A0253 - Burden of Disease in U.S. Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

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, Yanqing Xu, MS, PhD², Douglas C. Taylor, MBA³, Katherine J. Kosch, RPh⁴, Rachel Dobrescu, BA⁵, Amy Morlock, MA⁵, Robert Morlock, PhD⁶, Ceciel Rooker, BS⁷
¹Mayo Clinic, Jacksonville, FL; ²AbbVie, Inc., North Chicago, IL; ³Ironwood Pharmaceuticals, Inc., Cambridge, MA; 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 irritable bowel syndrome with diarrhea (IBS-D) impose a significant burden to patients. Our study examined disease burden and care-seeking behavior of patients with IBS-D.

Methods: A cross-sectional, on-line health survey collected data during 8/2020-12/2021 from US adults. IBS-D patients were defined using Rome IV criteria. Health outcomes comparing IBS-D patients to controls included anxiety and depression screeners, health-related quality of life (HRQoL) and productivity measures. Care, treatment and symptom burden were assessed for IBS-D patients. Differences in anxiety, depression, HRQoL, and productivity between IBS-D patients and the general population were assessed with a 1:1 matched sample by sex, age, race, region and Charlson Comorbidity Index score. Categorical data were described by percentage and continuous data by mean and standard deviation. Means were compared with ANOVA and proportions with chi-square tests.

Results: Data was collected from 29,359 participants. Matching IBS-D participants resulted in 669 patients and 669 controls. Most patients were female (74.6%), White (84.0%), with a mean age of 41.9 years. IBS-D 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 higher among IBS-D patients vs controls (Table 1). Of IBS-D patients, 91.5% sought care for their symptoms, 59.3% within the past year. Of those having an ER visit/hospitalization in the past year (17.3%), abdominal pain was the most reported reason (87.1%). 65.9% of IBS-D patients reported currently taking an Rx and/or an OTC for their symptoms (13.2% Rx alone, 13.9% Rx and OTC, and 38.9% OTC alone). Abdominal pain and abdominal discomfort were the symptoms most experienced (71.0% and 70.9%, respectively). Abdominal pain was reported to be the most bothersome (34.5%) (Figure 1). IBS-D patients currently taking an Rx with/without an OTC were more satisfied with the control of bowel (39.2% vs 21.5%) and abdominal (40.3% vs 22.7%) symptoms than those currently taking an OTC alone.

Discussion: This large survey study demonstrates that the health impact of IBS-D is high. Nearly 1 in 5 patients sought care at an ER for their symptoms. Abdominal pain and discomfort are common bothersome symptoms with patients reporting better control with Rx medications compared to OTC agents.

Figure: Figure 1. Symptom Experience, Frequency and Bothersomeness

	Rome IV IBS-D Cohort (N=669)	Control (N=669)	Sig.
Female	74.6%	74.6%	1.000

Age, mean (SD)	41.9 (15.0)	41.9 (15.0)	0.990

Black or African American	7.8%	7.8%	1.000
White	84.0%	84.0%
Other	8.2%	8.2%

Proportion of Hispanic, Latino or Spanish origin	7.8%	8.5%	0.617

Northeast	17.2%	17.2%	1.000
Midwest	22.6%	22.6%
South	42.8%	42.8%
West	17.5%	17.5%

Charlson Comorbidity Index (CCI) score, mean (SD)	0.6 (1.1)	0.6 (1.1)	1.000

Body Mass Index (BMI) (lbs/in²), mean (SD)	30.2 (9.0)	27.9 (7.4)	< 0.001

Proportion employed per Work Productivity and Impairment (WPAI) (1)	54.2%	58.7%	0.187

Median household income (Census derived from zip code), mean (SD)	65,468 (28,360)	65,459 (26,647)	0.996

Anxiety (GAD-7 [2]) score, mean (SD)	9.9 (6.1)	6.8 (5.8)	< 0.001
Depression (PHQ-9 [3]) score, mean (SD)	11.4 (7.3)	7.9 (7.1)	< 0.001

Chronic pain	61.4%	38.6%	< 0.001
Migraine	64.2%	35.8%	< 0.001
Insomnia	67.7%	32.3%	< 0.001
GERD	75.9%	24.1%	< 0.001

VR-12 Mental Component Summary (MCS [4]), mean (SD)	36.7 (12.5)	43.9 (11.8)	< 0.001
VR-12 Physical Component Summary (PCS [4]), mean (SD)	40.3 (11.2)	44.4 (10.6)	< 0.001
VR-12 Health utility (VR-6D [4]), mean (SD)	0.60 (0.11)	0.67 (.12)	< 0.001

Health problems affected work productivity rating (0-10 scale), mean, SD (5)	3.1 (2.9)	2.1 (2.8)	< 0.001

Health problems affected daily activities rating (0-10 scale), mean, SD (1)	4.3 (3.2)	2.6 (3.1)	< 0.001

Table: Table 1. Characteristics of the Rome IV IBS-D Cohort vs Controls

(1) WPAI fielded 12/20-12/21: Rome IV IBS-D cohort n=463; control n=397.
(2) GAD-7: Generalized Anxiety Disorder, 7-item; range: 0-21.
(3) PHQ-9: Patient Health Questionnaire, 9-item; range: 0-29.
(4) Veterans RAND 12-item Health Survey (VR12).
(5) Question fielded 12/20-12/21: Rome IV IBS-D cohort n=251; control n=233.

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.

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

Douglas Taylor: Ironwood Pharmaceuticals, 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, Yanqing Xu, MS, PhD², Douglas C. Taylor, MBA³, Katherine J. Kosch, RPh⁴, Rachel Dobrescu, BA⁵, Amy Morlock, MA⁵, Robert Morlock, PhD⁶, Ceciel Rooker, BS⁷. A0253 - Burden of Disease in U.S. Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D), ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.