Two recent uncontrolled studies have examined the efficacy of parenteral methotrexate in fistulizing CD. In the first, treatment with intramuscular methotrexate (25 mg/week), in 16 patients produced fistula closure in 4 and a partial response in 5, with an overall response of 56%. All the patients who achieved remission failed or were intolerant to AZA and 25% also failed to respond to CyA. However, fistulae recurred when methotrexate was reduced or was switched to an oral form [31]. In the second, a study of 20 patients with active CD who were AZA-resistant or intolerant and steroid dependent (8 with a fistula), a response was obtained in 14/20 at 12 weeks, in 10/20 at 6 months, and 4/14 at 12 months. Patients with fistulizing disease were not analyzed separately [32]. Adverse events have been reported in 50% of patients treated with parenteral methotrexate for more than 6 months and include elevation of transaminases (5-20% of patients), nausea (4-12%), bone marrow suppression (10-20%), and require discontinuation of the drug in 10% of patients [33].

Hepatic fibrosis was observed in 0-5% of patients who have undergone liver biopsy after a cumulative methotrexate dose of more than 1 500 mg [34]. A potentially life-threatening interstitial pneumonitis has been observed in 3-12% of long-term treated patients. Furthermore, methotrexate has a known toxicity on the fetus. In conclusion, MTX in a dose of 25 mg/week should be tried in AZA/6-mercaptop-urine resistant or intolerant patients.

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