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Monday Poster Session

Category: IBD

P2198 - The Efficacy of Induction Treatment with Guselkumab in Patients with Moderately to Severely Active Ulcerative Colitis: Phase 3 QUASAR Induction Study Results at Week 12 by Prior Advanced Therapy History

Monday, October 23, 2023
10:30 AM – 4:15 PM PT
Location: Exhibit Hall
Brian Bressler, MD, MS, FRCPC1, Laurent Peyrin-Biroulet, MD, PhD2, Jessica R.. Allegretti, MD, MPH3, Kuan-Hsiang G. Huang, MD, PhD4, Matthew Germinaro, MD4, Nicole Shipitofsky, PharmD4, Ye Miao, MS4, Hongyan Zhang, PhD4, Martin Bortlik, PhD5, Tibor Hlavaty, MD, PhD6, Toshimitsu Fujii, MD, PhD7, Brian G. Feagan, MD8, Bruce E. Sands, MD, MS, FACG9, Axel Dignass, MD, PhD10
1St. Paul’s Hospital, Vancouver, BC, Canada; 2Last Inserm U954 and CHU de Nancy, Lorraine University, Vandoeuvre-lès-Nancy, Lorraine, France; 3Brigham and Women's Hospital, Harvard Medical School, Boston, MA; 4Janssen Research & Development, LLC, Spring House, PA; 5Nemocnice České Budějovice, Ceske Budejovice, Moravskoslezsky kraj, Czech Republic; 6Cliniq s.r.o, Bratislava, Bratislava, Slovakia; 7Tokyo Medical and Dental University, Tokyo, Tokyo, Japan; 8Western University, London, ON, Canada; 9Icahn School of Medicine at Mount Sinai, New York, NY; 10Agaplesion Markus Hospital, Goethe University, Frankfurt, Hessen, Germany

Introduction: The Phase 3 QUASAR induction study (NCT04033445) was a randomized, double-blind, placebo-controlled study that evaluated guselkumab (GUS), an interleukin-23 p19 subunit antagonist, in patients (pts) with moderately to severely active ulcerative colitis (UC) who had an inadequate response, loss of response, or intolerance to corticosteroids, immunosuppressants and/or advanced therapy (ADT, i.e., tumor necrosis factor antagonists, integrin receptor antagonists [vedolizumab], and/or Janus kinase [JAK] inhibitors [tofacitinib]). Here we report induction efficacy results for GUS compared with placebo (PBO) by history of inadequate response, loss of response, or intolerance to ADT (ADT-IR).

Methods: Pts were randomized 3:2 to receive IV GUS 200mg or PBO at Weeks (Wks) 0, 4, and 8. The primary analysis population included pts with a baseline modified Mayo score of 5 to 9 and a centrally reviewed endoscopy subscore ≥2. Primary endpoint was clinical remission at Wk12. Symptomatic remission, clinical response, endoscopic improvement, histo-endoscopic mucosal improvement (HEMI), and endoscopic normalization were assessed at Wk12.

Results: Of the 701 pts in the primary analysis population, 357 (50.9%) had no history of ADT-IR (of which 95.0% were ADT-naïve) ; 344 (49.1%) had a history of ADT-IR. Among the ADT-IR pts, the proportions with a history of inadequate response/loss of response/intolerance to TNF antagonists, vedolizumab, tofacitinib and multiple ADT classes were 87.5%, 54.1%, 18.0% and 47.4%, respectively. At baseline, pts with a history of ADT-IR had longer disease duration (mean 8.9 vs 6.2 yrs), more severe endoscopic disease (endoscopy subscore of 3, 78.5% vs 57.7%), higher CRP (median 5.3 mg/L vs 3.4 mg/L and proportion of pts >3mg/L 64.1% vs 53.7%) and higher fecal calprotectin (median 1647 mg/kg vs 1589 mg/kg and proportion of pts >250 mg/kg 92.3% vs 86.9%) compared with pts without a history of ADT-IR. Greater proportions of patients treated with GUS vs PBO achieved primary and key secondary endpoints at Wk12 in both subgroups of pts with and without a history of ADT-IR (Table1). Treatment differences for GUS vs PBO were generally greater among pts without a history of ADT-IR compared with those with such a history.

Discussion: Induction treatment with GUS 200mg IV vs PBO resulted in greater improvements across key clinical, symptomatic, and endoscopic/histologic outcomes at Wk12 among moderately to severely active UC pts with and without a history of ADT-IR.


Disclosures:
Brian Bressler: AbbVie – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Alimentiv – Advisory Committee/Board Member. Allergan – Advisory Committee/Board Member. Alvine – Grant/Research Support. Amgen – Advisory Committee/Board Member, Grant/Research Support. AMT – Advisory Committee/Board Member. Bausch Health – Advisory Committee/Board Member. Boehringer Ingelheim – Grant/Research Support. Bristol Myers Squibb – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Celgene – Advisory Committee/Board Member, Grant/Research Support. Ferring – Advisory Committee/Board Member, Speakers Bureau. Fresenius Kabi – Advisory Committee/Board Member. Genentech – Advisory Committee/Board Member, Grant/Research Support. Gilead – Advisory Committee/Board Member. GlaxoSmithKline – Grant/Research Support. Iterative Scopes – Advisory Committee/Board Member. Janssen – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Merck – Advisory Committee/Board Member, Grant/Research Support, Speakers Bureau. Microbiome Insights – Advisory Committee/Board Member. Mylan – Advisory Committee/Board Member. Novartis – Advisory Committee/Board Member, Speakers Bureau. Pendopharm – Advisory Committee/Board Member. Pfizer – Advisory Committee/Board Member, Speakers Bureau. Protagonist – Advisory Committee/Board Member. Qu Biologic – Grant/Research Support, Stock Options. Takeda – Advisory Committee/Board Member, Speakers Bureau.
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.
Jessica Allegretti: Abbvie – Consultant, Speakers Bureau. Adiso Therapeutics – Consultant. Artizan – Consultant. Artugen Therapeutics – Consultant. Baccain – Consultant. Bristol-Myers Squibb/Celgene – Consultant, Speakers Bureau. Ferring Pharmaceuticals – Consultant. Finch Therapeutics – Consultant. Iterative Scopes – Consultant. Janssen – Consultant, Grant/Research Support, Speakers Bureau. Merck – Consultant, Grant/Research Support. Morphic – Consultant. Pandion Therapeutics – Consultant. Pfizer – Consultant, Grant/Research Support. Roivant Sciences – Consultant. Seres Therapeutics – Consultant. Servatus – Consultant. Summit – Consultant.
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).
Nicole Shipitofsky: 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).
Martin Bortlik: Janssen – Consultant, clinical investigator.
Tibor Hlavaty: Janssen – Consultant, clinical investigator.
Toshimitsu Fujii: AbbVie – Grant/Research Support, Speakers Bureau. Ajinomoto Pharma – Speakers Bureau. Alfresa – Grant/Research Support. Boehringer Ingelheim – Grant/Research Support, Speakers Bureau. Bristol-Myers Squibb – Grant/Research Support, Speakers Bureau. Celgene – Grant/Research Support. Daiichi Sankyo – Speakers Bureau. EA Pharma – Grant/Research Support, Speakers Bureau. Eisai – Grant/Research Support, Speakers Bureau. Gilead Sciences – Grant/Research Support. Janssen – Grant/Research Support, Speakers Bureau. Kissei – Grant/Research Support, Speakers Bureau. Kyorin – Speakers Bureau. Kyowa Hakko Kirin – Speakers Bureau. Lilly – Grant/Research Support. Mebix – Grant/Research Support. Mitsubishi-Tanabe – Speakers Bureau. Mochida – Speakers Bureau. Nichiiko – Speakers Bureau. Nippon Kayaku – Speakers Bureau. Pfizer – Speakers Bureau. Sanofi – Grant/Research Support. Taiho – Speakers Bureau. Takeda – Grant/Research Support, Speakers Bureau. Zeria Pharma – Speakers Bureau.
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.
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.
Axel Dignass: AbbVie – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Abivax – participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. Amgen – Consultant. Arena Pharmaceuticals – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. Biogen – Consultant, Speakers Bureau. Boehringer Ingelheim – Consultant. Bristol Myers Squibb/Celgene – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees. CED Service GmbH – Speakers Bureau. Celltrion – Consultant, Speakers Bureau. Dr Falk Foundation – Consultant, participation in clinical trials, review activities and manuscript preparation, Speakers Bureau. Ferring – Consultant, Speakers Bureau. Fresenius Kabi – Consultant. Galapagos – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Gilead – participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. High5MD – Speakers Bureau. Janssen – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Lilly – Consultant. Materia Prima – Speakers Bureau. MedToday – Speakers Bureau. MSD – Consultant, Speakers Bureau. Pfizer – Consultant, participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees, Speakers Bureau. Pharmacosmos – Consultant. Roche/Genentech – Consultant. Sandoz/Hexal – Consultant. Streamed-Up – Speakers Bureau. Takeda – Consultant, manuscript preparation, Speakers Bureau. Thieme – manuscript preparation. Tillotts – Consultant, Speakers Bureau. UniMed Verlag – manuscript preparation. Vifor Pharma – Consultant, Speakers Bureau.


Brian Bressler, MD, MS, FRCPC1, Laurent Peyrin-Biroulet, MD, PhD2, Jessica R.. Allegretti, MD, MPH3, Kuan-Hsiang G. Huang, MD, PhD4, Matthew Germinaro, MD4, Nicole Shipitofsky, PharmD4, Ye Miao, MS4, Hongyan Zhang, PhD4, Martin Bortlik, PhD5, Tibor Hlavaty, MD, PhD6, Toshimitsu Fujii, MD, PhD7, Brian G. Feagan, MD8, Bruce E. Sands, MD, MS, FACG9, Axel Dignass, MD, PhD10. P2198 - The Efficacy of Induction Treatment with Guselkumab in Patients with Moderately to Severely Active Ulcerative Colitis: Phase 3 QUASAR Induction Study Results at Week 12 by Prior Advanced Therapy History, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.