Methotrexate in refractory Crohn's disease

Recent trials suggested that methotrexate may be effective in refractory Crohn's disease (CD). We analyzed the data of 20 patients treated with methotrexate because of corticodependent or refractory CD. Between January 1995 and June 1997, 20 azathioprine-resistant or -intolerant patients with active CD requiring continuous glucocorticosteroid treatment were treated with parenteral methotrexate. Clinical response was assessed by the Harvey-Bradshaw clinical activity index. Concomitant steroid use and steroid withdrawal rates were recorded. Patients were assessed at 12 weeks, 6 months, 9 months, and 12 months after the start of methotrexate therapy. At 12 weeks, a clinical response was obtained in 14/20 patients (70%). These response rates decreased to 10/20 patients at 6 months, 8/17 patients at 9 months, and 4/14 evaluable patients at 12 months. In initial responders (n = 14), maintenance of remission was observed in 9/14, 6/11, and 3/9 patients at 6, 9, and 12 months, respectively. Methotrexate allowed corticosteroid tapering in 85% of patients and discontinuation in 60% of patients at 6 months. Side effects were rather frequent but usually mild and prompted discontinuation in two patients. In this retrospective study, parenteral methotrexate appeared to be effective in inducing a clinical response in 70% of azathioprine-resistant or -intolerant CD patients and often permitted corticosteroid tapering, with an acceptable short-term toxicity. The potential of methotrexate to maintain long-term remission in refractory patients, however, appears less convincing