The GEMINI Studies

The safety and efficacy of Entyvio are 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.

Ulcerative Colitis

GEMINI I.5
 

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 II.6
 

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

Crohn's  Disease

GEMINI III.16
 

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 (Crohn's disease activity index [CDAI] score ≤50 points) at Week 6 in the TNFα antagonist failure subpopulation was not met, exploratory analyses show that clinically meaningful results were observed1,16, 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 (p=0.433; relative risk, 1.2; 95% CI, 0.7–2.1).1,16

Long Term Safety

GEMINI LTS interim analysis15

2,830 UC and CD patients, exposed to at least one dose of vedolizumab during six double-blind or open-label trials.

A 5-year interim analysis of GEMINI LTS integrated long-term safety (LTS) study of data from six trials conducted between May 2009 and June 2013. The aim was to evaluate adverse events in patients who received at least one dose of Entyvio or placebo in at least one of the six trials. Results were presented as exposure-adjusted incidence rates of the adverse events (defined as the number of patients experiencing the event per 100 person-years [PYs] of exposure) and comprised a total of 2,830 patients with 4,811 PYs of vedolizumab exposure (median exposure range, 1–1977 days).15

Entyvio was found to have a favourable safety profile with no increased risk of any infection or serious infection and a low incidence of serious infections, infusion-related reactions and malignancies compared with placebo.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

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 (Crohn's disease activity index [CDAI] score ≤50 points) at Week 6 in the TNFα antagonist failure subpopulation was not met, exploratory analyses show that clinically meaningful results were observed1,16, 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 (p=0.433; relative risk, 1.2; 95% CI, 0.7–2.1).1,16

A 5-year interim analysis of GEMINI LTS integrated long-term safety (LTS) study of data from six trials conducted between May 2009 and June 2013. The aim was to evaluate adverse events in patients who received at least one dose of Entyvio or placebo in at least one of the six trials. Results were presented as exposure-adjusted incidence rates of the adverse events (defined as the number of patients experiencing the event per 100 person-years [PYs] of exposure) and comprised a total of 2,830 patients with 4,811 PYs of vedolizumab exposure (median exposure range, 1–1977 days).15

Entyvio was found to have a favourable safety profile with no increased risk of any infection or serious infection and a low incidence of serious infections, infusion-related reactions and malignancies compared with placebo.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.

Adverse events should be reported. In the United Kingdom, reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Takeda on 01628 537900 or e-mail DSO-UK@takeda.com