PMID: 8607496Feb 1, 1996Paper

Pilot study of low dose oral methotrexate treatment for primary biliary cirrhosis

The American Journal of Gastroenterology
N V BergasaJ H Hoofnagle

Abstract

To assess the efficacy of low doses of oral methotrexate as therapy for primary biliary cirrhosis. Ten symptomatic patients with this disease were treated with methotrexate at a dose of 15 mg/wk in an open label trial. Eight patients completed 1 yr of treatment and six completed 2. Pruritus and fatigue decreased in all patients treated for at least 1 yr. Mean levels of serum alkaline phosphatase, ALT, and IgM were less at 1 and 2 yr than corresponding baseline means. Total serum bilirubin increased in three patients during treatment. Serum aminotransferases and alkaline phosphatase became normal in one patient with stage I disease. Although liver biopsies at 1 and 2 yr revealed a decrease in the intensity of the inflammatory infiltrate, they also showed an increase in fibrosis suggestive of disease progression. Methotrexate was discontinued in five patients: for disease progression in four (one at 4 months, one at 1 yr, and two at 2 yr) and for intractable pruritus in one (at 4 months). All patients experienced transient mucositis and intermittent dyspepsia. These findings suggest that methotrexate treatment in patients with primary biliary cirrhosis is not beneficial in patients with advanced disease; in patients with early di...Continue Reading

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