| Number (%) of patients in clinical remission (CAI⩽4) at final visit (LOCF) | ||||
| Mesalazine 3 g OD (n = 191) | Mesalazine 1 g TID (n = 189) | Difference (%) OD − TID (95% CI) | p Value, χ2 (two-sided) | |
| Gender | ||||
| Male | 76/94 (81%) | 76/96 (79%) | 1.6 (−9.7 to 13.1) | 0.7717 |
| Female | 75/97 (77%) | 67/93 (72%) | 5.3 (−7.1 to 17.6) | 0.4027 |
| Disease duration | ||||
| ⩽5 years | 95/121 (79%) | 87/116 (75%) | 3.5 (−7.2 to 14.3) | 0.5220 |
| >5 years | 56/70 (80%) | 56/73 (77%) | 3.3 (−10.2 to 16.8) | 0.6334 |
| Severity (CAI at baseline) | ||||
| ⩽8 points (mild disease) | 103/121 (85%)* | 99/125 (79%) | 5.9 (−3.6 to 15.5) | 0.2255 |
| >8 points (moderate disease) | 48/70 (69%) | 44/64 (69%) | −0.2 (−15.9 to 15.5) | 0.9822 |
| Disease location | ||||
| Distal disease | 83/97 (86%)† | 73/100 (73%) | 12.6 (1.4 to 23.7) | 0.0298 |
| Proximal disease | 68/94 (72%) | 70/89 (79%) | −6.3 (−18.7 to 6.1) | 0.3217 |
Distal disease: proctosigmoiditis.
Proximal disease: left-sided ulcerative colitis/subtotal-/pancolitis.
*The difference (95%) in remission (mild vs moderate) within the OD group was 16.6% (4.0 to 29.1) (p = 0.0067).
†The difference (95%) in remission (proctosigmoiditis vs left-sided/pancolitis) within the OD group was 13.2% (1.8 to 24.7) (p = 0.0247).
CAI, clinical activity index; CI, confidence interval; LOCF, last observation carried forward; OD, once daily; TID, three times daily.