Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis

Mass General Brigham

Status: Terminated

Conditions: Hypertension; Psoriasis; Hyperlipidemia; Obesity; Metabolic Syndrome

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00477191

2007-P-000494

Details and patient eligibility

About

People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.

Full description

People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.

This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.

TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18
2. Subject willing and able to give informed consent.
3. Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
4. PASI > 10 and BSA affected with psoriasis > 10.
5. Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women and BMI ³ 30 kg/m2

Exclusion criteria

• On insulin or other diabetes (anti-hyperglycemic) medication
• Congestive Heart Failure
• Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
• Unstable angina
• Pulmonary disease requiring oxygen
• SLE, optic neuritis, transverse myelitis, epilepsy
• Positive PPD
• Scheduled for upcoming surgery
• Known immunosuppression (for example, HIV)
• Known autoimmune disease
• Hepatitis B or Hepatitis C
• Pregnant or nursing
• Renal insufficiency (Creatinine >1.5)
• Latex allergy
• Use of live vaccination in past 90 days
• Organ transplantation
• History of severe infection
• History of malignancy (except cured non-melanoma skin cancer)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Etanercept

Experimental group

Description:

Etanercept

Treatment:

Drug: Etanercept