Table 2.

Summary of the randomized clinical trials evaluating oral budesonide in patients with ulcerative colitis

Study/design	Study population	N	Budesonide formulation	Comparator group(s)	Duration	Primary outcome
Löfberg et al [1996]38 MC, DB, DD, R	Mild-moderate UC [endoscopic inflammation score ≥ 2 with symptoms of bloody stool and increased frequency ≥ 3]	72	Controlled-release budesonide [10mg × 4 wks then 8 mg ×5 wks]	Oral prednisolone [40 mg × 2 wks followed by 5 mg reduction every week]	9 weeks	Improvement in the endoscopic inflammation Score Main results: Mean decrease in endoscopic inflammation score was similar in both groups (1.2 and 1.36, respectively)
Gross et al [2011]39 MC, DB, DD, R	Mild-moderate UC [CAI ≥ 6 and endoscopic index ≥4]	343	PH-dependent release budesonide (Budenofalk®) 9 mg	Oral mesalazine (Salofalk®) 3 g	8 weeks	Clinical remission at 8 weeks defined by CAI<=4 and rectal bleeding score of 0 Main results: Primary outcome was achieved in 39.5% and 54.8% of patients treated with budesonide and mesalazine, respectively
D’Haens et al [2010]40 MC, DB, DD, R	Moderate left-sided UC	32	Budesonide-MMX® 9 mg	Placebo	8 weeks	Clinical remission at 8 weeks defined as CAI ≤ 4 and/or reduction in CAI score by 50% Main results: Primary endpoint achieved in 47.1% and 33.3% in the budesonide and placebo groups, respectively (NS)
Sandborn et al (CORE I) [2012]41 MC, DB, R	Mild to moderate active UC (UCDAI score 4–10)	509	Budesonide-MMX® 9 mg	Budesonide-MMX® 6 mg Mesalamine (Asacol®) 2.4 g Placebo	8 weeks	Combined clinical and endoscopic remission Main results: Primary endpoint achieved in 17.9%, 13.2%, and 12.1% in budesonide 9 mg, 6 mg, and mesalamine group, respectively, compared to 7.4% in placebo. The difference was only significant for budesonide 9 mg [P=0.01]
Travis et al (CORE II) [2014]42 MC, DB, R	Mild to moderate active UC (UCDAI score 4–10)	512	Budesonide-MMX® 9 mg	Budesonide-MMX® 6 mg Entocort® 9 mg Placebo	8 weeks	Combined clinical and endoscopic remission Maisa results: Primary endpoint achieved in 17.4%, 8.3%, and 12.6 % in budesonide 9 mg, 6 mg, and Entocort group, respectively, compared to 4.5% in placebo. The difference was only significant for budesonide 9 mg [P=0.005]
Rubin et al [2014]43* MC, DB, R	Mild to moderate active UC (UCDAI score 4–10) not adequately controlled by oral mesalamine therapy at dose ≥2.4 g/day for ≥ 6 weeks prior to entry	510	Budesonide-MMX® 9 mg	Placebo	8 weeks	Combined clinical and endoscopic remission Main results: Primary endpoint achieved in 13% in the budesonide group vs. 7.5% in placebo [p=0.048]
Sandborn et al [2012]46* MC, DB, R	patients in CORE I and CORE II who were in remission at the end of the induction phase (8 weeks)	122	Budesonide-MMX® 6 mg	Placebo	12 months	Proportion of patients in clinical remission after 1, 3, 6, 9, 12 months and/or end of the study Main results: No significant difference was noted in regard of the primary endpoint. The probability of clinical relapse was reduced in budesonide group (40.9% vs. 59.7%, respectively, and nd median time for relapse was longer in the budesonide-treated patients

MC: multicenter, DB: double-blind, DD: double-dummy, R: randomized, CAI: colitis activity index, UCDAI: ulcerative colitis disease activity index

^*Available in abstract format only