P1636 - Change in Urgency Among Crohn’s Disease 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: The objective of this study was to assess the changes in prevalence and severity of fecal urgency in Crohn’s Disease (CD) patients at 6-months from their enrollment visit.

Methods: Data from the Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD) were analyzed. CD 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. Chi-square tests and ANOVA were conducted to compare the distribution of baseline characteristics between change in urgency groups, with Bonferroni corrections used for multiple comparisons.

Results: Data from 554 CD patients were included in this analysis. 22.9% of CD patients had an improvement in urgency, 51.8% had no change, and 25.3% had a worsening in urgency at 6-months from their enrollment visit.

When compared to patients that had no change in urgency at 6-months, CD patients that had an improvement in urgency were more likely to be female (p=0.0125), have more frequent liquids stools (p=0.0197), moderate/severe fecal urgency (p< 0.0001), worse general well-being (p=0.0015), moderate/severe Physician Global Assessment (PGA) (p=0.0190), and more night-time bowel movements (p=0.0297) at enrollment (Table 1). When compared to patients with worsening urgency at 6-months, CD patients that had an improvement in urgency at 6-months, were more likely to have liquid stool consistency (p=0.0273), moderate/severe fecal urgency (p< 0.0001), and more night-time bowel movements (p< 0.0001) at enrollment. CD patients that had a worsening in urgency were more likely to have no urgency at enrollment than patients that had no change in urgency at 6-months (p=0.0374).

Discussion: Fecal urgency is a common symptom among CD patients. Fecal 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=127	No Change N=287	Worsening N=140	Overall N=554	p-value (Improvement vs. No Change)	p-value (Improvement vs. Worsening)	p-value (Worsening vs. No Change)
Age at enrollment, mean (SD)	39.9 (13.14)	42.1 (14.14)	42.4 (15.32)	41.7 (14.24)	0.4104	0.4464	1.0000
Gender, female n (%)	86 (67.7%)	151 (52.6%)	93 (66.4%)	330 (59.6%)	0.0125	1.0000	0.0203
Disease duration at enrollment, mean (SD)	13.8 (10.91)	15.0 (10.47)	14.2 (10.32)	14.5 (10.53)	0.9376	1.0000	1.0000
sCDAI total score, mean (SD)	130.6 (89.35)	116.9 (87.88)	114.2 (69.80)	118.9 (83.74)	0.7610	0.6730	1.0000
Fatigue, n (%)	34 (44.7%)	56 (42.4%)	31 (40.8%)	121 (42.6%)	1.0000	1.0000	1.0000
Average number of daily bowel movements, mean (SD)	4.0 (3.36)	3.6 (2.53)	3.7 (3.09)	3.7 (2.88)	0.5017	0.9865	1.0000
Average number of daily liquid bowel movements, mean (SD)	2.3 (3.17)	2.0 (2.84)	1.6 (2.61)	2.0 (2.86)	1.0000	0.3169	0.8532
Daily stool frequency, n (%) Normal 1-2 stools per day more than normal 3-4 stools per day more than normal 5 or more stools per day more than normal	68 (54.0%) 28 (22.2%) 15 (11.9%) 15 (11.9%)	186 (65.3%) 49 (17.2%) 29 (10.2%) 21 (7.4%)	95 (68.3%) 30 (21.6%) 6 (4.3%) 8 (5.8%)	349 (63.5%) 107 (19.5%) 50 (9.1%) 44 (8.0%)	0.4572	0.0579	0.4454
Stool description, n (%) Formed Soft or semi-formed Mostly or all liquid	21 (23.1%) 47 (51.6%) 23 (25.3%)	72 (42.1%) 72 (42.1%) 27 (15.8%)	46 (43.0%) 45 (42.1%) 16 (15.0%)	139 (37.7%) 164 (44.4%) 66 (17.9%)	0.0197	0.0273	1.0000
Blood in stool, n (%) No blood seen Blood less than 50% of the time Blood passed 50% or more or blood passed alone	110 (86.6%) 10 (7.9%) 7 (5.5%)	231 (80.5%) 40 (13.9%) 16 (5.6%)	115 (82.1%) 18 (12.9%) 7 (5.0%)	456 (82.3%) 68 (12.3%) 30 (5.4%)	0.6426	1.0000	1.0000
Abdominal pain, n (%) None Mild Moderate or Severe	58 (45.7%) 41 (32.3%) 28 (22.0%)	156 (54.4%) 91 (31.7%) 40 (13.9%)	73 (52.5%) 43 (30.9%) 23 (16.5%)	287 (51.9%) 175 (31.6%) 91 (16.5%)	0.2695	1.0000	1.0000
Fecal urgency, n (%) None Mild Moderate to severe	0 (0.0%) 47 (37.0%) 80 (63.0%)	121 (42.2%) 101 (35.2%) 65 (22.6%)	79 (56.4%) 42 (30.0%) 19 (13.6%)	200 (36.1%) 190 (34.3%) 164 (29.6%)	< .0001	< .0001	0.0374
General well-being, n (%) Generally well Slightly under par Poor to terrible	60 (47.2%) 45 (35.4%) 22 (17.3%)	192 (66.9%) 70 (24.4%) 25 (8.7%)	86 (61.9%) 41 (29.5%) 12 (8.6%)	338 (61.1%) 156 (28.2%) 59 (10.7%)	0.0015	0.0807	1.0000
Physician Global Assessment, n (%) Quiescent Mild Moderate or severe	46 (51.1%) 24 (26.7%) 20 (22.2%)	122 (70.1%) 33 (19.0%) 19 (10.9%)	72 (66.7%) 23 (21.3%) 13 (12.0%)	240 (64.5%) 80 (21.5%) 52 (14.0%)	0.0190	0.1784	1.0000
Bowel Incontinence, n (%)	13 (14.4%)	22 (13.2%)	15 (13.9%)	50 (13.7%)	1.0000	1.0000	1.0000
Night-time bowel movement, n (%)	36 (40.0%)	41 (24.6%)	14 (13.0%)	91 (24.9%)	0.0297	< 0.0001	0.0569
Leakage of Stool during sleep, n (%)	5 (5.5%)	21 (12.5%)	8 (7.4%)	34 (9.3%)	0.2551	1.0000	0.6851
Number of days of work/school missed, mean (SD)	2.1 (8.74)	1.1 (4.92)	0.2 (0.66)	1.1 (5.54)	0.7993	0.1224	0.6880
Medication, n(%) Biologics TNFi Non-TNFi 5-ASAs Antibiotics Immunomodulators Steroids	76 (75.2%) 51 (50.5%) 25 (24.8%) 10 (9.9%) 6 (5.9%) 33 (32.7%) 7 (6.9%)	158 (73.5%) 101 (47.0%) 57 (26.5%) 24 (11.2%) 6 (2.8%) 73 (34.0%) 13 (6.0%)	88 (80.0%) 58 (52.7%) 30 (27.3%) 14 (12.7%) 1 (0.9%) 29 (26.4%) 11 (10.0%)	322 (75.6%) 210 (49.3%) 112 (26.3%) 48 (11.3%) 13 (3.1%) 135 (31.7%) 31 (7.3%)	1.0000 1.0000 1.0000 1.0000 0.6262 1.0000 1.0000	1.0000 1.0000 1.0000 1.0000 0.1692 1.0000 0.9697	0.5860 0.9793 1.0000 1.0000 1.0000 0.4889 0.5916
SD=standard deviation; sCDAI= Short Crohn’s Disease Activity Index; TNFi=tumor necrosis factor inhibitor

Table: Table 1. Demographics and Clinical Characteristics at enrollment of Crohn’s Disease 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. P1636 - Change in Urgency Among Crohn’s Disease Patients: Analyses From the SPARC IBD, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.