A0254 - Disease Burden and Care-Seeking Behavior of Patients With Irritable Bowel Syndrome With Constipation (IBS-C) in the United States

Sunday, October 23, 2022

5:00 PM – 7:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

DT

Douglas CA Taylor, MBA

Ironwood Pharmaceuticals, Inc.
Boston, MA

Brian E. Lacy, MD, PhD, FACG¹, Douglas C. Taylor, MBA², Yanqing Xu, MS, PhD³, Katherine J. Kosch, RPh⁴, Rachel Dobrescu, BA⁵, Amy Morlock, MA⁵, Robert Morlock, PhD⁶, Ceciel Rooker, BS⁷
¹Mayo Clinic, Jacksonville, FL; ²Ironwood Pharmaceuticals, Inc., Cambridge, MA; ³AbbVie, Inc., North Chicago, IL; ⁴AbbVie Inc., North Chicago, IL; ⁵Acumen Health Research Institute, Ann Arbor, MI; ⁶YourCareChoice, Ann Arbor, MI; ⁷International Foundation for Functional Gastrointestinal Disorders, Milwaukee, WI

Introduction: Symptoms of IBS-C impose a significant negative burden to patients and the healthcare system. Our study examined disease burden and care-seeking behavior of patients with IBS-C.

Methods: A cross-sectional, on-line health survey collected data on US adults from 8/2020-12/2021. IBS-C patients were defined using Rome IV criteria and matched 1:1 by sex, age, race, region and Charlson Comorbidity Index score to the general population. Outcomes comparing IBS-C patients to controls included an anxiety/depression screener, health-related quality of life (HRQoL) and productivity. Means were compared with ANOVA; proportions with chi-square tests. Endpoints assessed descriptively for IBS-C patients were care, treatment, symptom burden and satisfaction with control, health care provider management, and treatment.

Results: Of 29,359 participants, 3.3% (956) met Rome IV criteria for IBS-C. Matching resulted in 910 patients and 910 controls. Most patients were female (76.9%), White (82.2%), with a mean age of 41.2 years. IBS-C patients had significantly higher proportions of moderate to severe anxiety and depression (p < .001) and significantly lower HRQoL vs controls (p < .001). Health impact on work productivity and daily activity was significantly worse among IBS-C patients vs controls (Table 1). Of IBS-C patients, 92.4% sought medical care for symptoms; 59.6% within the past year. 97.3% of IBS-C patients experienced ≥1 symptoms in the past 7 days. Abdominal discomfort was the symptom most experienced (71.0%); abdominal pain was the most bothersome (34.0%). Of the IBS-C patients that visited an ER or were hospitalized in the past 12-months due to bowel movement or abdominal symptoms, abdominal pain was the most common reason (90%). 74.2% reported currently taking an Rx and/or an OTC for their symptoms (12.6% Rx alone, 14.7% Rx and OTC, and 46.8% OTC alone). IBS-C patients were more dissatisfied than satisfied with control of bowel (47.4% vs 27.3%) and abdominal (45.9% vs 27.8%) symptoms. Those currently taking an Rx with or without an OTC were more satisfied with the control of bowel (42.6% vs 22.5%) and abdominal (46.6% vs 20.9%) symptoms than those taking only an OTC (Figure 1).

Discussion: New data from a large survey study demonstrates that there remains a considerable disease burden and unmet need for IBS-C patients, many of whom commonly experience pain and discomfort and are dissatisfied with their symptom control. This highlights the need to better address the multiple symptoms of IBS-C.

Figure: Figure 1. Satisfaction with Control, HCP Management and Treatment

	Rome IV IBS-C Cohort (N=910)	Control (N=910)	Sig.
Female	76.9%	76.9%	1.000

Age, mean (SD)	41.2 (14.9)	41.2 (14.9)	0.995

Black or African American	9.3%	9.3%	1.000
White	82.2%	82.2%
Other	8.5%	8.5%

Proportion of Hispanic, Latino or Spanish origin	8.6%	10.2%	0.296

Northeast	16.5%	16.5%	1.000
Midwest	24.7%	24.7%
South	39.7%	39.7%
West	19.1%	19.1%

Charlson Comorbidity Index (CCI) score, mean (SD)	0.5 (1.0)	0.5 (1.0)	1.000

Body Mass Index (BMI) (lbs/in²), mean (SD)	27.2 (7.3)	28.0 (7.3)	0.033

Proportion employed per Work Productivity and Impairment (WPAI) (1)	56.3%	61.2%	0.086

Proportion educated more than high school	75.5%	72.2%	0.110

Mean household income (Census derived from zip code), mean (SD)	64,553 (26,853)	64,629 (25,910)	0.951

Anxiety (GAD-7)[2]) score, mean (SD)	9.1 (6.1)	6.6 (6.0)	< 0.001

Depression (PHQ-9 [3]) score, mean (SD)	10.9 (7.3)	7.9 (7.4)	< 0.001

Chronic Pain	60.4%	39.6%	< 0.001
Migraine	60.2%	39.8%	< 0.001
Insomnia	67.1%	32.9%	< 0.001
GERD	74.6%	25.4%	< 0.001

VR-12 Mental Component Summary (MCS), mean (SD)	38.0 (12.5)	44.5 (12.2)	< 0.001
VR-12 Physical Component Summary (PCS), mean (SD)	41.2 (10.7)	45.6 (10.3)	< 0.001
VR-12 Health utility (VR-6D), mean (SD)	0.61 (0.11)	0.68 (0.12)	< 0.001

Health problems affected work productivity rating (0-10 scale), mean, SD (4)	2.8 (2.7)	1.8 (2.8)	< 0.001

Health problems affected daily activities rating (0-10 scale), mean, SD (1)	3.8 (3.1)	2.4 (3.1)	< 0.001

Table: Table 1. Rome IV IBS-C Cohort vs Control Comparisons

(1) Question fielded 12/20-12/21; cohort n=687 and control n=556.
(2) GAD-7: Generalized Anxiety Disorder, 7-item; range: 0-21.
(3) PHQ-9: Patient Health Questionnaire, 9-item; range 0-29.
(4) Question fielded 12/20-12/21; cohort n=387 and control n=340.

Disclosures:

Brian Lacy: Allakos – Advisory Committee/Board Member. Allergan Pharmaceuticals – Advisory Committee/Board Member. Arena Pharmaceuticals, Inc. – Advisory Committee/Board Member. Cosmos – Advisory Committee/Board Member. Ironwood Pharmaceuticals, Inc. – Advisory Committee/Board Member. Salix Pharmaceuticals, Inc. – Advisory Committee/Board Member. Viver Health – Consultant.

Douglas Taylor: Ironwood Pharmaceuticals, Inc. – Employee, Stock Options.

Yanqing Xu: AbbVie, Inc. – Employee, Stock Options.

Katherine Kosch: AbbVie Inc. – Employee, Stock Options.

Rachel Dobrescu indicated no relevant financial relationships.

Amy Morlock indicated no relevant financial relationships.

Robert Morlock indicated no relevant financial relationships.

Ceciel Rooker indicated no relevant financial relationships.

Brian E. Lacy, MD, PhD, FACG¹, Douglas C. Taylor, MBA², Yanqing Xu, MS, PhD³, Katherine J. Kosch, RPh⁴, Rachel Dobrescu, BA⁵, Amy Morlock, MA⁵, Robert Morlock, PhD⁶, Ceciel Rooker, BS⁷. A0254 - Disease Burden and Care-Seeking Behavior of Patients With Irritable Bowel Syndrome With Constipation (IBS-C) in the United States, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.