BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis

Study Overview
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Brief Summary
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Metabolomics of systemic psoriasis treatment

Official Title
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Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment

Conditions
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Psoriasis

Intervention / Treatment
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* Other: Withdrawal of venous blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18 - 80 years, body weight ≤ 180 kg Dermatological diagnosis of psoriasis Initiated therapy with TNFα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (FAE) within the scope of routine patient care by treating physician Signed informed consent from patient Exclusion Criteria: Patients with evidence of any skin condition that would interfere with the evaluation of psoriasis Use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of Visit 1 or used FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to Visit 1 Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits Patients who are unable to complete a patient diary or complete questionnaires on paper Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule Pregnancy or breast feeding women Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study. Effective contraception is defined as either: use of established oral, injected or implanted hormonal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Withdrawal of venous blood samples|Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm) Laboratory measurements: Fasting serum concentrations of 200 metabolites covering a biologically relevant panel of amino acids, sugars, acylcarnitines and phospholipids Genome-wide expression profiles generated from RNA derived from peripheral leukocytes|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of metabolic profiles associated with treatment response | The primary aim of this study is to analyze metabolic profiles as well as expression data in patients with chronic plaque psoriasis undergoing systemic treatment with TNF_-inhibitor agents (etanercept, adalimumab, infliximab) and fumaric acid ester (FAE) in order to identify clinical and metabolomic markers that underlie variability in response to therapy. | week 0 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of metabolomic signatures associated with psoriasis | The secondary aim is to identify metabolomic signatures associated with psoriasis and to identify possible treatment-specific metabolomic signatures. It is anticipated, to get insights into mechanisms of anti-TNF drug action and response as well as first indications for metabotypes that are associated with psoriasis. In addition, genetic variants correlated to these metabotypes might be identified. | week 0 and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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To identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis, To identify metabolomic signatures associated with psoriasis, To identify possible treatment-specific metabolomic signatures