BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis (Bostrip)
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Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm)
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
Analysis of metabolic profiles associated with treatment response [ Time Frame: week 0 and week 12 ]
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.
Secondary Outcome Measures :
Identification of metabolomic signatures associated with psoriasis [ Time Frame: week 0 and week 12 ]
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.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Keywords provided by Technische Universität München:
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