S1384 Exit Interviews Exploring Patients’ Experience of Changes in Their Fatigue During the Phase 3 Clinical Trial of Mirikizumab for Treatment of Moderately to Severely Active Crohn’s Disease

Introduction: Fatigue is a common and debilitating symptom of Crohn’s disease (CD), associated with functional impairment and reduced quality of life. Here we qualitatively explore change in fatigue in participants with moderately to severely active CD who completed the phase 3, randomised, double-blind, placebo- and active-controlled, mirikizumab clinical trial (VIVID-1). Methods: Qualitative, web-assisted, semi-structured, 90-minute exit interviews were conducted in 62 trial participants within 3 weeks of the final trial visit (May 2022–July 2023). A sub-set of participants from either mirikizumab, ustekinumab or placebo arms were asked open-ended questions to explore changes in fatigue. Interview audio recordings were transcribed verbatim and analysed using a directed content analysis approach in ATLAS.ti v9. Results: Among the 31 participants who were interviewed (61.3% male [n=19], 90.3% white [n=28]), median age was 42 (n=30; range: 24–75) years, median CD duration was 5.9 (n=30; range: 1.4–54.3) years, 31.0% (n=9/29) had a college degree or higher and 41.4% (n=12/29) were employed full-time. Participants were from the United States (n=15), Czech Republic (n=5), Germany (n=5), Poland (n=3), Australia (n=2) and Canada (n=1). At the start of the trial, participants reported varied impact of fatigue in their daily life (Table 1). Although it was unknown which treatment the participants had received, most participants reported experiencing an improvement in fatigue (74%, n=23/31) during the trial; 7 reported experiencing no change in fatigue (23%, n=7/31), of these, 4 reported experiencing no/little fatigue at the start of the trial, which did not change until their last visit. One participant reported worsening of fatigue (3%, n=1/31) during the trial which impacted their daily activities (needed more day-time sleep). Among those who experienced an improvement in fatigue, 11 reported an improved emotional well-being such as feeling more relaxed, confident, independent, and motivated (Table 1). Overall, 10 of 13 participants reported a meaningful improvement in fatigue. Conclusion: Exit interview results showed that irrespective of the treatment received, most interviewed participants with moderately to severely active CD experienced an improvement in fatigue by end of the trial, resulting in better energy levels, physical function, daily functioning, and emotional well-being. Table 1. - The exit interview findings Participant-reported impact of fatigue at the start of trial Difficulty in performing daily activities (n) 7 Unable to feel well-rested from sleep (n) 3 Feeling worried (n) 3 Felt exhausted (n) 1 Difficulty in walking or climbing stairs (n) 3 Lacked energy (n) 2 Demotivated (n) 2 Frustrated (n) 1 Difficulty in completing outdoor tasks and activities (n) 2 Dozed off in evening (n) 1 Grumpy (n) 1 Socializing less (n) 1 Difficulty in concentrating or focusing (n) 2 Took breaks during the day (n) 1 Depressed (n) 1 During the trial 23 of 31 participants that reported improvement in fatigue, it resulted in: Better friendships or relationships (n) 4 Being more successful in work or school (n) 3 Sleeping better (n) 2 Napping less (n) 2 Being able to exercise more (n) 2 Go out for longer duration (n) 2 Being able to work (n) 1 Gaining more enjoyment in life (n) 1 Improved emotional well-being (feeling more relaxed, confident, independent, and motivated) (n) 11 Improvement in physical function and ability to walk further, had more energy and felt stronger (n) 9 Able to function more day-to-day (n) 8 n = number of participants.

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