Methotrexate Safety with Chronic Hepatitis B Infection Save

Chronic liver disease, and in particular hepatitis B infection, is a contraindication to methotrexate (MTX) use. Specifically, the package insert states, "Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease should not receive methotrexate."  Also liver enzymes should be monitored and that "pretreatment liver biopsy should be performed for patients with a history of excessive alcohol consumption, persistently abnormal baseline liver function test values or chronic hepatitis B or C infection."

This issue has been studied further in a report from Nature researchers from Taiwan studied whether MTX use in RA patients with chronic HBV infection leads to liver cirrhosis. 

They culled National Health Insurance Research Database in Taiwan and identified 631 incident cases of RA with chronic HBV (CHB) - nearly half of whom were on MTX (358 MTX users and 273 MTX non-users). Chronic HBV was defined by ICD-9 codes and patients were excluded if they had cirrhosis or other causes of liver disease or coexistent hepatitis C infection.

A median of 6 years after the diagnosis of CHB, 6.5% (n=41) of all RA patients developed liver cirrhosis with no difference between those on or off MTX. They did not find any association between liver cirrhosis in CHB patients and long-term MTX use in RA. Furthermore, there was no occurrence of liver cirrhosis among 56 MTX users with a cumulative dose ≧3 grams after 97 months’ treatment.

This population and claims based data failed to correlate long-term MTX use with an increased risk for liver cirrhosis among RA patients with chronic HBV. The potential biases inherent in geographic restriction and claims analysis apply.