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Tuesday Poster Session

Category: IBD

P4358 - Disease Characteristics Associated With Bowel Urgency in Crohn’s Disease: Results From the Phase 3 VIVID-1 Trial

Tuesday, October 29, 2024
10:30 AM – 4:00 PM ET
Location: Exhibit Hall E
Has Audio
Geert R. D'Haens, MD, PhD1, Bruce E.. Sands, MD, FACG2, Vipul Jairath, MBChB3, Simon Travis, 4, Maria Chaparro, MD, PhD5, Laurent Peyrin-Biroulet, MD, PhD6, Minhu Chen, 7, Marla C. Dubinsky, MD2, Marc Ferrante, MD, PhD8, Stefan Schreiber, MD9, Kim McGinnis, 10, Aisha Vadhariya, 10, Guanglei Yu, 10, Marijana Protic, 10, Richard Moses, 10, Subrata Ghosh, MD11
1Amsterdam University Medical Center, Amsterdam, Limburg, Netherlands; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Western University, London, ON, Canada; 4University of Oxford, Oxford, England, United Kingdom; 5Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigacíon Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Diego de León, Madrid, Spain; 6INFINY Institute, FHU-CURE, INSERM NGERE, Nancy University Hospital, Vandœuvre-lès-Nancy, Lorraine, France; McGill University Health Centre, Montreal, QC, Canada, Nancy, Lorraine, France; 7First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China; 8University Hospitals, Leuven, Vlaams-Brabant, Belgium; 9University Hospital, Kiel, Schleswig-Holstein, Germany; 10Eli Lilly and Company, Indianapolis, IN; 11University College Cork, Cork, Cork, Ireland

Introduction: Data on bowel urgency (BU) in Crohn’s disease (CD) are limited, and associated factors are not well identified. Here we evaluate the association of BU with baseline (BL) disease characteristics in patients with moderately to severely active CD in the randomized, double-blind, double-dummy, treat-through design Phase 3 VIVID-1 trial.

Methods: BU was assessed using the average Urgency Numeric Rating Scale (UNRS) (range 0-10) from 7 days prior to the visit. Adults having UNRS ≥3 and no missing values at BL were included. The association of UNRS with Crohn’s Disease Activity Index (CDAI), abdominal pain (AP), stool frequency (SF), Simple Endoscopic Score for CD (SES-CD) total score, disease location, count of inflamed intestinal segments, rectal involvement, presence of narrowing, presence of perianal fistulae, number of bowel resections and inflammatory biomarkers were primarily analyzed. Random forest method (RFM) was applied to rank variables by importance associated with BU score at BL. Pearson correlation coefficients (r value) were calculated for continuous BL variables.

Results: At BL, 73.4% (782/1065) patients randomized to placebo (n=141), MIRI (n=433), or ustekinumab (n=208) reported UNRS ≥3 (median UNRS 7.0). Among BL disease characteristics, CDAI total score and AP were the top two important factors based on RFM and had moderate positive correlations with UNRS (Table). Notably, disease characteristics such as SF, SES-CD total score, age at diagnosis, age, fecal calprotectin, and C-reactive protein had weak correlations with UNRS. Also, count of inflamed segments (RFM=0.021; r=0.069), duration of CD (RFM=0.015; r=-0.007), presence of perianal fistula (RFM=0.009; r=0.090), and number of bowel resections (RFM=0.000; r=-0.036) had weak correlations with UNRS. BL corticosteroid (RFM=0.015) and immunomodulator (RFM=0.007) use, disease location (RFM=-0.005), rectal involvement (RFM=0.011), presence of narrowing (RFM=0.007), prior biologic failure (RFM=0.003), and sex (RFM=0.007) had weak correlations with UNRS implied by RFM.

Discussion: Most patients reported BU ≥3 at BL. Moderate positive correlations were observed only between BU, clinical disease severity (CDAI) and AP. Though the association of BU with other disease characteristics such as extent and severity of endoscopic inflammation, rectal involvement, presence of active perianal disease, disease location, previous resection and duration of CD were weak, they potentially interact and contribute together resulting in BU.


Note: The table for this abstract can be viewed in the ePoster Gallery section of the ACG 2024 ePoster Site or in The American Journal of Gastroenterology's abstract supplement issue, both of which will be available starting October 27, 2024.


Disclosures:
Geert D'Haens: AbbVie – Advisor or Review Panel Member, Speakers Bureau. Agomab Therapeutics – Advisor or Review Panel Member. Alimentiv – Advisor or Review Panel Member. Allergan – Advisor or Review Panel Member. Alphabiomics – Advisor or Review Panel Member. AstraZeneca – Advisor or Review Panel Member. Boehringer Ingelheim – Advisor or Review Panel Member. Bristol Myers Squibb – Advisor or Review Panel Member, Speakers Bureau. Celltrion – Advisor or Review Panel Member, Grant/Research Support. Eli Lilly – Advisor or Review Panel Member, Speakers Bureau. Ferring – Advisor or Review Panel Member. Galapagos – Advisor or Review Panel Member, Speakers Bureau. GlaxoSmithKline – Advisor or Review Panel Member. Immunic – Advisor or Review Panel Member. Johnson & Johnson – Advisor or Review Panel Member, Speakers Bureau. Pfizer Inc – Advisor or Review Panel Member, Grant/Research Support, Speakers Bureau. Seres – Advisor or Review Panel Member. Takeda – Advisor or Review Panel Member, Speakers Bureau. Tillotts – Advisor or Review Panel Member, Speakers Bureau. Ventyx – Advisor or Review Panel Member.
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speakers Bureau. Adiso Therapeutics – Consultant. Agomab – Consultant. Alimentiv – Consultant. Amgen – Consultant. AnaptysBio – Consultant. Arena Pharmaceuticals – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Biolojic Design – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Other support, Speakers Bureau. Calibr – Consultant. Celgene – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Enthera – Consultant. Envied Biosciences – Consultant. Equilium – Consultant. Evommune – Consultant. Ferring – Consultant. Fiat – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech (Roche) – Consultant. Gilead Sciences – Consultant. Glaxo SmithKline – Consultant. Gossamer Bio – Consultant. Imhotex – Consultant. Index Pharmaceuticals – Consultant. Innovation Pharmaceuticals – Consultant. Inotrem – Consultant. Janssen – Consultant, Grant/Research Support, Other support, Speakers Bureau. Kaleido – Consultant. Kallyope – Consultant. Lilly – Consultant, other support, Speakers Bureau. Merck & Co., Inc., Rahway, NJ, USA – Consultant. Microba – Consultant. Mobius Care – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. Nexus Therapeutics – Consultant. Nimbus Discovery – Consultant. Odyssey Therapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, Other support, Speakers Bureau. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. Rasayana Therapeutics – Consultant. Recludix Therapeutics – Consultant. Reistone Biopharma – Consultant. Sanofi – Consultant. Spyre Therapeutics – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Takeda – Consultant, Grant/Research Support, Other support, Speakers Bureau. Target RWE – Consultant. Teva – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. Tr1X – Consultant. Union Therapeutics – Consultant. Ventyx Biopharma – Consultant, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Vipul Jairath: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Alimentiv – Consultant, Employee, Grant/Research Support, Speakers Bureau. Arena Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Asahi Kasei Pharma – Consultant, Grant/Research Support, Speakers Bureau. Asieris Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. AstraZeneca – Consultant, Grant/Research Support, Speakers Bureau. Avoro Capital – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, Speakers Bureau. Celltrion – Consultant, Grant/Research Support, Speakers Bureau. Eli Lilly and Company – Consultant, Grant/Research Support, Speakers Bureau. Endpoint Health – Advisory Committee/Board Member, Consultant. Enthera – Advisory Committee/Board Member, Consultant. Ferring Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Flagship Pioneering – Consultant, Grant/Research Support, Speakers Bureau. Fresenius Kabi – Consultant, Grant/Research Support, Speakers Bureau. Galapagos NV – Consultant, Grant/Research Support, Speakers Bureau. Genentech – Consultant, Grant/Research Support, Speakers Bureau. Gilde Healthcare – Advisory Committee/Board Member, Consultant. Gilead Sciences – Consultant, Grant/Research Support, Speakers Bureau. GlaxoSmithKline – Consultant, Grant/Research Support, Speakers Bureau. Innomar – Advisory Committee/Board Member, Consultant. JAMP – Advisory Committee/Board Member, Consultant. Janssen – Consultant, Grant/Research Support, Speakers Bureau. London Health Sciences Centre – Employee. Merck – Consultant, Grant/Research Support, Speakers Bureau. Metacrine – Consultant, Grant/Research Support, Speakers Bureau. Mylan – Consultant, Grant/Research Support, Speakers Bureau. Pandion Therapeutics – Consultant, Grant/Research Support, Speakers Bureau. Pendopharm – Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Prometheus Therapeutics and Diagnostics – Consultant, Grant/Research Support, Speakers Bureau. Protagonist Therapeutics – Consultant, Grant/Research Support, Speakers Bureau. Reistone Biopharma – Consultant, Grant/Research Support, Speakers Bureau. Roche – Consultant, Grant/Research Support, Speakers Bureau. Roivant – Advisory Committee/Board Member, Consultant. Sandoz – Consultant, Grant/Research Support, Speakers Bureau. SCOPE – Advisory Committee/Board Member, Consultant. Second Genome – Consultant, Grant/Research Support, Speakers Bureau. Shire – Speakers Bureau. Sorriso Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Synedgen – Advisory Committee/Board Member, Consultant. Takeda – Consultant, Grant/Research Support, Speakers Bureau. TD Securities – Advisory Committee/Board Member, Consultant. Teva – Consultant, Grant/Research Support, Speakers Bureau. Topivert – Consultant, Grant/Research Support, Speakers Bureau. Ventyx Biosciences – Consultant, Grant/Research Support, Speakers Bureau. Vividion Therapeutics – Consultant, Grant/Research Support, Speakers Bureau.
Simon Travis: AbbVie – Grant/Research Support. Buhlmann – Grant/Research Support. ECCO – Grant/Research Support. Eli Lilly and Company – Grant/Research Support. Ferring Pharmaceuticals – Grant/Research Support. International Organization for the Study of IBD – Grant/Research Support. Janssen – Grant/Research Support. MSD – Grant/Research Support. Normal Collision Foundation – Grant/Research Support. Pfizer – Grant/Research Support. Procter & Gamble – Grant/Research Support. Schering-Plough – Grant/Research Support. Takeda – Grant/Research Support. UCB – Grant/Research Support. Vifor Pharma – Grant/Research Support. Warner Chilcott – Grant/Research Support.
Maria Chaparro: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Biogen – Consultant, Grant/Research Support, Speakers Bureau. Dr Falk Pharma – Consultant, Grant/Research Support, Speakers Bureau. Eli Lilly and Company – Consultant, Grant/Research Support, Speakers Bureau. Ferring – Consultant, Grant/Research Support, Speakers Bureau. Gilead – Consultant, Grant/Research Support, Speakers Bureau. Hospira – Consultant, Grant/Research Support, Speakers Bureau. Janssen – Consultant, Grant/Research Support, Speakers Bureau. MSD – Consultant, Grant/Research Support, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Shire Pharmaceuticals – Consultant, Grant/Research Support, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Tillotts Pharma – Consultant, Grant/Research Support, Speakers Bureau.
Laurent Peyrin-Biroulet: AbbVie – Grant/Research Support, Personal fees. Allergan – Personal Fees. Alma Bio Therapeutics – Personal Fees. Amgen – Personal Fees. Applied Molecular Transport – Personal Fees. Arena – Personal Fees. Biogen – Personal Fees. Boehringer Ingelheim – Personal Fees. Bristol Myers Squibb – Personal Fees. Celgene – Personal Fees. Celltrion – Personal Fees. CTMA – Stock Options. Enterome – Personal Fees. Enthera – Personal Fees. Ferring – Personal Fees. Fresenius Kabi – Personal Fees. Genentech – Personal Fees. Gilead – Personal Fees. Hikma – Personal Fees. InDex Pharmaceuticals – Personal Fees. Janssen – Personal Fees. Lilly – Personal Fees. MSD – Grant/Research Support, Personal Fees. Mylan – Personal Fees. Nestlé – Personal Fees. Norgine – Personal Fees. Oppilan Pharma – Personal Fees. OSE Immunotherapeutics – Personal Fees. Pfizer Inc – Personal Fees. Pharmacosmos – Fees. Samsung Bioepis – Personal Fees. Sandoz – Personal Fees. Sterna – Personal Fees. Sublimity Therapeutics – Personal Fees. Takeda – Grant/Research Support, Personal Fees. Tillotts – Personal Fees. Vifor – Personal Fees.
Minhu Chen: AbbVie – Provided educational activities. Boehringer Ingelheim – Advisor or Review Panel Member. China Medical System – Provided educational activities. IPSEN – Provided educational activities. Janssen – Advisor or Review Panel Member, Grant/Research Support, Provided educational activities. Takeda – Grant/Research Support, Provided educational activities.
Marla Dubinsky: AbbVie – Consultant. Abivax – Consultant. Arena – Consultant. AstraZeneca – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Eli Lilly – Consultant. Genentech – Consultant. Gilead – Consultant. Janssen – Consultant. Pfizer Inc – Consultant. Prometheus Labs – Consultant. Takeda – Consultant.
Marc Ferrante: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Agomab – Consultant. Amgen – Grant/Research Support, Speakers Bureau. Biogen – Grant/Research Support, Speakers Bureau. Boehringer Ingelheim – Consultant, Speakers Bureau. Celgene – Consultant. Celltrion – Consultant. Dr Falk Pharma – Speakers Bureau. EG Pharmaceuticals – Grant/Research Support. Eli Lilly and Company – Consultant, Grant/Research Support. Ferring – Speakers Bureau. Janssen – Grant/Research Support. Janssen-Cilag – Consultant, Speakers Bureau. Lamepro – Speakers Bureau. Medtronic – Consultant. MRM Health – Consultant. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Regeneron – Consultant. Samsung Bioepis – Consultant. Sandoz – Consultant, Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. ThermoFisher – Consultant. Truvion Healthcare – Speakers Bureau. Viatris – Grant/Research Support, Speakers Bureau.
Stefan Schreiber: AbbVie – Consultant, Personal fees, Speakers Bureau. Amgen – Personal fees. Arena Pharmaceuticals – Consultant, Personal fees, Speakers Bureau. Biogen – Consultant, Personal fees, Speakers Bureau. Bristol Myers Squibb – Consultant, Personal fees, Speakers Bureau. Celgene – Consultant, Personal fees, Speakers Bureau. Celltrion – Consultant, Personal fees, Speakers Bureau. Eli Lilly and Company – Personal fees. Falk – Consultant, Personal fees, Speakers Bureau. Ferring Pharmaceuticals – Personal fees. Fresenius – Consultant, Personal fees, Speakers Bureau. Galapagos – Personal fees. Gilead – Consultant, Personal fees. Hikma Pharmaceuticals – Advisory Committee/Board Member, Consultant. I-MAB – Consultant, Personal fees. Janssen – Consultant, Personal fees, Speakers Bureau. Morphic – Personal fees. MSD – Consultant, Personal fees, Speakers Bureau. Mylan – Consultant, Personal fees. Novartis – Personal fees. Pfizer Inc – Consultant, Personal fees, Speakers Bureau. Protagonist – Consultant, Personal fees. Provention Bio – Consultant, Personal fees. Roche – Personal fees. Sandoz/Hexal – Personal fees. Shire – Personal fees. Takeda – Consultant, Personal fees, Speakers Bureau. Theravance Biopharma – Consultant, Personal fees. Ventyx – Consultant, Personal fees.
Kim McGinnis: Eli Lilly and Company – Employee, Stock Options.
Aisha Vadhariya: Eli Lilly and Company – Employee, Stock Options.
Guanglei Yu: Eli Lilly and Company – Employee, Stock Options.
Marijana Protic: Eli Lilly and Company – Employee, Stock Options.
Richard Moses: Eli Lilly and Company – Employee, Stock Options.
Subrata Ghosh: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Bristol Myers Squibb – Consultant. Celgene – Speakers Bureau. Eli Lilly – Speakers Bureau. Ferring – Speakers Bureau. Galapagos – Speakers Bureau. Gilead – Speakers Bureau. GlaxoSmithKline – Grant/Research Support. Janssen – Consultant, Speakers Bureau. MSD – Speakers Bureau. Novo Nordisk – Consultant. Pfizer – Consultant, Speakers Bureau. Roche – Consultant. Takeda – Consultant, Speakers Bureau.


Geert R. D'Haens, MD, PhD1, Bruce E.. Sands, MD, FACG2, Vipul Jairath, MBChB3, Simon Travis, 4, Maria Chaparro, MD, PhD5, Laurent Peyrin-Biroulet, MD, PhD6, Minhu Chen, 7, Marla C. Dubinsky, MD2, Marc Ferrante, MD, PhD8, Stefan Schreiber, MD9, Kim McGinnis, 10, Aisha Vadhariya, 10, Guanglei Yu, 10, Marijana Protic, 10, Richard Moses, 10, Subrata Ghosh, MD11. P4358 - Disease Characteristics Associated With Bowel Urgency in Crohn’s Disease: Results From the Phase 3 VIVID-1 Trial, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.