P4289 - 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

Theresa Gibble, PhD¹, Jake Macey, ², Harriet Makin, ², Rodica Rosu, ¹, Katie Mellor, ², Helen Kitchen, ², Emily Hon, ¹, Aisha Vadhariya, ¹, Sylvia Su, ¹, Miguel D Regueiro, MD^3
1Eli Lilly and Company, Indianapolis, IN; ²Clinical Outcomes Assessment, Clarivate, London, England, United Kingdom; ³Cleveland Clinic, Cleveland, OH

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). 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; seven reported experiencing no change in fatigue (23%, n=7/31), of these, four 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). Overall, 10 of 13 participants reported a meaningful improvement in fatigue.

Discussion: 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.


Disclosures:


Theresa Gibble, PhD¹, Jake Macey, ², Harriet Makin, ², Rodica Rosu, ¹, Katie Mellor, ², Helen Kitchen, ², Emily Hon, ¹, Aisha Vadhariya, ¹, Sylvia Su, ¹, Miguel D Regueiro, MD³. P4289 - 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, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.