Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

Study Overview
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Brief Summary
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Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown. In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).

Official Title
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Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must understand and voluntarily sign an informed consent form. Must be male or female and age 18-55 years at time of consent. Must be able to adhere to the study visit schedule and other protocol requirements Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline. Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). Negative PPD at Screening or 3 months earlier. Have not used any biologic treatment for psoriasis in the past 12 months. Exclusion Criteria: Inability to provide voluntary consent Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant, trying to become pregnant or breastfeeding Prior diagnosis of coronary artery disease (CAD) or heart disease. Systemic fungal infection History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible. History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years) Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable. Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer) History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C Positive Hepatitis B Surface antigen at screening Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening) History of any demyelinating disorder such as multiple sclerosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab 40mg<br>Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months | Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]<br>* 40mg subcutaneously, every other week for 6 months<br>* Other names: Humira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Endothelial Function Compared to Baseline. | Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in IL-6 Profile Compared to Baseline | IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months. | 6 months | 
| Changes in Adiponectin Profile Compared to Baseline | Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to Severe Chronic plaque type psoriasis