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Tuesday Poster Session

Category: IBD

P3580 - Impact of Guselkumab Therapy on Histologic and Combined Histologic and Endoscopic Outcomes in Patients With Moderately to Severely Active Ulcerative Colitis: Week 12 Results From the Phase 3 QUASAR Induction Study

Tuesday, October 24, 2023
10:30 AM – 4:00 PM PT
Location: Exhibit Hall
Has Audio
Julian Panés, MD, PhD1, Bruce E. Sands, MD, MS, FACG2, Laurent Peyrin-Biroulet, MD, PhD3, Shadi Yarandi, MD4, Kuan-Hsiang G. Huang, MD, PhD4, Matthew Germinaro, MD4, Sunandini Sridhar, PhD4, Patrick Branigan, BS4, Ye Miao, MS4, Hongyan Zhang, PhD4, Xavier Hébuterne, MD, PhD5, Tibor Gyokeres, MD, PhD6, Fumihito Hirai, MD, PhD7, Tadakazu Hisamatsu, MD, PhD8, David T. Rubin, MD, FACG9, Brian G. Feagan, MD10
1Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France; 4Janssen Research & Development, LLC, Spring House, PA; 5CHU de Nice and University Côte d’Azur, Nice, Provence-Alpes-Cote d'Azur, France; 6North-Pest Central Hospital, Military Hospital, Budapest, Budapest, Hungary; 7Fukuoka University Hospital, Fukuoka, Fukuoka, Japan; 8Kyorin University School of Medicine, Tokyo, Tokyo, Japan; 9University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL; 10Western University, London, ON, Canada

Introduction: The Phase 3 QUASAR induction study evaluated efficacy and safety of guselkumab (GUS), an IL-23p19 subunit antagonist, in patients (pts) with moderately to severely active UC. Here we present results for effects of GUS induction on histologic and combined histologic and endoscopic outcomes at Week (Wk) 12.

Methods: Pts with modified Mayo score of 5-9 and a centrally reviewed Mayo endoscopy subscore (MES)≥2 at induction baseline (BL) were randomized 3:2 to receive either GUS 200mg IV or placebo (PBO) IV at Wks0, 4, and 8. Colonic biopsies collected during endoscopy at BL and Wk12 were used to evaluate treatment effect on histology using three methods: Geboes score (GS), Robarts Histopathology Index (RHI), and Nancy Histological Index (NHI). Histologic improvement (GS≤3.1), histologic remission (GS≤2 B.0), combined histologic improvement and endoscopic improvement (GS≤3.1 and MES of 0 or 1 with no friability; histo-endoscopic mucosal improvement; HEMI), and combined histologic remission and endoscopic normalization (GS≤2 B.0 and MES of 0) were evaluated at Wk12. HEMI at Wk12 was a major secondary endpoint. All other analyses were not multiplicity controlled (nominal p-values).

Results: A total of 701 pts were assessed (mean UC disease duration, 7.52yrs; mean modified Mayo score, 6.9; MES of 3, 67.9%). BL demographics and disease characteristics were similar across treatment groups. Histologic activity at BL was similar across the GUS and PBO cohorts: mean total GS (11.8 vs 11.9, respectively), mean RHI (16.6 vs 16.6), and mean NHI (2.7 vs 2.8). The proportion of GUS- and PBO-treated pts with histologic improvement at Wk12 was 44.9% and 21.4%, respectively (adjusted Δ: 23.7%; p< 0.001; Table). Histologic remission at Wk12 was achieved by 39.9% and 18.6% of GUS- and PBO-treated pts, respectively (adjusted Δ: 21.5%; p< 0.001). Identical results were seen across two additional definitions of histologic remission (ie, RHI and NHI). The proportion of GUS-treated pts achieving HEMI at Wk12 was significantly greater than PBO-treated pts (23.5% vs 7.5%, respectively; adjusted Δ: 16.2%; p< 0.001). The proportion of GUS- and PBO-treated pts with histologic remission and endoscopic normalization at Wk12 was 13.5% and 3.9%, respectively (adjusted Δ: 9.8%; p< 0.001).

Discussion: Pts with moderately to severely active UC treated with GUS 200mg IV induction experienced clinically meaningful improvements in histologic and combined histologic and endoscopic outcomes at Wk12.


Disclosures:
Julian Panés: AbbVie – Grant/Research Support, Personal fees. Arena – Consultant. Athos – Consultant. Atomwise – Consultant. Boehringer Ingelheim – Consultant. Celgene – Consultant. Celltrion – Consultant. Ferring – Consultant, Speakers Bureau. Galapagos – Consultant. Genentech/Roche – Consultant. GlaxoSmithKline – Consultant. Immunic – Personal fees. Janssen – Consultant, payment for development of educational presentations. Mirum – Consultant. Morphic – Consultant. Origo – Consultant. Pandion – Consultant. Pfizer Inc – Grant/Research Support, payment for development of educational presentations. Progenity – Consultant. Revolo – Consultant. Takeda – payment for development of educational presentations. Theravance – Consultant. Wasserman – Consultant.
Bruce Sands: AbbVie – Consultant. Abivax – Consultant, Speaker’s fees. Adiso Therapeutics – Consultant. Alimentiv – Consultant. Amgen – Consultant. Arena pharmaceuticals – Consultant. Artizan Biosciences – Consultant. Artugen Therapeutics – Consultant. AstraZeneca – Consultant. Bacainn Therapeutics – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Boston Pharmaceuticals – Consultant. Bristol Myers Squibb – Consultant, Grant/Research Support, speaking fees and other support. Calibr – Consultant. Celltrion – Consultant. ClostraBio – Consultant. Connect Biopharm – Consultant. Cytoki Pharma – Consultant. Eli Lilly – Consultant, speaking fees and other support. Enthera – Consultant. Evommune – Consultant. Ferring – Consultant. Fresenius Kabi – Consultant. Galapagos – Consultant. Genentech – Consultant. Gilead Sciences – Consultant. GlaxoSmithKline – Consultant. Gossamer Bio – Consultant. HMP Acquisition – Consultant. Imhotex – Consultant. Immunic – Consultant. InDex Pharmaceuticals – Consultant. Innovation Therapeutics – Consultant. Inotrem – Consultant. Ironwood Pharmaceuticals – Consultant. Janssen – Grant/Research Support, consulting and speaking fees and other support. Johnson & Johnson – Consultant. Kaleido Biosciences – Consultant. Kallyope – Consultant. Merck – Consultant. MiroBio – Consultant. Morphic Therapeutics – Consultant. MRM Health – Consultant. OSE Immunotherapeutics – Consultant. Pfizer Inc – Consultant, Grant/Research Support, speaking fees and other support. Progenity – Consultant. Prometheus Biosciences – Consultant. Prometheus Laboratories – Consultant. Protagonist Therapeutics – Consultant. Q32 Bio – Consultant. RedHill Biopharma – Consultant. Sun Pharma – Consultant. Surrozen – Consultant. Synlogic Operating Company – Consultant. Takeda – Grant/Research Support, consulting and speaking fees and other support. Target RWE – Consultant. Theravance Biopharma – Consultant, Grant/Research Support. TLL Pharmaceutical – Consultant. USWM Enterprises – Consultant. Ventyx Biosciences – Consultant, personal fees and stock options for consulting. Viela Bio – Consultant.
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.
Shadi Yarandi: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Kuan-Hsiang G. Huang: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Matthew Germinaro: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Sunandini Sridhar: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Patrick Branigan: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Ye Miao: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Hongyan Zhang: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Xavier Hébuterne: Abbvie – Advisory Committee/Board Member, Grant/Research Support, lectures and educational activities. Abivax – Advisory Committee/Board Member, Grant/Research Support. Alphasigma – Grant/Research Support. Amgen – lectures and educational activities. Arena – Grant/Research Support. Boehringer Ingelheim – Advisory Committee/Board Member. Celltrion – Advisory Committee/Board Member, lectures and educational activities. Eli Lilly – Advisory Committee/Board Member, Grant/Research Support. Enterome – Grant/Research Support. Fresenius-Kabi – Advisory Committee/Board Member, Grant/Research Support, lectures and educational activities. Galapagos – Advisory Committee/Board Member. Gilead – Grant/Research Support. InDex Pharmaceuticals – Grant/Research Support. Janssen – Advisory Committee/Board Member, Grant/Research Support, lectures and educational activities. MSD – lectures and educational activities. Nestlé Health Sciences – Advisory Committee/Board Member, lectures and educational activities. Nordic Pharma – Advisory Committee/Board Member, lectures and educational activities. Nutricia – lectures and educational activities. Pfizer – Advisory Committee/Board Member, Grant/Research Support, lectures and educational activities. Prometheus Biosciences – Grant/Research Support. Sangamo – Grant/Research Support. Takeda – Grant/Research Support, lectures and educational activities. Theravance – Grant/Research Support. Tillots – lectures and educational activities. Viatris – lectures and educational activities.
Tibor Gyokeres: Abbvie – Consultant, support for attending meetings and/or travel. BMS – lecture fees. Celltrion – support for attending meetings and/or travel. CSL Behring – lecture fees. Egis – Consultant. Ferring – Consultant, support for attending meetings and/or travel and lecture fees. Fresenius – lecture fees. Ipsen – Consultant, support for attending meetings and/or travel. Janssen – Consultant, support for attending meetings and/or travel and lecture fees. Micromedical – lecture fees. Oncompass – Consultant. Progastro – Consultant. Supremex – support for attending meetings and/or travel and lecture fees. Takeda – support for attending meetings and/or travel and lecture fees.
Fumihito Hirai: Janssen – Consultant, clinical investigator.
Tadakazu Hisamatsu: AbbVie GK – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Alfresa Pharma Corporation and EA Pharma Co., Ltd – Grant/Research Support. Daiichi-Sankyo – Grant/Research Support. EA Pharma Co, Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Eli Lilly – Consultant. Gilead Sciences – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Janssen Pharmaceutical K.K. – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. JIMRO Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. KISSEI PHARMACEUTICAL CO., LTD – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Kyorin Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mitsubishi Tanabe Pharma Corporation – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Mochida Pharmacuetical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nichi-Iko Pharmaceutical Co., Ltd – honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Nippon Kayaku Co., Ltd – Grant/Research Support. Pfizer Japan Inc. – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Takeda Pharmaceutical Co., Ltd – Grant/Research Support, honoraria and had expenses paid to attend or give a presentation/advice at a meeting. Zeria Pharmaceutical Co., Ltd – Grant/Research Support.
David T. Rubin: AbbVie – Consultant. Alike Health – Stock Options. AltruBio – Consultant, Stock Options. Aslan Pharmaceuticals – Consultant. Athos Therapeutics – Consultant. Bellatrix Pharmaceuticals – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Chronicles – Consultant. ClostraBio – Consultant. Connect BioPharma – Consultant. Cornerstones Health, Inc – Advisory Committee/Board Member. Crohn's & Colitis Foundation – Advisory Committee/Board Member. Datos Health – Stock Options. EcoR1 – Consultant. Eli Lilly – Consultant. GastroIntestinal Research Foundation – Grant/Research Support. Genentech/Roche – Consultant. Gilead Sciences – Consultant. Helmsley Charitable Trust – Grant/Research Support. Iterative Health – Consultant. Iterative Health – Stock Options. Janssen – Consultant. Kaleido Biosciences – Consultant. Pfizer – Consultant. Prometheus Biosciences – Consultant. Reistone – Consultant. Seres Therapeutics – Consultant. Syneos – Consultant. Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Trellus Health – Consultant.
Brian Feagan: AbbVie – Advisory Committee/Board Member, Consultant, Speakers Bureau. AbolerIS – Consultant. AgomAB Therapeutics – Consultant. Allianthera – Consultant. Amgen – Advisory Committee/Board Member, Consultant. AnaptysBio – Consultant. Applied Molecular Transport Inc. – Consultant. Arena Pharma – Consultant. Avir – Consultant. Azora Therapeutics – Consultant. Baxter – Consultant. BioJamp – Consultant. Biora Therapeutics – Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Boston Pharma – Consultant. Bristol Myers Squibb – Consultant. Celgene/BMS – Advisory Committee/Board Member, Consultant. Connect BioPharma – Consultant. Cytoki – Consultant. Disc Medicine – Consultant. Duality – Consultant. EcoR1 – Advisory Committee/Board Member, Consultant. Eli Lilly – Consultant. Equillium – Consultant. Ermium – Consultant. Everest Clinical Research Corp. – Consultant. Ferring Pharmaceuticals – Consultant. First Wave – Consultant. Galapagos – Consultant. Galen Atlantica – Consultant. Genentech/Roche – Advisory Committee/Board Member, Consultant. Gilead – Consultant. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. Glenmark – Consultant. Gossamer Pharma – Consultant, stock shareholder. Hoffmann-LaRoche – Consultant. Hot Spot Therapeutics – Consultant. Imhotex – Consultant. ImmunExt – Consultant. Immunic Therapeutics – Consultant. Index Pharma – Advisory Committee/Board Member, Consultant. Intact Therapeutics – Consultant. JAKAcademy – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Speakers Bureau. Japan Tobacco Inc. – Consultant. Kaleido Biosciences – Consultant. L.E.K. Consulting – Consultant. Landos Biopharma – Consultant. Leadiant – Consultant. LifeSci Capital – Consultant. Lument AB – Consultant. Millennium – Consultant. MiroBio – Consultant. Morphic Therapeutics – Advisory Committee/Board Member, Consultant. Mylan – Consultant. Novartis – Advisory Committee/Board Member. OM Pharma – Consultant. Origo BioPharma – Advisory Committee/Board Member, Consultant. Orphagen – Consultant. Otsuka – Consultant. Pandion Therapeutics – Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Play to Know AG – Consultant. Progenity – Advisory Committee/Board Member, Consultant. Prometheus Therapeutics and Diagnostics – Advisory Committee/Board Member, Consultant. Protagonist – Consultant. PTM Therapeutics – Consultant. Q32 Bio – Consultant. Rebiotix – Consultant. RedHill Biopharma – Consultant. Redx – Consultant. Roche – Consultant. Sandoz – Consultant. Sanofi – Consultant. Seres Therapeutics – Consultant. Silverback Therapeutics – Consultant. Surrozen Inc. – Consultant. Takeda – Advisory Committee/Board Member, Consultant, Speakers Bureau. Teva – Advisory Committee/Board Member, Consultant. Thelium – Consultant. Theravance – Consultant. Tigenix – Consultant. Tillotts Pharma – Advisory Committee/Board Member, Consultant. UCB Pharma – Consultant. VHSquared Ltd. – Consultant. Viatris – Consultant. Western University, Alimentiv Inc – Employee. Ysios – Consultant. Ysopia – Consultant. Zealand Pharma – Consultant.


Julian Panés, MD, PhD1, Bruce E. Sands, MD, MS, FACG2, Laurent Peyrin-Biroulet, MD, PhD3, Shadi Yarandi, MD4, Kuan-Hsiang G. Huang, MD, PhD4, Matthew Germinaro, MD4, Sunandini Sridhar, PhD4, Patrick Branigan, BS4, Ye Miao, MS4, Hongyan Zhang, PhD4, Xavier Hébuterne, MD, PhD5, Tibor Gyokeres, MD, PhD6, Fumihito Hirai, MD, PhD7, Tadakazu Hisamatsu, MD, PhD8, David T. Rubin, MD, FACG9, Brian G. Feagan, MD10. P3580 - Impact of Guselkumab Therapy on Histologic and Combined Histologic and Endoscopic Outcomes in Patients With Moderately to Severely Active Ulcerative Colitis: Week 12 Results From the Phase 3 QUASAR Induction Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.