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.