. 2021 Apr 7;17:285–292. doi: 10.2147/TCRM.S263835

Table 1.

Main Features and Results of Clinical Studies of Budesonide (BUD) MMX 9 mg, Compared with Placebo, at Week 8 in Ulcerative Colitis (Intention to Treat Analysis)

Author, Year	Study Design	Number of Patients	Clinical Improvement	Clinical Remission	Side Effects
Sandborn, 20126	RCT	123 vs 121	33.3% vs 24.8%	17.9% vs 7.4%	28.3% vs 26.4%§
Sandborn, 20126	BUD 9 mg vs placebo	123 vs 121	33.3% vs 24.8%	17.9% vs 7.4%	28.3% vs 26.4%§
Travis, 20147	RCT	109 vs 129	42.2% vs 33.7%	23.9% vs 11.2%	55.5% vs 44.2%
	RCT			17.4% vs 4.5%*
	BUD 9 mg vs placebo			17.4% vs 4.5%*
Rubin 20179	RCT	230 vs 228	47.0% vs 39.0%§	24.3% vs 22.8%§	31.8% vs 27.1%§
	BUD 9 mg vs placebo			24.3% vs 22.8%§
	BUD 9 mg vs placebo			13.0% vs 7.5%*
D’Haens 201017	Prospective multicentre study	18 vs 18	47.6% vs 33.3%^§#	n.a.	n.a.
D’Haens 201017	BUD 9 mg vs placebo	18 vs 18	47.6% vs 33.3%^§#	n.a.	n.a.
Danese, 201613	Prospective multicentre observational study	326	60.1%	51.8%	17.5%
Maconi, 201914	Retrospective study, multicentre study	89	52.4%	50%	30.5%
Fellerman, 202016	Prospective multicentre observational study	61	60.7%	47.5%	39.3%

Notes: RCT, randomised clinical trial. *Clinical remission plus endoscopic remission. ^§Not significant. ^#Clinical remission at 4 weeks.

Abbreviations: n.a., not available.