Nutritional therapy versus 6-mercaptopurine as maintenance therapy in patients with Crohn's disease

Background: 6-Mercaptopurine is often used as maintenance therapy in patients with Crohn's disease. However, toxicities like myelosuppression limit its clinical benefit. Aims: To evaluate the efficacy of elemental diet versus 6-mercaptopurine as maintenance therapy in Crohn's disease. Methods: Ninety-five eligible patients with Crohn's disease activity index <= 150 were randomly assigned to: 6-mercaptopurine (0.5-1.5 mg/kg/day, n = 30); Elental as an elemental diet (>= 900 kcal/day, n = 32); none (control, n = 33). In the three groups, patients were and remained on 5-aminosalicylic acid (2250-3000 mg/day). Patients were observed for 2 years and the rate of relapse (Crohn's disease activity index >= 200) was monitored. Results: At 24 months, the fractions of patients who had maintained remission were 60%, 46.9% and 27.2% for 6-mercaptopurine. Elental and the control groups, respectively. Log-rank test showed better efficacy for 6-mercaptopurine (P=0.0041) and Elental (P=0.0348) versus control. No significant difference was found between 6-mercaptopurine and Elental. Further, in the 6-mercaptopurine group, 2 patients experienced liver injury and one developed alopecia. Conclusions: This 24 months comparison study showed that Elental as maintenance therapy in Crohn's disease patients was as effective as 6-mercaptopurine. Elental should be useful for long-term maintenance therapy in Crohn's disease. This is the first comparison study evaluating nutritional therapy versus 6-mercaptopurine. (C) 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.