|
Outcome
|
Treatment
|
Participants, N
|
Infliximab, estimate (95% CI)a
|
Heterogeneity (%)
|
|---|
|
Efficacy: Induction phase (Week 6)
|
|
CDAI-70
|
Infliximab
|
220
|
72% (66%, 77%)
|
0
|
|
Vedolizumab
|
214
|
45% (32%, 60%)
|
89
|
|
CDAI-100
|
Infliximab
|
273
|
62% (56%, 68%)
|
0
|
|
Vedolizumab
|
423
|
36% (29%, 44%)
|
68
|
|
Clinical remission
|
Infliximab
|
611
|
38% (32%, 45%)
|
69
|
|
Vedolizumab
|
423
|
17% (12%, 24%)
|
71
|
|
Efficacy: Maintenance phase (Week 50 to 54)
|
|
CDAI-70
|
Infliximab
|
220
|
74% (68%, 79%)
|
0
|
|
CDAI-100
|
Infliximab
|
273
|
70% (64%, 75%)
|
0
|
|
Vedolizumab
|
148
|
44% (24%, 67%)
|
93
|
|
Clinical remission
|
Infliximab
|
611
|
54% (48%, 60%)
|
57
|
|
Vedolizumab
|
148
|
39% (24%, 56%)
|
88
|
|
Safety (≤ 1 year)
|
|
Any AE
|
Infliximab
|
717
|
75% (66%, 83%)
|
86
|
|
Vedolizumab
|
985
|
78% (59%, 90%)
|
98
|
|
Any SAE
|
Infliximab
|
717
|
12% (8%, 17%)
|
65
|
|
Vedolizumab
|
993
|
16% (8%, 30%)
|
93
|
|
Any infection
|
Infliximab
|
717
|
29% (22%, 37%)
|
80
|
|
Vedolizumab
|
427
|
17% (14%, 21%)
|
24
|
|
Any serious infection
|
Infliximab
|
562
|
4% (2%, 6%)
|
0
|
|
Vedolizumab
|
985
|
4% (2%, 8%)
|
67
|
|
Discontinuation due to AE
|
Infliximab
|
717
|
6% (3%, 12%)
|
79
|
|
Vedolizumab
|
976
|
7% (3%, 15%)
|
84
|
|
Discontinuation due to lack of efficacy
|
Infliximab
|
311
|
6% (4%, 10%)
|
49
|
- a Random-effects model
- All results reported as the proportion of patients achieving the response
- AE Adverse event, CDAI Crohn’s disease activity index, CI Confidence interval, SAE Serious adverse event
