title: The impact of MMX mesalazine on disease-specific health-related quality of life in ulcerative colitis patients.
abstract: BACKGROUND
  Past studies with ulcerative colitis (UC) patients indicate that disease activity strongly predicts health-related quality of life (HRQL).
  
  
  OBJECTIVE
  To examine the degree to which daily treatment with MMX mesalazine predicts improved HRQL for patients with active UC and with stable HRQL for patients with quiescent UC.
  
  
  METHODS
  Data from two phases of a multicentre open-label trial were examined. In the acute phase, 132 patients with mild-to-moderate active UC received MMX mesalazine 2.4-4.8 g/day for 8 weeks, while 206 patients with quiescent UC received MMX mesalazine 2.4 g/day for a 12-month maintenance phase. Disease-specific HRQL was measured at baseline and endpoint of each phase using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Repeated-measures anova models examined baseline-endpoint changes in SIBDQ, stool frequency (SF), and rectal bleeding severity (RBS). Correlations assessed the associations between SIBDQ and SF/RBS scores, while ancova techniques tested the sensitivity of SIBDQ to disease recurrence.
  
  
  RESULTS
  SIBDQ scores significantly increased for active mild-to-moderate UC patients following 8 weeks of treatment, while SIBDQ scores remained stable for quiescent UC patients following 12 months of treatment. Changes in SIBDQ scores correlated significantly with changes in SF and RBS scores. Patients with recurrent UC at maintenance phase endpoint had significantly lower SIBDQ scores than nonrecurrent patients.
  
  
  CONCLUSIONS
  Daily MMX mesalazine therapy was associated with significant improvement in disease-specific HRQL for patients with mild-to-moderate active UC and with the maintenance of HRQL for patients with quiescent UC. In both patient groups, HRQL was significantly associated with disease activity.
authors.affiliation: Clinical Development & Medical Affairs, Shire Development LLC, Wayne, PA 19087, USA. dsolomon@shire.com
authors.forename: D
authors.initials: D
authors.lastname: Solomon
authors.forename: A
authors.initials: A
authors.lastname: Yarlas
authors.forename: P
authors.initials: P
authors.lastname: Hodgkins
authors.forename: R
authors.initials: R
authors.lastname: Karlstadt
authors.forename: L
authors.initials: L
authors.lastname: Yen
authors.forename: S
authors.initials: S
authors.lastname: Kane
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage*; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine