The effect of mesalazine therapy on quality of life in patients with mildly and moderately active ulcerative colitis.
BACKGROUND
Ulcerative colitis (UC) has a major impact on the quality of life (QoL) of affected patients. Patient-reported outcomes have not been thoroughly evaluated in patients with UC receiving oral mesalazine (mesalamine).


OBJECTIVE
To examine the effect of mesalazine on QoL of patients with mildly and moderately active UC and assess the time course of change, baseline disease severity, mesalazine dose and responder status on QoL parameters.


METHODS
Inflammatory Bowel Disease Questionnaire (IBDQ) data were combined from two double-blind, randomized, multicentre, active-controlled trials assessing 2.4 and 4.8 g/day oral delayed-release mesalazine in 687 patients. Mean score changes from baseline were compared at 3 and 6 weeks and effects of baseline severity, mesalazine dose and response to therapy were examined.


RESULTS
Mesalazine significantly improved IBDQ scores at 3 and 6 weeks (mean increase, 29.6 and 39.7 points, respectively; P < 0.0001 for both). Improvement was greater for patients with moderate disease. Greater week 6 changes occurred in clinical responders than nonresponders (50.1 vs. 23.6 points, respectively; P < 0.0001).


CONCLUSIONS
Delayed-release oral mesalazine produces significant clinical and statistical improvements in QoL of patients with UC by 3 weeks, with further improvement at 6 weeks.
Irvine
E J
EJ
Division of Gastroenterology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Yeh
C-H
CH
Ramsey
D
D
Stirling
A L
AL
Higgins
P D R
PD
D000284:Administration, Oral; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000523:psychology*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D019804:Mesalamine