METHOTREXATE IN CHRONIC ACTIVE CROHNS-DISEASE - A DOUBLE-BLIND, RANDOMIZED, ISRAELI MULTICENTER TRIAL

Background: At present only one large controlled study has indicated t hat parenteral methotrexate may be effective in chronic active Crohn's disease (CD). Aim: To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD. Patients: Patients with active CD, w ho have received steroids and/or immunosuppressives for at least 4 mon ths during the preceding 12 months and with a current Harvey-Bradshaw index of greater than or equal to 7 were studied. Methods: Methotrexat e (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-a minosalicylic acid as clinically indicated. Results: Eighty-four patie nts were included (methotrexate, 26 patients; 6-mercaptopurine, 32 pat ients; placebo, 26 patients). The proportion of patients entering firs t remission as well as the proportions of patients relapsing after fir st remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own c ontrol, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotre xate treated patients. Conclusions: Methotrexate at a weekly oral dose of 12.5 mg was found to be moderately better than 6-mercaptopurine an d placebo in patients with chronic active CD.