Table 2.
Primary and secondary outcomes
| Treatment effect (difference between groups; 95% CI) | p value | ||
|---|---|---|---|
| Top-down vs accelerated step-up treatment effect | |||
| Primary outcome measure | |||
| Sustained steroid-free and surgery-free remission | 64 percentage points (57 to 72) | <0·0001 | |
| Secondary outcome measure | |||
| Endoscopic remission | 23 percentage points (11 to 36) | <0·0001 | |
| Quality of life (IBD-Q) numerical score | 8·54 (3·51 to 13·60) | <0·0001 | |
| Number of flares | −1·29 (−1·42 to −1·16) | <0·0001 | |
| Number of steroid courses | −0·87 (−0·97 to −0·76) | <0·0001 | |
| Number of hospital admissions and surgeries | −0·12 (−0·23 to −0·02) | 0·023 | |
| Biomarker–treatment interaction effect | |||
| Primary outcome measure | |||
| Sustained steroid-free and surgery-free remission | 1 percentage point (−15 to 15) | 0·944 | |
| Secondary outcome measure | |||
| Endoscopic remission | 2 percentage points (−24 to 25) | 0·902 | |
| Quality of life (IBD-Q) numerical score | 1·42 (−8·76 to 11·60) | 0·784 | |
| Number of flares | 0·06 (−0·33 to 0·20) | 0·640 | |
| Number of steroid courses | 0·05 (−0·16 to 0·26) | 0·638 | |
| Number of hospital admissions and surgeries | −0·11 (−0·32 to 0·11) | 0·332 | |
Sustained steroid-free and surgery-free remission and endoscopic remission data are presented as absolute differences (absolute difference in percentage points). Quality of life data are presented as absolute differences using the IBD-Q numerical score. Number of flares, steroid courses, hospital admissions and surgeries are presented as difference in number of events per patient per year.