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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356758
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : December 21, 2015
Aarhus University Hospital
Aage Bangs Fond
Region Midt Forskningsfond
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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
Time Perspective: Prospective
Official Title: Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
Study Start Date : March 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
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
Other Names:
  • Adalimumab
  • Etanercept
  • Infliximab
  • Ustekinumab

Severe atopic dermatitis
Severe atopic dermatitis
No intervention. No inflammatory skin disease.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA
blood and skin samples.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe psoriasis recruited from a dermatological in- and out patient clinic. Patients with severe atopic dermatitis.

Inclusion Criteria:

  1. Males and females aged 18 years or above.
  2. 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.
  3. Signed informed consent form prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  1. Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
  2. Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
  3. Congestive heart failure (NYHA group III and IV).
  4. Reduced kidney function (eGFR below 60).
  5. 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.
  6. UVB phototherapy and PUVA photochemotherapy within 1 month prior to study start.
  7. Prior treatment with infliximab, etanercept, adalimumab or ustekinumab unless less than PASI-50% reduction have been observed during this treatment.
  8. Investigational biological agents within 6 months prior to inclusion.
  9. Any other investigational drug within 1 month or 5 half lives prior to inclusion, which ever is longer.
  10. Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356758

Dep. of Dermatology
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Aage Bangs Fond
Region Midt Forskningsfond
Principal Investigator: Kasper F Hjuler, M.D. Aarhus University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01356758     History of Changes
Other Study ID Numbers: j-nr 20100249
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: August 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases, Papulosquamous
Skin Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases