A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease

Abstract Background & Aims: Clinical experience suggests that 6-mercaptopurine (6-MP) is effective therapy for children with active steroid-dependent Crohn's disease (CD). We report the results of a prospective, placebo-controlled, multicenter trial evaluating the combination of 6-MP and prednisone as therapy for children with newly diagnosed moderate-to-severe CD. Methods: Fifty-five children (age, 13 ± 2 years) were randomized to treatment with 6-MP (1.5 mg · kg −1 · day −1 ) or placebo within 8 weeks of initial diagnosis. Both groups also received prednisone (40 mg/day). Prednisone dosage adjustments were based on a defined schedule determined by the change in a subject's disease activity score, and steroid administration was discontinued as remission was achieved. Study treatment with 6-MP or placebo continued for 18 months. Results: Groups were comparable for age, sex, and site and activity of disease. In the 6-MP group, the duration of steroid use was shorter ( P P P = 0.007). Growth was comparable in both groups. No clinically significant adverse events occurred, although mild leukopenia and increases in aminotransferase activity were noted in the 6-MP group. Conclusions: Addition of 6-MP to a regimen of corticosteroids significantly lessens the need for prednisone and improves maintenance of remission. 6-MP should be part of the initial treatment regimen for children with newly diagnosed moderate-to-severe CD. GASTROENTEROLOGY 2000;119:895-902