Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study

Aaron Yarlas, Geert D'Haens, Mary Kaye Willian, Megan Teynor, Aaron Yarlas, Geert D'Haens, Mary Kaye Willian, Megan Teynor

Abstract

Background: Disease activity of patients with ulcerative colitis (UC) predicts health-related quality of life (HRQL) and work-related outcomes (eg, absenteeism, productivity). We tested whether outcomes differed among patients in complete (clinical and endoscopic) remission, partial remission, or not in remission following treatment with multimatrix mesalamine.

Methods: Data were from an open-label, multicountry, prospective trial (ClinicalTrials.gov identifier: NCT01124149) of 717 adults with active mild-to-moderate UC treated with 4.8 g/day multimatrix mesalamine tablets for 8 weeks (induction period); 459 patients who achieved partial or complete remission received daily 2.4 g/day multimatrix mesalamine for 12 additional months (maintenance period). HRQL (SF-12v2 Health Survey and Short Inflammatory Bowel Disease Questionnaire) and work-related outcomes (Work Productivity and Activity Impairment questionnaire) were assessed at baseline and final visits of each treatment period. Differences in scores by remission status within each treatment period were tested using analysis of variance and analysis of covariance models, whereas mixed-effects models with repeated measures tested changes over time.

Results: At their final visit of each treatment period, patients in partial remission scored significantly better on all HRQL and work-related domains than patients not in remission (all Bonferroni-adjusted P < 0.05). Scores for patients in partial remission were, almost without exception, statistically equivalent to those for patients in complete remission. Fluctuating between complete and partial remission during maintenance treatment had no impact on outcomes.

Conclusions: Patients in partial remission following multimatrix mesalamine treatment had HRQL and work-related outcomes equivalent to patients in complete remission. Achievement and maintenance of partial remission may be sufficient for improvements in patients' functioning, well-being, and work performance.

Keywords: health-related quality of life; multimatrix mesalamine; presenteeism; ulcerative colitis; work-related outcomes.

© 2018 Crohn’s & Colitis Foundation of America.

Figures

FIGURE 1.
FIGURE 1.
Flow Chart for Disposition of Trial Patients. aThe efficacy population within each period was defined as all patients who took at least 1 dose of the investigational product and had at least 1 postdose efficacy assessment during that period. bThe specific adverse events experienced by patients in this study have been detailed elsewhere.
FIGURE 2.
FIGURE 2.
Changes in HRQL and WRO Across Induction and Maintenance Period Visits for the Maintenance Subset as a Function of Remission Status at the Final Maintenance Period Visit. Panel A: SIBDQ total score, Panel B: SF-12v2 PCS score, Panel C: SF-12v2 MCS score, Panel D: WPAI:UC overall work impairment (OWI) score. Adjusted means derived using mixed-effects models with repeated measures (MMRM) with patients’ age, gender, duration of disease, and disease extent at study baseline included as covariates. HRQL, health-related quality of life; MCS, Mental Component Summary; PCS, Physical Component Summary; SF-12v2, SF-12v2 Health Survey; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; WPAI:UC, Work Productivity and Activity Impairment–Ulcerative Colitis; WRO, work-related outcomes.

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