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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.
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.
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
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Adalimumab treatment arm, Fumaric acid esters treatment group, Narrow band UVB radiation
Medical University Vienna Department of Dermatology
Not yet recruiting
Medical University of Vienna
Published on BioPortfolio: 2014-08-27T03:15:10-0400
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Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.
A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.
An enzyme that catalyzes the reversible hydration of fumaric acid to yield L-malic acid. It is one of the citric acid cycle enzymes. EC 126.96.36.199.
Procedures, surgery, or other treatment without consent of person or persons receiving treatment.
Refusal of the health professional to initiate or continue treatment of a patient or group of patients. The refusal can be based on any reason. The concept is differentiated from PATIENT REFUSAL OF TREATMENT see TREATMENT REFUSAL which originates with the patient and not the health professional.
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