P0735 - The Effect of Patients’ Current Ulcerative Colitis Disease Severity Perception on Prevalence and Experiences of Bowel Urgency: Results from the Communicating Needs and Features of IBD Experiences (CONFIDE) Survey

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Presenting Author(s)

David Rubin, MD, FACG (he/him/his)

University of Chicago Medicine, Inflammatory Bowel Disease Center
Chicago, IL

David T. Rubin, MD¹, Marla C. Dubinsky, MD², Theresa Hunter Gibble, PhD, MPH³, Stefan Schreiber, MD⁴, Remo Panaccione, MD⁵, Toshifumi Hibi, MD, PhD⁶, Tommaso Panni, PhD⁷, Cem Kayhan, MD³, Alison Potts Bleakman, PhD³, Eoin Flynn, PhD³, Christian Atkinson, BSc, MRes⁸, Simon Travis, MD, PhD⁹
¹Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, IL; ²Mount Sinai Kravis Children’s Hospital, New York, NY; ³Eli Lilly and Company, Indianapolis, IN; ⁴University Hospital Schleswig Holstein, Kiel, Schleswig-Holstein, Germany; 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: Bowel urgency (BU) is a highly disruptive symptom among patients (pts) with ulcerative colitis (UC).¹ We aim to characterize BU based on pts’ current disease severity perception (“disease perception”) of UC in the United States (US) and Europe (EU5: France, Germany, Italy, Spain, and UK).

Methods: The Communicating Needs and Features of IBD Experiences (CONFIDE) survey is an online, quantitative, cross-sectional survey that was conducted among pts with UC in the US, EU5, and Japan. Survey inclusion required moderate-to-severe UC as defined by previous treatment experience, steroid use, and/or hospitalization. Pts who met the entry criteria were asked: “How severe do you think your UC is currently?” to determine their disease perception using self-ratings of mild, moderate, severe, or do not know. Descriptive statistics summarise the data.

Results: A total of 200 US pts (62% males, mean age 40 years) and 556 EU5 pts (57% males, mean age 39 years) completed the survey and met study entry criteria for moderate-to-severe UC. Most pts perceived their current disease severity as moderate (71% US, 71% EU5; Table).
Of pts who reported ever experiencing BU, 79% of US and 71% of EU5 pts had experienced BU at least once/week in past 3 months, irrespective of their disease perception (Table). Of pts who reported ever experiencing BU-related accidents, 9% US, 13% EU5 in mild, 62% US, 56% EU5 in moderate, and 75% US, 57% EU5 in severe disease perception groups had BU-related accidents at least once/week in past 3 months (Table). A greater proportion of pts with moderate (49% US, 39% EU5) or severe (43% US, 61% EU5) disease perception reported wearing diaper/pad/protection at least once/week in past 3 months due to fear of BU-related accidents, compared to mild disease perception (14% US, 19% EU5; Table).
Of pts who had ever experienced BU, a greater proportion of pts who indicated severe (67% US, 56% EU5) or moderate (50% US, 55% EU5) disease perception reported that they worked fewer hours due to BU versus those who indicated mild disease perception (17% US, 33% EU5; Figure).

Discussion: Bowel urgency, BU-related accidents, BU-related diaper/pad/protection use, and an impact of BU on work were more frequently reported among patients with moderate or severe perceptions of their disease severity compared to those with mild disease perception. BU and BU-related experiences affect a patient’s perception of UC disease severity.

Reference: ¹Carpio D, et al. Eur J Gastroenterol Hepatol. 2016.

Figure: Impact of bowel urgency on education/work by patients’ disease perception.
US: United States; EU5: France, Germany, Italy, Spain, and the UK; DP: disease perception; N=Total number of patients who had ever experienced BU.

	US patients’ disease perception				EU5 patients’ disease perception
	Overall	Mild	Moderate	Severe	Overall	Mild	Moderate	Severe
Patient-perceived severity of UC, N (%)	200 (100)	21 (11)	142 (71)	35 (18)	556 (100)	106 (19)	392 (71)	54 (10)
Patients receiving advanced therapy, n (%)	153 (76)	8 (38)	114 (80)	30 (86)	301 (54)	42 (40)	232 (59)	27 (50)
Patients who experienced BU in the past month, n (%)	94 (47)	7 (33)	63 (44)	22 (63)	165 (30)	29 (27)	118 (30)	15 (28)
Patients who experienced BU-related accidents in the past month n (%)	55 (28)	4 (19)	35 (25)	14 (40)	98 (18)	6 (6)	74 (19)	15 (28)
Patients wearing diaper/pad/other protection at least once a week due to fear/anticipation of BU-related accidents in the past 3 months, n (%)	90 (45)	3 (14)	70 (49)	15 (43)	206 (37)	20 (19)	151 (39)	33 (61)
Deferral time before bowel movements in the past 3 days, n (%)
Can wait 15 minutes or longer	28 (14)	10 (48)	15 (11)	3 (9)	112 (20)	41 (39)	50 (13)	20 (37)
Needed to get to the bathroom within 5-15 minutes	104 (52)	5 (24)	75 (53)	23 (66)	273 (49)	42 (40)	216 (55)	15 (28)
Needed to get to the bathroom within 2-5 minutes	45 (22)	3 (14)	37 (26)	5 (14)	114 (21)	18 (17)	83 (21)	13 (24)
Needed to get to the bathroom in less than 2 minutes	17 (8)	2 (10)	13 (9)	2 (6)	43 (8)	4 (4)	34 (9)	5 (9)
Unable to make it to the bathroom in time	6 (3)	1 (5)	2 (1)	2 (6)	14 (3)	1 (1)	9 (2)	1 (2)
Patients who had ever experienced BU, N (%)	123 (100)	12 (100)	82 (100)	27 (100)	250 (100)	55 (100)	166 (100)	25 (100)
Patients reporting BU at least once a week in the past 3 months, n (%)	97 (79)	7 (58)	67 (82)	21 (78)	177 (71)	29 (53)	128 (77)	17 (68)
Patients who had ever experienced BU-related accidents, N (%)	90 (100)	11 (100)	61 (100)	16 (100)	175 (100)	31 (100)	117 (100)	23 (100)
Patients reporting BU-related accidents at least once a week in the past 3 months, n (%)	52 (58)	1 (9)	38 (62)	12 (75)	85 (49)	4 (13)	65 (56)	13 (57)
N= total number of patients; n= number of patients reporting the information. BU: bowel urgency; UC: ulcerative colitis; US: United States; EU5: France, Germany, Italy, Spain, and the UK 2 US and 4 EU5 patients self-reported their UC severity as ‘Do not know’ (data not shown due to small sample size) Advanced therapy: adalimumab, infliximab, golimumab, certolizumab-pegol, vedolizumab, natalizumab, ustekinumab, and tofacitinib.

Table: Experiences and frequency of bowel urgency and BU-related accidents based on patients’ disease perception.

Disclosures:

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.

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.

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

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.

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.

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

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

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

Eoin Flynn: 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.