Vedolizumab for inflammatory bowel disease: From randomized controlled trials to real-life evidence

Table 1 Phase III randomized controlled trials of vedolizumab in patients with ulcerative colitis and Crohn’s disease

Study	n (patients)	Setting of trial	Treatment arms	Clinical response (%)	Clinical remission (%)	CS-free remission (%)	Mucosal healing (%)
GEMINI 1[10] 2013	374	Induction	300 mg	47.1	16.9	-	40.9
			Placebo	25.5	5.4		24.8
		Maintenance	300 mg 4 weekly	-	44.8	45.2	56.0
			300 mg 8 weekly		41.8	31.4	51.6
			Placebo		15.9	13.9	19.8
GEMINI 2[11] 2013	368	Induction	300 mg	31.4	14.5	-	-
			Placebo	25.7	6.8
		Maintenance	300 mg 4 weekly	45.5	36.4	28.8	-
			300 mg 8 weekly	43.5	39.0	31.7
			Placebo	30.1	21.6	15.9
GEMINI 3[12] 2015	315	Induction	300 mg	-	15.2	-	-
			Placebo		12.1

Clinical response was defined as a reduction in the Mayo score of at least 3 points plus a decrease of at least 30% from the baseline score, with a decrease in the rectal bleeding subscore ≥ 1, an absolute rectal bleeding subscore ≤ 1 (GEMINI 1), or as a ≥ 100-point decrease in the CDAI score (GEMINI 2). Clinical remission defined as a Mayo score of ≤ 2 and no subscore > 1 (GEMINI 1) or as a CDAI score ≤ 150 points (GEMINI 2, GEMINI 3). CS: Corticosteroid.

Table 2 Real-world studies on vedolizumab in patients with inflammatory bowel disease, Crohn’s disease, or ulcerative colitis

Study author (country) years	IBD	CD	UC
Amiot et al[15,16] (France), 2016-2017	294	173	121
Eriksson et al[19] (Sweden), 2017	246	147	991
Baumgart et al[17] (Germany), 2016	212	97	115
Dulai et al[23] (United States, multicentre), 2016	212	212	-
Kopylov et al[20] (Israel), 2017	204	130	741
Shelton et al[24] (United States, Boston), 2015	172	107	651
Macaluso et al[22] (Italy, Sicily), 2018	163	84	79
Allegretti et al[26] (United States, Boston), 2017	136	96	40
Stallmach et al[18] (German Registry), 2016	127	67	60
Vivio et al[25] (United States, Saint Louis), 2016	102 (51)2	30	21
Samaan et al[21] (United Kingdom), 2017	50	27	231
Total	1.918	1.170	697

¹UC + IBD unclassified;

²102 patients started vedolizumab, and 51 patients were followed prospectively. IBD: Inflammatory bowel disease; CD: Crohn’s disease; UC: Ulcerative colitis.