Preliminary data has suggested possible benefits of methotrexate in primary biliary cirrhosis.
In this study, researchers from the United States assessed the effectiveness of methotrexate use in primary biliary cirrhosis.
|Methotrexate therapy did not prevent disease progression.|
|American Journal of Gastroenterology|
The team also examined its tolerance in patients with this disease.
The team studied a total of 110 primary biliary cirrhosis patients who were started on methotrexate 15 mg per week. For most patients, ursodeoxycholic acid was added during the course of the study.
The researchers analyzed data from patients completing 5 years of treatment with methotrexate to assess the effects on biochemical and histologic parameters.
Based on an intent to treat analysis, the team also compared survival in the study group with a control group of 180 individuals.
Only half of the study group completed 5 years of methotrexate therapy.
The team found that the therapy did not prevent disease progression, as indicated by a rising Mayo risk score.
Portal fibrosis also tended to remain the same.
Furthermore, methotrexate was not found to diminish the risk of death or liver transplantation, compared with controls.
However, the team found that the use of ursodeoxycholic acid decreased the risk of death or transplant.
Dr Nancy Bach's team concluded, "Methotrexate is not well tolerated in primary biliary cirrhosis".
"The toxicity of methotrexate and its inability to prevent complications of progressive liver disease or improve survival and the need for liver transplantation limits its utility".
"The benefits of ursodeoxycholic acid were again confirmed".