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Abstract Number: 1136

Efficacy And Safety of Guselkumab Therapy in Patients With Moderately to Severely Active Crohn’s Disease: Results of the Galaxi 2 & 3 Phase 3 Studies

Remo Panaccione1, Silvio Danese2, Brian G. Feagan3, Geert D’Haens4, Anita Afzali5, Walter Reinisch6, Julián Panés7, David T. Rubin8, Jane Andrews9, Tadakazu Hisamatsu10, Natalie A. Terry11, Leonardo Salese11, Rian Van Rampelbergh12, Mary Ellen Frustaci11, Zijiang Yang11, Jewel Johanns11, Kitty Yuen Yi Wan13, Jacqueline Yee14 and Bruce E. Sands15, 1Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada, Calgary, AB, Canada, 2Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy, 3Alimentiv Inc, London, ON, Canada, London, ON, Canada, 4Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, The Netherlands, Amsterdam, Netherlands, 5Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA, Cincinnati, OH, 6Division of Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria, Vienna, Austria, 7Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain, Barcelona, Spain, 8University of Chicago School of Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA, Chicago, IL, 9Gastrointestinal Services, Surgery Program, Central Adelaide Local Health Network and University of Adelaide, Adelaide, SA, Australia, Adelaide, South Australia, Australia, 10Department of Gastroenterology and Hepatology, Kyorin University, Tokyo, Japan, Tokyo, Japan, 11Janssen Research & Development, LLC, Spring House, PA, USA, Spring House, PA, 12Janssen Research & Development, Antwerp, Belgium, Antwerp, Belgium, 13Janssen Research & Development, Basel, Switzerland, Basel, Switzerland, 14Janssen Research & Development, LLC, Raritan, NJ, USA, Raritan, NJ, 15Icahn School of Medicine at Mount Sinai, New York, NY, USA, New York, NY

Meeting: ACR Convergence 2024

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Session Information

Date: Sunday, November 17, 2024

Title: Miscellaneous Rheumatic & Inflammatory Diseases Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: GALAXI 2 & 3 (G2 & G3) are identical 48-week, randomized, double-blind, double-dummy, placebo (PBO)- and active- comparator (ustekinumab; UST) treat-through registrational trials assessing the efficacy and safety of guselkumab (GUS), a dual-acting IL-23p19 subunit antagonist, in patients with Crohn’s disease (CD).

Methods: Patients with moderately to severely active CD (Crohn’s Disease Activity Index [CDAI] 220–450 + mean daily SF >3 or AP >1), Simple Endoscopic Score [SES]-CD≥6 (≥4 for isolated ileal disease), and inadequate response or intolerance to conventional or biologic (BIO-ir) therapy were eligible. Randomization was stratified by CDAI (≤300 or >300), SES-CD (≤12 or >12), BIO-ir status, and corticosteroid (CS) use with patients assigned 2:2:2:1 to GUS 200 mg intravenous (IV) every 4 weeks (q4w) (x3)→200 mg subcutaneous (SC) q4w, GUS 200 mg IV q4w (x3)→100 mg SC q8w, UST ~6 mg/kg IV (x1)→90 mg SC q8w, or PBO. PBO patients not in clinical response at week 12 (W12) switched to UST IV→90 mg SC q8w. In each trial, the composite co-primary endpoints were clinical response at W12 + clinical remission at W48 and clinical response at W12 + endoscopic response at W48, comparing each GUS regimen to PBO. Primary and major secondary endpoints were multiplicity controlled; treatment differences were analyzed based on the common risk difference test. Pooled analyses of GUS vs UST were prespecified major secondary endpoints.

Results: The primary analysis sets in G2 & G3 included 508 and 513 patients, respectively. Baseline characteristics were similar across trials: CDAI (G2: 295.0, G3: 294.7), SES-CD (13.1, 12.8), BIO-ir history (52.8%, 51.9%), oral CS use (37.4%, 36.1%). Patients receiving GUS 200 mg IV had significantly greater (P< .001) rates at W12 vs PBO of clinical remission (G2: 47.1% vs 22.4%, ∆25.1%; G3: 47.1% vs 15.3%, ∆31.2%) and endoscopic response (G2: 37.7% vs 10.5%, ∆27.7%; G3: 36.2% vs 13.9%, ∆22.1%). In both trials, significantly greater (P< .001) proportions of patients receiving GUS 100 mg SC q8w or 200 mg SC q4w achieved the co-primary endpoints relative to PBO (Fig 1a & 1b). In the W48 pooled analyses (Fig 1c) both GUS doses demonstrated superiority to UST for endoscopic response (GUS 100 mg SC q8w vs UST: ∆10.6%, GUS 200 mg SC q4w vs UST: ∆15.6%), endoscopic remission (∆8.5%, ∆12.3%), deep remission (∆7.4%, ∆11.3%), and clinical remission + endoscopic response (∆7.8%, ∆13.6%). Through W48, the proportions of GUS patients with ≥1 adverse events (AEs), ≥1 serious AEs, AEs leading to discontinuation, and infections were similar to PBO and UST (Table). Overall, the proportions of patients with serious infections and AEs of interest were low and similar between GUS and UST.

Conclusion: In the double-blind GALAXI 2 & 3 trials, GUS was statistically superior to PBO for short- and long-term clinical and endoscopic endpoints. Both GUS doses were statistically superior to UST at W48 across multiple major secondary endpoints in the pooled analyses. Safety data for both GUS regimens in patients with CD were consistent with the known safety profile of GUS in approved indications.

Supporting image 1

Supporting image 2


Disclosures: R. Panaccione: Abbivax, 12, Consulting fees, Abbott, 12, Consulting fees, AbbVie, 5, 12, Consulting fees, Speeker's fee, Alimentiv (formerly Robarts), 12, Consulting fees, Amgen, 12, Consulting fees, Speeker's fee, Arena Pharmaceuticals, 12, Consulting fees, Speeker's fee, AstraZeneca, 12, Consulting fees, Biogen, 12, Consulting fees, Boehringer Ingelheim, 12, Consulting fees, Bristol-Myers Squibb, 12, Consulting fees, Speeker's fee, Celgene, 12, Consulting fees, Speeker's fee, Celltrion, 12, Consulting fees, Cosmos Pharmaceuticals, 12, Consulting fees, Eisai, 12, Consulting fees, Elan, 12, Consulting fees, Eli Lilly, 12, Consulting fees, Speeker's fee, Ferring, 12, Consulting fees, Speeker's fee, Fresenius Kabi, 12, Consulting fees, Speeker's fee, Galapagos, 12, Consulting fee, Genentech, 12, Consulting fees, Gilead Sciences, 12, Consulting fees, Speeker's fee, GlaxoSmithKline, 12, Consulting fees, JAMP Bio, 12, Consulting fees, Janssen, 5, 12, Consulting fees, Speeker's fee, Merck, 12, Consulting fees, Speeker's fee, Mylan, 12, Consulting fees, Novartis, 12, Consulting fees, Oppilan Pharma, 12, Consulting fees, Organon, 12, Consulting fees, Speeker's fee, Pandion Pharma, 12, Consulting fees, Pendopharm, 12, Consulting fees, Pfizer, 5, 12, Consulting fees, Speeker's fee, Progenity, 12, Consulting fees, Prometheus Biosciences, 12, Consulting fees, Protagonist Therapeutics, 12, Consulting fees, Roche, 12, Consulting fees, Speeker's fee, Sandoz, 12, Consulting fees, Speeker's fee, Satisfai Health, 12, Consulting fees, Shire, 12, Consulting fees, Speeker's fee, Sublimity Therapeutics, 12, Consulting fees, Takeda Pharmaceuticals, 5, 12, Consulting fees, Speeker's fee, Theravance Biopharma, 12, Consulting fees, Trellus, 12, Consulting fees, UCB, 12, Consulting fees, Ventyx, 12, Consulting fees, Viatris, 12, Consulting fees; S. Danese: AbbVie, 12, Consultancy fees, Lecture fees, Alimentiv, 12, Consultancy fees, Allergan, 12, Consultancy fees, Amgen, 12, Consultancy fees, Lecture fees, AstraZeneca, 12, Consultancy fees, Athos Therapeutics, 1, Biogen, 12, Consultancy fees, Boehringer Ingelheim, 12, Consultancy fees, Celgene, 12, Consultancy fees, Celltrion, 12, Consultancy fees, Eli Lilly, 12, Consultancy fees, Enthera, 12, Consultancy fees, Ferring Pharmaceuticals, 12, Consultancy fees, Lecture fees, Gilead, 12, Consultancy fees, Lecture fees, Hospira, 12, Consultancy fees, Inotrem, 12, Consultancy fees, Janssen, 12, Consultancy fees, Lecture fees, Johnson & Johnson, 12, Consultancy fees, MSD, 12, Consultancy fees, Mundipharma, 12, Consultancy fees, Mylan, 12, Consultancy fees, Lecture fees, Pfizer, 12, Consultancy fees, Lecture fees, Roche, 12, Consultancy fees, Sandoz, 12, Consultancy fees, Sublimity Therapeutics, 12, Consultancy fees, Takeda, 12, Consultancy fees, Lecture fees, TiGenix, 12, Consultancy fees, UCB Inc, 12, Consultancy fees, Vifor, 12, Consultancy fees; B. Feagan: AbbVie, 6, 12, Consulting fees, received support for attending meetings or for travel, participated on a data safety monitoring board or advisory board, AbolerIS, 12, Consulting fees, AgomAB Therapeutics, 12, Consulting fees, Allianthera, 12, Consulting fees, Amgen, 12, Consulting fees, participated on a data safety monitoring board or advisory board, AMT, 12, Participated on a data safety monitoring board or advisory board, AnaptysBio, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Applied Molecular Transport, 12, Consulting fees, Arena Pharma, 12, Consulting fees, Atomwise, 12, mConsulting fees, Avoro Capital Advisors, 12, Consulting fees, Axio Research, 12, Participated on a data safety monitoring board or advisory board, BioJamp, 12, Consulting fees, Biora Therapeutics, 12, Consulting fees, Boehringer-Ingelheim, 12, Consulting fees, support for attending meetings or for travel, participated on a data safety monitoring board or advisory board, Boxer, 12, Consulting fees, Celgene/Bristol-Myers Squibb, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Celsius Therapeutics, 12, Consulting fees, Connect BioPharma, 12, Consulting fees, Cytoki, 12, Consulting fees, Disc Medicine, 12, Consulting fees, Duality, 12, Consulting fees, EcoR1, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Eli Lilly, 12, Participated on a data safety monitoring board or advisory board, Equillium, 12, Consulting fees, Ermium, 12, Consulting fees, First Wave, 12, Consulting fees, First Word Group, 12, Consulting fees, Galapagos, 12, Consulting fees, Galen Atlantica, 12, Consulting fees, Genentech/Roche, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Gilead, 12, Consulting fees, GlaxoSmithKline, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Gossamer Pharma, 11, 12, Consulting fees, Hinge Bio, 12, Consulting fees, Hot Spot Therapeutics, 12, Consulting fees, Imhotex, 12, Consulting fees, Immunic Therapeutics, 12, Consulting fees, Index Pharma, 12, Consulting fees, participated on a data safety monitoring board or advisory board, JAKAcademy, 12, Consulting fees, Janssen, 6, 12, Consulting fees, support for attending meetings or for travel, participated on a data safety monitoring board or advisory board, Japan Tobacco Inc, 12, Consulting fees, Kaleido Biosciences, 12, Consulting fees, Landos Biopharma, 12, Consulting fees, Leadiant, 12, Consulting fees, LEK Consulting, 12, Consulting fees, Lenczner Slaght, 12, Payment for expert testimony, LifeSci Capital, 12, Consulting fees, Lument AB, 12, Consulting fees, Millennium, 12, Consulting fees, MiroBio, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Morgan Lewis, 12, Payment for expert testimony, Morphic Therapeutics, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Mylan, 12, Consulting fees, OM Pharma, 12, Consulting fees, Origo, 12, Participated on a data safety monitoring board or advisory board, Orphagen, 12, Consulting fees, Pandion Therapeutics, 12, Pandion Therapeutics, Pendopharm, 12, Consulting fees, Pfizer, 12, Consulting fees, support for attending meetings or for travel, participated on a data safety monitoring board or advisory board, PlayToKnow, 12, Consulting fees, Progenity, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Prometheus Therapeutics and Diagnostics, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Protagonist, 12, Consulting fees, PTM Therapeutics, 12, Consulting fees, Q32 Bio, 12, Consulting fees, Rebiotix, 12, Consulting fees, REDX, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Roche, 12, Consulting fees, Sandoz, 12, Consulting fees, Sanofi, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Seres Therapeutics, 12, Consulting fees, Silverback Therapeutics, 12, Consulting fees, Surrozen, 12, Consulting fees, Takeda, 6, 12, Consulting fees, support for attending meetings or for travel, participated on a data safety monitoring board or advisory board, Teva, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Thelium, 12, Consulting fees, Tigenix, 12, Consulting fees, Tillotts Pharma, 12, Consulting fees, participated on a data safety monitoring board or advisory board, Ventyx Biosciences, 12, Consulting fees, VHSquared Ltd., 12, Consulting fees, Viatris, 12, Consulting fees, Ysios, 12, Consulting fees, Ysopia, 12, Consulting fees, Zealand Pharma, 12, Consulting fees; G. D’Haens: AbbVie, 2, 6, 12, Data monitoring board activities, Agomab, 2, Alimentiv, 2, AMT, 2, AstraZeneca, 2, 12, Data monitoring board activities, Boehringer Ingelheim, 2, Bristol-Myers Squibb, 2, 6, Celltrion, 2, Eli Lilly, 2, Exeliom Biosciences, 2, Galapagos, 2, 6, 12, Data monitoring board activities, GlaxoSmithKline, 2, Gossamerbio, 2, Immunic, 2, Index Pharmaceuticals, 2, Johnson & Johnson, 2, Kaleido, 2, Origo, 2, Pfizer, 2, 6, Polpharma, 2, Procise Diagnostics, 2, Progenity, 2, Prometheus Biosciences, 2, Prometheus Laboratories, 2, Protagonist Therapeutics, 2, Seres Health, 12, Data monitoring board activities, Takeda, 6; A. Afzali: AbbVie, 1, 5, 6, 12, Consulting fees, Bristol-Myers Squibb, 1, 5, 6, Bristol-Myers Squibb/Celgene,, 12, Consulting fees, DiaSorin, 12, Consulting fees, Eli Lilly, 1, 12, Consulting fees, Gilead, 1, 12, Consulting fees, IBD Horizons, 12, Co-founder, Janssen, 1, 5, 6, 12, Consulting fees, Lilly, 5, Pfizer, 1, 5, 6, 12, Consulting fees, Takeda, 1, 5, 6, 12, Consulting fees, TLL Pharmaceuticals, 12, Consulting fees; W. Reinisch: 4SC, 2, AbbVie, 1, 2, 6, 12, Research funding, Aesca, 1, Agomab, 2, Algernon, 2, AltruBio, 2, AM Pharma, 1, 2, Amgen, 1, 2, AMT, 2, AOP Orphan, 2, Aptalis, 6, Arena Pharmaceuticals, 2, Astellas, 1, 2, 6, AstraZeneca, 1, 2, Avaxia, 1, 2, Bioclinica, 2, Biogen IDEC, 1, 2, Boehringer Ingelheim, 1, 2, Bristol-Myers Squibb, 1, 2, Calyx, 2, Celgene, 1, 2, Cellerix, 1, 2, Celltrion, 1, 2, 6, Chemocentryx, 1, 2, Covance, 2, Danone Austria, 1, 2, 6, DSM, 1, 2, Elan, 1, 2, 6, Eli Lilly, 2, Ernst & Young, 2, Falk Pharma, 2, 6, Ferring, 1, 2, 6, Fresenius, 2, Galapagos, 1, 2, Gatehouse Bio, 2, Genentech, 1, 2, Gilead, 2, Grünenthal, 1, 2, ICON, 2, Immundiagnostik, 6, Index Pharma, 2, Inova, 1, 2, Intrinsic Imaging, 2, Janssen, 1, 2, 12, Research funding, Johnson & Johnson, 1, 2, Kyowa Hakko Kirin Pharma, 1, 2, Landos Biopharma, 2, Lipid Therapeutics, 1, 2, LivaNova, 2, Mallinckrodt, 2, Medahead, 2, Medice, 6, MedImmune, 1, 2, Millenium, 1, 2, Mitsubishi Tanabe Pharma Corporation, 1, 2, 6, mRobarts Clinical Trial, 2, MSD, 1, 2, 6, 12, Research funding, Nash Pharmaceuticals, 2, Nestle, 1, 2, Nippon Kayaku, 2, Novartis, 1, 2, Ocera, 1, 2, OMass, 2, Otsuka, 1, 2, 6, Parexel, 2, PDL, 1, 2, 6, Periconsulting, 2, Pfizer, 2, Pharmacosmos, 1, 2, 6, PLS Education, 6, Procter & Gamble, 2, Prometheus, 2, Protagonist, 2, Provention, 2, Quell Therapeutics, 2, Robarts Clinical Trial, 2, Roland Berger, 2, Sandoz, 2, 12, Research funding, Schering-Plough, 1, 2, 6, Second Genome, 1, 2, Seres Therapeutics, 2, Setpointmedical, 2, Shire, 5, Sigmoid, 2, Sublimity, 2, Takeda, 1, 2, 6, 12, Research funding, Teva Pharma, 2, Therakos, 2, 6, Theravance, 2, Tigenix, 2, UCB, 2, Vifor, 2, 6, Yakult, 6, Zealand, 2, Zyngenia, 2; J. Panés: Abbott, 6, AbbVie, 5, 12, Consulting fees, support for travel to meetings during the conduct of the study, Alimentive, 12, Participated on a Data Safety Monitoring Board or Advisory Board, Arena, 2, 12, Consulting fees, Athos, 12, Consulting fees, Atomwise, 12, Consulting fees, Boehringer-Ingelheim, 12, Consulting fees, Celgene, 12, Consulting fees, Celltrion, 12, Consulting fees, Ferring, 12, Consulting fees, Galapagos, 12, Consulting fees, Genentech/Roche, 12, Consulting fees, GlaxoSmithKline, 12, Consulting fees, Janssen, 6, 12, Consulting fees, Mirum, 12, Consulting fees, Morphic, 12, Consulting fees, Neste, 2, Origo, 12, Consulting fees, Pandion, 12, Consulting fees, Pfizer, 5, 12, Consulting fees, Progenity, 12, Consulting fees, Protagonist Therapeutics Inc., 12, Consulting fees, Revolo, 12, Consulting fees, Robarts, 12, Consulting fees, Sanofi, 12, Participated on a data safety monitoring board or advisory board, Takeda, 12, Consulting fees, support for travel to meetings during the conduct of the study, TGenix, 2, Theravance, 12, Consulting fees, Wassermann, 12, Consulting fees; D. Rubin: AbbVie, 2, Allergan, 2, Altrubio, 2, Arena Pharmaceuticals, 2, Aslan Pharmaceuticals, 2, Athos Therapeutics, 2, Bellatrix Pharmaceuticals, 2, Boehringer Ingelheim, 2, Bristol-Myers Squibb, 2, Celgene Corp/Syneos, 2, Connect BioPharma, 2, Cornerstones Health, 12, Co-founder, Eli Lilly, 2, GalenPharma/Atlantica, 2, Genentech/ Roche, 2, InDex Pharmaceuticals, 2, Ironwood Pharmaceuticals, 2, Iterative Scopes, 2, Janssen Pharmaceuticals, 2, Materia Prima, 2, Pfizer, 2, Prometheus Biosciences, 2, Reistone, 2, Takeda, 2, 12, Research funding, Techlab, 2; J. Andrews: AbbVie, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Allergan, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Anatara, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Atmo Capsule, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Bayer, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Bristol-Myers Squibb, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Celgene, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Celltrion, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Crohn’s and Colitis Australia, 12, Unpaid adviser, Crohn’s Colitis Cure, 12, Board Chair, Falk, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, GESA, 12, Board Director, Gilead, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Hospira, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Immuninc, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, ImmunsanT, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Janssen, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, MSD, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Nestle, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Novartis, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Pfizer, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, RAH Research Fund, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Sandoz, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Shire, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Takeda, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, The Helmsley Trust, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, The Hospital Research Fund, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events, Vifor, 5, 6, 12, the Crohn’s Colitis Cure for advisory board participation and coordination of educational events; T. Hisamatsu: AbbVie, 5, 12, Consulting fees, lecture fees, Daiichi-Sankyo, 5, EA Pharma, 5, 12, Consulting fees, lecture fees, Eli Lilly, 12, Consulting fees, Gilead Sciences, 12, Consulting fees, Janssen Research & Development, 12, Consulting fees, JIMRO, 5, Kissei Pharmaceutical, 12, Lecture fees, Mitsubishi Tanabe Pharma, 5, 12, Lecture fees, Mochida Pharmaceutical, 5, Nippon Kayaku, 5, Pfizer, 5, Takeda Pharmaceutical, 5, 12, Lecture fees; N. Terry: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; L. Salese: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; R. Rampelbergh: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; M. Frustaci: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; Z. Yang: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; J. Johanns: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; K. Wan: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; J. Yee: Janssen Research & Development, LLC, 3, Johnson & Johnson, of which Janssen is a subsidiary, 11; B. Sands: AbbVie, 12, Consultant or speaker’s fees, Abivax, 12, Consulting or speaking fees, Adiso Therapeutics, 12, Consultant or speaker’s fees, AgomAb, 12, Consultant or speaker’s fees, Alimentiv, 12, Consultant or speaker’s fees, Amgen, 12, Consultant or speaker’s fees, Arena Pharmaceuticals, 12, Consultant or speaker’s fees, Artizan Biosciences, 12, Consultant or speaker’s fees, Artugen Therapeutics, 12, Consultant or speaker’s fees, AstraZeneca, 12, Consultant or speaker’s fees, Bacainn Therapeutics, 12, Consultant or speaker’s fees, Biora Therapeutics, 12, Consultant or speaker’s fees, Boehringer Ingelheim, 12, Consultant or speaker’s fees, Boston Pharmaceuticals, 12, Consultant or speaker’s fees, Bristol-Myers Squibb, 12, Consultant or speaker’s fees, Calibr, 12, Consultant or speaker’s fees, Celltrion, 12, Consultant or speaker’s fees, ClostraBio, 12, Consultant or speaker’s fees, Connect Biopharm, 12, Consultant or speaker’s fees, Cytoki Pharma, 12, Consultant or speaker’s fees, Eli Lilly and Company, 12, Consultant or speaker’s fees, Enthera, 12, Consultant or speaker’s fees, Evommune, 12, Consultant or speaker’s fees, Fresenius Kabi, 12, Consultant or speaker’s fees, Galapagos, 12, Consultant or speaker’s fees, Genentech, 12, Consultant or speaker’s fees, Gilead Sciences, 12, Consultant or speaker’s fees, GlaxoSmithKline, 12, Consultant or speaker’s fees, Gossamer Bio, 12, Consultant or speaker’s fees, HMP Acquisition, 12, Consultant or speaker’s fees, Imhotex, 12, Consultant or speaker’s fees, Immunic, 12, Consultant or speaker’s fees, Index Pharmaceuticals, 12, Consultant or speaker’s fees, Innovation Pharmaceuticals, 12, Consultant or speaker’s fees, Inotrem, 12, Consultant or speaker’s fees, Ironwood Pharmaceuticals, 12, Consultant or speaker’s fees, Janssen, 12, Consultant or speaker’s fees, Johnson & Johnson, 12, Consultant or speaker’s fees, Kaleido, 12, Consultant or speaker’s fees, Kallyope, 12, Consultant or speaker’s fees, Merck, 12, Consultant or speaker’s fees, MiroBio, 12, Consultant or speaker’s fees, Morphic Therapeutics, 12, Consultant or speaker’s fees, MRM Health, 12, Consultant or speaker’s fees, OSE Immunotherapeutics, 12, Consultant or speaker’s fees, Pfizer, 12, Consultant or speaker’s fees, Progenity, 12, Consultant or speaker’s fees, Prometheus Biosciences, 12, Consultant or speaker’s fees, Prometheus Laboratories, 12, Consultant or speaker’s fees, Protagonist Therapeutics, 12, Consultant or speaker’s fees, Q32 Bio, 12, Consultant or speaker’s fees, RedHill Biopharma, 12, Consultant or speaker’s fees, Sun Pharma Global, 12, Consultant or speaker’s fees, Surrozen, 12, Consultant or speaker’s fees, Synlogic Operating Company, 12, Consultant or speaker’s fees, Takeda, 12, Consultant or speaker’s fees, Target RWE, 12, Consultant or speaker’s fees, Theravance Biopharma, 12, Consultant or speaker’s fees, TLL Pharmaceutical, 12, Consultant or speaker’s fees, USWM Enterprises, 12, Consultant or speaker’s fees, Ventyx Biosciences, 11, 12, Consultant or speaker’s fees, Viela Bio, 12, Consultant or speaker’s fees.

To cite this abstract in AMA style:

Panaccione R, Danese S, Feagan B, D’Haens G, Afzali A, Reinisch W, Panés J, Rubin D, Andrews J, Hisamatsu T, Terry N, Salese L, Rampelbergh R, Frustaci M, Yang Z, Johanns J, Wan K, Yee J, Sands B. Efficacy And Safety of Guselkumab Therapy in Patients With Moderately to Severely Active Crohn’s Disease: Results of the Galaxi 2 & 3 Phase 3 Studies [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-guselkumab-therapy-in-patients-with-moderately-to-severely-active-crohns-disease-results-of-the-galaxi-2-3-phase-3-studies/. Accessed .
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All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

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