P456. Impact of short-term and long-term daily therapy with MMX mesalazine on work-related outcomes in patients with mild-to-moderate ulcerative colitis
A. Yarlas1, M.K. Willian2, A.V. Joshi2, 1Optum, Life Sciences, Lincoln, RI, United States, 2Shire, Health Economics and Outcomes Research, Wayne, PA, United States
Ulcerative colitis (UC) is linked to deficits in work-related outcomes (WRO), such as work productivity. This analysis examines changes in WRO for patients with mild-to-moderate UC who received short-term (8 weeks) and long-term (12 months) treatment in the course of a clinical trial of MMX mesalazine.
Data were analysed from a completed, open-label, prospective, multinational trial (MOMENTUM study; ClinicalTrials.gov: NCT01124149; sponsor, Shire Development LLC) in which adults with active mild-to-moderate UC received 8 weeks of treatment with MMX mesalazine 4.8 g/d once daily (QD). Those who achieved 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) in this acute phase received an additional 12 months of maintenance treatment with MMX mesalazine 2.4 g/d QD.
At baseline, Week 3, Week 8, and Month 12 visits, patients completed the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) survey, which measured the impact of UC on respondents' WRO during the preceding 7 days. Employed patients received scores on absenteeism, presenteeism, overall work impairment (OWI), and activity impairment (AI) domains; nonemployed patients received AI scores. Scores represent percentage of impairment. Changes in scores over time were tested using repeated-measures analysis of variance models. Multiplicity was controlled using Bonferroni-adjusted P values.
Key results are in the Table. Scores on all 4 domains decreased (improved) significantly from baseline to both Week 3 and Week 8 visits. Further, with the exception of the absenteeism domain (already <5% by Week 3), significant decreases were observed between Week 3 and Week 8. Month 12 scores were nearly identical to Week 8 scores, with all differences less than 1%.
|N||Mean±SD||P values (Bonferroni-adjusted)|
|Baseline||Week 3||Week 8||Month 12|
|Acute efficacy population||Baseline vs Week 3||Baseline vs Week 8||Week 3 vs Week 8|
|Maintenance efficacy population||Baseline vs Week 8||Baseline vs Month 12||Week 8 vs Month 12|
|SD, standard deviation; ns, not significant.|
Patients with active mild-to-moderate UC showed improvements in all domains of WRO within 3 weeks of MMX mesalazine 4.8 g/d QD treatment initiation. Improvement continued until Week 8, and was sustained for 12 more months for patients who achieved CR or PR by Week 8 and received MMX mesalazine 2.4 g/d QD during the maintenance phase. Thus, short-term treatment significantly improved WRO, and long-term treatment maintained these improvements.