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

NCT01356758 | Completed

• 1 other identifier: j-nr 20100249
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Atopic Dermatitis; Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Cardiovascular risk markers

  0, 3 and 12 months

• interleukines in blood

  0, 3 and 12 months

• traditional cardiovascular risk factors

  0, 3 and 12 months

Study Arms (4)

Psoriasis topical treatment

Psoriasis topical treatment. No systemic drugs.

Psoriasis biological treatment

Psoriasis biological treatment. Anti-Tnf and anti-il12/23.

Drug: biological treatment

Severe atopic dermatitis

Severe atopic dermatitis

Control

No intervention. No inflammatory skin disease.

Interventions

biological treatment DRUG

patients treated with anti-psoriatic biological agents

Also known as: Adalimumab, Etanercept, Infliximab, Ustekinumab

Psoriasis biological treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Congestive heart failure (NYHA group III and IV).
• Reduced kidney function (eGFR below 60).
• 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.
• Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Aage Bangs Fond: collaborator
• AbbVie: collaborator
• Region Midt Forskningsfond: collaborator

Study Sites (1)

Dep. of Dermatology

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 26093174 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and skin samples.

MeSH Terms

Conditions

Psoriasis; Dermatitis, Atopic; Atherosclerosis

Interventions

Adalimumab; Etanercept; Infliximab; Ustekinumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Kasper F Hjuler, M.D.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 19, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2014-08

Locations

DK (1)