C0413 - Burden of Bowel Urgency Across Specific Treatment Groups Among Crohn’s Disease Patients: Real World Global Study Analyses

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

TH

Theresa Hunter Gibble, PhD

Eli Lilly and Company
Martinsville, IN

Raja Atreya, MD¹, Marijana Protic, MD, PhD², Petra Streit, PharmD², Susanne Hartz, ², Hannah Knight, MSc³, Sophie Barlow, MSc³, Fritha Hennessy, PhD⁴, Theresa Hunter Gibble, PhD²
¹University Hospital Erlangen-Nürnberg, Erlangen, Hamburg, Germany; ²Eli Lilly and Company, Indianapolis, IN; ³Adelphi Real World, Macclesfield, England, United Kingdom; ⁴Adelphi Real World, Cheshire, England, United Kingdom

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 inactive^1-2. 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 1). 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 1).

Discussion: 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.

¹Petryszyn PW, et al. Adv Clin Exp Med. 2018;27:813-818.

²Farrell D, et al. J Crohns Colitis. 2016;10:315-322.

³Anderson P. et al, Current Medical Research and Opinion 2008;24:3063-72

	TT-naïve N=110	1L TT N=126	TT-exp N=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=103 9 (8.7)	N=115 17 (14.8)	N=58 17 (29.3)	0.0024*
Current treatment: Steroids, n (%)	N=110 50 (45.4)	N=126 19 (15.1)	N=60 7 (11.7)	< 0.0001*
SIBDQ¹: Total score, mean (SD)	N=53 49.0 (8.5)	N=37 47.9 (14.7)	N=30 45.4 (11.9)	0.3873
EQ-5D: VAS², mean (SD)	N=55 76.3 (13.6)	N=39 71.6 (21.0)	N=30 71.8 (13.6)	0.2893
WPAI: Activity impairment, mean % (SD)	N=53 27.2 (16.2)	N=38 31.1 (27.0)	N=27 29.3 (20.0)	0.6839
WPAI: Absenteeism³, mean % (SD)	N=29 1.1 (4.1)	N=19 11.7 (31.4)	N=17 3.9 (6.7)	0.1247
WPAI: Presenteeism³, mean % (SD)	N=38 24.5 (15.0)	N=21 19.0 (14.1)	N=18 25.0 (14.7)	0.3332
WPAI: Overall work impairment³, mean % (SD)	N=29 26.4 (17.5)	N=17 22.0 (15.6)	N=17 27.9 (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 Impairment¹Scores 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

Table: Table 1: Patients with CD on treatment for >3 months with presence of bowel urgency by treatment groups – physician reported data

Disclosures:

Raja Atreya: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Amgen – Consultant, Speakers Bureau. Arena Pharmaceuticals – Consultant, Speakers Bureau. Biogen – Consultant, Grant/Research Support, Speakers Bureau. Boehringer-Ingelheim – Consultant, Speakers Bureau. Bristol-Myers Squibb(BMS) – Consultant, Speakers Bureau. Celgene – Consultant, Speakers Bureau. Celltrion – Consultant, Speakers Bureau. Dr FALK Pharma – Consultant, Speakers Bureau. Eli Lilly – Consultant, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Fresenius Kabi – Consultant, Speakers Bureau. Galapagos – Consultant, Speakers Bureau. Gilead – Consultant, Speakers Bureau. GlaxoSmithKlein(GSK) – Consultant, Speakers Bureau. InDex Pharmaceuticals – Grant/Research Support. Janssen-Cilag – Consultant, Speakers Bureau. Kliniksa Pharmaceuticals – Consultant, Speakers Bureau. Merck/MSD – Consultant, Speakers Bureau. Novartis – Consultant, Speakers Bureau. Pandion Therapeutics – Consultant, Speakers Bureau. Pfizer – Consultant, Speakers Bureau. Roche – Consultant, Speakers Bureau. Samsung Bioepis – Consultant, Speakers Bureau. Stelic Institute – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Tillots Pharma – Consultant, Grant/Research Support, Speakers Bureau. Viatrris – Consultant, Speakers Bureau.

Marijana Protic: Eli Lilly and Company – Employee, Stock-publicly held company(excluding mutual/index funds).

Petra Streit: Eli Lilly and Company – Employee, Stock-publicly held company(excluding mutual/index funds).

Susanne Hartz: Eli Lilly and Company – Employee, Stock-publicly held company(excluding mutual/index funds).

Hannah Knight indicated no relevant financial relationships.

Sophie Barlow indicated no relevant financial relationships.

Fritha Hennessy: Adelphi Real World – Employee.

Theresa Hunter Gibble: Eli Lilly and Company – Employee.

Raja Atreya, MD¹, Marijana Protic, MD, PhD², Petra Streit, PharmD², Susanne Hartz, ², Hannah Knight, MSc³, Sophie Barlow, MSc³, Fritha Hennessy, PhD⁴, Theresa Hunter Gibble, PhD². C0413 - Burden of Bowel Urgency Across Specific Treatment Groups Among Crohn’s Disease Patients: Real World Global Study Analyses, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.