Skip to main content
ACG 2024 Annual Meeting Main banner
Icon Legend
This session is not in your Favorites.
This session is in your Favorites. Click again to remove it.
Presentation Icons
ACG Award Winner
ACG Award Winner
ACG Newsworthy Abstract
ACG Newsworthy Abstract
Registration Required
Registration Required
No CME
No CME
On-Demand Video
On-Demand Video
Livestream
Livestream
Back
Livestream

Oral Paper Presentation

Annual Scientific Meeting

Session: Plenary Session 4B - IBD

73 - Week 48 Efficacy Of Guselkumab And Ustekinumab In Crohn’s Disease Based On Prior Response/Exposure To Biologic Therapy: Results From The GALAXI 2 and 3 Phase 3 Studies

Wednesday, October 30, 2024
9:50 AM – 10:00 AM ET
Location: Terrace Ballroom 2-3
Livestream
Silvio Danese, MD, PhD1, Anita Afzali, MD, MPH, MHCM, FACG2, Remo Panaccione, MD3, Julián Panés, MD4, Walter Reinisch, MD, PhD5, Natalie A. Terry, MD, PhD6, Leonardo Salese, MD7, Rian Van Rampelbergh, MD8, Kitty Y.Y.. Wan, PhD9, Zijiang Yang, PhD10, Jewel Johanns, PhD6, Marcin Zmudziński, MD, PhD11, Eran Zittan, MD12, Katsuyoshi Matsuoka, MD13, Vipul Jairath, MBChB14, David T. Rubin, MD, FACG15
1Humanitas Clinical and Research Center - IRCCS, Rozzano and Humanitas University, Pieve Emanuele, Milan, Lombardia, Italy; 2University of Cincinnati College of Medicine, Cincinnati, OH; 3University of Calgary, Calgary, AB, Canada; 4Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Catalonia, Spain; 5Medical University of Vienna, Vienna, Wien, Austria; 6Janssen Research & Development, LLC, Spring House, PA; 7Janssen Research & Development, LLC, Horsham, PA; 8Janssen Research and Development, Antwerp, Antwerpen, Belgium; 9Janssen Research & Development, Binningen, Basel-Landschaft, Switzerland; 10Janssen Research and Development, Horsham, PA; 11Gastromed, Toruń, Kujawsko-Pomorskie, Poland; 12The Abraham and Sonia Rochlin IBD Unit, Emek Medical Center, Afula, HaZafon, Israel; 13Toho University Sakura Medical Center, Sakura, Chiba, Japan; 14Western University, London, ON, Canada; 15University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL

Introduction: GALAXI 2 & 3 (NCT03466411) are identically designed 48-week (Wk), randomized, double-blind, double-dummy, placebo (PBO)- and ustekinumab (UST)-comparator, treat-through registrational trials assessing the efficacy and safety of therapy with guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, in participants (pts) with moderately to severely active Crohn’s disease (CD). Wk48 comparisons of GUS and UST in the pooled GALAXI 2 & 3 dataset were previously reported. Here we explore the impact of biologic therapy exposure on GUS and UST efficacy for these same endpoints.

Methods: Pts with inadequate response or intolerance to conventional therapies or biologic therapies (BIO-ir), active CD (CDAI 220–450 + mean daily SF >3 or AP >1), and SES-CD≥6 (≥4 for isolated ileal disease) were eligible. Randomization was stratified by CDAI score, SES-CD score, BIO-ir status, and corticosteroid use with pts assigned 2:2:2:1 to GUS 200mg IV q4w (x3)→100mg SC q8w, GUS 200mg IV q4w (x3)→200mg SC q4w, UST ~6mg/kg IV (x1)→90mg SC q8w, or PBO. Pooled Wk48 analyses comparing GUS and UST (active comparator) in all pts were prespecified major secondary, multiplicity-controlled endpoints. Pooled analyses in the BIO-ir and BIO-naïve subgroups were prespecified but not controlled for multiple comparisons.

Results: Across the pooled GALAXI 2 & 3 dataset, 52% (456/873) of pts randomly assigned to GUS or UST had prior history of BIO-ir and 42% (365/873) were BIO-naïve (6% [52/873] had prior exposure to biologics but no documented failure). At Wk48, in both the BIO-ir and BIO-naïve subgroups, both GUS dose groups demonstrated greater rates of endoscopic response, endoscopic remission, and the composite endpoints of clinical remission and endoscopic response and clinical remission and endoscopic remission (deep remission) compared with the UST group (Table). Rates of clinical remission at Wk48 in the BIO-ir subgroup were greater in both GUS dose groups compared to UST and similar in the BIO-naïve subgroup.

Discussion: Guselkumab was efficacious in pts with CD regardless of prior biologic exposure. In pooled analyses of the double-blind GALAXI 2 & 3 trials, both GUS doses demonstrated greater rates of efficacy versus UST across multiple endpoints in the BIO-naïve subgroup and the more refractory BIO-ir subgroup.
Upload Image

Table: Table. Comparison of guselkumab (GUS) and ustekinumab (UST) for long-term clinical and endoscopic endpoints in all participants and BIO-ir and BIO-naïve subgroups in the pooled GALAXI 2 & 3 dataset


Disclosures:
Silvio Danese: AbbVie – Consultant, Speakers Bureau. Alimentiv – Consultant. Allergan – Consultant. Amgen – Consultant, Speakers Bureau. Applied Molecular Transport – Consultant. AstraZeneca – Consultant. Athos Therapeutics – Consultant. Biogen – Consultant. Boehringer Ingelheim – Consultant. Bristol Myers Squibb – Consultant. Celgene – Consultant. Celltrion Healthcare – Consultant. Dr Falk Pharma – Consultant. Eli Lilly and Company – Consultant. Enthera – Consultant. Ferring – Consultant, Speakers Bureau. Gilead – Consultant, Speakers Bureau. Hospira – Consultant. Inotrem – Consultant. Janssen – Consultant, Speakers Bureau. Johnson & Johnson – Consultant. Morphic – Consultant. MSD – Consultant. Mundipharma – Consultant. Mylan – Consultant, Speakers Bureau. Pfizer Inc – Consultant, Speakers Bureau. Roche – Consultant. Sandoz – Consultant. Sublimity Therapeutics – Consultant. Takeda – Consultant, Speakers Bureau. Teladoc Health – Consultant. TiGenix – Consultant. UCB Inc. – Consultant. Vial – Consultant. Vifor – Consultant.
Anita Afzali: AbbVie – Consultant. Bristol Myers Squibb/Celgene – Consultant. Cullgen – Consultant. DiaSorin – Consultant. Eli Lilly – Consultant. Gilead – Consultant. IBD Horizons – Consultant. Janssen – Consultant. Pfizer – Consultant. Takeda – Consultant. TLL Pharmaceuticals – Consultant.
Remo Panaccione: Élan – Consultant. Abbivax – Consultant. Abbott – Consultant. AbbVie – Advisory Committee/Board Member, Consultant, Speaking Fees. Alimentiv – Advisory Committee/Board Member, Consultant. Amgen – Advisory Committee/Board Member, Consultant, Speaker Fees. Arena Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speaker Fees. AstraZeneca – Advisory Committee/Board Member, Consultant. Biogen – Advisory Committee/Board Member, Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant, Speaker Fees. Celgene – Advisory Committee/Board Member, Consultant, Speaker Fees. Celltrion – Consultant. Cosmos Pharmaceuticals – Consultant. Eisai – Consultant. Ferring – Advisory Committee/Board Member, Consultant, Speaker Fees. Fresenius Kabi – Advisory Committee/Board Member, Consultant, Speaker Fees. Galapagos – Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Advisory Committee/Board Member, Consultant, Speaker Fees. GlaxoSmithKline – Advisory Committee/Board Member, Consultant. JAMP Bio – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant, Speaker Fees. Lilly – Advisory Committee/Board Member, Consultant, Speaker Fees. Merck – Advisory Committee/Board Member, Consultant, Speaker Fees. Mylan – Advisory Committee/Board Member, Consultant. Novartis – Advisory Committee/Board Member, Consultant. Oppilan Pharma – Advisory Committee/Board Member, Consultant. Organon – Advisory Committee/Board Member, Consultant, Speaker Fees. Pandion Pharma – Advisory Committee/Board Member, Consultant. Pendopharm – Consultant. Pfizer Inc – Advisory Committee/Board Member, Consultant, Speaker Fees. Progenity – Advisory Committee/Board Member, Consultant. Prometheus Biosciences – Consultant. Protagonist Therapeutics – Advisory Committee/Board Member, Consultant. Roche – Advisory Committee/Board Member, Consultant, Speaker Fees. Sandoz – Advisory Committee/Board Member, Consultant, Speaker Fees. Satisfai Health – Consultant. Shire – Advisory Committee/Board Member, Consultant, Speaker Fees. Sublimity Therapeutics – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant, Speaker Fees. Theravance – Consultant. Trellus – Consultant. UCB – Consultant. Ventyx – Advisory Committee/Board Member, Consultant. Viatris – Consultant.
Julián Panés: AbbVie – Consultant, Honorarium. Alimentiv – Advisory Committee/Board Member, Consultant, Honorarium. Athos – Consultant, Honorarium. Atomwise – Consultant, Honorarium. Boehringer Ingelheim – Consultant, Honorarium. Celsius – Consultant, Honorarium. Ferring – Consultant, Honorarium. Galapagos – Consultant, Honorarium. Genentech/Roche – Consultant, Honorarium. GlaxoSmithKline – Consultant, Honorarium. Janssen – Consultant, Honorarium. Mirum – Advisory Committee/Board Member, Consultant, honorarium. Nimbus – Consultant, Honorarium. Pfizer – Consultant, Honorarium. Progenity – Consultant, Honorarium. Prometheus – Consultant, Honorarium. Protagonist – Consultant, Honorarium. Revolo – Consultant, Honorarium. Sanofi – Advisory Committee/Board Member, Consultant, Honorarium. Sorriso – Advisory Committee/Board Member, Consultant, Honorarium. Surrozen – Advisory Committee/Board Member, Consultant, Honorarium. Takeda – Consultant, Honorarium. Wasserman – Consultant, Honorarium.
Walter Reinisch: AbbVie – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Amgen – Advisory Committee/Board Member, Consultant. AOP Orphan – Consultant. Boehringer Ingelheim – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Calyx – Consultant. Celltrion – Advisory Committee/Board Member, Consultant, Speakers Bureau. Eli Lilly – Consultant. Ferring – Speakers Bureau. Galapagos – Advisory Committee/Board Member, Consultant, Speakers Bureau. Gilead – Consultant. Index Pharma – Consultant. Janssen – Advisory Committee/Board Member, Consultant, Grant/Research Support, Speakers Bureau. Medahead – Consultant. Microbiotica – Consultant. MSD – Speakers Bureau. Pfizer – Advisory Committee/Board Member, Consultant, Speakers Bureau. Roche – Speakers Bureau. Sandoz – Grant/Research Support. Sanofi – Grant/Research Support. Sobi – Speakers Bureau. Takeda – Consultant, Grant/Research Support, Speakers Bureau.
Natalie A. Terry: Janssen Research & Development, LLC – Employee, Stock Options.
Leonardo Salese: Johnson & Johnson – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Rian Van Rampelbergh: Janssen Research & Development (a Johnson & Johnson Company) – Employee, Stock Options.
Kitty Wan: Johnson & Johnson – Employee, Stock-publicly held company(excluding mutual/index funds). Novartis – Stock-publicly held company(excluding mutual/index funds).
Zijiang Yang: Janssen Research & Development (a Johnson & Johnson Company) – Employee, Stock Options.
Jewel Johanns: Janssen Research & Development, LLC – Employee, Stock-publicly held company(excluding mutual/index funds).
Marcin Zmudziński: Abbvie – Consultant. Alimentiv – Consultant. Allergan – Consultant. AstraZeneca – Consultant. Celgene – Consultant. Celltrion – Consultant. Eli Lilly – Consultant. Gilead – Consultant. Index – Consultant. Janssen – Clinical trial investigator. Pfizer – Consultant. Polpharma – Consultant. Prometheus – Consultant. Protagonist Therapeutics – Consultant. Rejston – Consultant. Roche – Consultant. Takeda – Consultant. Teva – Consultant. Theravance Biopharma – Consultant.
Eran Zittan: AbbVie – Consultant, Grant/Research Support. Celgene – Consultant, Grant/Research Support. Janssen – Consultant, Grant/Research Support. Neopharm – Consultant, Grant/Research Support. Pfizer – Consultant, Grant/Research Support. Takeda – Consultant, Grant/Research Support.
Katsuyoshi Matsuoka: AbbVie – Grant/Research Support, Speakers Bureau. EA Pharma – Speakers Bureau. Eli Lilly – Speakers Bureau. Gilead – Speakers Bureau. Janssen – Speakers Bureau. JIMRO – Grant/Research Support. Kissei – Speakers Bureau. Mitsubishi Tanabe – Speakers Bureau. Mochida – Grant/Research Support, Speakers Bureau. Nippon Kayaku – Grant/Research Support. Pfizer – Speakers Bureau. Takeda – Speakers Bureau. Zeria – Grant/Research Support.
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.
David T. Rubin: AbbVie – Consultant. Altrubio – Consultant. Apex – Consultant. Avalo Therapeutics – Consultant. Boehringer Ingelheim – Consultant. Bristol-Myers Squibb – Consultant. Buhlmann Diagnostics Corp – Consultant. Celgene – Consultant. Connect BioPharma – Consultant. Intouch Group – Consultant. Iterative Health – Consultant. Janssen – Consultant. Lilly – Consultant. Pfizer – Consultant. Samsung Neurologica – Consultant. Takeda – Consultant, Grant/Research Support.


Silvio Danese, MD, PhD1, Anita Afzali, MD, MPH, MHCM, FACG2, Remo Panaccione, MD3, Julián Panés, MD4, Walter Reinisch, MD, PhD5, Natalie A. Terry, MD, PhD6, Leonardo Salese, MD7, Rian Van Rampelbergh, MD8, Kitty Y.Y.. Wan, PhD9, Zijiang Yang, PhD10, Jewel Johanns, PhD6, Marcin Zmudziński, MD, PhD11, Eran Zittan, MD12, Katsuyoshi Matsuoka, MD13, Vipul Jairath, MBChB14, David T. Rubin, MD, FACG15, 73, Week 48 Efficacy Of Guselkumab And Ustekinumab In Crohn’s Disease Based On Prior Response/Exposure To Biologic Therapy: Results From The GALAXI 2 and 3 Phase 3 Studies, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.