P2627 - Change in Urgency Status Among Ulcerative Colitis Patients: Understanding a Potential Unmet Patient Need From CorEvitas’ Inflammatory Bowel Disease Registry

Tuesday, October 26, 2021

10:30 AM – 4:00 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Douglas C. Wolf, MD

Center for Crohn’s Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates
Atlanta, GA, United States

Douglas C. Wolf, MD¹, April N. Naegeli, DrPH, MPH², Page C. Moore, PhD³, Jud C. Janak, PhD, MPH³, Margaux M. Crabtree, MPH³, Mingyang Shan, PhD², Theresa M. Hunter, PhD, MPH, MS², Angelina Sontag, PhD, MBA², Raymond K. Cross, MD, MS⁴
¹Center for Crohn’s Disease & Ulcerative Colitis, Atlanta Gastroenterology Associates, Atlanta, GA; ²Eli Lilly and Company, Indianapolis, IN; ³CorEvitas, LLC, Waltham, MA; ⁴University of Maryland School of Medicine, Baltimore, MD

Introduction: Stooling urgency (also known as urgency to defecate) is one of the most common symptoms for Ulcerative Colitis (UC) patients (pts) and impacts quality of life. Identifying factors related to changes in urgency status are necessary to address UC pts unmet needs. Differences in patient characteristics and patient-reported outcomes (PROs) were explored at enrollment among UC pts stratified by a change in urgency status from enrollment to 6-month follow-up (6M).

Methods: Study participants (n=400) included UC pts in CorEvitas’ IBD Registry between 5/3/17-9/1/20 with non-missing urgency data at enrollment and 6M. Stooling urgency was defined using the Simple Clinical Colitis Activity Index’s none or hurry/immediate categories. Incontinence was not included due to a limited number of pts. Urgency status groups were formed by urgency at enrollment and 6M: no persistent urgency at both visits (NPU); change from urgency to no urgency (UN); change from no urgency to urgency (NU); and persistent urgency at both visits (PU). Descriptive statistics from the pts enrollment visit were reported for each urgency group. The difference in means/proportions and their 95% confidence intervals were reported to compare between groups (NPU=reference group).

Results: Groups included: 44% (n=175) NPU, 21% (n=86) UN, 14% (n=56) NU, and 21% (n=83) PU. At enrollment, differences in comorbidities were found between groups for depression, NPU (5%) vs UN (13%) and NPU (5%) vs PU (13%); anxiety, NPU (10%) vs PU (24%); prior infections, NPU (13%) vs PU (24%); and diabetes, NPU (5%) vs UN (14%). Using Partial Mayo Scores, the proportion of pts in remission was similar for NPU (71%) and NU (69%) pts, yet the prevalence of pts in remission at enrollment was lower for UN (42%) vs PU (23%) pts. NU and PU pts reported worse PROs, and a higher number experienced moderate to severe fatigue and pain interference vs NPU pts. A markedly lower percent of NPU pts suffered UC-related work impairment (37%), work hours affected (38%), and daily activities impacted (40%) vs UN (67%, 68%, 75%), NU (58%, 58%, 59%), and PU pts (91%, 92%, 93%), respectively.

Discussion: Among UC pts in a real-world setting, urgency status is associated with increased comorbidities (depression, anxiety, prior infections, and diabetes) and worse PROs (fatigue, pain interference, work impairment, work hours affected, and daily activities impacted), indicating that urgency status can diminish UC pts quality of life.

	No Persistent Urgency (NPU) N=175	Urgency to None (UN) N=86	None to Urgency (NU) N=56	Persistent Urgency (PU) N=83	Difference (95% CI)^a UN vs. NPU	Difference (95% CI)^a NU vs. NPU	Difference (95% CI)^a PU vs. NPU
Demographics and Lifestyle
Age in years, mean (SD)	49.5 (17.4)	46.8 (15.6)	45.7 (16.9)	46.0 (14.6)	-2.7 (-6.9, 1.5)	-3.8 (-9.0, 1.4)	-3.5 (-7.5, 0.6)
Gender, Female, n (%)	77 (44.0%)	50 (58.8%)	28 (50.0%)	50 (60.2%)	14.8 (2.0, 27.6)	6.0 (-9.0, 21.0)	16.2 (3.4, 29.1)
White, n (%)	149 (85.1%)	76 (88.4%)	50 (89.3%)	72 (86.7%)	3.2 (-5.4, 11.8)	4.1 (-5.5, 13.8)	1.6 (-7.4, 10.6)
History of Comorbidities and Infections
History of Depression, n (%)	8 (4.6%)	11 (12.8%)	7 (12.5%)	11 (13.3%)	8.2 (0.5, 15.9)	7.9 (-1.3, 17.1)	8.7 (0.8, 16.6)
History of Anxiety, n (%)	18 (10.3%)	11 (12.8%)	5 (8.9%)	20 (24.1%)	2.5 (-5.9, 10.9)	-1.4 (-10.1, 7.4)	13.8 (3.6, 24.1)
History of Infections,^b n (%)	23 (13.1%)	9 (10.5%)	6 (10.7%)	20 (24.1%)	-2.7 (-10.9, 5.5)	-2.4 (-12.0, 7.1)	11 (0.5, 21.4)
History of Diabetes, n (%)	9 (5.1%)	12 (14.0%)	5 (8.9%)	7 (8.4%)	8.8 (0.8, 16.8)	3.8 (-4.4, 11.9)	3.3 (-3.5, 10.1)
Disease Characteristics
Proctitis, n (%)	16 (9.1%)	16 (18.6%)	9 (16.1%)	16 (19.3%)	9.5 (0.2, 18.7)	6.9 (-3.6, 17.5)	10.1 (0.6, 19.6)
Left-side Disease, n (%)	81 (46.3%)	37 (43.0%)	26 (46.4%)	38 (45.8%)	-3.3 (-16.1, 9.5)	0.1 (-14.9, 15.1)	-0.5 (-13.5, 12.5)
Pan-colitis, n (%)	78 (44.6%)	34 (39.5%)	23 (41.1%)	33 (39.8%)	-5.0 (-17.7, 7.6)	-3.5 (-18.3, 11.3)	-4.8 (-17.7, 8.0)
Disease Severity
Mayo Score (Partial) (0-9)^c - categorical
Remission (0-1)	120 (71.0%)	36 (42.4%)	37 (68.5%)	18 (23.4%)	-28.7 (-41.2, -16.1)	-2.5 (-16.6, 11.7)	-47.6 (-59.3, -36)
Mild Disease (2-4)	46 (27.2%)	31 (36.5%)	13 (24.1%)	39 (50.6%)	9.2 (-3.0, 21.5)	-3.1 (-16.4, 10.1)	23.4 (10.4, 36.5)
Moderate/Severe Disease (5-9)	3 (1.8%)	18 (21.2%)	4 (7.4%)	20 (26.0%)	19.4 (10.5, 28.3)	5.6 (-1.6, 12.9)	24.2 (14.2, 34.2)
Patient Reported Outcomes Measurement Information System (PROMIS)^d
Fatigue,^e mean (SD)	46.1 (10.1)	52.9 (9.9)	51.3 (9.8)	55.4 (9.4)	6.9 (4.2, 9.5)	5.2 (2.2, 8.2)	9.3 (6.8, 11.9)
Pain interference,^f mean (SD)	46.1 (7.4)	52.3 (9.6)	49.1 (8.3)	55.1 (9.4)	6.2 (3.8, 8.5)	3.0 (0.5, 5.5)	9.0 (6.7, 11.3)
Work Productivity and Activity Impairment (WPAI) Domains
Current employment, n (%)	122 (69.7%)	58 (68.2%)	33 (58.9%)	55 (66.3%)	-1.5 (-13.5, 10.5)	-10.8 (-25.4, 3.8)	-3.4 (-15.7, 8.8)
Impairment while working due to UC,^g n (%)	45 (36.9%)	39 (67.2%)	19 (57.6%)	49 (90.7%)	30.3 (15.5, 45.2)	20.7 (1.8, 39.6)	53.8 (42.3, 65.4)
Work hours affected by UC,^h n (%)	41 (37.6%)	39 (68.4%)	19 (57.6%)	47 (92.2%)	30.8 (15.7, 45.9)	20.0 (0.8, 39.1)	54.5 (42.8, 66.3)
Daily activities affected by UC,ⁱ n (%)	70 (40.2%)	64 (75.3%)	33 (58.9%)	77 (92.8%)	35.1 (23.3, 46.8)	18.7 (3.9, 33.5)	52.5 (43.4, 61.7)

Table: Title:
Table 1. Patient sociodemographics, comorbidities, disease characteristics, disease severity, and patient-reported outcomes (at enrollment) by change in physician-reported patient’s stooling urgency* from time of enrollment to 6-month follow-up, among patients with ulcerative colitis

- Footnotes:
*Stooling urgency is also known as urgency to defecate; a95% Confidence Interval (CI); bInfections include: Bronchitis, C. difficile colitis, Candida, Diverticulitis, Gastroenteritis, Herpes zoster, Joint/Bursa, Meningitis/encephalitis, Pneumonia, Sepsis, Sinusitis, Upper respiratory infection (URI), Urinary tract infection (UTI), TB, and Other infections; cMayo Score Partial (0-9), categorical: NPU=169, UNf85, NU=54, PU=77; dPROMIS scores: Within Normal Limits ( < 55), Mild (55-60), Moderate/Severe (≥ 60); eFatigue: NPU=172, UNf84, NU=56, PU=82; fPain interference: NPU=175, UNf85, NU=56, PU=82; gImpairment while working: NPU=122, UNf58, NU=33, PU=54;hWork hours affected: NPU=109, UNf57, NU=33, PU=51;iDaily activities affected: NPU=174, UNf85, NU=56, PU=83

Disclosures:
Douglas Wolf: AbbVie – Consultant. CorEvitas – Consultant. Eli Lilly and Company – Consultant. Janssen – Consultant. Pfizer – Consultant. Prometheus – Consultant. Takeda – Consultant. UCB – Consultant.
April Naegeli: Eli Lilly and Company – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Page Moore: CorEvitas – Employee.
Jud Janak indicated no relevant financial relationships.
Margaux Crabtree: CorEvitas, LLC – Employee.
Mingyang Shan: Eli Lilly and Company – Employee.
Theresa Hunter: Eli Lilly and Company – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Angelina Sontag: Eli Lilly and Company – Employee, Patent Holder, Stockholder/Ownership Interest (excluding diversified mutual funds).
Raymond Cross: Abbvie – Advisory Committee/Board Member. Bristol Myers Squibb – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member.

Douglas C. Wolf, MD¹, April N. Naegeli, DrPH, MPH², Page C. Moore, PhD³, Jud C. Janak, PhD, MPH³, Margaux M. Crabtree, MPH³, Mingyang Shan, PhD², Theresa M. Hunter, PhD, MPH, MS², Angelina Sontag, PhD, MBA², Raymond K. Cross, MD, MS⁴. P2627 - Change in Urgency Status Among Ulcerative Colitis Patients: Understanding a Potential Unmet Patient Need From CorEvitas’ Inflammatory Bowel Disease Registry, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.