Table 3.
Summary of vedolizumab phase III studies in patients with active Crohn’s disease (CD).
| Reference | Design | Population | Treatment | Response endpoints |
|
|---|---|---|---|---|---|
| Primary | Secondary | ||||
| GEMINI 2 [Sandborn et al. 2013] | R, parallel group, DB, PC | Moderate to severe CD* (n = 1115) | Induction | Induction | |
| Intravenous infusion on weeks 0, 2 | Clinical remission† at week 6 | ||||
| C1R1: VDZ 300 mg (n = 220) | 14.5% C1R1 vs. 6.8% C1R2, p = 0.02 17.7% C2 | ||||
| C1R2: PBO (n = 148) | CDAI-100 response‡ at week 6 | ||||
| C2: open label VDZ 300 mg (n = 747) | 31.4% C1R1 vs. 25.7% C1R2, p = 0.23 34.4% C2 | ||||
| Maintenance | Maintenance | Maintenance | |||
| R1: VDZ every 8 weeks (n = 154) | Clinical remission$ at week 52 | CDAI-100 response‡ at week 52 | |||
| R2: VDZ every 4 weeks (n = 154) | 39% R1 and 36.4% R2 versus 21.6% PBO 17.4, p < 0.001 and 14.8, p = 0.004, respectively | 43.5% R1 and 45.5% R2 versus 30.1% PBO 13.4, p = 0.01 and 15.4, p = 0.005, respectively | |||
| PBO (n = 153) | Glucocorticoid-free remission§ | ||||
| 31.7% R1 and 28.8% R2 versus 15.9% PBO 15.8, p = 0.02 and 12.9, p = 0.04, respectively | |||||
| GEMINI 3 [Sands et al. 2014] | R, DB, PC | Moderate to severe CD* (n = 416) | Intravenous infusion on weeks 0, 2, 6 | TNF-α antagonist failure population | TNF-α antagonist failure population |
| VDZ 300 mg (n = 209) | Clinical remission$ at week 6 | CDAI-100 response‡ at week 6 | |||
| PBO (n = 207) | 15.2% VDZ versus 12.1% PBO 3.0 (95% CI −4.5 to 10.5), p = 0.433 | 39.2% VDZ versus 22.3% PBO 16.9 (95% CI 6.7–27.1), p = 0.001 | |||
| Clinical remission$ at week 10 | |||||
| 26.6% VDZ versus 12.1% PBO 14.4 (95% CI 5.7–23.1), p = 0.001 | |||||
| Overall population | |||||
| Clinical remission† at week 6 | |||||
| 19.1% VDZ versus 12.1% PBO 6.9 (95% CI 0.1–13.8), p = 0.048 | |||||
| Clinical remission$ at week 10 | |||||
| 28.7% VDZ versus 13.0% PBO 15.5 (95% CI 7.8–23.3), p < 0.0001 | |||||
*
Moderate to severe active disease: CD Activity Index (CDAI) score of 220–450.
$
Clinical remission: CDAI score up to 150 points.
‡
CDAI-100 response: decrease of at least 100 points in CDAI score.
§
Glucocorticoid-free remission: clinical remission without corticosteroids at week 52.
C1R1, cohort 1 regimen 1; C1R2, cohort 1 regimen 2; C2, cohort 2; CI, confidence interval; DB, double blind; PBO, placebo; PC, placebo controlled; R, randomized; R1, regimen 1; R2, regimen 2; VDZ, vedolizumab.