Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
|ClinicalTrials.gov Identifier: NCT01356758|
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : December 21, 2015
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US. Similarly to other inflammatory diseases there is now substantial and accumulating evidence that psoriasis has a systemic inflammatory component.
It is known that patients suffering from psoriasis have increased prevalence of traditional cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and diabetes mellitus. This would logically explain an increased rate of cardiovascular events, but even when adjusting for theses risk factors, psoriasis carry an independent risk for developing cardiovascular disease.
Recent large epidemiological studies have shown a strong correlation between psoriasis and myocardial infarction.
Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the disease has not been associated with cardiovascular disease.
In conclusion, convincing and increasing evidence is supporting that psoriasis induce accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular, this is seen in young patients with early disease onset.
Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A number of these cytokines are suggested to be atherogenic. In contrast, another chronic inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest to compare the presence of cardiovascular disease in these two inflammatory skin diseases.
Hypothesis: That the risk of developing cardiovascular disease and especially coronary artery disease is increased in psoriasis patients and that this process can be influenced by treatment of psoriasis with biological treatment.
|Condition or disease||Intervention/treatment|
|Psoriasis Atopic Dermatitis Atherosclerosis||Drug: biological treatment|
|Study Type :||Observational|
|Actual Enrollment :||126 participants|
|Observational Model:||Case Control|
|Official Title:||Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents|
|Study Start Date :||March 2011|
|Primary Completion Date :||September 2015|
|Study Completion Date :||November 2015|
Psoriasis topical treatment
Psoriasis topical treatment. No systemic drugs.
Psoriasis biological treatment
Psoriasis biological treatment. Anti-Tnf and anti-il12/23.
Drug: biological treatment
patients treated with anti-psoriatic biological agents
Severe atopic dermatitis
Severe atopic dermatitis
No intervention. No inflammatory skin disease.
- Change in coronary calcium score (CAC score) [ Time Frame: baseline: 0 months, and follow-up: approximately 12 months ]Psoriasis groups evaluated at 0 and approximately 12 months. AD group and controls at baseline only.
- Repeated Coronary CT Angiography (CCTA) [ Time Frame: 0 and approximately 12 months ]
Assessment according to the 18-segment model (as suggested by AHA): Changes in number of coronary plaques, stenosis, severity, composition. Changes in coronary plaque volume index.
Psoriasis groups evaluated at 0 and approximately 12 months. AD group and untreated controls at baseline only.
- Cardiovascular risk markers [ Time Frame: 0, 3 and 12 months ]hs-crp, homocystein, SBHG, apolipoprotein B, MBL, PAPP-A.
- interleukines in blood [ Time Frame: 0, 3 and 12 months ]selected cytokines (amongst: TNFα, IL-1, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL17A, IL-19, IL-20, IL-23, IFN, ICAM-1, E-selectin)
- traditional cardiovascular risk factors [ Time Frame: 0, 3 and 12 months ]monitoring of blood cholesterol levels and blood glucose.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356758
|Dep. of Dermatology|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Kasper F Hjuler, M.D.||Aarhus University Hospital|