Psoriatic Inflammation Markers Predictive of Response to Adalimumab

Study Overview
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Brief Summary
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The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.

Official Title
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Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Diagnostic Test: cutaneous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score >10, Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception, Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis), Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed Exclusion Criteria: Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection), History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis Ongoing pregnancy or breastfeeding Absence of written consent, Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab<br> | Diagnostic Test: cutaneous<br>* SKIN BIOPSY<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment | messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction | From baseline to 16 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline drug and anti-drug concentrations at 16 weeks of treatment | assessed by enzyme-linked-immunoassay | From baseline to 16 weeks treatment |