Table 2.
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% |
p = 0.02 vs. placebo.
p = 0.23 vs. placebo.
p < 0.001 vs. placebo.
p = 0.004 vs. placebo.
p = 0.01 vs. placebo.
p = 0.005 vs. placebo.
p < 0.001 vs. placebo.
p = 0.001 vs. placebo.
p < 0.001 vs. placebo.
p < 0.001 vs. placebo.
p < 0.001 vs. placebo.
p < 0.001 vs. placebo.