Review of vedolizumab for the treatment of ulcerative colitis

Table 1 Principal trial results

Ref.	Sample size (n)	Phase of trial	Treatment arms (n)	Clinical remission (%)	Clinical response (%)
Feagan et al[14], 2005	181	II	Placebo	14	33
			0.5 mg/kg IV	33	66
			2 mg/kg IV	32	53
Parikh et al[15], 2012	47	II	Placebo	33	22-33
			2 mg/kg IV	68-891	> 501
			6 mg/kg IV
			10 mg/kg IV
Feagan et al[16], 2012	374	III
		Induction phase	Placebo	5.4	25.5
			300 mg IV	16.9	47.1
		Maintenance phase	Placebo	15.9	23.8
			300 mg IV 4 weekly	44.8	56.6
			300 mg IV 8 weekly	41.8	52

¹Collective results for all vedolizumab groups combined. IV: Intravenously.

Table 2 Adverse events

Ref.	Group	UC aggravated	Nausea/vomiting	Headache	Frequent bowel movement	Fatigue	Upper respiratory tract infection	Abdominal pain	Arthralgia	Dizziness	Rash
Feagan et al[14], 2005	Placebo	24	15	13	10	7	5	16	5	1	4
	0.5 mg/kg IV	29	21	12	10	8	8	10	4	6	6
	2 mg/kg IV	22	13	11	5	5	8	6	7	4	4
Parikh et al[15],	Placebo	4		1			4			1
2012	2 mg/kg IV	2		2			4			1
	6 mg/kg IV	1		3			3			0
	10 mg/kg IV	0		2			1			0
Feagan et al[16], 2012	Placebo	58	19	28		10	21	10	25
	300 mg IV	97	38	80		33	52	35	56

IV: Intravenously; UC: Ulcerative colitis.