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. Author manuscript; available in PMC: 2017 Mar 1.
Published in final edited form as: Expert Opin Investig Drugs. 2016;25(3):263–273. doi: 10.1517/13543784.2016.1148137

Table 2.

Summary of vedolizumab trials.

Study Sample size Treatment arms Clinical remission (%) Clinical response (%) Follow-up period Conclusion Ref
CD Induction 368 Patients with active CD (Cohort 1) Vedolizumab 300 mg Week 0 and 2 14.5%a 31.4%b 6 weeks At week 6, patients receiving vedolizumab more likely to attain remission [27]
747 Patients with active CD (Cohort 2) Placebo 6.8% 25.7%
Week 0 and 2 Open-label vedolizumab 17.7% 34.4%
CD Maintenance 461 Patients who responded to induction therapy with vedolizumab Vedolizumab 300 mg every 8 weeks 39.0%c 43.5%e 52 weeks Patients responding to induction therapy more likely to be in remission at week 52 [27]
Vedolizumab 300 mg every 4 weeks 36.4%d 45.5%f
Placebo 21.6% 30.1%
UC Induction 374 Patients with active UC (Cohort 1) Vedolizumab 300 mg Week 0 and 2 47.1%g 16.9%h 6 weeks Vedolizumab was more effective than placebo for induction therapy for UC [28]
521 Patients with active UC (Cohort 2) Placebo 25.5% 5.4%
Week 0 and 2
UC Maintenance 373 Patients who responded to induction therapy with vedolizumab Vedolizumab 300 mg every 8 weeks. 41.8%i 56.6%k 52 weeks Vedolizumab was more effective than placebo for maintenance therapy for UC [28]
Vedolizumab 300 mg every 4 weeks 44.8%j 52.0%l
Placebo 15.9% 23.8%
a

p = 0.02 vs. placebo.

b

p = 0.23 vs. placebo.

c

p < 0.001 vs. placebo.

d

p = 0.004 vs. placebo.

e

p = 0.01 vs. placebo.

f

p = 0.005 vs. placebo.

g

p < 0.001 vs. placebo.

h

p = 0.001 vs. placebo.

i

p < 0.001 vs. placebo.

j

p < 0.001 vs. placebo.

k

p < 0.001 vs. placebo.

l

p < 0.001 vs. placebo.