Skip to main content
ACG 2023 Annual Meeting Posters Main banner
Back
Rate ePoster

Sunday Poster Session

Category: IBD

P0723 - Response Trajectory by the Clinical Decision Support Tool Probability Groups in Vedolizumab-Treated Patients With Crohn’s Disease: A Pooled Analysis of GEMINI 2, VISIBLE 2, and VERSIFY

Sunday, October 22, 2023
3:30 PM – 7:00 PM PT
Location: Exhibit Hall
ACG Award Winner

    Presenting Author(s)

  • PD

    Parambir Dulai, MD

    Feinberg School of Medicine, Northwestern University
    Chicago, Illinois

Award: Presidential Poster Award

Parambir S. Dulai, MD1, Giorgios Bamias, MD2, Vipul Jairath, MBChB, DPhil3, Anthony Buisson, MD4, Marlies Neuhold, MD5, Dirk Lindner, MSc6, Christian Agboton, MD7, Laurent Peyrin-Biroulet, MD, PhD8
1Feinberg School of Medicine, Northwestern University, Chicago, IL; 2University of Athens, Sotiria Hospital, Athina, Attiki, Greece; 3Western University, London, ON, Canada; 4University Hospital Estaing, Clermont-Ferrand, Auvergne, France; 5Takeda, Luzern, Luzern, Switzerland; 6Takeda, Zurich, Zurich, Switzerland; 7Takeda, Cambridge, MA; 8Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France

Introduction: Previously, a clinical decision support tool (CDST) has been developed to support treatment decisions in vedolizumab (VDZ)-treated patients (pts) with Crohn’s disease (CD).1 The patient reported outcome PRO2, comprising the sum of the Crohn’s disease activity index (CDAI) scores for stool frequency and abdominal pain, and quality of life (QoL) are treatment targets for pts with CD.2 We evaluated the PRO2 and QoL response according to the CDST probability groups.

Methods: Pooled analysis of data from pts treated with VDZ in the 3 clinical trials GEMINI 2, VISIBLE 2 and VERSIFY. Based on STRIDE-II, symptomatic response was defined as decrease in PRO2 ≥50% from baseline, and symptomatic remission as an average daily stool frequency ≤3 and an average daily abdominal pain ≤1.2 Inflammatory Bowel Disease Questionnaire (IBDQ) remission was defined as total IBDQ score of ≥170. The analysis included only timepoints assessed in all 3 studies. Nonresponse imputation was applied on missing data.

Results: A total of 1190 pts were included in this analysis and were categorized at baseline according to CDST as having a low (n=241), intermediate (n=548) or high (n=401) probability of response to VDZ. Mean (SD) PRO2 score decreased from baseline in all 3 CDST groups, with the high probability group showing the fastest and greatest change from baseline (Fig 1A). Symptomatic response at Week 6 was achieved by 162 (40.4%), 131 (23.9%), and 23 (9.5%) pts in the high, intermediate, and low CDST groups, respectively. The rates of symptomatic response in the high group continued to exceed those of the low and intermediate groups through Week 52. The rates of symptomatic remission were greater in the high probability group at Week 6 and continued to exceed those of the low and intermediate groups through Week 52 (Fig 1B). Mean (SD) IBDQ total score increased from baseline in all 3 CDST groups (Fig 1C). In the high probability CDST group, 26 (6.5%), 140 (41.7%), 185 (46.1%) and 167 (44.3%) pts, respectively, were in IBDQ remission at baseline, Week 6, Week 26/30 and Week 52.

Discussion: Based on patient reported outcomes, CDST is able to predict the probability of symptomatic response and remission with faster onset and higher rates observed in the high CDST group. Fast and greater improvement in QoL is also seen in the high CDST group.



References:

1. Dulai PS et al. (2018) Gastroenterology 155:687-695.e10. 2. Turner D et al. (2021) Gastroenterology.160(5):1570-1583.



Figure: Figure 1. Mean PRO2 score (A), symptomatic remission (B), and mean IBDQ total score (C) by CDST probability group.
CDST, clinical decision support tool; IBDQ, inflammatory bowel disease questionnaire; PRO, patient reported outcome.
Panels A and C show observed data, panel B shows results based on nonresponse imputed data.
PRO2 is the sum of the stool frequency and abdominal pain score of the Crohn’s disease activity index.


Disclosures:
Parambir S. Dulai: Abbvie – Consultant. Abivax – Consultant. Adiso Therapeutics, Inc – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support. GlaxoSmithKline – Consultant. Janssen – Consultant, Grant/Research Support. Lilly – Consultant. Pfizer – Consultant, Grant/Research Support. PreciDiag – Royalties. Roivant – Consultant. Takeda – Consultant, Grant/Research Support.
Giorgios Bamias: AbbVie – Advisor or Review Panel Member, Grant/Research Support, investigator in research/clinical trials. Adacyte – Advisor or Review Panel Member. Aenorasis – Grant/Research Support. Amgen – Advisor or Review Panel Member. Cooper – Advisor or Review Panel Member. Ferring – Advisor or Review Panel Member. Genesis – Advisor or Review Panel Member. Janssen – Advisor or Review Panel Member. Merck Sharp & Dohme – Advisor or Review Panel Member. Mylan – Advisor or Review Panel Member. Pfizer – Advisor or Review Panel Member, Grant/Research Support. Takeda – Advisor or Review Panel Member, Grant/Research Support, investigator in research/clinical trials.
Vipul Jairath: AbbVie – Advisory Committee/Board Member, consulting/advisory board fees, speaker’s fees. Alimentiv Inc – consulting/advisory board fees. Arena pharmaceuticals – consulting/advisory board fees. Asahi Kasei Pharma – consulting/advisory board fees. Asieris – consulting/advisory board fees. Astra Zeneca – consulting/advisory board fees. Bristol Myers Squibb – consulting/advisory board fees, speaker’s fees. Celltrion – consulting/advisory board fees. Eli Lilly and Company – consulting/advisory board fees. Ferring – consulting/advisory board fees, speaker’s fees. Flagship Pioneering – consulting/advisory board fees. Fresenius Kabi – consulting/advisory board fees, speaker’s fees. Galapagos – consulting/advisory board fees, speaker’s fees. Genentech – consulting/advisory board fees. Gilead – consulting/advisory board fees. GlaxoSmithKline – consulting/advisory board fees. Janssen – consulting/advisory board fees, speaker’s fees. Merck – consulting/advisory board fees. Metacrine – consulting/advisory board fees. Mylan – consulting/advisory board fees. Pandion – consulting/advisory board fees. Pendopharm – consulting/advisory board fees. Pfizer – consulting/advisory board fees, speaker’s fees. Prometheus – consulting/advisory board fees. Protagonist – consulting/advisory board fees. Reistone Biopharma – consulting/advisory board fees. Roche – consulting/advisory board fees. Sandoz – consulting/advisory board fees. Second Genome – consulting/advisory board fees. Shire – speaker’s fees. Sorriso pharmaceuticals – consulting/advisory board fees. Takeda – consulting/advisory board fees, speaker’s fees. Teva – consulting/advisory board fees. Topivert – consulting/advisory board fees. Ventyx – consulting/advisory board fees. Vividion – consulting/advisory board fees.
Anthony Buisson: AbbVie – Consultant, Grant/Research Support, Speakers Bureau. Amgen – Consultant, Speakers Bureau. Arena – Consultant. Biogen – Consultant. Celltrion Healthcare – Consultant, Grant/Research Support, Speakers Bureau. CTMA – Consultant. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant, Speakers Bureau. Guty Care – Consultant. Janssen – Consultant, Grant/Research Support, Speakers Bureau. Lessaffre – Grant/Research Support. Lilly – Consultant, Grant/Research Support, Speakers Bureau. Mayoli-Spindler – Speakers Bureau. MSD – Speakers Bureau. Mylan – Consultant. Nexbiome – Consultant. Pfizer – Consultant, Grant/Research Support, Speakers Bureau. Roche – Consultant, Grant/Research Support. Sanofi-Aventis – Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau. Tillotts – Consultant, Grant/Research Support. Vifor-Pharma – Speakers Bureau.
Marlies Neuhold: Takeda – Employee, Stock Options.
Dirk Lindner: Takeda – Employee, Stock Options.
Christian Agboton: Takeda – Employee, Stock Options.
Laurent Peyrin-Biroulet: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Allergan – personal fees. Alma – personal fees. Amgen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Applied Molecular Transport – personal fees. Arena – personal fees. Biogaran – Advisory Committee/Board Member, Consultant, Speakers Bureau. Biogen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant, Speakers Bureau. Bristol Myers Squibb – personal fees. Celgene – Advisory Committee/Board Member, Consultant, Speakers Bureau. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. CTMA – Stock Options. Eli Lilly – Advisory Committee/Board Member, Consultant, Speakers Bureau. Enterome – personal fees. Enthera – personal fees. Ferring – Advisory Committee/Board Member, Consultant, Speakers Bureau. Forward Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Fresenius – personal fees. Genentech – Advisory Committee/Board Member, Consultant, Speakers Bureau. Gilead – personal fees. H.A.C. Pharma – Advisory Committee/Board Member, Consultant, Speakers Bureau. Hikma – personal fees. Hospira/Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Index Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Lycera – Advisory Committee/Board Member, Consultant, Speakers Bureau. Merck – Advisory Committee/Board Member, Consultant, Speakers Bureau. Mitsubishi – Advisory Committee/Board Member, Consultant, Speakers Bureau. MSD – Grant/Research Support, personal fees. Mylan – personal fees. Nestlé – personal fees. Norgine – Advisory Committee/Board Member, Consultant, Speakers Bureau. Oppilan Pharma – personal fees. OSE Immunotherapeutics – personal fees. Pfizer – personal fees. Pharmacosmos – personal fees. Roche – personal fees. Samsung Bioepis – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sandoz – Advisory Committee/Board Member, Consultant, Speakers Bureau. Sterna – personal fees. Sublimity Therapeutics – personal fees. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Theravance – Advisory Committee/Board Member, Consultant, Speakers Bureau. Tillots – Advisory Committee/Board Member, Consultant, Speakers Bureau. Vifor – Advisory Committee/Board Member, Consultant, Speakers Bureau.


Parambir S. Dulai, MD1, Giorgios Bamias, MD2, Vipul Jairath, MBChB, DPhil3, Anthony Buisson, MD4, Marlies Neuhold, MD5, Dirk Lindner, MSc6, Christian Agboton, MD7, Laurent Peyrin-Biroulet, MD, PhD8. P0723 - Response Trajectory by the Clinical Decision Support Tool Probability Groups in Vedolizumab-Treated Patients With Crohn’s Disease: A Pooled Analysis of GEMINI 2, VISIBLE 2, and VERSIFY, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.