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OpenTrials
Completed

NCT Number: NCT01356758

Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents

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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Key information

Conditions

Psoriasis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atopic Dermatitis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Dermatology

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18 years or above.
  • Intervention group: Severe plaque psoriasis with indication for biological therapy according to national guidelines. Psoriasis Control group: Patients with similar disease activity who for personal reasons decline systemic treatment and only receive topical therapy. Atopic dermatitis group: Patients matched regarding sex, disease duration, body surface involvement, BMI and smoking habits.
  • Signed informed consent form prior to initiation of any study-mandated procedure.

Exclusion criteria

  • Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
  • Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
  • Congestive heart failure (NYHA group III and IV).
  • Reduced kidney function (eGFR below 60).
  • Oral methotrexate, ciclosporin, acitretin and fumarate esters within 1 month before inclusion. In the intervention group, patients receiving oral anti-psoriatic treatment for at least 6 months before the study start can be included, if they are maintained on the same dose during the study period.
  • UVB phototherapy and PUVA photochemotherapy within 1 month prior to study start.
  • Prior treatment with infliximab, etanercept, adalimumab or ustekinumab unless less than PASI-50% reduction have been observed during this treatment.
  • Investigational biological agents within 6 months prior to inclusion.
  • Any other investigational drug within 1 month or 5 half lives prior to inclusion, which ever is longer.
  • Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.

Treatment and study plan

biological treatment

Drug

patients treated with anti-psoriatic biological agents

Other names: Adalimumab, Etanercept, Infliximab, Ustekinumab

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Cardiovascular risk markers

    Time frame: 0, 3 and 12 months

    hs-crp, homocystein, SBHG, apolipoprotein B, MBL, PAPP-A.

  2. 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)

  3. traditional cardiovascular risk factors

    Time frame: 0, 3 and 12 months

    monitoring of blood cholesterol levels and blood glucose.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aage Bangs Fond
  • Aarhus University Hospital
  • AbbVie
  • Region Midt Forskningsfond

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 19, 2011
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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