New and emerging treatments for ulcerative colitis: a focus on vedolizumab

Figures & data

Table 1 Results of a Phase I trial of an α₄β₇ integrin antagonist involving 29 moderately severe ulcerative colitis patients²⁰

Dose of LDP02 (mg/kg)	0.15 SC	0.15 IV	0.50 IV	2.00 IV	Placebo
Meaningful endoscopic response (two-grade improvement in modified Baron score)	1/5	0/5	3/5	1/5	2/8
Median Mayo score	7	10	1	7	4.5

Abbreviations: IV, intravenous; SC, subcutaneous.

Table 2 Results of a randomized controlled trial of MLN02 involving 181 patients with active ulcerative colitis (UC)²³

Dose of MLN02 (mg/kg)	Patients (n) achieving clinical remissiona	Patients (%) achieving clinical responseb	Patients (n) achieving endoscopic remissionc	Patients (%) achieving endoscopic responsed
Placebo	9/63 (14%)	33%	5/63 (8%)	48%
0.5 IV	19/58 (33%) P = 0.02	66%	16/58 (28%)	35%
2.0 IV	19/60 (32%) P = 0.02	53%	7/60 (12%)	16%

Notes:

a Defined as a UC clinical score of 0 or 1 and a modified Baron score of 0 or 1 and no rectal bleeding;

b defined as an improvement in UC clinical score of ≥3 points;

c defined as a modified Baron score of 0;

d defined as an improvement in modified Baron score of more than two grades.

Abbreviation: IV, intravenous.

Table 3 Results of the GEMINI I study of vedolizumab induction therapy for ulcerative colitis²⁹

Endpoint	Placebo (N = 149)	Vedolizumab (N = 225)	Difference	P value
Clinical response (%)	25.5	47.1	21.7	<0.0001
Clinical remission (%)	5.4	16.9	11.5	0.0009
Mucosal healing (%)	24.8	40.9	16.1	0.0012

© 2012. BMJ Publishing Group Ltd. Rutgeerts P. Vedolizumab induction therapy for ulcerative colitis: results of GEMINI I, a randomized, placebo-controlled, double-blind, multicentre phase 3 trial. Gut. 2012;2012(Supp 3):A65.

Table 4 Results of the GEMINI I study of vedolizumab as maintenance therapy for ulcerative colitis³⁰

Endpoint	Placebo (N = 126)	Vedolizumab 8 weekly (N = 122)	Vedolizumab 4 weekly (N = 125)	Difference 8 weeks versus placebo/4 weeks versus placebo	P value
Clinical remission, 52 weeks (%)	15.9	41.8	44.8	26.1/29.1	<0.0001/<0.0001
Mucosal healing, 52 weeks (%)	19.8	51.6	56.0	32.0/36.3	<0.0001/<0.0001
Glucocorticoid-free remission (in those taking oral glucocorticoids at baseline), 52 weeks (%)	(N = 72) 13.9	(N = 70) 31.4	(N = 73) 45.2	17.6/31.4	0.0120/<0.0001

© 2013. BMJ Publishing Group Ltd. Reproduced with permission from Rutgeerts P. Vedolizumab maintenance therapy for ulcerative colitis (uc): results of GEMINI I, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial. Gut. 2012;61(Supp 3):A65.

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