Exploring the disease burden and quality of life in patients with short bowel syndrome with intestinal failure: Insights from exit interviews in the glepaglutide EASE SBS‐1 phase 3 trial

BACKGROUND: A randomized, double-blind, placebo-controlled trial was conducted to evaluate efficacy and safety of glepaglutide in patients who have short bowel syndrome with intestinal failure (SBS-IF). At the end of the trial, exit interviews were conducted to explore participants' experiences and to assess the impact of the disease and treatment during the trial. METHODS: Thirty patients from four countries were interviewed over the phone. Data were collected using a semistructured interview manual, and interviews were recorded and transcribed for analysis. RESULTS: Patients reported that SBS-IF negatively impacted their lives before the trial, causing loss of freedom, disrupted sleep, limited physical activity, and pain. During the interviews, patients reported that the treatment improved their well-being across multiple domains. Seventy-three percent of the patients receiving glepaglutide (n = 16/22) reported positive changes in health-related quality of life compared with 25% receiving placebo (n = 2/8). Twenty-six patients reported experiencing a reduction in parenteral support (PS) volume. Of these, 21 patients (18 glepaglutide, three placebo) reported a change in overall status, with 94% receiving glepaglutide (n = 17/18) and 67% (n = 2/3) receiving the placebo finding this change meaningful. Although descriptive, these findings should be interpreted cautiously given the small number of patients. CONCLUSION: During exit interviews, patients receiving glepaglutide reported improvements in well-being across multiple domains, noting meaningful reductions in PS volume and a reduced impact of SBS-IF on daily life, which was proportionally greater than in those receiving placebo. These findings underscore the patient-reported positive experiences of glepaglutide and its beneficial effects.