Abstract
A few studies showed that long-term methotrexate (MTX) use exacerbates liver fibrosis and even leads to liver cirrhosis in rheumatoid arthritis (RA) patients. We therefore conducted a population-based cohort study to investigate the impact of long-term MTX use on the risk of chronic hepatitis B (CHB)-related cirrhosis among RA patients. We analyzed data from the National Health Insurance Research Database in Taiwan and identified 631 incident cases of RA among CHB patients (358 MTX users and 273 MTX non-users) from January 1, 1998 to December 31, 2007. After a median follow-up of more than 6 years since the diagnosis of CHB, a total of 41 (6.5%) patients developed liver cirrhosis. We did not find an increased risk of liver cirrhosis among CHB patients with long-term MTX use for RA. Furthermore, there was no occurrence of liver cirrhosis among 56 MTX users with a cumulative dose ≧3 grams after 97 months’ treatment. In conclusion, our data showed that long-term MTX use is not associated with an increased risk for liver cirrhosis among RA patients with CHB. However, interpretation of the results should be cautious due to potential bias in the cohort.
Highlights
Among the 22 MTX users who developed liver cirrhosis, 18 patients had a cumulative dose of ≦ 1.5 grams and 4 patients had a cumulative dose of ≧ 1.5 grams and
There was no occurrence of liver cirrhosis among 56 MTX users with a cumulative dose of ≧3 grams
There was no statistically significant difference between MTX non-users and MTX users with different cumulative doses (p = 0.176, log-rank test), there was a trend toward a higher probability of liver cirrhosis-free survival among MTX users with a cumulative dose of ≧ 1.5 grams when compared to MTX non-users and MTX users with a cumulative dose of
Summary
Kaplan-Meier survival analysis and the log rank test were used to compare the probability of liver cirrhosis-free survival since the diagnosis of CHB between MTX non-users and MTX users with different cumulative doses. After a median follow-up of more than 6 years since the diagnosis of CHB, a total of 41 (6.5%) patients developed liver cirrhosis: 22 (6.1%) of 358 MTX users and 19 (7.0%) of 273 MTX non-users. Among patients with diabetes mellitus, there was a lower incidence rate of liver cirrhosis among MTX users compared to MTX non-users (8.1 versus 26.0 events per 1000 person-years, p = 0.041).
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