Methotrexate induced liver fibrosis
Research type
Research Study
Full title
Evaluation of the role of AST:ALT ratio, ELF markers and fibroscan in the detection of methotrexate induced hepatotoxicity.
IRAS ID
131770
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
Methotrexate is an effective treatment for psoriasis as well as rheumatoid arthritis. But its use is limited by adverse effects, mainly the concern regarding liver scarring. Currently, doctors rely upon performing liver biopsy to detect liver scarring. Although liver biopsy is the standard procedure used routinely to monitor liver scarring, it is preferable if we could develop a strategy to diagnose and monitor scarring in the liver using non-invasive tests.
We will enrol patients with psoriasis from dermatology clinic at a tertiary referral centre (Nottingham University Hospitals NHS Trust/ treatment centre) and rheumatoid arthritis from Gastroenterology clinics at Bradford Teaching Hospitals NHS Foundation Trust over the period of 1 year. We will invite all patients who are on methotrexate treatment to participate in this study. All patients would complete a questionnaire and we will collect routine information such as height, weight, waist, hip circumference and blood pressure measurements. At the same consultation, alongside routine blood tests, an additional sample would be taken for biochemical markers (ELF markers and AST:ALT ratio)and we would perform a non-invasive test called fibroscan using ultrasound-like probe. When combination of non-invasive raise the possibility of scarring patients will be assessed by liver specialists to decide whether liver biopsy is appropriate. This will allow us to evaluate the performance of different tests to predict significant scarring in the liver. This will inform us as to what strategy is best for future monitoring of patients on methotrexate.
We will also involve patients who are being considered for methotrexate therapy in this study as these have risk factors such as obesity and diabetes which can themselves cause scarring in the liver. Comparison of patients who are on and not yet on methotrexate will allow us to estimate the excess risk particularly due to methotrexate which is still uncertain.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/0145
Date of REC Opinion
28 Apr 2014
REC opinion
Further Information Favourable Opinion