Study	Reason for exclusion
Chopra 2006	Retrospective chart review of patients with IBD (CD and UC) who received oral budesonide
Danese 2013	This study analysed pooled data from Sandborn 2012 and Travis 2014 and found that remission rates (combined clinical and endoscopic remission) as well as symptom resolution in budesonide‐MMX® treated patients was independent of previous mesalamine exposure
Díaz Blasco 1995	Review paper, Spanish article was translated to English The reference list was manually searched and no new trials were identified
Feagan 1996	Overview paper describing the use of oral budesonide for UC The reference list was manually searched and no new trials were identified
Fedorak 2005	Review paper The reference list was manually searched and no new trials were identified
Gomollón 1999	Review paper, Spanish article was translated to English The reference list was manually searched and no new trials were identified
Keller 1997	Not a randomised controlled trial Pilot study describing the use of oral budesonide in 14 patients with steroid‐dependent ulcerative colitis Budesonide was not commenced to induce remission, but rather it was commenced during the phase of weaning of conventional corticosteroids once remission had been induced with conventional corticosteroids
Kolkman 2004	Budesonide was not compared to either a placebo or another active agent Two different budesonide dosing regimens were compared ‐ budesonide 9 mg once daily with 3 mg three times daily (TID) The aim of the study was to assess the pharmacokinetics, pharmacodynamics and efficacy of 2 dosing regimens for patients with active UC Although, it was a multicenter trial, only a small number of patients were actually randomised ‐ 7 patients were randomised to receive 9 mg once daily and 8 patients were randomised to receive 3 mg TID
Lamers 1996	Review paper The reference list was manually searched and no new trials were identified
Lichtenstein 2012	Open label extension study
Lichtenstein 2013	This study analysed pooled data from Sandborn 2012 and Travis 2014 and found that remission rates (combined clinical and endoscopic remission) as well as symptom resolution in budesonide‐MMX® treated patients was independent of previous mesalamine exposure
Marín‐Jiménez 2006	Review paper The reference list was manually searched and no new trials were identified
Sandborn 2013a	This study analysed pooled data from Sandborn 2012 and Travis 2014 and looked at quality of life in these patients
Sandborn 2013b	This study analysed pooled data from Sandborn 2012 and Travis 2014 and looked at improvement in symptoms
Sandborn 2015	This study analysed pooled data from Sandborn 2012 and Travis 2014 and looked at clinical and endoscopic remission
Silverman 2011	Review paper The reference list was manually searched and no new trials were identified
Travis 2011	Open label extension study
Travis 2012b	This study analysed pooled data from Sandborn 2012 and Travis 2014 and looked at clinical and endoscopic remission