Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
NCT ID: NCT01356758
Last Updated: 2015-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
126 participants
OBSERVATIONAL
2011-03-31
2015-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Psoriasis topical treatment
Psoriasis topical treatment. No systemic drugs.
No interventions assigned to this group
Psoriasis biological treatment
Psoriasis biological treatment. Anti-Tnf and anti-il12/23.
biological treatment
patients treated with anti-psoriatic biological agents
Severe atopic dermatitis
Severe atopic dermatitis
No interventions assigned to this group
Control
No intervention. No inflammatory skin disease.
No interventions assigned to this group
Interventions
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biological treatment
patients treated with anti-psoriatic biological agents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Aage Bangs Fond
OTHER
AbbVie
INDUSTRY
Region Midt Forskningsfond
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kasper F Hjuler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Dep. of Dermatology
Aarhus C, , Denmark
Countries
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References
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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.
Other Identifiers
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j-nr 20100249
Identifier Type: -
Identifier Source: org_study_id