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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
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.
||Observational Model: Cohort, Time Perspective: Prospective
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
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-
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
- Investigator: Batya Davidovici, MD - Principal Investigator - The Rockefeller University