Psoriasis Chronic, Liver Fibrosis, Fatty Liver, Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Chronic plaque psoriasis, Liver fibrosis, Fatty liver disease, Non-alcoholic fatty liver disease, Transient elastography, Fibroscan, Procollagen-3 N-Terminal peptide, Alanine aminotransferase, Liver function tests
Brief summary
• Main objectives and outcome measures. 1. 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). 2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP. 3. 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
Interventions
DEVICETransient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis
Sponsors
Pfizer
King's College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with liver fibrosis. | 12 months after enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with fatty liver disease diagnosed by ultrasound | Within 12 months of enrollment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis | Within 12 months of enrollment | The performance of non-invasive markers of fibrosis including standard liver function tests, P3NP, transient elastography and abdominal ultrasound will be assessed in this cohort of patients with chronic plaque psoriasis. |
| Response to treatment measured by PASI and PGA scores | 12-24 months following enrollment | Response to treatment will be measure by physician global assessment (PGA) PASI and DLQI. Factors assessed include demographic data, psoriasis disease history, co-morbid disease and family history assessed by questionnaire. Lipid and glycaemic status assessed by fasting bloods. |
Countries
United Kingdom
Outcome results
None listed