Assessment of liver fibrosis with transient elastography and FibroTest in patients treated with methotrexate for chronic inflammatory diseases: a case-control study

J Hepatol. 2010 Dec;53(6):1035-40. doi: 10.1016/j.jhep.2010.04.043. Epub 2010 Aug 12.


Background & aims: Although methotrexate (MTX) is used in the effective treatment of inflammatory disorders, its use is hampered by the risk of liver fibrosis. Non-invasive methods for the diagnosis of liver fibrosis, such as transient elastography (FibroScan) and FibroTest could be useful for monitoring MTX-liver toxicity. The aim of this case-control study was to determine factors associated with liver fibrosis in a large cohort of patients requiring MTX.

Methods: Consecutive adults with various benign inflammatory diseases were prospectively assessed using FibroScan and FibroTest when they were treated with MTX (cases) or before beginning treatment (controls).

Results: Among 518 included patients, 44 patients (8.5%) had FibroScan and/or FibroTest results suggesting severe liver fibrosis. In a multivariate analysis, factors associated with abnormal markers of liver fibrosis were the body mass index >28 kg/m(2) and high alcohol consumption. Neither long MTX duration nor cumulative doses were associated with elevated FibroScan or FibroTest results.

Conclusions: Severe liver fibrosis is a rare event in patients treated with MTX and is probably unrelated to the total dose. Patients with other risk factors for liver disease should be closely monitored with non-invasive methods before and during MTX treatment.

MeSH terms

  • Adult
  • Aged
  • Alanine Transaminase / blood
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Aspartate Aminotransferases / blood
  • Biomarkers / blood
  • Biopsy
  • Case-Control Studies
  • Elasticity Imaging Techniques / methods*
  • Female
  • Humans
  • Inflammation / drug therapy*
  • Liver Cirrhosis / blood
  • Liver Cirrhosis / chemically induced
  • Liver Cirrhosis / diagnosis*
  • Liver Function Tests / methods
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / adverse effects*
  • Middle Aged
  • Prospective Studies
  • Risk Factors


  • Anti-Inflammatory Agents, Non-Steroidal
  • Biomarkers
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Methotrexate