Background and aims: Methotrexate (MTX) safety is questioned by the risk of inducing liver fibrosis (LF). As transient elastography (FibroScan (R)) is an effective non-invasive technique to evaluate LF, our aims were to assess LF in MTX-treated patients, to evaluate LF regarding treatment duration and cumulative dose, and to determine differences depending on the underlying disease. Patients and methods: Prospective study including patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis treated with MTX. Hepatic stiffness was determined by FibroScan (R). The LF cut-off values were established using METAVIR score. Results: Of 53 patients, 22 were men (41.5%), mean age was 55 (15) years, 17(32%) had rheumatoid arthritis, 18 (34%) inflammatory bowel disease, and 18 (34%) psoriasis. Mean MIX cumulative dose was 1,805 (1,560) mg, and mean treatment duration was 178 weeks. Mean hepatic stiffness was 6.19 (2.43) KPa. In 49 patients (92.5%), absence/mild LF was found (F <= 2), and 4 patients (7.5%) had advanced LF (F >= 3). Treatment duration or cumulative doses of MTX were not associated with LF. Conclusions: Regarding LF development, MTX therapy is safe. FibroScan (R) is useful for monitoring LF in MTX-treated patients. (C) 2010 Elsevier Espana, S.L. All rights reserved.