Abstract

Introduction: Bowel urgency (BU) is a sudden and immediate need to have a bowel movement, a common symptom in Crohn’s disease (CD) patients. The pathophysiology /mechanism of BU in CD is very complex. BU may persist despite treatment for CD and when disease is considered inactive1-2. This study explored differences in disease burden among CD patients with BU based on their treatment pathway. Methods: Data were extracted from the Adelphi Disease Specific Programme for CD3, a point-in-time survey of gastroenterologists (GIs) and patients from Jan 2020-Mar 2021 in Germany, France, Spain, Italy, UK and US. GIs provided patient demographics, clinical characteristics and treatment history. The same patients were invited to complete the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), EQ-5D and Work Productivity and Activity Impairment (WPAI) questionnaire. Three patient subgroups were identified: never received targeted therapy (biologics and JAK inhibitors) (TT-naïve), receiving first TT currently (1L TT) and receiving TT with prior TT use (TT-exp). Within these groups, patients currently experiencing BU, reported by physicians, with current treatment duration >3 months, were included. ANOVA, chi-square and/or Kruskal-Wallis tests were used to compare across groups. Results: Of the CD patients in the TT-naïve (n=643), 1L TT (n=994) and TT-exp (n=404) groups, 17%, 13% and 15% experienced BU, respectively (Table). 9% of the TT-naïve group were flaring vs. 15% 1L TT and 29% TT-exp patients (p=0.0024). Steroid use was higher in the TT-naïve group (45%) vs. 15% 1L TT and 12% TT-exp (p< 0.0001). The patient reported outcome measures indicated substantial and similar quality of life impairment across all patients with BU (Table). Conclusion: This study confirmed that a substantial proportion of patients with CD across all three groups still experience BU despite receiving treatment. Since BU is known to negatively impact patients’ quality of life, there is a therapeutic need to address this symptom. Table 1. - Patients with CD on treatment for >3 months with presence of bowel urgency by treatment groups – physician reported data TT-naïveN=110 1L TTN=126 TT-expN=60 p-value Age, mean (SD) 37.8 (13.1) 40.0 (13.0) 44.7 (14.1) 0.0059* Sex, male, n (%) 62 (56.4) 59 (46.8) 30 (50.0) 0.3381 BMI, mean (SD) 23.4 (2.9) 24.0 (3.9) 23.9 (3.5) 0.2910 Smoking status N=103 N=117 N=59 0.5772 Current smoker, n (%) 28 (27.2) 22 (18.8) 14 (23.7) Ex-smoker, n (%) 30 (29.1) 44 (37.6) 20 (33.9) Never smoked, n (%) 45 (43.7) 51 (43.6) 25 (42.4) Flare status: Currently flaring, n (%) N=1039 (8.7) N=11517 (14.8) N=5817 (29.3) 0.0024* Current treatment: Steroids, n (%) N=11050 (45.4) N=12619 (15.1) N=607 (11.7) < 0.0001* SIBDQ1: Total score, mean (SD) N=5349.0 (8.5) N=3747.9 (14.7) N=3045.4 (11.9) 0.3873 EQ-5D: VAS2, mean (SD) N=5576.3 (13.6) N=3971.6 (21.0) N=3071.8 (13.6) 0.2893 WPAI: Activity impairment, mean % (SD) N=5327.2 (16.2) N=3831.1 (27.0) N=2729.3 (20.0) 0.6839 WPAI: Absenteeism3, mean % (SD) N=291.1 (4.1) N=1911.7 (31.4) N=173.9 (6.7) 0.1247 WPAI: Presenteeism3, mean % (SD) N=3824.5 (15.0) N=2119.0 (14.1) N=1825.0 (14.7) 0.3332 WPAI: Overall work impairment3, mean % (SD) N=2926.4 (17.5) N=1722.0 (15.6) N=1727.9 (16.2) 0.5582 SD – standard deviation; BMI – body mass index; SIBDQ – Short Inflammatory Bowel Disease Questionnaire; VAS – Visual analogue scale; WPAI – Work Productivity and Activity Impairment.1Scores range from 10 – 70, with higher scores indicating better health related quality of life.2Scores range from 0 – 100, with higher scores indicating better health related quality of life.3Includes working patients only with known data.*statistical significance of α= 0.05.

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