Table 1.
Baseline characteristics of individual patients including disease activity parameters, vedolizumab serum concentrations, adverse events which were reasons to de-escalate subcutaneous vedolizumab, and corresponding scores 6 months after de-escalation.
| Patient | A | B | C | D | E | F | G | H | I |
|---|---|---|---|---|---|---|---|---|---|
| Baseline characteristics | |||||||||
| Clinical score | SCCAI = 0 | HBI = 1 | HBI = 0 | HBI = 2 | HBI = 0 | HBI = 2 | HBI = 1 | HBI = 0 | HBI = 1 |
| C-reactive protein (mg/L) | 2.9 | 3.3 | 0.3 | 4.3 | 5.2 | N/A | 0.6 | 1.0 | 5.2 |
| Fecal calprotectin (µg/g) | 52 | 11 | 20 | 44 | 84 | 56 | 28 | 18 | 12 |
| VDZ serum concentration (µg/mL) | 45 | 29 | 33 | 44 | 28 | 45 | 24 | 49 | 40 |
| Adverse event(s) | Headache and arthralgia | Fatigue | Injection site reaction | Frequent respiratory and skin infections | Fatigue | Constipation | Headache | Arthralgia | Fatigue |
| Six months after subcutaneous vedolizumab de-escalation | |||||||||
| SC VDZ dosing interval | Q4W | Q3W | Q3W | Q3W | Q3W | Q3W | Q3W | Q3W | Q3W |
| Clinical score | SCCAI = 0 | HBI = 1 | HBI = 0 | HBI = 2 | HBI = 1 | HBI = 1 | HBI = 0 | HBI = 0 | HBI = 0 |
| C-reactive protein (mg/L) | 1.4 | 4.1 | N/A | 3.0 | 3.7 | N/A | N/A | 1.4 | 4.5 |
| Fecal calprotectin (µg/g) | 43 | 9 | N/A | 17 | 111 | 43 | N/A | 10 | 24 |
| VDZ serum concentration (µg/mL) | 22 | 21 | 16 | N/A | 20 | 40 | N/A | 33 | 22 |
HBI, Harvey–Bradshaw index; N/A, not available; QXW, every X weeks; SCCAI, simple clinical colitis activity index; SC, subcutaneous; VDZ, vedolizumab.