P0791 - Healthcare Resource Utilization And Treatment Usage Among Flaring And Non-Flaring Patients with Ulcerative Colitis – A Real-World Global Study

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

TH

Theresa Hunter Gibble, PhD, MPH

Eli Lilly and Company
Indianapolis, IN

Axel Dignass, MD, PhD¹, Isabel Redondo, ², Petra Streit, ³, Susanne Hartz, ⁴, Hannah Knight, MSc⁵, Sophie Barlow, MSc⁵, Niamh Harvey, BSc⁵, Theresa Hunter Gibble, PhD, MPH²
¹Agaplesion Markus Hospital, Goethe University, Frankfurt, Hessen, Germany; ²Eli Lilly and Company, Indianapolis, IN; ³Eli Lilly and Company, Vernier, Geneve, Switzerland; ⁴Eli Lilly and Company, Bracknell, England, United Kingdom; ⁵Adelphi Real World, Bollington, England, United Kingdom

Introduction: Despite increasing treatment opportunities for ulcerative colitis (UC), patients often suffer acute periods of increased disease severity. Since little is known regarding how healthcare resource utilization (HCRU) and drug dosing differ between flaring and non-flaring patients in a real-world clinical setting, we aimed to assess these differences.

Methods: Data were extracted from the Adelphi UC Disease Specific Programme, a point-in-time survey of gastroenterologists and patients conducted in France, Germany, Italy, Spain, UK, and US from January 2020-March 2021. Gastroenterologists provided clinical characteristics, treatment history and HCRU for their next 5-7 consulting UC patients with a history of moderate-severe disease. Patients were categorized based on whether they experienced a flare (last 12 months). Two subgroups were analysed separately, to explore drug dosing patterns for flaring and non-flaring patients, receiving targeted therapies (≥12 months) (TT; biologics, Janus kinase inhibitors) or currently receiving corticosteroids.

Results: This study included 2,019 patients of which 968 (47.9%) were reported by their gastroenterologist to have flared (last 12 months). While age and sex were similar across subgroups, flaring patients had a shorter disease duration (p=0.05) and greater disease extension (p< 0.01) vs non-flaring patients (Table 1). Differences were seen across all HCRU measures with a greater number of consultations (7.2 vs 5.3), hospitalizations (0.4 vs 0.1), biopsies, endoscopies, stool and blood tests in the last 12 months for flaring patients vs non-flaring patients (all p< 0.01). A higher proportion of flaring patients had received corticosteroids in the last 12 months vs non-flaring patients (39.4% vs 13.9%, p< 0.01), and among those currently receiving corticosteroids, 9.9% of flaring patients had their corticosteroid dose escalated vs 5.6% of non-flaring patients (p=0.28). Of those patients receiving their current TT for ≥12 months, 25.7% of flaring patients had their TT dose escalated vs 11.7% of non-flaring patients (p< 0.01).

Discussion: Almost half of patients with UC in our cohort had experienced a flare within the last 12 months. These patients had greater HCRU, increased corticosteroid use, and those on TT were more likely to receive escalated drug doses, highlighting the need for additional treatment options to target disease control, entailing the potential for a reduced burden of flares on UC patients and healthcare systems.

	Not flared in the last 12 months (n=1,051)	Flared in the last 12 months (n=968)	p-value
Age, mean (SD)	40.4 (14.4)	40.1 (14.3)	0.63
Sex, Male, n (%)	576 (54.8)	511 (52.8)	0.37
Ethnicity, White/ Caucasian, n (%)	939 (89.3)	826 (85.3)	< 0.01*
Disease duration¹, years Mean (SD)	n=956 5.3 (6.2)	n=924 4.7 (5.6)	0.05*
Disease extension¹ Ulcerative proctitis, n (%) Proctosigmoiditis, n (%) Left-sided colitis, n (%) Pan-ulcerative (total) colitis, n (%)	n=903 160 (17.7) 224 (24.8) 241 (26.7) 278 (30.8)	n=911 135 (14.8) 165 (18.1) 308 (33.8) 303 (33.3)	< 0.01*
Total number of consultations in the last 12 months¹ Mean (SD)	n=740 5.3 (4.6)	n=767 7.2 (6.2)	< 0.01*
Number of hospitalizations in the last 12 months¹ Mean (SD)	n=947 0.1 (0.9)	n=892 0.4 (0.8)	< 0.01*
Number of tests in the last 12 months² Biopsy, mean (SD) Colonoscopy, mean (SD) Sigmoidoscopy, mean (SD) Ultrasound, mean (SD) Fecal calprotectin, mean (SD) Fecal lactoferrin, mean (SD) Hemoglobin, mean (SD) Hematocrit, mean (SD) C-reactive protein, mean (SD) Erythrocyte Sedimentation Rate, mean (SD) Liver function, mean (SD)	0.4 (0.6) 0.7 (0.7) 0.2 (0.4) 0.3 (0.8) 1.0 (1.2) 0.1 (0.4) 1.9 (1.7) 1.5 (1.7) 1.9 (1.8) 0.8 (1.3) 1.2 (1.6)	0.5 (0.7) 0.9 (0.7) 0.3 (0.6) 0.6 (1.1) 1.4 (1.4) 0.2 (0.6) 2.4 (1.9) 2.0 (1.9) 2.4 (1.9) 1.1 (1.5) 1.5 (1.8)	< 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01* < 0.01*
Has the patient received corticosteroids in the last 12 months? Yes, n (%)	146 (13.9)	381 (39.4)	< 0.01*
During the course of the current regimen, has the corticosteroid dose changed?¹ Escalated, n (%) Not escalated, n (%)	n=90 5 (5.6) 85 (94.4)	n=274 27 (9.9) 247 (90.2)	0.28
During the maintenance phase, has the dose of targeted therapy changed?³ Escalated, n (%) Not escalated, n (%)	n=436 51 (11.7) 385 (88.3)	n=171 44 (25.7) 127 (74.3)	< 0.01*
SD – standard deviation; ¹Includes patients with known data; ²Includes patients with known data: ²Sample sizes range 1027-1044 for patients who have not flared in the last 12 months, and 912-956 for patients who flared in the last 12 months; ³Patients who have received their current targeted therapy for at least 12 months; ^*significant difference α=0.05

Table: Table 1. Gastroenterologist-reported patient demographics, clinical characteristics, healthcare resource utilization, and treatment usage

Disclosures:

Axel Dignass: AbbVie – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Abivax – participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. Amgen – Consultant. Arena Pharmaceuticals – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. Biogen – Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant. Bristol Myers Squibb/Celgene – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. CED Service GmbH – Speakers Bureau. Celltrion – Consultant, Speakers Bureau. Dr Falk Foundation – Consultant, participation in clinical trials, review activities and manuscript preparation, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Fresenius Kabi – Consultant. Galapagos – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Gilead – participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. High5MD – Speakers Bureau. Janssen – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Lilly – Consultant. Materia Prima – Speakers Bureau. MedToday – Speakers Bureau. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Pharmacosmos – Consultant. Roche/Genentech – Consultant. Sandoz/Hexal – Consultant. Streamed-Up – Speakers Bureau. Takeda – Consultant, manuscript preparation, Speakers Bureau. Thieme – manuscript preparation. Tillotts – Consultant, Speakers Bureau. UniMed Verlag – manuscript preparation. Vifor Pharma – Consultant, Speakers Bureau.

Isabel Redondo: Eli Lilly and Company – Employee.

Petra Streit: Eli Lilly and Company – Employee.

Susanne Hartz: Eli Lilly and Company – Employee.

Hannah Knight indicated no relevant financial relationships.

Sophie Barlow indicated no relevant financial relationships.

Niamh Harvey indicated no relevant financial relationships.

Theresa Hunter Gibble: Eli Lilly and Company – Employee, stockholder.

Axel Dignass, MD, PhD¹, Isabel Redondo, ², Petra Streit, ³, Susanne Hartz, ⁴, Hannah Knight, MSc⁵, Sophie Barlow, MSc⁵, Niamh Harvey, BSc⁵, Theresa Hunter Gibble, PhD, MPH². P0791 - Healthcare Resource Utilization And Treatment Usage Among Flaring And Non-Flaring Patients with Ulcerative Colitis – A Real-World Global Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.