Secondary Outcomes from Dulai Prediction Models | ||||||
Low probability | Intermediate probability | High probability | p-value | |||
Drug exposure | Pre-Dose VDZ Concentrations (ug/mL) by Probability of Response | |||||
Week 2 | UC | 22.9 | 27.4 | 32 | <0.001 | |
CD | 24.7 | 28.45 | 32.7 | <0.001 | ||
Week 6 | UC | 17.2 | 23.5 | 34.9 | <0.001 | |
CD | 15.3 | 23.5 | 33.4 | <0.001 | ||
Week 22 | UC | 18.0 | 23.8 | 32.5 | <0.001 | |
CD | 15.8 | 23.4 | 30.3 | <0.001 | ||
Week 46 | UC | 22.5 | 27.8 | 31.5 | 0.016 | |
CD | 18.7 | 25.8 | 32.6 | 0.0008 | ||
Onset of action | Change in Partial Mayo Score (UC) or Harvey-Bradshaw Index (CD) from Baseline by Probability of Response | |||||
Week 6 | UC | −1.22 | −1.89 | −2.21 | <0.001 | |
CD | −1.69 | −2.61 | −4.22 | <0.001 | ||
Week 22 | UC | −2.68 | −3.2 | −3.75 | 0.003 | |
CD | −3.76 | −4.53 | −5.82 | <0.001 | ||
Week 38 | UC | −3.24 | −4.21 | −4.13 | 0.002 | |
CD | −4.62 | −5.57 | −6.76 | <0.001 | ||
Week 52 | UC | −3.64 | −4.42 | −4.33 | 0.029 | |
CD | −4.68 | −6.32 | −7.17 | <0.001 |
AUROC, Area Under Receiver Operator Curse; CSFR, Corticosteroid-Free Remission; CSFER, Corticosteroid-Free Endoscopic Remission; CREM, Clinical Remission; CSF-REM, Corticosteroid-free Remission; MH, Mucosal Healing; DR, Deep Remission.
Dulai et al. CDST for CD Probability of response: Low (Intermediate ≤ 13), Intermediate (>13 to ≤19 points), High (>19 points).
Dulai et al. CDST for UC Probability of response: Low (≤ 26 points), Intermediate (>26 to ≤32 points), High (>32 points).