P646 Relative association of bowel urgency clinically meaningful improvement and bowel urgency remission versus stool frequency remission and rectal bleeding remission with improvement in Work Productivity and Activity Impairment Scores in patients with moderately-to-severely active Ulcerative Colitis: An analysis from LUCENT-1 and LUCENT-2 Phase 3 clinical trials.
Authors: Sands B E , Feagan B G , Gibble T H , Keohane A , Eastman W J , Traxler K A , Schreiber S , Jairath V , Armuzzi A 
Published: January 2023

Background

Bowel urgency is increasingly recognized as a common and impactful symptom in patients with Ulcerative Colitis (UC).1 However, there are limited data exploring the relationship of bowel urgency with work productivity. We examined the relative association of bowel urgency clinically meaningful improvement (CMI) and bowel urgency remission with Work Productivity and Activity Impairment (WPAI) scores in the presence of rectal bleeding (RB) remission and stool frequency (SF) remission as potential confounding variables using data from LUCENT-1 (NCT03518086) and LUCENT-2 (NCT03524092) phase 3 trials.

Methods

Bowel urgency severity was assessed using the Urgency Numeric Rating Scale (UNRS; 0=no urgency to 10=worst possible urgency). Bowel urgency CMI is a ≥3-point decrease and bowel urgency remission is a UNRS score of 0 or 1.2 WPAI scores (absenteeism, presenteeism, and work productivity loss in employed patients, and activity impairment in all patients) were measured using a 6-item questionnaire; higher scores indicate greater impairment and less productivity. Mediation analyses were performed to separately examine the relative association between the direct effect of bowel urgency CMI and bowel urgency remission (predictor) and WPAI scores while adjusting for the potential confounding effects of RB remission and SF remission (mediator). Analyses were treatment agnostic and combined patients from mirikizumab and placebo groups from LUCENT-1 (N=1162) and LUCENT-2 (N=544) trials.

Results

At week (W)12 and W52, the direct effect of bowel urgency remission accounted for 43%–49% and 27%–57% of the improvement in all WPAI domain scores except absenteeism, respectively. The association values greater than 100% at W12 and W52 (153% and 148%, respectively) reflect the critical importance of SF remission in the improvement of absenteeism score (Table 1). Bowel urgency CMI resulted in the largest proportion of improvement in WPAI domain scores (except absenteeism) at W12 (71%–74%) and W52 (66%–78%). Bowel urgency CMI accounted for 68% and 239% of the improvement in absenteeism scores at W12 and W52, respectively. At W52, 750% of the effect was mediated by RB remission (Table 2).

Conclusion

Improvement in work productivity and regular activities were primarily ascribed to bowel urgency remission or bowel urgency CMI relative to RB remission and SF remission in patients with moderately-to-severely active UC. These findings suggest that bowel urgency is a critical and independent symptom that considerably impacts patients’ productivity.

Reference:

1Dubinsky MC, et al. Crohn's & Colitis 360. Volume 4, Issue 3, July 2022;7(4):3.

2Dubinsky MC, et al. J Patient Rep Outcomes. 2022;6(1):114.