| | |
Baseline
|
Week 8
|
Change
|
|---|
|
N
|
LS Mean
|
SE
|
LS Mean
|
SE
|
LS Mean Difference (95% CI)
|
Effect size dz, (95% CI)
|
|---|
|
SF-12v2
|
|
Physical functioning
|
673
|
46.3
|
0.36
|
51.0
|
0.34
|
4.6‡ (3.7, 5.6)
|
0.41 (0.32, 0.49)
|
|
Role physical
|
673
|
43.8
|
0.32
|
49.4
|
0.30
|
5.6‡ (4.7, 6.5)
|
0.61 (0.52, 0.70)
|
|
Bodily pain
|
673
|
43.5
|
0.37
|
51.6
|
0.33
|
8.1‡ (7.2, 9.1)
|
0.74 (0.63, 0.83)
|
|
General health
|
674
|
41.6
|
0.40
|
48.8
|
0.37
|
7.3‡ (6.2, 8.3)
|
0.63 (0.54, 0.73)
|
|
Vitality
|
672
|
46.8
|
0.38
|
53.2
|
0.39
|
6.4‡ (5.3, 7.5)
|
0.53 (0.43, 0.61)
|
|
Social functioning
|
674
|
42.5
|
0.37
|
49.2
|
0.35
|
6.8‡ (5.8, 7.8)
|
0.63 (0.53, 0.71)
|
|
Role emotional
|
673
|
41.9
|
0.38
|
47.5
|
0.37
|
5.6‡ (4.6, 6.6)
|
0.49 (0.39, 0.58)
|
|
Mental health
|
674
|
44.2
|
0.38
|
50.8
|
0.39
|
6.6‡ (5.5, 7.6)
|
0.56 (0.47, 0.65)
|
|
PCS
|
673
|
44.9
|
0.31
|
50.8
|
0.28
|
5.9‡ (5.1, 6.8)
|
0.65 (0.55, 0.74)
|
|
MCS
|
674
|
43.2
|
0.37
|
49.5
|
0.36
|
6.4‡ (5.3, 7.4)
|
0.58 (0.49, 0.66)
|
|
SIBDQ
|
|
Bowel symptoms
|
602
|
12.6
|
0.13
|
16.7
|
0.15
|
4.1‡ (3.7, 4.5)
|
1.00 (0.88, 1.10)
|
|
Systemic symptoms
|
602
|
8.9
|
0.11
|
10.9
|
0.11
|
2.0‡ (1.7, 2.3)
|
0.68 (0.57, 0.77)
|
|
Emotional function
|
602
|
12.8
|
0.17
|
16.1
|
0.17
|
3.2‡ (2.8, 3.7)
|
0.74 (0.64, 0.86)
|
|
Social function
|
601
|
9.0
|
0.13
|
11.6
|
0.12
|
2.6‡ (2.3, 3.0)
|
0.77 (0.66, 0.86)
|
|
Total score
|
600
|
43.3
|
0.45
|
55.3
|
0.49
|
12.0‡ (10.7, 13.3)
|
0.92 (0.80, 1.02)
|
- CI confidence interval, LS least squares, MCS mental component summary, PCS physical component summary, SE standard error, SF-12v2 SF-12v2 Health Survey, SIBDQ Short Inflammatory Bowel Disease Questionnaire
- Findings for each outcome are based on mixed-effects models for repeated measures with subject as a random effect and visit as a fixed effect
- Week 8 includes early withdrawal visits during the acute phase
- ‡P < 0.001
