The safety and tolerability of methotrexate for treating patients with Crohn's disease.

GOALS

To determine the safety and tolerance of methotrexate for treating patients with Crohn's disease in clinical practice.

BACKGROUND

Methotrexate is effective for treating patients with Crohn's disease. However, concerns about potential toxicity, particularly to the liver, have limited its use.

STUDY

A retrospective chart review was performed of Crohn's disease patients in our practice treated with methotrexate. Data related to the safety and tolerance of methotrexate was extracted and analyzed.

RESULTS

Of 92 patients treated with methotrexate, there was enough data for 79 patients for analysis (49 women and 30 men; mean age 28.8 y). Forty-two patients (53%) had previously received azathioprine. Overall, 40 patients (51%) achieved and maintained remission on methotrexate, including 13 of 30 (43%) who concomitantly received anti-tumor necrosis factor therapy. The mean total accumulated dose of methotrexate was 1727 mg [SD 1572 mg], with a mean total duration of methotrexate use of 25.4 months (SD 43.1 mo). The most common adverse events were nausea (22%) and elevated liver enzymes (10%). Only 6% of patients stopped methotrexate therapy because of persistently abnormal liver enzymes. No patients underwent liver biopsy.

CONCLUSIONS

This retrospective study showed that methotrexate is safe and well-tolerated in treating patients with Crohn's disease in clinical practice.