Table 4.

Subgroup analysis of clinical remission, mucosal healing and histological remission stratified by localisation of disease (ITT population).

n/N (%)	Total	95% CI
Clinical remissiona at Week 8 in patients with:
Proctosigmoiditisb	17/37 (45.9)	29.5–63.1
Left-sided colitisc	7/16 (43.8)	19.8–70.1
Subtotal/total colitisd	5/8 (62.5)	24.5–91.5
Mucosal healinge at Week 8 in patients with:
Proctosigmoiditisb	16/29 (55.2)	35.7–73.6
Left-sided colitisc	8/15 (53.3)	26.6–78.7
Subtotal/total colitisd	5/6 (83.3)	35.9–99.6
Histological remissionf at Week 8 in patients with:
Proctosigmoiditisb	11/29 (37.9)	20.7–57.7
Left-sided colitisc	4/15 (26.7)	7.8–55.1
Subtotal/total colitisd	3/6 (50.0)	11.8–88.2

^aDefined as CAI ≤4, with stool frequency <18 per week and absence of rectal bleeding. Analysed using last observation carried forward.

^bInflammation up to sigmoid colon.

^cInflammation up to descending colon (excluding proctosigmoiditis).

^dInflammation seen at least up to transverse colon.

^eDefined as an mDAI mucosal appearance subscore of ≤1 point, if associated with a decrease of ≥1 point from baseline; any mucosal friability was scored using a mucosal appearance subscore of ≥2.

^fDefined 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.

CAI: Clinical Activity Index; CI: confidence interval; HI: Histological Index; ITT: intention-to-treat; mDAI: modified Disease Activity Index.