| BACKGROUND: The objective of this study was to evaluate the safety of liver transaminases monitoring every 12
weeks in patients with inflammatory connective tissue disorders who are treated with methotrexate (MTX).
METHODS: In a retrospective study, the data from the rheumatic patients receiving MTX were analyzed. Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) were measured at baseline and every 12 weeks. The
patients were classified according to their ALT and AST levels as no change, 1-2 times increase, 2-3 times increase, and
more than 3 times increase in their ALT or AST levels. Based on the physician’s decision on the dose of MTX, the
patients were classified into no change in MTX dose, decrease in MTX dose, and discontinuation of MTX. Based on the
physician’s final decision about the continuation of MTX, the patients were classified into one of the following groups:
continuation of MTX without MTX dose reduction; MTX dose reduction; MTX discontinuation due to liver
complication; and MTX discontinuation due to other reasons.
RESULTS: A total of 809 patients who were on MTX were included in the study. The mean follow-up duration and the
mean duration of treatment with MTX were 31.22 and 19.76 months, respectively. The mean accumulation dose of
MTX was 865.85 mg. Due to the increase in the level of transaminases in 26 (3.2%) of the patients the dose of MTX
was reduced, and in 9 (1.1%) cases it was temporarily discontinued. During the follow-up of the patients with elevated
transaminases levels, they returned to normal limits in 90 (99.5%) of the patients; however, in 4 of the cases (0.5%)
they remained elevated and MTX was discontinued. The probability of the patients remaining on MTX for 5 years
without discontinuation for liver complications was 98.5%.
CONCLUSIONS: Liver transaminases monitoring every 12 weeks for MTX treated patients is safe. |