Psoriasis Inflammation and Systemic Co Morbidities

• Status: Completed
• Trial end date: 2013-09-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockefeller University
• Collaborator: Weill Medical College of Cornell University
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Age ≥ 18years

• Psoriasis affecting Body Surface Area (BSA) ≥ 10% after washout

• No systemic anti psoriatic therapy ≤ 30days

• Plaque type Psoriasis

Exclusion Criteria:

• Overt diabetes (> 135 mg/dL fasting blood glucose on two (2) separate occasions

• Hypertension as defined as a systolic BP > 140 &/or a diastolic pressure > 90. -Cannot be on more then one (1) antihypertensive medication.

• Currently have any known malignancy or have a history of malignancy in the 5 past years excluding basal cell carcinoma.

• S/P Cardiovascular event such as Myocardial infarction, any open heart surgery, stroke or other vascular occlusive event.

• Known allergy to etanercept

• HIV positive

• HBV positive

• HbA1C >7

• Current use of hypoglycemic medication

• Current use of any anticoagulants

• Current use of any anti-inflammatory medications (except inhaled steroids)

• Females of childbearing age who are pregnant or breast-feeding or not using a contraceptive.

• NYHA Class III and Class IV heart failure

• Positive PPD

• 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.