Background: Impairment of health-related quality of life, employment, and productivity has been documented in patients with moderate to severe ulcerative colitis.
Methods:
Using prospectively collected data from the Active Ulcerative Colitis Trials 1 and 2, we examined the impact of clinical response or remission, as defined using the Mayo score, on healthrelated quality of life, employment, disability, productivity, and hours worked per week. These analyses were based on observed data and included all 728 patients, regardless of their randomized treatment group (i.e., placebo and infliximab patients were grouped for analysis). Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) and Medical Outcomes Study 36-Item Short Form (SF-36) scores among nonresponders, responders, and patients in remission were compared. In addition, changes in employment, disability status, productivity, and hours worked per week of patients in clinical remission and patients not in clinical remission were compared.
Results:
Ulcerative colitis patients in clinical response or remission had significantly improved IBDQ and SF-36 scores at week 30 compared with those of nonresponders (P Ͻ 0.001). Among those not employed at baseline, including those receiving disability compensation, greater percentages of patients in remission at week 30 were employed (20.6%) and not receiving disability compensation (58.8%) than were those not in remission (8.3% and 20.0%, respectively; P Ͻ 0.05 for both comparisons). At week 30, improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission compared with those not in remission (P Ͻ 0.05 for all three comparisons).
Conclusions:
These results confirm the validity of response and remission as defined using the Mayo score.