Exit interviews exploring patients’ experience of change in Crohn’s disease symptoms during the mirikizumab Phase 3 clinical trial in adult patients with moderately-to-severely Crohn’s disease

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Abstract Background Exit interviews with patients who completed the Phase 3 VIVID-1 mirikizumab clinical trial for moderately-to-severely active Crohn’s disease explored the content validity of bowel urgency, stool frequency and abdominal pain patient-reported outcome measures and perceptions of meaningful within-patient change and remission in these key Crohn’s disease symptoms. Methodology Cognitive debriefing explored patient understanding of the bowel urgency numeric rating scale (Urgency NRS), Crohn’s Disease Activity Index: Stool Frequency (CDAI-SF) and Abdominal Pain (CDAI-AP) and patient global rating/impression of severity/change (PGRS/PGIC). Perceptions of meaningful change and remission were explored qualitatively. Transcripts were analyzed using directed content and framework analysis. Results Interviewed participants (N=62; mean age 44.8 years, 55% female, mean 12.0 years since Crohn’s disease diagnosis) 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 understood the Urgency NRS, CDAI-SF and CDAI-AP and could use them to rate their bowel urgency, stool frequency and abdominal pain. Participants considered these symptoms when responding to the PGRS/PGIC. Meaningful change was described as symptom relief resulting in the ability to live daily life without pain or fear/need of rushing to the toilet. Most participants agreed with a proposed remission definition of ≤3 type 6/7 bowel movements and None/Mild abdominal pain. Discussion The Urgency NRS, CDAI-SF and CDAI-AP are content valid patient-reported outcome measures in Crohn’s disease. The PGRS/PGIC are conceptually related global assessments of bowel urgency, stool frequency and abdominal pain. Patients considered reduction in these symptoms as meaningful and remission.