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Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?

This study is currently Recruiting

October 2011 By Rockefeller University

First Recieved on July 26, 2010

Last Updated on October 11, 2011

Sponsor: Rockefeller University
Collaborators: Weill Medical College of Cornell University
Information provided by: Rockefeller University
Identifier: NCT01170715

Purpose

Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the world's population. Severe psoriasis is a disabling disease affecting the physical and emotional well being of patients, and its effect on quality of life is similar to that seen with other major medical diseases such as diabetes, rheumatoid arthritis, and cancer. Lately, it is increasingly being recognized that psoriasis is not merely a skin disease but is probably associated with other co-morbidities such as psoriatic arthritis, Crohn's disease, the metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome is a combination of diabetes mellitus type II (or insulin resistance), hypertension, central obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides). As the literature linking psoriasis and the metabolic syndrome expands, also reports of an increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that metabolic dysregulations are the leading risk factors for occlusive vascular events and early death in patients with severe psoriasis. Progress in understanding the pathogenesis of these apparently diverse diseases has discovered that low-grade systemic inflammation might be the common physiological pathway that may provide the biological plausibility of the associations discovered in the epidemiological studies. Since some of these co-morbidities often become clinically apparent years after the onset of psoriasis we assume that controlling systemic inflammation might prevent or reverse some of these co-morbidities. Presently there is no study in psoriasis that shows that a "systemic" co-morbidity can be prevented or treated by reversing skin inflammation.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Age > 18years 2. Psoriasis affecting Body Surface Area (BSA) > 10% after washout 3. No systemic anti psoriatic therapy < 30days 4. Features of the metabolic syndrome (At least one of the following) : Insulin resistance e.g. fasting insulin>9 pmol/L Blood glucose 100-125 mg/dl TG 150-350 mg/dl HDL<40 mg/dl (for females) and HDL<50 mg/dl (for males) BP > 120/85 BMI > 25 5. Plaque type Psoriasis- Exclusion Criteria: Overt diabetes (> 135 mg/dL fasting blood glucose on two (2) separate occasions 2. Hypertension as defined as a systolic BP > 140 &/or a diastolic pressure > 90. Cannot be on more then one (1) antihypertensive medication 3. Currently have any known malignancy or have a history of malignancy in the 5 past years excluding basal cell carcinoma 4. S/P Cardiovascular event such as Myocardial infarction, any open heart surgery, stroke or other vascular occlusive event 5. Current smokers 6. Known allergy to etanercept 7. Positive PPD 8. HIV positive 9. HCV or HBV positive 10. HbA1C >7 11. current use of hypoglycemic medication 12. Current use of a statin 13. Current use of any anticoagulants 14. Current use of any anti-inflammatory medications (except inhaled steroids) 15. History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the Principal Investigator, make the candidate ineligible for the study. 16.Females of childbearing age who are pregnant or breast-feeding or not using a contraceptive. 17. NYHA Class III and Class IV heart failure -

Investigators

  • Investigator: Batya Davidovici, MD - Principal Investigator - The Rockefeller University

Locations

  • The Rockefeller University

    New york, New York 10065 United States

Conditions related to this trial:

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