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An international cooperative study was organized to evaluate whether the treatment of severe psoriasis with methotrexate significantly affects the liver of these patients. From a study population of 550 patients, 742 liver biopsy specimens together with pertinent clinical and laboratory data were evaluated as a function of methotrexate usage.

Factors found to be significantly associated with histologic liver damage include: increased alcohol intake, the daily orally administered methotrexate dosage schedule, obesity, and diabetes. The evidence implicating increasing cumulative methotrexate dosage as a cause of hepatic fibrosis is not clear. Of 247 patients with biopsyproven fibrosis or cirrhosis, 88 patients had no recorded abnormalities in history, physical examination, or laboratory test results which casts serious doubt on the reliability of detecting fibrosis or cirrhosis without a liver biopsy.