Table 3.

Primary analysis of remission rates for clinical remission and mucosal healing by the end of treatment or discontinuation [PPS and FAS]

	BUS 4 mg	BUF 2 mg	p-value	Difference BUS 4 mg—BUF 2 mg
	n [%]	n [%]		Estimate	95% CI
PPS	N = 250	N = 261
Clinical remission
Yes	197 [78.8]	194 [74.3]	0.00007	4.5%	-3.0%, 11.9%
No	53 [21.2]	67 [25.7]
Mucosal healing
Yes	203 [81.2]	212 [81.2]	0.00224	0.0%	-6.9%, 6.9%
No	47 [18.8]	49 [18.8]
FAS	N = 281	N = 290
Clinical remission
Yes	211 [75.1]	204 [70.3]	0.00004	4.7%	-2.6%, 12.1%
No	70 [24.9]	86 [29.7]
Mucosal healing
Yes	214 [76.2]	220 [75.9]	0.00209	0.3%	-6.7%, 7.3%
No	67 [23.8]	70 [24.1]

Clinical remission was defined as having a UC-DAI stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mucosal healing was defined as having a mucosal appearance subscore of 0 or 1. p-value: Farrington–Manning test [one-sided] with non-inferiority margin = 10%. 95% CI: 95% confidence interval for the difference of 4 mg BUS—2 mg BUF [asymptotic confidence interval].

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