Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis

Table 1 Characteristics of studies included in the meta-analysis

Ref.	Study type	Follow-up periods	Group	Drug	Drug dosage	Number of cases	Age, yr	Male
Feaganet al[14], 2005	RCT	6 wk	Intervention 1	MLN-02	0.5 mg/kg	58	41.6 ± 14.7	56.9%
			Intervention 2		2 mg/kg	60	43.8 ± 14.6	50.0%
			Control	Placebo	NA	63	38.9 ± 13.4	55.6%
Feagan et al[15], 2013	Randomized allocation	6 wk	Intervention	Vedolizumab	300 mg	746	40.1 ± 13.2	58.0%
			Control	Placebo	NA	149	41.1 ± 1.25	61.7%
Parikh et al[16], 2012	RCT	43 d	Intervention 1	Vedolizumab	2 mg/kg	12	39 (30-49)1	33.3%
			Intervention 2		6 mg/kg	14	47 (19-61)1	50.0%
			Intervention 3		10 mg/kg	11	41 (26-69)1	45.5%
			Control	Placebo	NA	9	33 (21-51)1	33.3%

¹Median (range). RCT: Randomized controlled trial; NA: No data available.

Table 2 Clinical response and clinical remission rates of studies included in the meta-analysis

Ref.	Group	Drug	Definition of clinical response	Clinical response rate		Definition of clinical remission	Clinical remission rate
Feagan et al[14]	Intervention 1	MLN-02	An improvement of 3 points or more on the ulcerative colitis clinical score (modification of the Mayo Clinic Scoring system)	66%	59.3%1	Ulcerative colitis clinical score of 0 or 1 and a modified Baron score of 0 or 1 with no evidence of rectal bleeding	32.2%1
	Intervention 2			53%
	Control	Placebo		33%			14.0%
Feagan et al[15]	Intervention	Vedolizumab	A reduction in the Mayo Clinic score of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1	47.1%		Mayo Clinic score of 2 or lower and no subscore higher than 1, and mucosal healing, defined as an endoscopic subscore of 0 or 1	16.9%
	Control	Placebo		25.5%			5.4%
Parikh et al[16]	Intervention 1	Vedolizumab	A decrease from baseline in the partial Mayo score (PMS) of ≥ 2 points and ≥ 25%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or an absolute subscore for rectal bleeding of 0 or 1.	50%	56.8%1	PMS of ≤ 2 with no individual subscore > 1	58%1
	Intervention 2			63.3%
	Intervention 3			53.3%
	Control	Placebo		33.3%			50%

¹Pooled of all intervention groups. MNL-02: Vedolizumab.

Table 3 Summary of most common adverse events (occurring in 10% or more of patients in any group)

Ref.	Group	General adverse events1
		Ulcerative colitis aggravated	Nausea/vomiting	Headache	Frequent bowel movements	Fatigue	Upper respiratory tract infection	Abdominal pain/tenderness	Arthralgia	Dizziness	Rash
Feagan et al[14]	Intervention 1	29 (50)	21 (36)	12 (21)	10 (17)	8 (14)	8 (14)	10 (17)	4 (7)	6 (10)	6 (10)
	Intervention 2	22 (37)	13 (22)	11 (18)	5 (8)	5 (8)	8 (13)	6 (10)	7 (12)	4 (7)	4 (7)
	Control	24 (38)	15 (24)	13 (21)	10 (16)	7 (11)	5 (8)	16 (25)	5 (8)	1 (2)	4 (6)
Feagan et al[15]	Intervention	97 (13)	38 (5)	80 (11)	NA	33 (4)	132 (18)	50 (7)	56 (8)	NA	NA
	Control	58 (39)	19 (13)	28 (19)	NA	10 (7)	47 (32)	10 (7)	25 (17)	NA	NA
Parikh et al[16]	Intervention 1	2 (17)	NA	2 (17)	NA	NA	4 (33)	NA	NA	1 (8)	NA
	Intervention 2	1 (7)	NA	3 (21)	NA	NA	3 (21)	NA	NA	0 (0)	NA
	Intervention 3	0 (0)	NA	2 (18)	NA	NA	1 (9)	NA	NA	0 (0)	NA
	Control	4 (44)	NA	1 (11)	NA	NA	4 (44)	NA	NA	1 (11)	NA
Feagan et al[14]	Intervention 1	6 (10)	NA	NA	NA	NA	NA	NA	6 (10)	18 (15)2
	Intervention 2	3 (5)	NA	NA	NA	NA	NA	NA	12 (20)
	Control	8 (13)	NA	NA	NA	NA	NA	NA	6 (10)
Feagan et al[15]	Intervention	NA	35 (5)	13 (2)	NA	NA	NA	NA	77 (10)
	Control	NA	16 (11)	36 (24)	NA	NA	NA	NA	37 (25)
Parikh et al[16]	Intervention 1	NA	NA	0 (0)	0 (0)	0 (0)	1 (8)	0 (0)	1 (8)	2 (5)2
	Intervention 2	NA	NA	2 (14)	2 (14)	2 (14)	0 (0)	0 (0)	0 (0)
	Intervention 3	NA	NA	0 (0)	0 (0)	0 (0)	0 (0)	1 (9)	1 (9)
	Control	NA	NA	0 (0)	0 (0)	0 (0)	1 (11)	1 (11)	0 (0)

¹Data reported as n (%);

²Pooled of all intervention groups. NA: Not available.