disease
in rheumatoid arthritis patients, no research data exist on the effects of these therapeutic
agents in patients with moderate to severe chronic plaque psoriasis.
The present study aims at determining the effects of adalimumab, a potent and frequently
prescribed TNF alpha blocker for the treatment of psoriasis, on different diabetic and
cardiovascular risk factors in patients receiving this treatment as a remedy for moderate to
severe plaque type psoriasis. The study is designed to explore whether adalimumab is capable
to prevent or modulate psoriasis-associated comorbidities by blocking systemic inflammation.
The effects of adalimumab will be compared with those of fumaric acids, which represent an
established traditional systemic treatment option for moderate to severe psoriasis.
Study hypothesis:
Therapy with adalimumab will lead to an improvement of several parameters that reflect the
risk for diabetes and cardiovascular disease in patients with chronic plaque psoriasis due to
chronic inflammation. Endothelial dysfunction, as assessed by ultrasound flow mediated
dilatation, will serve as primary outcome measure. Other risk factors such as blood lipids,
hsCRP, IL-6, endothelial adhesion molecules, parameters of glucose metabolism and carotid
intima-media thickness will be secondary outcomes.
Aim:
If adalimumab and/or fumaric acids will show a significant impact on the above mentioned
parameters, these findings would offer a new perspective for the long term management of
psoriatic patients and their comorbidities.
Study design: Randomized, prospective, controlled, parallel group study
Study population: 66 patients