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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Aage Bangs Fond | OTHER |
| AbbVie | INDUSTRY |
| Region Midt Forskningsfond |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis topical treatment | Psoriasis topical treatment. No systemic drugs. | ||
| Psoriasis biological treatment | Psoriasis biological treatment. Anti-Tnf and anti-il12/23. |
| |
| Severe atopic dermatitis | Severe atopic dermatitis | ||
| Control | No intervention. No inflammatory skin disease. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological treatment | Drug | patients treated with anti-psoriatic biological agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in coronary calcium score (CAC score) | Psoriasis groups evaluated at 0 and approximately 12 months. AD group and controls at baseline only. | baseline: 0 months, and follow-up: approximately 12 months |
| Repeated Coronary CT Angiography (CCTA) | 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. | 0 and approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk markers | hs-crp, homocystein, SBHG, apolipoprotein B, MBL, PAPP-A. | 0, 3 and 12 months |
| interleukines in blood | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe psoriasis recruited from a dermatological in- and out patient clinic. Patients with severe atopic dermatitis.
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| Name | Affiliation | Role |
|---|---|---|
| Kasper F Hjuler, M.D. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Dermatology | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26093174 | Derived | Hjuler KF, Bottcher M, Vestergaard C, Deleuran M, Raaby L, Botker HE, Iversen L, Kragballe K. Increased Prevalence of Coronary Artery Disease in Severe Psoriasis and Severe Atopic Dermatitis. Am J Med. 2015 Dec;128(12):1325-34.e2. doi: 10.1016/j.amjmed.2015.05.041. Epub 2015 Jun 18. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| D000069285 | Infliximab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| UNKNOWN |
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blood and skin samples.
| 0, 3 and 12 months |
| traditional cardiovascular risk factors | monitoring of blood cholesterol levels and blood glucose. | 0, 3 and 12 months |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |