Table II.

Characteristics of RCTs included in the systematic review (qualitative synthesis)

Study	Participants	Intervention	Clinical endpoints	Follow-up period	Study design	Jadad quality score
Sandborn et al. 2013 [10]	Patients (age 18 to 80 years) with Crohn's disease for at least 3 months (score of 220 to 450 on the Crohn's Disease Activity Index (CDAI)) and with no response to or unacceptable side effects from one or more of the following: glucocorticoids, immunosuppressive agents or TNF antagonists	Vedolizumab 300 mg intravenously, n = 220 (in this group there were also patients with TNF antagonist failure, n = 105) vs. placebo intravenously, n = 148 (patients with TNF antagonist failure, n = 70); treatment was given at weeks 0 and 2 for induction therapy	Clinical remission (CDAI score of ≤ 150 points) Clinical response (CDAI-100 response: ≥ 100-point decrease in the CDAI score)	6 weeks – induction phase (+ maintenance phase – 52 weeks)	RCT, double-blind, placebo-controlled, phase III	4
Sands et al. 2014 [11]	Patients (age 19 to 77 years) with Crohn's disease for at least 3 months (score of 220 to 400 on the Crohn's Disease Activity Index (CDAI)) and with no response to or unacceptable side effects from one or more of the following: glucocorticoids, immunosuppressive agents or TNF antagonists	Vedolizumab 300 mg intravenously, n = 209 (in this group there were also patients with TNF antagonist failure, n = 158) vs. placebo intravenously, n = 207 (patients with TNF antagonist failure, n = 157); treatment was given at weeks 0, 2 and 6 for induction therapy	Clinical remission (CDAI score of ≤ 150 points) Clinical response (CDAI-100 response: ≥ 100-point decrease in the CDAI score)	6 weeks – induction phase	RCT, double-blind, placebo-controlled, phase III	4
Feagan et al. 2008 [12]	Adult patients (age 23 to 52 years) with endoscopic, histopathologic, or radiologic documentation of Crohn's disease of the ileum and/or colon and a Crohn's Disease Activity Index (CDAI) score of 220 to 400 at screening	Vedolizumab 2.0 mg/kg (n = 65) or 0.5 mg/kg (n = 62) intravenously vs. an identical-appearing placebo (n = 58); treatment was given on days 1 and 29	Primary end point: the rate of clinical response at day 57, defined as a 70-point or higher decrement in the CDAI score from baseline	57 days	RCT, double-blind, placebo-controlled, phase II	4

^*Patients with TNF antagonist failure – patients who reported no response and/or poor tolerance of prior treatment with TNF antagonists.