| |
Did not sustain remission
|
Sustained remission
|
|---|
|
N
|
Change in LS Mean (SE)
|
N
|
Change in LS Mean (SE)
|
P
a
|
|---|
|
SF-12v2, mean (SD)
|
|
Physical functioning
|
110
|
−4.2 (0.79)‡
|
225
|
1.6 (0.56)*
|
‡
|
|
Role physical
|
109
|
−6.0 (0.73)‡
|
225
|
1.6 (0.51)*
|
‡
|
|
Bodily pain
|
110
|
−7.2 (0.76)‡
|
223
|
0.8 (0.53)
|
‡
|
|
General health
|
110
|
−8.9 (0.88)‡
|
225
|
3.0 (0.62)*
|
‡
|
|
Vitality
|
110
|
−5.2 (1.00)‡
|
221
|
2.5 (0.71)*
|
‡
|
|
Social functioning
|
110
|
−6.3 (0.82)‡
|
225
|
1.0 (0.58)
|
‡
|
|
Role emotional
|
110
|
−4.9 (0.78)‡
|
223
|
1.8 (0.55)*
|
‡
|
|
Mental health
|
110
|
−5.1 (0.87)‡
|
225
|
2.0 (0.62)*
|
‡
|
|
PCS
|
110
|
−6.3 (0.67)‡
|
225
|
1.5 (0.48)*
|
‡
|
|
MCS
|
110
|
−4.9 (0.77)‡
|
225
|
1.9 (0.54)*
|
‡
|
|
SIBDQ, mean (SD)
|
|
Bowel symptoms
|
95
|
−4.1 (0.33)‡
|
204
|
0.4 (0.23)
|
‡
|
|
Systemic symptoms
|
96
|
−1.9 (0.24)‡
|
206
|
0.5 (0.17)*
|
‡
|
|
Emotional function
|
95
|
−3.2 (0.32)‡
|
205
|
0.6 (0.22)*
|
‡
|
|
Social function
|
96
|
−2.7 (0.24)‡
|
208
|
0.5 (0.16)*
|
‡
|
|
Total score
|
92
|
−12.0 (0.96)‡
|
199
|
1.8 (0.67)*
|
‡
|
|
WPAI:UC, mean (SD)
|
|
Absenteeism
|
54
|
9.3 (2.17)‡
|
113
|
−1.6 (1.54)
|
‡
|
|
Presenteeism
|
58
|
19.6 (2.42)‡
|
117
|
−2.5 (1.75)
|
‡
|
|
Overall work impairment
|
54
|
25.4 (3.00)‡
|
111
|
−3.7 (2.13)
|
‡
|
|
Activity impairment
|
92
|
22.3 (2.04)‡
|
199
|
−2.4 (1.42)
|
‡
|
- LS least squares, MCS mental component summary, PCS physical component summary, PRO patient-reported outcome, SD standard deviation, SE standard error, SF-12v2 SF-12v2 Health Survey, SIBDQ Short Inflammatory Bowel Disease Questionnaire, WPAI:UC Work Productivity and Activity Impairment questionnaire for ulcerative colitis
- Findings for each outcome are based on mixed-effects models for repeated measures with subject as a random effect, and sustainer status, visit, and the sustainer status x visit interaction as fixed effects
- Week 8 includes early withdrawal visits during the acute phase. “Month 12” includes early withdrawal visits during the maintenance phase
- aIndicates statistical significance of the sustainer status x visit interaction effect
- *P < 0.05, ‡P < 0.001
