Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients with mildly to moderately active Crohn's disease.
Author(s): Tromm A, Bunganic I, Tomsova E, Tulassay Z, Lukas M, Kykal J, Batovsky M, Fixa B, Gabalec L, Safadi R, Kramm HJ, Altorjay I, Lohr H, Koutroubakis I, Bar-Meir S, Stimac D, Schaffeler E, Glasmacher C, Dilger K, Mohrbacher R, Greinwald R
Affiliation(s): Ev. Krankenhaus Hattingen GmbH, Klinik fur Innere Medizin, Hattingen, Germany. firstname.lastname@example.org
Publication date & source: 2011-02, Gastroenterology., 140(2):425-434.e1
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND & AIMS: Comparative data on budesonide vs mesalamine for the treatment of mild-to-moderately active Crohn's disease (CD) are sparse. We assessed the efficacy and safety of each therapy in patients with mildly to moderately active CD. METHODS: We performed a randomized, double-blind, double-dummy, 8-week, multicenter study in which 309 patients with mildly to moderately active CD received pH-modified-release oral budesonide (9 mg/day once daily or 3 mg/day 3 times daily) or Eudragit-L-coated oral mesalamine (4.5 g/day). RESULTS: The primary efficacy variable, clinical remission (defined as Crohn's Disease Activity Index </=150), at the final visit occurred in 69.5% (107 of 154) of patients given budesonide vs 62.1% (95 of 153) of patients given mesalamine (difference, 7.4%; 95% repeated confidence interval, -4.6% to 18.0%; P = .001 for noninferiority). Clinical remission rates did not differ significantly between the 2 budesonide groups. Treatment response, defined as Crohn's Disease Activity Index of 150 or less and/or a decrease of 70 or more (Delta70) or 100 or more (Delta100) points from baseline to final visit, did not differ significantly between patients given budesonide vs mesalamine (Delta70, P = .11; Delta100, P = .15), or between the 2 budesonide groups (Delta70, P = .38; Delta100, P = .78). No other efficacy end points differed significantly between groups. Discontinuation because of adverse events occurred in 3% and 5% of budesonide- and mesalamine-treated patients, respectively. There were no clinically relevant differences in adverse events between the 2 budesonide groups. CONCLUSIONS: Budesonide (9 mg/day) was numerically, but not statistically, more effective than Eudragit-L-coated mesalamine (4.5 g/day) in patients with mildly to moderately active CD. Budesonide (9 mg/day), administered once daily, was as effective as the standard (3 times daily) regimen. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.