P0678 - Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Burden and Impact of Bowel Urgency Is Similar in Patients With Moderate-to-Severe Crohn’s Disease and Ulcerative Colitis

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Stefan Schreiber, MD

University Hospital Schleswig Holstein
Kiel, Schleswig-Holstein, Germany

Stefan Schreiber, MD¹, Theresa Hunter Gibble, PhD, MPH², Marla C. Dubinsky, MD³, David T. Rubin, MD⁴, Remo Panaccione, MD⁵, Toshifumi Hibi, MD, PhD⁶, Cem Kayhan, MD², Alison Potts Bleakman, PhD², Tommaso Panni, PhD⁷, Angelo D. Favia, PhD², Christian Atkinson, BSc, MRes⁸, Simon Travis, MD, PhD⁹
¹University Hospital Schleswig Holstein, Kiel, Schleswig-Holstein, Germany; ²Eli Lilly and Company, Indianapolis, IN; ³Mount Sinai Kravis Children’s Hospital, New York, NY; ⁴Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; ⁵University of Calgary, Calgary, AB, Canada; ⁶Kitasato University, Minato City, Tokyo, Japan; ⁷Eli Lilly and Company, Bad Homburg, Hessen, Germany; ⁸Adelphi Real World, Bollington, England, United Kingdom; ⁹University of Oxford, Oxford, England, United Kingdom

Introduction: Although bowel urgency (BU) is known to be disruptive in patients with ulcerative colitis (UC),¹ its impact on patients with Crohn’s disease (CD) is unclear. This study aimed to explore the burden and impacts of BU on patients with moderate-to-severe CD compared to previously reported UC data.¹

Methods: Communicating Needs and Features of IBD Experiences (CONFIDE), an online, quantitative, cross-sectional survey, explores the experiences and impacts of symptoms on lives of patients with CD or UC in the United States (US), Europe (EU5: France, Germany, Italy, Spain, and UK), and Japan.¹ Moderate-to-severe CD and UC were defined using criteria based on previous treatment, steroid use, and/or hospitalization. Data from the US and EU5 are presented as descriptive statistics.

Results: A total of 2706 patients were contacted, of which 215 US (55% male; mean age:41 years) and 547 EU5 (55% male, mean age:38 years) patients with CD completed the survey. Of these, 58% US and 63% EU5 patients were receiving advanced therapies at the time of survey completion (Table).

BU was among the top three most common symptoms currently (past month) experienced by US (42%) and EU5 (38%) patients with CD, similar to the findings in patients with UC (Figure). Most US and EU5 patients with CD reported experiencing BU and/or BU-related accidents at least once a month in the past 3 months (Table). Nearly half of patients with CD (US:49%, EU5:40%) reported wearing diaper/pad/protection at least once a week due to fear of BU-related accidents, comparable to patients with UC. For patients receiving advanced therapies, similar patterns were observed (Table). As reported in patients with UC, BU and BU-related accidents were among the top three most common CD-related reasons for declining participation in social events, work/school, and sports/physical exercise in both US and EU5 patients (Table).

Discussion: The impact of BU is as common in patients with moderate-to-severe CD as in those with UC,¹ despite the phenotypic differences between the diseases. Even though most patients were young (aged < 55 years) and receiving advanced therapies, almost half of patients reported wearing diaper/pad/protection at least once a week due to fear of BU-related accidents in both US and EU5, demonstrating the impact of BU in patients with CD.

¹Rubin DT, et al. Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Patient and Healthcare Professional Perspectives on Experience of Ulcerative Colitis Symptoms. 2021;116:p S7

Figure: Figure: Top three symptoms experienced by US and EU5 patients with UC or CD in the past month.

CD: Crohn’s disease, UC: Ulcerative colitis, US: United states of America, EU5: France, Germany, Italy, Spain, and the United Kingdom

	Symptoms/impacts		CD		UC
	Symptoms/impacts		US patients, n (%)	EU5 patients, n (%)	US patients, n (%)	EU5 patients, n (%)
Frequency of symptoms/impacts in past three months	Bowel urgency	Total number of patients (N)^*	126	295	123	250
		At least once a week	95 (75.4)	207 (70.2)	97 (78.9)	177 (70.8)
		Every 2–3 weeks/monthly	25 (19.9)	58 (19.7)	17 (13.9)	45 (18)
		Less frequently than monthly	2 (1.6)	19 (6.4)	7 (5.7)	19 (7.6)
		Not in the last three months	4 (3.2)	11 (3.7)	2 (1.6)	9 (3.6)
	Bowel urgency-related accidents	Total number of patients (N)^†	84	202	90	175
		At least once a week	51 (60.7)	90 (44.5)	52 (57.8)	85 (48.6)
		Every 2–3 weeks/monthly	17 (20.2)	55 (27.2)	25 (27.8)	39 (22.3)
		Less frequently than monthly	9 (10.7)	30 (14.9)	5 (5.6)	25 (14.3)
		Not in the last three months	7 (8.3)	27 (13.4)	8 (8.9)	26 (14.9)
	Diaper/pad/other protection use due to fear/anticipation of bowel urgency-related accidents	Total number of patients (N)	215	547	200	556
		At least once a week	105 (48.8)	216 (39.5)	90 (45.0)	206 (37)
		Every 2–3 weeks/monthly	36 (16.8)	111 (20.3)	47 (23.5)	155 (27.8)
		Less frequently than monthly	13 (6.0)	40 (7.3)	15 (7.5)	60 (10.8)
		Not in the last three months	61 (28.4)	180 (32.9)	48 (24.0)	135 (24.3)
Frequency of symptoms/impacts among patients receiving advanced therapies^§in past three months	Bowel urgency	Total number of patients (N)^**	76	189	91	126
		At least once a week	59 (77.6)	131 (69.2)	73 (80.2)	93 (73.8)
		Every 2–3 weeks/monthly	16 (21.1)	40 (21.2)	12 (13.2)	25 (19.8)
		Less frequently than monthly	1 (1.3)	9 (4.8)	4 (4.4)	7 (5.6)
		Not in the last three months	-	9 (4.8)	2 (2.2)	1 (0.8)
	Bowel urgency-related accidents	Total number of patients (N)^††	48	138	65	90
		At least once a week	27 (56.3)	70 (50.8)	42 (64.6)	47 (52.3)
		Every 2–3 weeks/monthly	11 (22.9)	35 (25.4)	16 (24.7)	24 (26.6)
		Less frequently than monthly	6 (12.5)	19 (13.8)	3 (4.6)	13 (14.4)
		Not in the last three months	4 (8.3)	14 (10.1)	4 (6.2)	6 (6.7)
	Diaper/pad/other protection use due to fear/anticipation of bowel urgency-related accidents	Total number of patients (N)^#	125	347	153	301
		At least once a week	64 (51.2)	157 (45.2)	72 (47.1)	115 (38.3)
		Every 2–3 weeks/monthly	21 (16.8)	76 (21.9)	37 (24.1)	101 (33.5)
		Less frequently than monthly	5 (4)	17 (4.9)	13 (8.5)	34 (11.3)
		Not in the last three months	35 (28)	97 (28.0)	31 (20.3)	51 (16.9)
Top reasons for declining daily activities		Total number of patients (N)	215	547	200	556
	Participating in work/school (for example, academic, professional work	Bowel urgency	83 (38.6)	151 (27.6)	74 (37.0)	151 (27.2)
		Fear of bowel urgency-related accidents	87 (40.5)	169 (30.9)	84 (42.0)	185 (33.3)
	Participating in social events (for example meeting with friends or family)	Bowel urgency	69 (32.1)	160 (29.3)	86 (43.0)	164 (29.5)
		Fear of bowel urgency-related accidents	80 (37.2)	156 (28.5)	80 (40.0)	177 (31.8)
	Participating in sports/physical exercise	Bowel urgency	67 (31.2)	141 (25.8)	75 (37.5)	162 (29.1)
	Participating in sports/physical exercise	Fear of bowel urgency-related accidents	84 (39.1)	146 (26.7)	71 (35.5)	156 (28.1)

Table: Table: Frequency of symptoms and impacts of Crohn’s disease and ulcerative colitis and most common reasons for declining daily activities.

N=Total number of patients, n=number of patients
*Patients who had ever experienced BU
†Patients who had ever experienced BU-related accidents
§Advanced therapies included adalimumab (including biosimilars), infliximab (including biosimilars), golimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, and tofacitinib.
**Patients who were receiving advanced therapies who had ever experienced BU
††Patients who were receiving advanced therapies who had ever experienced BU-related accidents
# Patients who were receiving advanced therapies at the time of survey completion
CD: Crohn’s disease, UC: Ulcerative colitis, US: United states of America, EU5: France, Germany, Italy, Spain, and the United Kingdom

Disclosures:

Stefan Schreiber: AbbVie – Consultant, Speakers Bureau. Arena – Consultant. Biogen – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb, – Consultant, Speakers Bureau. Celgene – Consultant. Celltrion – Advisory Committee/Board Member, Consultant. Eli Lilly – Consultant, Speakers Bureau. Falk Pharma – Consultant, Speakers Bureau. Fresenius – Consultant. Galapagos/Gilead – Consultant, Speakers Bureau. Hikma – Consultant, Speakers Bureau. IMAB – Advisory Committee/Board Member, Consultant. Janssen – Consultant, Speakers Bureau. MSD – Consultant, Speakers Bureau. Mylan – Advisory Committee/Board Member, Consultant. Pfizer – Consultant, Speakers Bureau. Protagonist – Consultant. Provention Bio – Consultant. Takeda – Consultant, Speakers Bureau. Theravance – Consultant.

Theresa Hunter Gibble: Eli Lilly and Company – Employee, stockholder.

Marla Dubinsky: AbbVie – Consultant, Grant/Research Support. Arena Pharmaceuticals – Consultant. Astra Zeneca – Consultant. Celgene – Consultant. Genentech Inc. – Consultant. Gilead Sciences – Consultant. Janssen – Consultant, Grant/Research Support. Merck – Consultant. Pfizer – Consultant, Grant/Research Support. Prometheus Biosciences – Consultant, Grant/Research Support. Prometheus Labs – Consultant, Grant/Research Support. Takeda – Consultant, Licensing fees. Thabor – Consultant. Trellus Health – Stock-publicly held company(excluding mutual/index funds). UCB Pharma – Consultant.

David Rubin: AbbVie – Consultant, personal fees. AltruBio – Consultant, personal fees. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant, personal fees. Bristol Myers Squibb – Consultant. Celgene Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Corp/Syneos – Consultant. Eco R1 – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant, personal fees. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Janssen Pharmaceuticals – Consultant, personal fees. Kaleido Biosciences – Consultant. Lilly – Consultant. Pfizer – Consultant, personal fees. Prometheus Biosciences – Consultant. Reistone Biopharma – Consultant, personal fees. Seres Therapeutics – Consultant. Takeda – Consultant, Grant/Research Support, Personal fees. Target RWE – Consultant. Trellus Health – Consultant.

Remo Panaccione: Abbivax – Consultant. Abbott – Consultant. AbbVie – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena – Consultant. AstraZeneca – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion – Consultant. Cosmos Technology – Consultant. Eisai – Consultant. Elan – Consultant. Eli Lilly – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. JAMP Bio – Consultant. Janssen – Consultant. Merck – Consultant. Mylan – Consultant. Novartis – Consultant. Oppilan Pharma – Consultant. Organon – Consultant. Pandion Pharma – Consultant. Pendopharm – Consultant. Pfizer Inc – Consultant. Progenity – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Roche – Consultant. Sandoz – Consultant. Satisfai Health – Consultant. Shire – Consultant. Sublimity Therapeutics – Consultant. Takeda Pharmaceuticals – Consultant. Theravance Biopharma – Consultant. Trellus – Consultant. UCB – Consultant. Ventyx – Consultant. Viatris – Consultant.

Toshifumi Hibi: AbbVie GK – Consultant, Grant/Research Support, Speakers Bureau. Activaid – Grant/Research Support. Alfresa Pharma – Grant/Research Support. Apo Puls Station – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Grant/Research Support. Celltrion – Advisory Committee/Board Member, Consultant. EA Pharma – Advisory Committee/Board Member, Consultant, Study group sponorship. Eli Lilly and Company – Advisory Committee/Board Member, Consultant. Ferring – Grant/Research Support, Speakers Bureau. Gilead Sciences – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. JIMRO – Study group sponorship, Speakers Bureau. JMDC Inc – Grant/Research Support. Kyorin – Advisory Committee/Board Member, Consultant, Study group sponsorship. Mitsubishi-TanabePharma – Advisory Committee/Board Member, Consultant, Scholarship contributions, Speakers Bureau. Mochida Pharmaceutical – Grant/Research Support, Study group sponorship, Speakers Bureau. Nichi-Iko Pharmaceutical – Advisory Committee/Board Member, Consultant. Nippon Kayaku Co – Grant/Research Support, Scholarship contributions. Otsuka Holdings – Study group sponsorship. Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Pfizer Japan Inc – Grant/Research Support. Takeda – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Zeria Pharmaceutical – Advisory Committee/Board Member, Consultant, Scholarship contributions and study group sponsorship.

Cem Kayhan: Eli Lilly and Company – Employee, Stock Options.

Alison Potts Bleakman: Eli Lilly and Company – Employee, Stock Options.

Tommaso Panni: Eli Lilly and Company – Employee, Stock Options.

Angelo Favia: Eli Lilly and Company – Employee, Stock Options.

Christian Atkinson: Adelphi Real World – Employee.

Simon Travis: AbbVie – Consultant, Grant/Research Support. Allergan – Consultant. Amgen – Consultant. Apexian – Consultant. Asahi Kasei Pharma – Consultant. Bioclinica – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. ChemoCentryx – Consultant. Cosmo Pharmaceuticals – Consultant. ECCO – Grant/Research Support. Eli Lilly and Company – Consultant, Grant/Research Support. Enterome – Consultant. Equillium – Consultant. Ferring Pharmaceuticals – Consultant. Genentech/Roche – Consultant. Giuliani SpA – Consultant. GlaxoSmithKline – Consultant. Helmsley Trust International, – Grant/Research Support. Immunocore – Consultant. Immunometabolism – Consultant. Janssen – Consultant. Merck – Consultant. Merck Sharp & Dohme – Consultant. Mestag Therapeutics – Consultant. Neovacs – Consultant. Norman Collision Foundation – Grant/Research Support. Novartis – Consultant. Novo Nordisk – Consultant. NPS Pharmaceuticals/Nycomed – Consultant. Organization for the Study of Inflammatory Bowel Disease – Grant/Research Support. Pfizer – Consultant, Grant/Research Support. Protagonist Therapeutics – Consultant. Proximagen – Consultant. Receptos – Consultant. Satisfai Health – Consultant. Sensyne Health – Consultant. Shire – Consultant. Sigmoid Pharma – Consultant. Sorriso Pharmaceuticals – Consultant. Takeda – Consultant, Grant/Research Support. UCB Pharma – Consultant, Grant/Research Support. UKIERI – Grant/Research Support. VHsquared – Consultant. Vifor Pharma – Consultant. Vifor Pharma – Grant/Research Support. Zeria Pharmaceutical – Consultant.