The GEMINI Studies

The safety and efficacy of Entyvio is supported by the results of the GEMINI™ Studies. These phase III studies involved 2,400 individuals with UC or CD who were recruited from nearly 40 countries.

Study Information

Click on STUDY DETAILS in the table below to find out more about each of the GEMINI studies or click MORE INFO to access the full study.

Ulcerative Colitis

GEMINI I5

895, moderately to severely active UC despite treatment with at least one conventional therapy or an anti-TNFα biologic.

GEMINI I was a phase III randomised, double blind, placebo-controlled study of vedolizumab induction and maintenance treatment in patients with active ulcerative colitis (UC). This pivotal study was conducted between 2008 and 2012 and involved 895 patients.5

Study results showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of ≥3 points and ≥30% from baseline, along with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at 6 weeks and clinical remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks.1

A significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at 6 and 52 weeks, and steroid remission at 52 weeks, both secondary endpoints, as compared with placebo.1

In addition, a greater proportion of patients in the groups treated with vedolizumab maintained clinical response and demonstrated durable clinical remission, both secondary endpoints of the study.1

Crohn's

GEMINI II6

1,115, moderately to severely active CD despite treatment with at least one conventional therapy or an anti-TNFα biologic.

GEMINI II was a phase III randomised, double blind, placebo-controlled study of vedolizumab induction and maintenance treatment in patients with active Crohn’s disease. This pivotal study was conducted between 2008 and 2012 and involved 1,115 patients.6

Results showed that vedolizumab demonstrated statistically significant improvements in the primary endpoint of clinical remission (Crohn’s disease activity index [CDAI] score ≤150 points) at 6 weeks and at 52 weeks compared to placebo.1

At 6 weeks, no significant difference was observed in the alternate primary endpoint of CDAI-100 response (≥100-point decrease in the CDAI score) between the vedolizumab and placebo groups. At 52 weeks a significantly greater proportion of patients met the secondary endpoints of CDAI-100 response and CS-free remission. This beneficial effect appeared to be similar; however, a significantly greater proportion of patients showed CDAI-100 response at 52 weeks.1

Secondary endpoints of enhanced clinical response and steroid remission were also met. The beneficial effect of vedolizumab on clinical remission, enhanced clinical response, and steroid remission, all at Week 52, appeared to be similar in patients naïve to TNFα antagonist exposure and in those who had failed prior TNFα antagonist therapy.17

Crohn's  Disease

GEMINI III16

416, moderately to severely active CD despite treatment with at least one conventional therapy or an anti-TNFα biologic.

GEMINI III was a second randomised, double blind, placebo controlled phase III clinical trial conducted in patients with CD. The aim of the study was to look at the efficacy of vedolizumab versus placebo at Week 6 and at Week 10 in patients who had failed at least one conventional therapy and failed anti-TNFα therapy, as well as the overall population.16

While the primary endpoint of proportion of patients in clinical remission at Week 6 in the TNFα antagonist failure subpopulation was not met, exploratory analyses show that clinically meaningful results were observed1, in particular the observation that the efficacy of vedolizumab significantly improves from Week 6 to Week 10 after an additional dose of vedolizumab.

The clinical remission rate at Week 6 for the patients who had failed TNFα antagonists was 15% for the vedolizumab treated patients versus 12% for those who received placebo.1

Long Term Safety

GEMINI LTS15

Estimated enrollment 2,200. Expected completion 2016.

GEMINI LTS is an ongoing, open-label, long-term safety study in patients with either CD or UC. The results of this study are not yet available.15

GEMINI I was a phase III randomised, double blind, placebo-controlled study of vedolizumab induction and maintenance treatment in patients with active ulcerative colitis (UC). This pivotal study was conducted between 2008 and 2012 and involved 895 patients.5

Study results showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of ≥3 points and ≥30% from baseline, along with a decrease of at least 1 point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1) at 6 weeks and clinical remission (Mayo score of 2 or lower and no subscore higher than 1) at 52 weeks.1

A significantly greater proportion of patients receiving vedolizumab achieved mucosal healing (Mayo endoscopic subscore of 0 or 1) at 6 and 52 weeks, and steroid remission at 52 weeks, both secondary endpoints, as compared with placebo.1

In addition, a greater proportion of patients in the groups treated with vedolizumab maintained clinical response and demonstrated durable clinical remission, both secondary endpoints of the study.1

GEMINI II was a phase III randomised, double blind, placebo-controlled study of vedolizumab induction and maintenance treatment in patients with active Crohn’s disease. This pivotal study was conducted between 2008 and 2012 and involved 1,115 patients.6

Results showed that vedolizumab demonstrated statistically significant improvements in the primary endpoint of clinical remission (Crohn’s disease activity index [CDAI] score ≤150 points) at 6 weeks and at 52 weeks compared to placebo.1

At 6 weeks, no significant difference was observed in the alternate primary endpoint of CDAI-100 response (≥100-point decrease in the CDAI score) between the vedolizumab and placebo groups. At 52 weeks a significantly greater proportion of patients met the secondary endpoints of CDAI-100 response and CS-free remission. This beneficial effect appeared to be similar; however, a significantly greater proportion of patients showed CDAI-100 response at 52 weeks.1

Secondary endpoints of enhanced clinical response and steroid remission were also met. The beneficial effect of vedolizumab on clinical remission, enhanced clinical response, and steroid remission, all at Week 52, appeared to be similar in patients naïve to TNFα antagonist exposure and in those who had failed prior TNFα antagonist therapy.17

GEMINI III was a second randomised, double blind, placebo controlled phase III clinical trial conducted in patients with CD. The aim of the study was to look at the efficacy of vedolizumab versus placebo at Week 6 and at Week 10 in patients who had failed at least one conventional therapy and failed anti-TNFα therapy, as well as the overall population.16

While the primary endpoint of proportion of patients in clinical remission at Week 6 in the TNFα antagonist failure subpopulation was not met, exploratory analyses show that clinically meaningful results were observed1, in particular the observation that the efficacy of vedolizumab significantly improves from Week 6 to Week 10 after an additional dose of vedolizumab.

The clinical remission rate at Week 6 for the patients who had failed TNFα antagonists was 15% for the vedolizumab treated patients versus 12% for those who received placebo.1

GEMINI LTS is an ongoing, open-label, long-term safety study in patients with either CD or UC. The results of this study are not yet available.15

If you have been prescribed Entyvio and get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed within this website or in the Patient Information Leaflet for Entyvio.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://yellowcard.mhra.gov.uk/ for how to report side effects.