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Table 6 Change in PRO scores from Week 8 to Month 12 for patients in the maintenance phase sample who sustained or did not sustain remission at Month 12

From: Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study

  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)
  1. 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
  2. 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
  3. Week 8 includes early withdrawal visits during the acute phase. “Month 12” includes early withdrawal visits during the maintenance phase
  4. aIndicates statistical significance of the sustainer status x visit interaction effect
  5. *P < 0.05, ‡P < 0.001