Document Classification

Section Type: RESULTS

Text: Patients randomized to methotrexate had, compared with patients randomized to placebo, (1) significantly lower on-treatment serum alkaline phosphatase, gamma-glutamyltransferase, immunoglobulin (Ig) M, IgG, and (after 24 months) aspartate aminotransferase and alanine aminotransferase levels (P < 0. 02-0. 001 by analysis of covariance to adjust for baseline differences) ; (2) a nonsignificant trend toward lower on-treatment pruritus scores ; (3) similar on-treatment Knodell inflammatory scores but nonsignificant trends toward lower Knodell fibrosis score and less ductopenia ; (4) a trend toward greater increases in serum bilirubin level and Mayo score with time (both significant after 5 years of follow-up) ; and (5) a 2. 9-fold (95 % confidence interval, 0. 85-10. 25 - fold) increase the rate of death or liver transplantation as a result of liver disease during or after the trial (P = 0. 09) in a Cox multivariate regression analysis compared with patients randomized to placebo.