Table 2.
Clinical, endoscopic and histological endpoints (ITT population).
| Total | 95% CI | |
|---|---|---|
| Clinical (n=61)a | ||
| Clinical remission, n (%)b | 35 (57.4) | 44.1–70.0 |
| Clinical improvement, n (%)c | 37 (60.7) | 47.3–72.9 |
| CIA score, mean | ||
| Baseline | 7.6 | 7.1–8.1 |
| Week 8 | 3.7* | 2.9–4.6 |
| Stools per week, mean | ||
| Baseline | 32.5 | 28.1–36.9 |
| Week 8 | 22.9* | 18.3–27.5 |
| Bloody stools per week, mean | ||
| Baseline | 17.6 | 13.8–21.4 |
| Week 8 | 8.1* | 4.6–11.5 |
| Median days to first of ≥3 consecutive days each with: | ||
| ≤3 stools per day | 5 | 0–9.0 |
| No bloody stools per day | 21 | 10.0–35.0 |
| ≤3 stools per day, all without blood | 31 | 20.0–49.0 |
| Endoscopic (n=50), n (%) | ||
| Endoscopic improvementd | 33 (66.0) | 51.2–78.8 |
| Endoscopic remissione | 27 (54.0) | 39.3–68.2 |
| Mucosal healingf | 29 (58.0) | 43.2–71.8 |
| Combined clinical and endoscopic remissiong | 28 (56.0) | 41.3–70.0 |
| Combined clinical and endoscopic remission using a strict definitionh | 10 (20.0) | 10.7–35.7 |
| Histological (n=50), n (%) | ||
| Histological remissioni | 18 (36.0) | 22.9–50.8 |
| Histological improvementj | 25 (50.0) | 35.5–64.5 |
| Histo-endoscopic mucosal healingk | 17 (34.0) | 21.2–48.8 |
*p<0.0001.
aAnalysed using LOCF.
bDefined as mDAI stool frequency subscore of ≤1 and rectal bleeding subscore of 0 at Week 8.
cDefined as CAI decrease of ≥3 from baseline to final in-treatment visit.
dDefined as a decrease of ≥1 point in EI score from baseline.
eDefined as an EI score of <4.
fDefined as an mDAI mucosal appearance subscore of ≤1 point, if associated with a decrease of ≥1 point from baseline.
gDefined as an mDAI stool frequency subscore and mucosal appearance subscore of ≤1 and an mDAI rectal bleeding subscore of 0.
hDefined as an mDAI total score of ≤2 with mDAI stool frequency and rectal bleeding subscores of 0, and mDAI mucosal appearance subscores and mDAI physician’s rating of disease activity subscores of ≤1.
iDefined as an HI of ≤1, which signifies a complete absence of neutrophils in the lamina propria and epithelium, no crypt abscesses, no mucin depletion, normal surface epithelial integrity, no or mild round cells in the lamina propria or epithelium, mild-to-moderate crypt architectural irregularities and no erosions or ulcers.
jDefined as a decreased HI of ≥1 from baseline scores of 2, 3 or 4 by Week 8. No sufficient biopsies were obtained for the transverse colon, ascending colon and coecum.
kThis was a post hoc analysis to assess histo-endoscopic mucosal healing (defined as an mDAI mucosal appearance score and an HI score of ≤1).17
CAI: Clinical Activity Index; CI: confidence interval; EI: Endoscopic Index; HI: Histology Index; ITT: intention-to-treat; LOCF: last observation carried forward; mDAI: modified Disease Activity Index.