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As difficult as it may now be to believe, there was a time when it was unclear whether methotrexate (MTX) would be tolerated in the long-term treatment of patients with rheumatoid arthritis (RA). Data from Scandinavian patients with psoriasis indicated that there was an incidence of hepatic cirrhosis of 26%.1 There was thus a need to establish the actual risk of clinically significant liver disease (CSLD) in patients with RA treated for many years with the drug.
Because of the obvious clinical effectiveness of MTX, and the absence of effective alternatives in the first few decades of its widespread use, there was a need to demonstrate the ability to sustain treatment without creating a population of subjects with chronic liver disease.
Thus, studies of hepatic safety were performed that included both baseline and annual liver biopsies.2 3 This experience along with other publications on hepatic safety of MTX4 lead to the publication of suggested guidelines for the hepatic monitoring of MTX.5 The guidelines were derived from the experience from baseline and annual liver biopsies prospectively performed over a period of many years along with regular monitoring of hepatic transaminase enzymes and serum albumin with a mean interval of 37.7 days between the sequential laboratory measures.6
It was thus possible to seek correlations of any elevation in transaminase enzymes with the evolution of hepatic histological changes by different grading systems, with particular attention paid to early fibrosis.2 In doing so, we …
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