Primary and secondary end points at week 12
| Intention-to-treat | Per protocol | |||||||
|---|---|---|---|---|---|---|---|---|
| End point | Algorithm* (n=33) | IFX intensification (n=36) | p Value | RR (binary) or mean difference (scale) (95% confidence interval) | Algorithm (n=19) | IFX intensification (n=36) | p Value | RR (binary) or mean difference (scale) (95% confidence interval) |
| Primary | ||||||||
| Costs of Crohn's disease (€), mean (SD) | 6038 (4146) | 9178 (2058) | <0.001 | −3141 (−4617; −1373) | 4062 (2763) | 9178 (2058) | <0.001 | −5116 (−6482; −3561) |
| Clinical response, n (%) | 19 (58) | 19 (53) | 0.810 | 1.091 (0.713–1.670) | 9 (47) | 19 (53) | 0.781 | 0.898 (0.510–1.580) |
| Secondary | ||||||||
| CDAI 100 response, n (%) | 16 (49) | 17 (47) | 1.000 | 1.027 (0.627–1.681) | 8 (42) | 17 (47) | 0.781 | 0.892 (0.475–1.675) |
| Clinical remission, n (%) | 10 (30) | 14 (39) | 0.613 | 0.779 (0.403–1.507) | 4 (21) | 14 (39) | 0.234 | 0.541 (0.207–1.417) |
| CDAI decrease†, mean (SEM) | 98 (18) | 108 (20) | 0.683 | −11 (−64–43) | 90 (24) | 109 (20) | 0.573 | −19 (−84–47) |
| PDAI decrease‡, mean (SEM) | 2.4 (0.8) | 1.5 (0.7) | 0.421 | 0.9 (−1.4–3.2) | 1.4 (0.5) | 1.5 (0.7) | 0.911 | −0.1 (−2.1–1.9) |
| IBDQ increase, mean (SEM) | 8.8 (1.7) | 8.8 (1.9) | 0.996 | 0.0 (−5.1–5.2) | 5.4 (2.0) | 8.8 (1.9) | 0.264 | −3.4 (−9.6–2.7) |
| CRP change (mg/L), median (IQR) | −3 (−15–0) | −1 (−16–0) | 0.985 | −2 | −3 (−3–0) | −1 (−16–0) | 0.870 | −2 |
| WBC change (×109/L), median (IQR) | 0.0 (−1.1–1.0) | −0.6 (−2.1–0.1) | 0.055 | 0.6 | 0.1 (−0.9–1.3) | −0.6 (−2.1–0.1) | 0.022 | 0.7 |
| Hb change (mM), median (IQR) | 0.0 (−0.4–0.3) | 0.1 (−0.2–0.3) | 0.506 | −0.1 | 0.1 (−0.4–0.2) | 0.1 (−0.2–0.3) | 0.478 | 0 |
| Albumin change (g/L), median (IQR) | 0 (−2–2) | 0 (−1–2) | 0.556 | 0 | 0 (−2–2) | 0 (−1–2) | 0.310 | 0 |
*Cost data were unavailable for one patient in the algorithm group.
†Patients with active luminal disease at inclusion (CDAI ≥220).
‡Patients with active fistulising disease at inclusion (≥1 draining fistula).
CDAI, Crohn's Disease Activity Index; CRP, C-reactive protein; Hb, haemoglobin; IFX, infliximab; IBDQ, Inflammatory Bowel Disease Questionnaire; PDAI, Perianal Disease Activity Index; WBC, white blood cell.