The American College of Rheumatology (ACR) proposed guidelines for monitoring patients with rheumatoid arthritis being treated with methotrexate. These can help reduce the chances of liver toxicity.


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


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