Table 2.
Remission rates at week 8, overall and by subgroup (full analysis set, n = 112)
| Budesonide |
Mesalazine |
Difference in remission, % (90% CI) | pa | |||
|---|---|---|---|---|---|---|
| n | remission, n (%) | n | remission, n (%) | |||
| Overall | 56 | 17 (30.4) | 56 | 14 (25.0) | 5.4 (−8.5 to 18.9) | 0.526 |
| By subgroup | ||||||
| Age | ||||||
| <30 years | 19 | 5 (26.3) | 20 | 4 (20.0) | 6.3 (−15.7 to 27.9) | 0.640 |
| ≥30 years | 37 | 12 (32.4) | 36 | 10 (27.8) | 4.7 (−12.8 to 21.7) | 0.665 |
| Sex | ||||||
| Female | 19 | 5 (26.3) | 13 | 4 (30.8) | −4.5 (−30.6 to 20.3) | 0.783 |
| Male | 37 | 12 (32.4) | 43 | 10 (23.3) | 9.2 (−7.1 to 28.3) | 0.359 |
| Mean BMI | ||||||
| ≥25 | 4 | 2 (50.0) | 4 | 1 (25.0) | 25.0 (−25.6 to 62.1) | 0.465 |
| <25 | 52 | 15 (28.8) | 52 | 13 (25.0) | 3.8 (−10.4 to 17.9) | 0.658 |
| Disease duration | ||||||
| ≥10 years | 21 | 7 (33.3) | 22 | 3 (13.6) | 19.7 (−1.7 to 39.4) | 0.126 |
| <10 years | 35 | 10 (28.6) | 34 | 11 (32.4) | −3.8 (−21.4 to 14.1) | 0.733 |
| Affected area | ||||||
| Ascending colon only | 6 | 3 (50.0) | 3 | 1 (33.3) | 16.7 (−33.2 to 54.5) | 0.635 |
| Ileum only | 22 | 5 (22.7) | 32 | 10 (31.3) | −8.5 (−26.8 to 12.2) | 0.492 |
| Ileocecal region and ascending colon | 28 | 9 (32.1) | 21 | 3 (14.3) | 17.9 (−2.8 to 35.5) | 0.150 |
| Smoking status | ||||||
| Current | 12 | 4 (33.3) | 15 | 5 (33.3) | 0.0 (−27.4 to 28.5) | 1.000 |
| Former | 14 | 2 (14.3) | 7 | 1 (14.3) | 0.0 (−32.4 to 23.7) | 1.000 |
| Never | 30 | 11 (36.7) | 34 | 8 (23.5) | 13.1 (−5.6 to 31.0) | 0.251 |
| Concomitant nutritional therapy | ||||||
| No | 30 | 9 (30.0) | 29 | 9 (31.0) | −1.0 (−20.2 to 18.1) | 0.931 |
| Yes | 26 | 8 (30.8) | 27 | 5 (18.5) | 12.3 (−7.2 to 30.8) | 0.300 |
| Concomitant azathioprine or 6-mercaptopurine therapy | ||||||
| No | 42 | 13 (31.0) | 42 | 13 (31.0) | 0.0 (−16.3 to 16.3) | 1.000 |
| Yes | 14 | 4 (28.6) | 14 | 1 (7.1) | 21.4 (−3.1 to 44.1) | 0.139 |
| Remission rate at week 8 in mesalazine-naïve | ||||||
| patients | 8 | 3 (37.5) | 9 | 1 (11.1) | NC | NC |
BMI, body mass index; CI, confidence interval; NC, not calculated.
a
Calculated using the χ2 test.