The safety and efficacy of vedolizumab was supported by the GEMINI™ Studies, a four-study clinical program investigating vedolizumab in 2,700 patients across nearly 40 countries.
GEMINI is the largest Phase 3 clinical trial program conducted to date evaluating both UC and CD patient populations simultaneously.1,2,3,4
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥2) was demonstrated in a randomised, double blind, placebo controlled study evaluating efficacy endpoints at Week 6 and Week 52 (GEMINI I).1
GEMINI I study results showed that vedolizumab met primary endpoints of improvement in clinical response (reduction in the Mayo Clinic score of ≥3 points and ≥30 percent 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 six 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 six and 52 weeks, and glucocorticoid-free remission at 52 weeks, both secondary endpoints, as compared with placebo. 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.
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active Crohn’s Disease (Crohn’s Disease Activity Index [CDAI] score of 220 to 450) were evaluated in two studies (GEMINI II and III).1
GEMINI II 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 six weeks and at 52 weeks compared to placebo. At six 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; however, a significantly greater proportion of patients showed CDAI-100 response at 52 weeks. Secondary endpoints of enhanced clinical response and corticosteroid-free remission were also met. The beneficial effect of vedolizumab on clinical remission, enhanced clinical response, and corticosteroid-free remission, all at Week 52, appeared to be similar in patients naïve to TNFα antagonist exposure as well as in those who had failed prior TNFα antagonist therapy.1
The GEMINI III Study was a second randomised, double-blind, placebo-controlled study that evaluated efficacy at Week 6 and Week 10 in the subgroup of patients defined as having failed at least one conventional therapy and failed TNFα antagonist therapy (including primary non-responders) as well as the overall population, which also included patients who failed at least one conventional therapy and were naïve to TNFα antagonist therapy. Patients (n=416), which included approximately 75% TNFα antagonist failures patients, were randomised in a double-blind fashion (1:1) to receive either vedolizumab 300 mg or placebo at Weeks 0, 2, and 6. The primary endpoint was the proportion of patients in clinical remission at Week 6 in the TNFα antagonist failure subpopulation. Although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed.1
Entyvio Summary of Product Characteristics. Takeda Pharmaceuticals. 2014
Data on File: Vedolizumab Integrated Summary of Safety.
The Electronic Medicines Compendium. Remicade 100mg powder for concentrate for solution for infusion Summary of Product Characteristics. http://www.medicines.org.uk/EMC/medicine/3236/SPC/Remicade+100mg+powder+for+concentrate+for+solution+for+infusion/. Updated January 6, 2013. Accessed February 13, 2013.
- The Electronic Medicines Compendium. Humira Pre-filled Pen, Pre-filled Syringe and Vial Summary of Product Characteristics. http://www.medicines.org.uk/emc/medicine/21201/SPC/Humira+Pre-filled+Pen%2c+Pre-filled+Syringe+and+Vial. Updated December 4, 2012. Accessed February 13, 2013.