Baseline studies in all patients:
(1) AST (SGOT)
(2) ALT (SGPT)
(3) alkaline phosphatase
(4) albumin
(5) bilirubin
(6) viral hepatitis B serology (antigen and antibodies)
(7) viral hepatitis C antibodies
(8) CBC
(9) serum creatinine
Indications for liver biopsy at initiation of therapy:
(1) history of excessive alcohol consumption
(2) persistent abnormal baseline AST values
(3) chronic viral hepatitis B or C infection
Monitoring testing during therapy, performed every 4-8 weeks:
(1) AST
(2) ALT
(3) serum albumin
Indications for liver biopsy during monitoring:
(1) abnormal AST (above the upper limit of normal) values in 50% or more of monitoring tests
(1a) >= 5 of 9 determinations in a given 12 month interval
(1b) >= 6 of 12 determinations in a given 12 month interval if performed monthly
(2) decrease in serum albumin below the lower limit of normal in a patient with well-controlled rheumatoid arthritis
Continue methotrexate therapy with ongoing monitoring if the liver biopsy shows Roenigke Grade I, II or IIIA changes.
Discontinuation of methotrexate therapy:
(1) Roenigke Grade IIIB or IV findings on liver biopsy
(2) persistent liver function test abnormalities
(3) patients who refuse liver biopsy
