Disease-specific health-related quality of life in adult patients with mild to moderate ulcerative colitis receiving short-term and long-term daily treatment with MMX mesalazine

Background: Symptoms (eg, rectal bleeding, stool frequency) experienced by mild-to-moderate ulcerative colitis (UC) patients, negatively affect health-related quality of life (HRQL). These analyses examine the magnitude of improvements in UC patients' HRQL following short-term and long-term treatment with MMX mesalazine. Methods: Data were from a completed, open-label, prospective, multi-country trial of mild-to-moderate UC patients (NCT01124149). In the acute phase, adults with active UC received 8 wks MMX mesalazine 4.8 g/d once daily (QD). Patients achieving complete remission (CR; modified UC Disease Activity Index [UCDAI] ≤1; rectal bleeding and stool frequency scores of 0; ≥1-point reduction in endoscopy score) or partial remission (PR; modified UCDAI ≤3; combined stool frequency and rectal bleeding score ≤1; not in CR) by Wk 8 subsequently received 12 mos of maintenance with MMX mesalazine 2.4 g/d QD. Patients' HRQL (a tertiary endpoint), as impacted by UC symptoms, was assessed with the Shortened Inflammatory Bowel Disease Questionnaire (SIBDQ), a 10-item survey measuring inflammatory bowel disease (IBD)-specific HRQL over a 2-wk recall period. The SIBDQ has 4 domains: Bowel Symptoms (BS), Systemic Symptoms (SS), Emotional Function (EF), and Social Function (SF). Total score is used to assess overall IBDrelated HRQL. Higher SIBDQ scores indicate better HRQL. Changes over time were tested using paired-samples t-tests or repeated-measures analysis of variance models. Multiplicity was controlled using Bonferroni-adjusted P values. Cohen's dz effect sizes for standardised differences in means for pairedsamples were calculated to interpret magnitude of change. Results: Patients who completed the 8 wk acute phase showed significant improvement in all SIBDQ scores, with mean increases of 4.5 points for BS (n = 425), 2.1 for SS (n = 442), 3.6 for EF (n = 439), 3.0 for SF (n = 446), and 13.2 for total score (n = 413; all Ps <0.0001). Effect sizes for change were all ≥0.77, with BS showing the largest improvement (dz = 1.16). Patients completing maintenance showed significant increases in all SIBDQ scores from baseline to Mo 12, with mean increases of 5.0 points for BS (n = 209), 2.6 for SS (n = 221), 4.6 for EF (n = 215), 3.6 for SF (n = 221), and 15.7 for total score (n = 198; all Ps <0.0001). There were no significant changes in any scores from the end of the acute phase to the Mo 12 visit (all changes ≤0.5 points; all Ps >0.24). Conclusions: Patients with active mild-to-moderate UC showed significant, medium to large improvements in disease-specific HRQL following 8 wks of MMX mesalazine 4.8 g/d QD. These improvements were maintained among patients in CR or PR who subsequently received 12 mos of MMX mesalazine 2.4 g/d QD.