Objective: To determine the efficacy and patient tolerance of parenteral methotrexate in the treatment of Crohn's disease at a dose of 25mg per week for three months, then at 15-25mg per week as maintenance therapy.
Patients and methods: Thirty-five patients (27 women, eight men; mean age 36 years) with steroid-dependent Crohn's disease were included in the study after failure of azathioprine in 34 cases. Clinical remission was defined as a Harvey-Bradshaw disease-activity index less than or equal to 4 and complete weaning from steroids.
Results: At the end of the three-month induction treatment, the Harvey-Bradshaw index decreased significantly (4.6+/-2.9 versus 9.4+/-5.2; P=0.0001), as did serum CRP (24+/-27 versus 43+/-45 mg/L; P=0.01) and prednisone dose (5.63+/-7.3 versus 21.1+/-18.7 mg/L; P=0.00001). The mean maintenance dose of methotrexate was 20.3+/-3.8 mg per week. The rate of clinical remission was 50% at three months and 28% at one year and two years. Nine patients had an adverse event attributed to methotrexate that led to drug withdrawal in six cases (17%).
Conclusion: Our findings suggest that, for steroid-dependent Crohn's disease which has failed to respond to thiopurines, long-term methotrexate remains effective in fewer than one in three patients.