Budesonide versus mesalamine for maintaining remission in patients refusing other immunomodulators for steroid-dependent Crohn's disease  Gerassimos J. Mantzaris, Kalliopi Petraki, Michael Sfakianakis, Emmanuel Archavlis, Angeliki Christidou, Helen Chadio-Iordanides, George Triadaphyllou  Clinical Gastroenterology and Hepatology  Volume 1, Issue 2, Pages 122-128 (March 2003) DOI: 10.1053/cgh.2003.50015 Copyright © 2003 American Gastroenterological Association Terms and Conditions

Fig. 1 Study protocol. Patients with steroid-dependent Crohn's disease achieving remission (CDAI <150) after treatment were eligible for the study and were evaluated prospectively during screening (S, 30 days). Patients fulfilling the entry criteria were randomized (R) to receive budesonide 6 mg/day or mesalamine 3 g/day for 12 months. Patients were followed-up in the outpatient clinic every 2 months with a physical examination, laboratory tests, compliance check, CDAI calculation, and completion of the IBDQ. A colonoscopy with biopsy examination was performed at screening, the end of the study, or whenever the study was prematurely stopped. Clinical Gastroenterology and Hepatology 2003 1, 122-128DOI: (10.1053/cgh.2003.50015) Copyright © 2003 American Gastroenterological Association Terms and Conditions

Fig. 2 Trial profile of patients with inactive, steroid-dependent Crohn's disease assigned randomly to budesonide or mesalamine therapy. Clinical Gastroenterology and Hepatology 2003 1, 122-128DOI: (10.1053/cgh.2003.50015) Copyright © 2003 American Gastroenterological Association Terms and Conditions

Fig. 3 Cumulative probability of maintaining remission during 12 months of budesonide or mesalamine therapy (log-rank test, 8.6; P < 0.005). Clinical Gastroenterology and Hepatology 2003 1, 122-128DOI: (10.1053/cgh.2003.50015) Copyright © 2003 American Gastroenterological Association Terms and Conditions

Fig. 4 Mean IBDQ scores for budesonide and mesalamine therapy during 12 months of the study (analysis of variance, F = 17.7; P < 0.0001). Clinical Gastroenterology and Hepatology 2003 1, 122-128DOI: (10.1053/cgh.2003.50015) Copyright © 2003 American Gastroenterological Association Terms and Conditions