Table 4.

Key secondary analyses of remission rates by the end of treatment or discontinuation [FAS]

	BUS 4 mg N = 281	BUF 2 mg N = 290	p-value	Difference BUS 4 mg—BUF 2 mg
	n [%]	n [%]		Estimate	95% CI
CR + MH	186 [66.2]	185 [63.8]	0.00093	2.4	-5.4, 10.2
dMH	115 [40.9]	111 [38.3]	0.00095	2.6	-5.3, 10.6
dCR	125 [44.5]	118 [40.7]	0.00040	3.8	-4.3, 11.9
dCR + dMH	74 [26.3]	63 [21.7]	0.00002	4.6	-2.4, 11.7

Clinical remission [CR] was defined as having a modified UC-DAI stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mucosal healing [MH] was defined as having a mucosal appearance subscore of 0 or 1. Deepened clinical remission [dCR] was defined as having a stool frequency subscore of 0 and a rectal bleeding subscore of 0. Deepened mucosal healing [dMH] was defined as having a mucosal appearance subscore of 0. 95% confidence interval [CI] was calculated for remission rate by treatment group [Clopper–Pearson] or for the difference of remission rates between groups. p-value was calculated from Farrington–Manning test [one-sided] with non-inferiority margin = 10%.

BUS, budesonide suppository; BUF, budesonide foam; FAS, full analysis set; PPI, per-protocol set; CI, confidence interval; UC-DAI, Ulcerative Colitis-Disease Activity Index.