Clinical trial NCT01753245: Analysis Of The Influence Of Metabolic Syndrome On Treatment Efficacy With Anti-Tnf In Moderate-Severe Psoriasis In Real Clinical Practice.
Official title: CARDIOVASCULAR RISK FACTORS IN A SPANISH POPULATION OF PATIENTS WITH MODERATE-TO-SEVERE PSORIASIS VULGARIS, WITH OR WITHOUT ARTHRITIS, TREATED WITH ANTI-TNF IN REAL CLINICAL PRACTICE. ANALYSIS OF THE INFLUENCE OF METABOLIC SYNDROME ON TREATMENT EFFICACY.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis Vulgaris
Metabolic Syndrome
Keywords: Anti-TNF drugs efficacy
Moderate-to-severe psoriasis vulgaris
Gene polymorphism
Lead sponsor: Hospital Universitario Reina Sofia de Cordoba
Sponsor class: OTHER_GOV
Collaborators: name: Pfizer
First posted: 2012-12-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Moderate-to-severe psoriasis treated \>1 ys with anti-TNFalpha drugs at Reina Sofia University Hospital

Brief summary: It has been reported in various epidemiological studies that patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, have an increased frequency of cardiovascular risk factors, such as hypertension, obesity, type-2 diabetes mellitus (T2DM, and metabolic syndrome (MetS). The presence of endothelial dysfunction in early stages, especially in moderate-to-severe plaque psoriasis forms, could explain the higher prevalence of cardiovascular disease and mortality observed in this population. Existing evidence showing improvement in psoriasis after correcting some factors, such as obesity or hypercholesterolemia, and the reduction of certain surrogate markers of cardiovascular risk with different modalities of psoriasis treatment suggest a biological interaction between the two diseases beyond mere epidemiological association. Recently published results support this hypothesis and suggest that the link between psoriasis and cardiovascular disease could be the existence of an inflammatory state in different organs, including skin, joints, adipose and hepatic tissue, and vascular endothelium (16). Patients with MetS have an increased risk of developing T2DM and cardiovascular disease. This syndrome is characterized by the association of an adipose tissue inflammatory state and diminished sensitivity to insulin. In recent years, a new mechanism participating in the development of MetS has been added: the Wnt signaling pathway. Polymorphisms in genes of the Wnt signaling pathway have been associated with metabolic abnormalities that predispose to cardiovascular disease, the development of moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, and response to treatment with anti-TNF-alpha.

This study aims to describe the cardiovascular risk factors of a Spanish population of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis,treated with anti-TNF under routine clinical practice conditions. Possible differences in efficacy relative to the presence or absence of criteria of metabolic syndrome will be analyzed. Similarly, we will explore the role of markers of inflammatory activity and genetic polymorphisms in the Wnt pathway in predicting response to treatment during the first year.

Detailed description: 1. Eligibility criteria:

   1.1. Inclusion criteria:
   1. -Age \>18 ys.
   2. -Male and female.
   3. -Moderate-to-severe psoriasis vulgaris, with or without psoriatic arthritis.
   4. -Treated with anti-TNF drugs (infliximab, etanercept, adalimumab). 1.2. Exclusion criteria:

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   1. -Enrolled in another clinical trial.
   2. -Lack of clinical information at the hospital database.
2. Objectives:

2.1. Primary objective: Evaluate the efficacy of anti-TNF- drugs in the treatment of patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, in terms of the presence or absence of cardiovascular risk factors, including metabolic syndrome.

2.2. Secondary objectives:

* 2.2.1. Analyze the possible modulatory role of genetic factors, such as Wnt pathway's gene polymorphisms, and other nongenetic factors on responsiveness to treatment with anti-TNF drugs in the overall study population and in the subgroup of patients with metabolic syndrome.
* 2.2.2. Describe the cardiovascular risk factors in patients with moderate-to-severe plaque psoriasis, with or without associated psoriatic arthritis, treated with anti-TNF- in the Spanish population under routine clinical practice conditions.

Eligibility criteria: Inclusion Criteria:

* Moderate-to-severe psoriasis treated \>1 ys with anti-TNFalpha drugs
* Age \>18 ys/\<80 ys
* With or without psoriatic arthritis

Exclusion Criteria:

* Enrolled in another trial
* Lack of clinical information
* Pregnant

Primary outcomes:
measure: Role of Metabolic Syndrome on anti-TNF-drug efficacy.
timeFrame: After one year of treatment
Secondary outcomes:
measure: Effect of 'Wnt pathway' genetic polymorphisms on anti-TNF-drug efficacy
timeFrame: First year of treament
Other outcomes:
measure: Cardiovascular disease factors
timeFrame: First year of treatment
Locations:
city: Cordoba
country: Spain
facility: Department of Dermatology. Reina Sofia University Hospital.
Study officials:
affiliation: Departament of Dermatology. Reina Sofia University Hospital.
name: Juan Ruano, M.D., Ph.D., Ms. C.
role: PRINCIPAL_INVESTIGATOR
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