Table 3.

Proportion of Patients with Clinical Remission at Week 52 by Prior TNF-α Antagonist Therapy (FAS)

Prior TNF-α antagonist therapy	Placebo (n=10)		Vedolizumab SC (n=10)		Vedolizumab IV (n=2)
	No. (%)	95% CI	No. (%)	95% CI	No. (%)	95% CI
Prior TNF-α antagonist therapy	2		5		2
Yes	0		1 (20.0)	(0.5, 71.6)	1 (50.0)	(1.3, 98.7)
No	2 (100.0)	(15.8, 100.0)	4 (80.0)	(28.4, 99.5)	1 (50.0)	(1.3, 98.7)
TNF-α antagonist therapy naïve	8		5		0
Yes	2 (25.0)	(3.2, 65.1)	3 (60.0)	(14.7, 94.7)	0
No	6 (75.0)	(34.9, 96.8)	2 (40.0)	(5.3, 85.3)	0
Vedolizumab vs. placebo	-	-	35.0a	(–23.4, 78.9)	-	-

^aRisk difference (%).

TNF-α, tumor necrosis factor α; FAS, full analysis set; SC, subcutaneous; IV, intravenous; CI, confidence interval.