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Adjustment Recommended to ACR Guidelines for Monitoring Hepatic Methotrexate Toxicity: Presented at ACR

By Jerry Ingram

ORLANDO, FL -- November 4, 2003 -- Methotrexate hepatic toxicity in rheumatoid arthritis patients appears to be an unusual occurrence, which may allow for less frequent liver-function tests, according to research presented here on October 27^th at the Annual Meeting of the American College of Rheumatology.

"Methotrexate appears to safer than was previously assumed. The guidelines that require testing for hepatic toxicity about every month are probably not necessary," said Yusuf Yazici, MD, lead researcher, Brooklyn Heights Arthritis Associates, New York, United States.

For this investigation and longitudinal analysis, Dr. Yazici and colleagues enrolled 313 rheumatoid arthritis patients who visited an academic rheumatology clinic on a weekly basis between 1990 and 2002. All of the patients were being treated with methotrexate. Seventy-three percent of the patients were female. In addition, 92% of the patients were white, with a mean age of 57.8 years and a mean disease duration of 13.2 years. The mean dose of methotrexate was 10.0 mg/week.

Patients were cautioned to limit their alcohol intake to 2 drinks per day, but were not told to abstain.

The researchers conducted their analysis of a longitudinal database, evaluating disease characteristics in these patients, aspartate aminotransferase (AST) and albumin monitoring, disease-modifying anti-rheumatic drug use, responses of doctors to abnormal test results, adverse events and rates and reasons for discontinuation of treatment.

Dr. Yazici reported that 53% of the patients had liver-function test evaluations every 3 months or less often. Forty patients ceased taking methotrexate during the study period. Patients discontinued use most often due to inefficacy (n=9) followed by oral ulcers and gastrointestinal intolerability (n=5). Only 5.2% of all AST results and 10% of all albumin results were abnormal. Eighty-four percent of those with abnormal AST results had 3 or fewer abnormal results throughout the study period.

Dr. Yazici observed that 98% of the abnormal ASTs resulted in no change of treatment or monitoring frequency, and no patients had their dose of methotrexate decreased because of high AST levels. Only 1 patient stopped methotrexate due to liver-function-test abnormalities.

Dr. Yazici concluded that, given the cost incurred in frequent blood tests as well as the burden on the patient, monitoring guidelines may need to be examined and updated to recommend monitoring of patients every 4 months rather than every month.


[Study Title: Methotrexate Hepatic Toxicity in Rheumatoid Arthritis Patients is Unusual. Abstract 157]

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