P0657Real-world patient-reported outcomes by Crohn’s disease location: A retrospective analysis of SPARC IBD registry data

Background Ileal Crohn’s disease (CD) is associated with refractory inflammation and an increased risk of surgery. Few real-world studies have reported on the patient-reported outcomes (PROs) of those with ileal disease. The objective of this study was to describe real-world PROs by disease location (ileal, ileocolonic and colonic) and explore any differences. Methods A retrospective analysis of data collected from CD patients enrolled in the Crohn’s and Colitis Foundation SPARC IBD registry between September 1, 2019 and January 30, 2023 was conducted. PROs were collected at enrolment and included: CD PRO3 items (loose stool frequency, abdominal pain, general wellbeing), as well as overall bowel movement frequency, rectal bleeding, urgency, and PROMIS scales (pain interference, fatigue and social interference). PRO2 and PRO3 scores were also calculated. Descriptive analyses were conducted for each measure at enrolment for the total sample and by disease location. Results The total sample was 1,260 adult patients with CD according to Montreal classification (291 ileal, 773 ileocolonic and 196 colonic). Completion rates at enrolment were high for bowel-related symptom assessments (>80%) and somewhat lower for PROMIS assessments (>68%) due to the measures not being available for all patients during the study period. Demographic characteristics were similar across disease location groups. History of IBD-related surgery was greater in ileal (51.6%) and ileocolonic (62.5%) vs colonic (29.1%) patients. Ileal and ileocolonic patients more frequently reported having “often active” or “constantly active” disease over the past 6 months in addition to more symptoms at enrolment, compared to colonic patients: ileal and ileocolonic patients reported on average 2.6 and 2.7 daily loose stools, respectively, compared with 1.9 in the colonic group. PRO2 and PRO3 scores at enrolment were higher (worse) for ileal and ileocolonic vs colonic patients (PRO2: 10.1, 10.1, 7.6, respectively; PRO3: 15.3, 14.8, 11.6, respectively). PROMIS Pain Interference and Fatigue scores were worse in ileal and ileocolonic patients vs colonic patients, while PROMIS social interference scores were comparable across disease location groups and similar to general population norms. Conclusion In the real world, patients with ileal involvement exhibit greater symptom burden than those with isolated colonic disease, characterized by increased abdominal pain and a higher frequency of loose stools, which may contribute to greater impairment in daily activity. Conflict of interest: Ms. Flood, Emuella: I am an AstraZeneca employee and may own stock or stock options. Turner, Ralph: None Cline, Jennifer: I am an employee of IQVIA Ivanescu, Cristina: CI is an employee of IQVIA. AstraZeneca provided funding to IQVIA for the conduct of this study. Eberhardson, Michael: ME is an employee of AstraZeneca and may own stock or stock options. Melhuish, Mia: MM is an employee of AstraZeneca and may own stock or stock options. Marks, Daniel: Employee of AstraZeneca