Clinical—Alimentary TractBudesonide 9 mg Is at Least as Effective as Mesalamine 4.5 g in Patients With Mildly to Moderately Active Crohn's Disease
Section snippets
Study Design and Conduct
This was a double-blind, double-dummy, randomized, active-controlled, 8-week, phase III study conducted during the period from November 2004 to May 2008 at 46 gastroenterology centers in 7 countries (Croatia, Czech Republic, Germany, Greece, Hungary, Israel, Slovak Republic). In this 3-arm trial, patients were randomized (1:1:2 ratio) to receive budesonide (Budenofalk 3-mg capsules; Dr. Falk Pharma GmbH, Freiburg, Germany) at an oral dose of either 3 × 3 mg/day or 1 × 9 mg/day, or oral
Patient Population
In total, 311 patients were recruited (Figure 1). Two patients randomized to budesonide 3 mg, 3 times a day, took no verum study medication and were not evaluable. The remaining 309 patients formed the safety population (79 budesonide 3 mg 3 times a day, 77 budesonide 9 mg OD, and 153 mesalamine). Two patients randomized to budesonide had baseline CDAI of less than 150 and were excluded from the ITT population (78 budesonide 3 mg, 3 times a day, 76 budesonide 9 mg OD, and 153 mesalamine).
Discussion
The results of this double-blind, double-dummy, multicenter trial show that budesonide 9 mg/day (3-mg capsules) is significantly noninferior to mesalamine 4.5 g/day (500-mg tablets) for inducing remission in patients with mildly to moderately active CD within the predefined 10% noninferiority margin. The results indicate that high-dose Eudragit-L–coated mesalamine is associated with a very high rate of remission in mildly to moderately active CD (62% in the ITT population). As anticipated,
Acknowledgments
The authors give special thanks to P. Heine and R. Schwarz (medicomp GmbH, Planegg, Germany) for their assistance in conducting the clinical trial. The authors would like to thank all patients and investigators for their participation and contribution to the study.
Editorial assistance, comprising revision and finalization of the draft manuscript prepared by the authors, was provided by freelance writer Caroline Dunstall, with funding from Dr. Falk Pharma GmbH.
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This article has an accompanying continuing medical education activity on page e13. Learning Objective: Upon completion of this exam, successful learners will be able to identify patients with mild to moderately active Crohn's disease for the treatment with either mesalamine or budesonide.
Conflicts of interest The authors disclose the following: Andreas Tromm has received speaker's honoraria and travel funding from Dr Falk Pharma GmbH; Karin Dilger, Ralf Mohrbacher, and Roland Greinwald are employees of Dr Falk Pharma GmbH. The remaining authors disclose no conflicts.
Funding The study was funded by Dr. Falk Pharma GmbH, Freiburg, Germany. The study sponsor contributed to the design of the study in collaboration with the authors, funded the analysis of the data by an independent biostatistics company, and worked in conjunction with the authors to interpret the data. The sponsor was not involved in data collection. ES was supported by the Robert-Bosch Foundation, Stuttgart, Germany and from the Federal Ministry for Education and Research (BMBF, Berlin, Germany; 03 IS 2061C).