To identify the incidence and characteristics of liver enzyme elevations following initiation of biological treatments in patients with rheumatological diseases. Patients with rheumatological diseases taking biological treatments were analyzed retrospectively for new onset liver test abnormalities. Disease type, duration of treatment, concomitant medications, hepatitis b status and laboratory tests were recorded. Elevation of transaminases was defined as grade 1 if ALT elevation was 2–3 times the ULN, grade 2 if ALT ≥3xULN and grade 3 if ALT was ≥5xULN. RUCAM score was used to assess likelihood of causal association between liver toxicity and biological treatments. A total 418 patients were included. 46 (11%) patients had grade 2 ALT elevation. Mean treatment duration to ALT elevation from baseline was 200.5±255.4 and 67.3±54.0 days for patients with grade 2 and grade 3 ALT elevation, respectively (p:0.001). DMARDs use and the type of the biological agent used were not different for patient with grade 2 ALT elevation or not. 29 (6.9%) patients had RUCAM score of 3-5, thus possibly having DILI. No patient had RUCAM score of six or higher. Mild and transient enzyme elevations are relatively frequent with biological treatments. But, likelihood of causal association between liver toxicity and these therapies is usually low. Concurrent medications should be reviewed cautiously in each issue.
Key words: Anti-TNF, biological agents, liver toxicity
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