An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis

Study Overview
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Brief Summary
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• Main objectives and outcome measures. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis. Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP). Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis. Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI). Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study. Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust

Official Title
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An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis

Conditions
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Psoriasis Chronic, Liver Fibrosis, Fatty Liver, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Device: Transient elastography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given written informed consent Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past. 18 yrs. of age Exclusion Criteria: Patients who have not given written informed consent Patients under 18 yrs. of age Patients with a PASI less than 10. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis<br>Patients with moderate to sever psoriasis attending a tertiary referral center. patients will be evaluated with a questionnaire, measurement of height,weight, waist circumference, fasting bloods, abdominal ultrasound and transient elastography. | Device: Transient elastography<br>* a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis<br>* Other names: Fibroscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with liver fibrosis. | Liver fibrosis will be assessed by transient elastography and the use of standard liver function tests and other serum markers of fibrosis including P3NP. In a minority of cases fibrosis will be diagnosed by liver biopsy and evaluation of histology. Risk factors for the development of fibrosis including metabolic syndrome, alcohol and methotrexate use will be evaluated. | 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with fatty liver disease diagnosed by ultrasound | Fatty liver disease will be defined by the presence or absence of fatty changes on abdominal ultrasound. Risk factors for the development of fatty liver disease including abdominal obesity, diabetes, and alcohol use will be evaluated. | Within 12 months of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver function tests, Chronic plaque psoriasis, Liver fibrosis, Fatty liver disease, Non-alcoholic fatty liver disease, Transient elastography, Fibroscan, Procollagen-3 N-Terminal peptide, Alanine aminotransferase