Table 49, Study Characteristics Included in the Network Meta-Analysis by Hazelwood et al. - Entyvio (Vedolizumab)

Drug	Study	Treatment Group Included in IDC	Primary End Point	Baseline CD Severity	Prior Anti-TNF Alpha (%)	Concomitant CD Treatment (%)
Induction Studies
VDZ	Feagan 2008	VDZ 0.5 or 2.0 mg/kg at weeks 0 and 4 PLA	Clinical remission CDAI < 150 (week 8)	CDAI (220 to 450)	0	33	29
GEMINI II 2012	VDZ 300 mg at weeks 0 and 2 PLA	Clinical remission CDAI < 150 (week 6)	CDAI (220 to 450)	62	34	17
GEMINI III 2012	VDZ 300 mg at weeks 0, 2, and 6 PLA	Clinical remission CDAI < 150 (week 6)	CDAI (220 to 450)	76	54	34
ADA	CLASSIC I 2006	ADA 160/80 mg or 80/40 mg at weeks 0 and 2 PLA	Clinical remission CDAI < 150 (week 4)	CDAI (220 to 450)	0	33	29
GAIN 2007	ADA 160/80 mg at weeks 0 and 2 PLA	Clinical remission CDAI < 150 (week 4)	CDAI (220 to 450)	100	39	49
Watanabe 2012	ADA 160/80 mg or 80/40 mg at weeks 0 and 2 PLA	Clinical remission CDAI < 150 (week 4)	CDAI (220 to 450)	58	21	32
IFX	T16 1996	IFX 5, 10 or 20 mg/kg at week 0 PLA	Clinical remission CDAI < 150 (week 4)	CDAI (220 to 400)	0	59	37
CRT	Sandborn 2011	CRT 400 mg at weeks 0, 2, and 4 PLA	Clinical remission CDAI ≤ 150 (week 6)	CDAI (220 to 450)	0	45	33
	Schreiber 2005	CRT 100, 200 or 400 mg at weeks 0, 4, and 8 PLA	Clinical remission CDAI ≤ 150 (week 12)	CDAI (220 to 450)	22	36	37
	Winter 2004	CRT 5, 10 or 20 mg/kg at week 0 PLA	Clinical remission CDAI ≤ 150 (week 4)	CDAI (220 to 450)	24	28	45
Maintenance Studies
VDZ	GEMINI II 2012	VDZ 300 mg every 4 or 8 weeks PLA	Clinical remission CDAI < 150 (week 52)	CDAI < 150 after induction therapy	54	36	17
ADA	EXTEND 2012	ADA 40 mg every other week PLA	Mucosal healing (week 52)	70-point decrease in baseline CDAI (220 to 450) after induction therapy	52	26	41
CHARM 2007	ADA 40 mg every week or every other week PLA	Clinical remission CDAI < 150 (week 56)	70-point decrease in baseline CDAI (220 to 450) after induction therapy	50	44	47
CLASSIC II 2007	ADA 40 mg every week or every other week PLA	Clinical remission CDAI < 150 (week 60)	CDAI < 150 after induction therapy	0	49	22
Watanabe 2012	ADA 40 mg every other week PLA	Clinical remission CDAI < 150 (week 56)	70-point decrease in baseline CDAI (220 to 450) after induction therapy	54	16	36
IFX	ACCENT I 2001	IFX 5 or 10 mg/kg at weeks 2, 6, and every 8 weeks PLA	Clinical remission CDAI < 150 (week 30)	70-point decrease in baseline CDAI (220 to 400) after induction therapy	0	52	27
Rutgeerts 1999	IFX 10 mg/kg every 8 weeks PLA	Clinical remission CDAI < 150 (week 44)	70-point decrease in baseline CDAI (220 to 400) after induction therapy	0	NR	NR
CRT	PRECISE II 2007	CRT 400 mg every 4 weeks PLA	Clinical remission CDAI < 150 (week 26)	100-point decrease in baseline CDAI (220 to 450) after induction therapy	24	36	40
PRECISE I 2007	CRT 400 mg at weeks 0, 2, and 4 PLA	Clinical remission CDAI ≤ 150 (week 26)	CDAI (220 to 450)	28	39	37

Drug

Study

Treatment Group Included in IDC

Primary End Point

Baseline CD Severity

Prior
Anti-TNF
Alpha
(%)

Concomitant CD
Treatment (%)

Induction Studies

VDZ

Feagan
2008

VDZ 0.5 or 2.0 mg/kg at weeks 0 and 4
PLA

Clinical remission CDAI
< 150 (week 8)

CDAI (220 to 450)

GEMINI II
2012

VDZ 300 mg at weeks 0 and 2
PLA

Clinical remission CDAI
< 150 (week 6)

CDAI (220 to 450)

GEMINI III
2012

VDZ 300 mg at weeks 0, 2, and 6
PLA

Clinical remission CDAI
< 150 (week 6)

CDAI (220 to 450)

ADA

CLASSIC I
2006

ADA 160/80 mg or 80/40 mg at weeks 0 and 2
PLA

Clinical remission CDAI
< 150 (week 4)

CDAI (220 to 450)

GAIN
2007

ADA 160/80 mg at weeks 0 and 2
PLA

Clinical remission CDAI
< 150 (week 4)

CDAI (220 to 450)

100

Watanabe
2012

ADA 160/80 mg or 80/40 mg at weeks 0 and 2
PLA

Clinical remission CDAI
< 150 (week 4)

CDAI (220 to 450)

IFX

T16
1996

IFX 5, 10 or 20 mg/kg at week 0
PLA

Clinical remission CDAI
< 150 (week 4)

CDAI (220 to 400)

CRT

Sandborn
2011

CRT 400 mg at weeks 0, 2, and 4
PLA

Clinical remission CDAI
≤ 150 (week 6)

CDAI (220 to 450)

Schreiber
2005

CRT 100, 200 or 400 mg at weeks 0, 4, and 8
PLA

Clinical remission CDAI
≤ 150 (week 12)

CDAI (220 to 450)

Winter
2004

CRT 5, 10 or 20 mg/kg at week 0
PLA

Clinical remission CDAI
≤ 150 (week 4)

CDAI (220 to 450)

Maintenance Studies

VDZ

GEMINI II
2012

VDZ 300 mg every 4 or 8 weeks
PLA

Clinical remission CDAI
< 150 (week 52)

CDAI < 150 after induction
therapy

ADA

EXTEND
2012

ADA 40 mg every other week
PLA

Mucosal healing
(week 52)

70-point decrease in baseline CDAI (220 to 450) after induction therapy

CHARM
2007

ADA 40 mg every week or every other week
PLA

Clinical remission CDAI
< 150 (week 56)

70-point decrease in baseline CDAI (220 to 450) after induction therapy

CLASSIC II
2007

ADA 40 mg every week or every other week
PLA

Clinical remission CDAI
< 150 (week 60)

CDAI < 150 after induction therapy

Watanabe
2012

ADA 40 mg every other week
PLA

Clinical remission CDAI
< 150 (week 56)

70-point decrease in baseline CDAI (220 to 450) after induction therapy

IFX

ACCENT I
2001

IFX 5 or 10 mg/kg at weeks 2, 6, and every 8 weeks
PLA

Clinical remission CDAI
< 150 (week 30)

70-point decrease in baseline CDAI (220 to 400) after induction therapy

Rutgeerts
1999

IFX 10 mg/kg every 8 weeks
PLA

Clinical remission CDAI
< 150 (week 44)

70-point decrease in baseline CDAI (220 to 400) after induction therapy

CRT

PRECISE II
2007

CRT 400 mg every 4 weeks
PLA

Clinical remission CDAI
< 150 (week 26)

100-point decrease in baseline CDAI (220 to 450) after induction therapy

PRECISE I
2007

CRT 400 mg at weeks 0, 2, and 4
PLA

Clinical remission CDAI
≤ 150 (week 26)

CDAI (220 to 450)

From: APPENDIX 7, SUMMARY OF PUBLISHED INDIRECT COMPARISONS

Entyvio (Vedolizumab) [Internet].

Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Dec.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

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Table 49Study Characteristics Included in the Network Meta-Analysis by Hazelwood et al.