P0596Efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease who had maintenance dose adjustment: Results from the phase 3 GALAXI 2 & 3 long-term extension

Abstract Background The Phase 3 GALAXI 2 150] AND CDAI ≥220) received a one-time dose adjustment/sham dose adjustment to GUS 200 q4w. Clinical response and clinical remission were assessed 16 weeks after dose adjustment and at Week 96. Endoscopic response and endoscopic remission were assessed at Week 96 (definitions in Figure). Safety was assessed through Week 96. Results From Weeks 52–80, a total of 64 pts had a dose adjustment to GUS 200 q4w from GUS 100 q8w (N = 36) or GUS 200 q4w (N = 28; sham dose adjustment). 78.1% of pts underwent dose adjustment by Week 64. Of these 64 pts, 53 were eligible for the efficacy analyses since 11 pts were excluded because they continued treatment and entered the LTE despite meeting discontinuation criteria prior to Week 48. Among pts who switched from GUS 100 q8w to 200 q4w, 41.4% achieved clinical response and 31.0% were in clinical remission 16 weeks after dose adjustment (Figure). At Week 96 (up to 44 weeks after dose adjustment), 58.6% were in clinical response, 48.3% were in clinical remission, 48.3% were in endoscopic response, and 34.5% were in endoscopic remission. Efficacy outcomes in GUS 200 q4w pts who received a sham dose adjustment were generally similar to those observed in pts switching from GUS 100 q8w to 200 q4w. Adverse event rates were similar before and after dose adjustment during the LTE (Table). Conclusion Maintenance dose adjustment to GUS 200 mg q4w may benefit CD pts who experience inadequate response on GUS 100 mg q8w, with nearly half of switchers achieving clinical remission or endoscopic response up to ∼1 year after dose adjustment. Safety outcomes after dose adjustment were consistent with the established safety profile of GUS in approved indications. Interpretation is affected by small sample sizes. Conflict of interest: Panaccione, Remo: Consulting fees from Abbivax, Abbott, AbbVie, Alimentiv (formerly Robarts), Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, BioJAMP, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Spyre Therapeutics, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx Biosciences, and UCB speaker’s fees from AbbVie, Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Johnson & Johnson, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals and participation in advisory boards for AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, GlaxoSmithKline, BioJAMP, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, Sandoz, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, and Ventyx Biosciences. Hisamatsu, Tadakazu: Grant support: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, JIMRO Co. Ltd., Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co. Ltd., Boston Scientific Corporation, Kissei Pharmaceutical Co. Ltd. Consulting: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer Inc., Eli Lilly, Gilead Sciences, Bristol Myers Squibb, Abivax, MSD, Chugai. Lecture fee: Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA pharma Co. Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Kissei Pharmaceutical Co. Ltd. Afzali, Anita: Speaker for AbbVie, Bristol Myers Squibb, Johnson & Johnson, Pfizer, and Takeda consultant for AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Johnson & Johnson, Pfizer, and Takeda advisory board member for AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Johnson & Johnson, Pfizer, and Takeda received educational/research grants from AbbVie, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Pfizer, and Takeda and Co-Founder and Board Member of Scrubs & Heels Foundation. Van Rampelbergh, Rian: Employee of Johnson & Johnson Yee, Jacqueline: Employee and shareholder of Johnson & Johnson van Duijnhoven, Wilbert: Employee and shareholder of Johnson & Johnson Corbett, Christopher: Employee and shareholder of Johnson & Johnson Sands, Bruce E: Grants from Johnson & Johnson personal fees from Abivax SA, AbbVie, Adiso Therapeutics, Agomab Therapeutics, Alimentiv, Amgen, AnaptysBio, AstraZeneca, Biora Therapeutics, Boehringer-Ingelheim, Bristol Myers Squibb, Celltrion, ClostraBio, Cytoki Pharma, EcoR1 Capital, Eli Lilly, Enthera, Equilium, Ensho Therapeutics, Evommune, Ferring, Galapagos, Genentech, Gilead Sciences, GSK, Gossamer Bio, Imhotex, Immunyx Pharma Ltd., Index Pharmaceuticals, Innovation Pharmaceuticals, Johnson & Johnson, Kaleido, Kallyope, Kyowa Kirin, Merck & Co., Microba, Microbiotica Limited, Mirador Therapeutics, Morphic Therapeutic, MRM Health NV, Palisade Therapeutics, Pfizer, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Sanofi, Sorriso Therapeutics, Surrozen, Takeda, Target RWE, Teva, TLL Pharmaceutical, Tr1X Bio, Union Therapeutics, Ventyx Biosciences non-financial support from Bristol Myers Squibb, Johnson & Johnson, Lilly, Pfizer, Takeda stock/stock options from Ventyx Biosciences Danese, Silvio: Personal Fees: AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor Lecture fees from Abbvie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda