Table 4.
Vedolizumab trough serum concentrations (µg/mL) from phase III studies (data obtained from Feagan et al. [11], Sandborn et al. [12], and Sands et al. [13])
| Timepoint | GEMINI 1 | GEMINI 2 | GEMINI 3 | |||
|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | |
| Induction phase | ||||||
| Week 6 predose | 654 | 27.9 (15.5) | 827 | 26.8 (17.5) | 195 | 26.5 (15.8) |
| Week 10 | – | – | – | – | 190 | 28.4 (17.9) |
| Maintenance phase | ||||||
| Week 46 predosea | ||||||
| ITT q8wb | 77 | 11.2 (7.2) | 72 | 13.0 (9.1) | – | – |
| ITT q4wc | 220 | 38.3 (24.4) | 247 | 34.8 (22.6) | – | – |
Patients who were persistently ADA positive (positive at ≥2 consecutive visits) were excluded from the analysis
ADA anti-drug antibody, ITT intent-to-treat, q4w every 4 weeks, q8w every 8 weeks, SD standard deviation, – not determined
aSteady-state trough serum concentration
bPatients who responded to vedolizumab 300 mg induction therapy at week 6 and received vedolizumab 300 mg q8w during maintenance
cPatients who responded to vedolizumab 300 mg induction therapy at week 6 and received vedolizumab 300 mg q4w during maintenance