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Methotrexate therapy for the symptomatic treatment of primary biliary cirrhosis patients, who are biochemical incomplete responders to ursodeoxycholic acid therapy
Author(s) -
BABATIN M. A.,
SANAI F. M.,
SWAIN M. G.
Publication year - 2006
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2006.03048.x
Subject(s) - ursodeoxycholic acid , medicine , methotrexate , primary biliary cirrhosis , gastroenterology , adverse effect , hepatology , biliary cirrhosis , asymptomatic , cholestasis , disease , autoimmune disease
Summary Background Ursodeoxycholic acid is widely used as the standard therapy for the treatment of primary biliary cirrhosis and other cholestatic liver diseases. Although it has been shown to improve biochemical markers and delay disease progression, its effect upon fatigue and pruritus, is at best uncertain. Aim To assess the safety and efficacy of methotrexate for treating symptomatic primary biliary cirrhosis patients who were biochemical partial responders or non‐responders to ursodeoxycholic acid therapy. Methods We treated eight consecutive primary biliary cirrhosis patients with methotrexate who were followed in a single hepatology clinical practice, who were symptomatic, and who had had an incomplete biochemical response to ursodeoxycholic acid therapy. Pruritus and fatigue were assessed at each clinic visit and graded from 0 (asymptomatic) to 4 (incapacitating). Results The median dose of methotrexate was 13.75 mg/week (range 7.5–15) and the mean duration of methotrexate therapy was 49 months (range 11–126). At the end of follow‐up pruritus in six of seven patients had improved, and fatigue in all patients had improved with the addition of methotrexate therapy (pruritus: baseline 2.9 ± 1.1 vs. end of treatment 0.6 ± 1.5, P ≤ 0.0175, and fatigue: baseline 3.0 ± 0.8, vs. end of treatment 1.0 ± 0.8, P ≤ 0.0023). Improvement in symptoms was associated with a significant improvement in biochemical markers of cholestasis. No significant adverse effects of methotrexate were documented. Conclusions Methotrexate should be considered as a potential additive treatment for symptomatic primary biliary cirrhosis patients who are incomplete biochemical responders to ursodeoxycholic acid therapy.