Methotrexate as single therapy in Crohn's disease: Is its long-term efficacy limited?

Objective. -To determine the efficacy and patient tolerance of parenteral methotrexate in the treatment of Crohn's disease at a dose of 25 mg per week for three months, then at 15-25 mg 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. (D 2008 Elsevier Masson SAS. All rights reserved.