P1634 - Change in Urgency Among Ulcerative Colitis Patients: Analyses From the SPARC IBD

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

JL

James D. Lewis, MD, MSCE

University of Pennsylvania
Philadelphia, PA, United States

James D. Lewis, MD, MSCE¹, Mingyang Shan, PhD², Xian Zhou, ², April N. Naegeli, DrPH, MPH², Theresa M. Hunter, PhD, MPH, MS²
¹University of Pennsylvania, Philadelphia, PA; ²Eli Lilly and Company, Indianapolis, IN

Introduction: This study was assessed the changes in prevalence and severity of fecal urgency in Ulcerative Colitis (UC) patients at 6-months from their enrollment visit.

Methods: Data from patients in the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) were analyzed. UC patients that had an enrollment visit and 6-month visit were included in these analyses. Fecal urgency at each visit was assessed on a scale: ranging from 0 (none) to 4 (severe). The change in urgency status from enrollment visit to 6-months is categorized as Improvement (decrease of 1-3 points), No Change, or Worsening (increase of 1-3 points). Descriptive statistics and contingency tables were created to summarize baseline characteristics by fecal urgency group.

Results: Data from 272 UC patients were included in this analysis. 25% patients had an improvement in urgency, 54.4% had no change, 20.6% had a worsening of urgency at 6-months from their enrollment visit.

When compared to patients that had no change in urgency at 6-months, UC patients that had improvement in urgency were more likely to have a higher baseline UCDAI (p< 0.0001), mean daily bowel movements (p< 0.0001), mean daily liquid bowel movements (p< 0.0001), elevated stool frequency relative to their normal when well (p< 0.0001), liquid stool consistency (p=0.0418), blood in stools (p=0.0001), abdominal pain (p=0.0065), moderate/severe fecal urgency (p< 0.0001), worse general well-being (p< 0.0001), moderate/severe Physician Global Assessment (PGA) (p=0.0013), and steroid use (p=0.0287) (Table 1). When compared to patients with worsening urgency at 6-months, UC patients that had an improvement in urgency at 6-months were more likely to have a higher baseline UCDAI (p< 0.0001), mean daily bowel movements (p< 0.0001), mean daily liquid bowel movement (p< 0.0001), more stool frequency relative to their normal when well (p< 0.0001), moderate/severe fecal urgency (p< 0.0001), worse general well-being (p=0.0053), and moderate/severe PGA (p=0.0022). There were no statistically significant differences in baseline characteristics between UC patients that had a worsening or no change in urgency at 6-months.

Discussion: Fecal urgency is a common symptom among UC patients. Urgency is not a stable symptom, with nearly 50% experiencing either worsening or improvement over 6-months. Worse disease activity at enrollment in the cohort was associated with improved fecal urgency symptoms over 6-months.

	Improvement N=68	No Change N=148	Worsening N=56	Overall N=272	p-value (Improvement vs. No Change)	p-value (Improvement vs. Worsening)	p-value (Worsening vs. No Change)
Age at enrollment, mean (SD)	44.8 (14.71)	41.0 (14.13)	45.2 (14.03)	42.8 (14.34)	0.2074	1.0000	0.1970
Gender, n (%)					1.0000	0.1971	0.5988
Female	30 (44.1%)	75 (50.7%)	34 (60.7%)	139 (51.1%)
Male	38 (55.9%)	73 (49.3%)	22 (39.3%)	133 (48.9%)
Disease duration at enrollment, mean (SD)	14.3 (13.02)	11.1 (8.80)	12.4 (10.72)	12.1 (10.32)	0.1868	1.0000	1.0000
UCDAI 6-point score, mean (SD)	2.2 (1.87)	0.8 (1.46)	0.8 (1.27)	1.2 (1.64)	< 0.0001	< 0.0001	1.0000
UCDAI 9-point score, mean (SD)	3.5 (2.60)	1.3 (2.11)	0.9 (1.46)	1.7 (2.35)	< 0.0001	< 0.0001	1.0000
Fatigue, n (%)	17 (50.0%)	23 (29.9%)	12 (42.9%)	52 (37.4%)	0.1252	1.0000	0.6357
Average number of daily bowel movements, mean (SD)	5.8 (4.41)	3.3 (2.75)	3.1 (3.06)	3.9 (3.48)	< 0.0001	< 0.0001	1.0000
Daily stool frequency, n(%)					< 0.0001	< 0.0001	1.0000
Normal	20 (30.3%)	103 (69.6%)	43 (76.8%)	166 (61.5%)
1-2 stools per day more than normal	17 (25.8%)	25 (16.9%)	6 (10.7%)	48 (17.8%)
3-4 stools per day more than normal	9 (13.6%)	7 (4.7%)	4 (7.1%)	20 (7.4%)
5 or more stools per day more than normal	20 (30.3%)	13 (8.8%)	3 (5.4%)	36 (13.3%)
Stool description, n (%)					0.0418	0. 0652	1.0000
Formed	15 (31.3%)	50 (51.5%)	22 (57.9%)	87 (47.5%)
Soft or semi-formed	20 (41.7%)	37 (38.1%)	13 (34.2%)	70 (38.3%)
Mostly or all liquid	13 (27.1%)	10 (10.3%)	3 (7.9%)	26 (14.2%)
Blood in stool, n (%)					0.0001	0.0821	1.0000
No blood seen	37 (54.4%)	121 (82.3%)	43 (76.8%)	201 (74.2%)
Blood less than 50% of the time	15 (22.1%)	17 (11.6%)	8 (14.3%)	40 (14.8%)
Blood passed 50% or more or blood passed alone	16 (23.5%)	9 (6.1%)	5 (8.9%)	30 (11.1%)
Abdominal pain, n (%)					0.0065	0.9474	0.8528
None	29 (42.6%)	100 (67.6%)	31 (56.4%)	160 (59.0%)
Mild	25 (36.8%)	33 (22.3%)	15 (27.3%)	73 (26.9%)
Moderate or Severe	14 (20.6%)	15 (10.1%)	9 (16.4%)	38 (14.0%)
Fecal urgency, n (%)					< 0.0001	< 0.0001	0.5405
None	0 (0.0%)	85 (57.4%)	39 (69.6%)	124 (45.6%)
Mild	19 (27.9%)	39 (26.4%)	13 (23.2%)	71 (26.1%)
Moderate to severe	49 (72.1%)	24 (16.2%)	4 (7.1%)	77 (28.3%)
General well-being, n (%)					< 0.0001	0.0065	1.0000
Generally well	29 (42.6%)	108 (73.0%)	38 (67.9%)	175 (64.3%)
Slightly under par	21 (30.9%)	29 (19.6%)	15 (26.8%)	65 (23.9%)
Poor to terrible	18 (26.5%)	11 (7.4%)	3 (5.4%)	32 (11.8%)
Physician Global Assessment, n (%)					0.0013	0.0027	1.0000
Quiescent	14 (35.9%)	73 (70.9%)	25 (73.5%)	112 (63.6%)
Mild	10 (25.6%)	16 (15.5%)	7 (20.6%)	33 (18.8%)
Moderate or severe	15 (38.5%)	14 (13.6%)	2 (5.9%)	31 (17.6%)
Bowel Incontinence, n (%)	11 (23.4%)	9 (9.2%)	1 (2.6%)	21 (11.5%)	0.1104	0.0293	0.8472
Night-time bowel movement, n (%)	17 (36.2%)	18 (18.4%)	7 (18.4%)	42 (23.0%)	0.0571	0. 2121	1.0000
Leakage of Stool during sleep, n (%)	3 (6.4%)	2 (2.0%)	0 (0.0%)	5 (2.7%)	0.9875	0.7487	1.0000
Number of days of work/school missed, mean (SD)	12.0 (62.59)	1.2 (3.87)	1.1 (4.09)	3.9 (31.72)	0.3119	0.5170	1.0000
Medication, n(%)
Biologics	31 (54.4%)	57 (46.7%)	23 (51.1%)	111 (49.6%)	1.0000	1.0000	1.0000
TNFi	18 (31.6%)	40 (32.8%)	15 (33.3%)	73 (32.6%)	1.0000	1.0000	1.0000
Non-TNFi	13 (22.8%)	17 (13.9%)	8 (17.8%)	38 (17.0%)	0.4161	1.0000	1.0000
5-ASAs	35 (61.4%)	64 (52.5%)	24 (53.3%)	123 (54.9%)	0.7864	1.0000	1.0000
Antibiotics	2 (3.5%)	2 (1.6%)	0 (0.0%)	4 (1.8%)	1.0000	1.0000	1.0000
Immunomodulators	13 (22.8%)	34 (27.9%)	12 (26.7%)	59 (26.3%)	1.0000	1.0000	1.0000
Steroids	14 (24.6%)	11 (9.0%)	3 (6.7%)	28 (12.5%)	0.0287	0. 0526	1.0000
SD=standard deviation; TNFi=tumor necrosis factor inhibitor; UCDAI= Ulcerative Colitis Disease Activity Index

Table: Table 1. Demographics and clinical characteristics at enrollment of ulcerative colitis patients by change in urgency at 6-months

Disclosures:
James Lewis: AbbVie – Other Financial or Material Support, Personal Fees. Arena Parmaceuticals – Other Financial or Material Support, Personal Fees. Bridge Biotherapeutics – Other Financial or Material Support, Personal Fees. Bristol-Myers Squibb – Other Financial or Material Support, Personal Fees. Celgene – Other Financial or Material Support, Personal Fees. Eli Lilly and Company – Consultant, Other Financial or Material Support, Personal Fees. Gilead – Other Financial or Material Support, Personal Fees. Janssen Pharmaceuticals – Grant/Research Support, Other Financial or Material Support, Personal Fees. Johnson & Johnson Consumer Inc – Other Financial or Material Support, Personal Fees. Merck – Other Financial or Material Support, Personal Fees. Nestle Health Science – Grant/Research Support, Other Financial or Material Support, Personal Fees. Pfizer – Other Financial or Material Support, Personal Fees. Protagonist Therapeutics – Other Financial or Material Support, Personal Fees. Samsung Bioepis – Other Financial or Material Support, Personal Fees. Takeda Pharmaceuticals – Grant/Research Support, Other Financial or Material Support, Personal Fees. UCB – Other Financial or Material Support, Personal Fees.
Mingyang Shan: Eli Lilly and Company – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Xian Zhou indicated no relevant financial relationships.
April Naegeli: Eli Lilly and Company – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Theresa Hunter: Eli Lilly and Company – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).

James D. Lewis, MD, MSCE¹, Mingyang Shan, PhD², Xian Zhou, ², April N. Naegeli, DrPH, MPH², Theresa M. Hunter, PhD, MPH, MS². P1634 - Change in Urgency Among Ulcerative Colitis Patients: Analyses From the SPARC IBD, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.