P720 Exit interviews exploring Crohn’s disease patients’ experience of changes in their bowel urgency during the mirikizumab Phase 3 clinical trial in adult patients with moderate to severe Crohn disease

Abstract Background The objective of this study was to explore the clinical trial experience of patients with Crohn’s disease (CD), including perceptions of the Urgency Numeric Rating Scale (Urgency NRS) and meaningful within-patient change (MWPC). Methods Qualitative, 90-minute exit interviews were conducted with patients who had moderate to severe CD and completed the VIVID-1 phase 3, multicentre, randomized, double-blind, placebo and active-controlled, mirikizumab clinical trial in the past 3 weeks. The semi-structured interview guide included cognitive debriefing to explore the content validity of the 11-point Urgency NRS (0=No urgency to 10=Worst possible urgency in the past 24 hours). Interview transcripts were analysed using qualitative directed content analysis and framework analysis. Results Interviewed participants (N=62) were from the US (n=29), Czech Republic (n=10), Poland (n=8), Germany (n=7), Canada (n=4), Australia (n=3) and the UK (n=1). Participants (age 22–75 years, 55% female, 53% high school education or lower) were diagnosed with CD for 1–54 years. Most participants understood the Urgency NRS as assessing the severity of feeling an immediate need to go to the bathroom and used it accurately and without difficulty. Participants interpreted the Urgency NRS as ranging from “no urgency” [0] to an “immediate, sudden need or loss of bowel control” [10]. Participants reported that a ‘good day’ or ‘remission’ would feature reduced or no or minimal bowel urgency and permit adequate time to find a bathroom, feature no accidents and allow participation in daily/leisure/social activities and work away from home. Participants considered Urgency NRS scores ≤3 as a ‘good day’ (n=45/59) and ≤2 as ‘remission’ (n=41/57). Most reported that the bowel urgency improvement they experienced was meaningful (n=51/55; Table 1) because it improved their quality of life. A 3-point Urgency NRS improvement was identified as the smallest meaningful change (n=40/54; Table 1). Most participants associated bowel urgency with CD severity when responding to a Patient Global Rating of Severity (PGRS; n=42) and a Patient Global Impression of Change (PGIC; n=32). Most participants related Urgency NRS scores of 0 to None, 2 to Very Mild, 4 to Mild, 6 to Moderate, 8 to Severe and 10 to Very Severe on the PGRS (Figure 1). Urgency NRS improvements of 3-10 points were considered Much better or Very much better on the PGIC (Figure 1). Conclusion The Urgency NRS was well understood and a ≥3-point improvement in Urgency NRS score was considered a MWPC. Participants with CD who had completed the mirikizumab clinical trial perceived a meaningful change in bowel urgency to feature reduced or minimal bowel urgency enabling improved daily functioning.

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