Table 2.
Efficacy statistics.
| Week 16 change from Baseline | N | Mean | Std | Min | Q1 | Median | Q3 | Max | Lower 95% CI | Upper 95% CI | T-test p-value |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CDAI | 151 | -86.2 | 92.79 | -249 | -160 | -121 | -7 | 101 | -137.6 | -34.8 | 0.003 |
| SES-CD | 15 | -2.1 | 6.43 | -11 | -6.5 | -3 | 0.5 | 15 | -5.6 | 1.5 | 0.23 |
| IBDQ | 15 | 9.4 | 34.14 | -41 | -23 | 7 | 46 | 60 | -9.5 | 28.3 | 0.3 |
| SHS | 15 | -33.7 | 107.74 | -240 | -121 | -39 | 68 | 128 | -93.3 | 26 | 0.25 |
| Faecal calprotectin [µg/g] | 15 | -2923 | 4104 | -10871 | -5357 | -1623 | -4622 | 4395 | -5196 | -650 | 0.015 |
| hsCRP [mg/dL] | 16 | -0.5 | 2.71 | -4.7 | -2.3 | -0.4 | 0.4 | 5.5 | -2 | 0.9 | 0.46 |
1Week 16 or Early Termination samples not available for every patient.
Abbreviations: CDAI = Crohn’s Disease Activity Index, hsCRP = High-Sensitivity C-Reactive Protein, IBDQ = Inflammatory Bowel Disease Questionnaire, SES-CD = Simple Endoscopic Score-Crohn’s Disease, SHS = Simple Health Score.