Liver Fibrosis in Psoriasis
Research type
Research Study
Full title
Investigation of the prevalence of liver fibrosis in patients with psoriasis using Transient Elastography and evaluation of the relationship between liver fibrosis and risk factors for liver fibrosis including methotrexate.
IRAS ID
265303
Contact name
Philip Hampton
Contact email
Sponsor organisation
Newcastle Joint Research Office
Clinicaltrials.gov Identifier
9205, R&D Reference
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients with psoriasis appear to have higher rates of liver fibrosis in comparison to the general population. The higher rates of risk factors for liver fibrosis such as obesity, alcohol and diabetes are important; however there have been concerns that methotrexate can contribute to liver fibrosis. Despite the increasing importance of biologic therapies, methotrexate remains the most commonly used systemic agent in the UK. The majority of patients needing systemic therapy will try methotrexate first as per National Institute of Clinical Excellence (NICE) guidance.
This study aims to investigate the prevalence of liver fibrosis in a group of patients with chronic plaque psoriasis by measuring liver stiffness measurement (LSM) using Transient Elastography. This is a non-invasive technique similar to an ultrasound. The cumulative methotrexate dose in addition to other important factors including body mass index (BMI), waist circumference and alcohol intake will be recorded.
Statistical analysis will be performed to investigate the relationship between all measured factors and LSM. The relationship between the cumulative dose of Methotrexate and liver fibrosis will be addressed.
The ultimate goal is to use the prevalence data to perform a power calculation to determine the number of participants required to conduct a study to determine which factors can predict the risk of liver fibrosis and whether or not methotrexate is an independent risk factor for liver fibrosis in patients with psoriasis. Using this data a risk prediction model can be built to allow optimal and safe prescribing of methotrexate.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0039
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion