P1099Efficacy and safety of guselkumab through week 96 after intravenous or subcutaneous induction in participants with Crohn’s disease: Phase 3 long-term extension data from GALAXI 2, GALAXI 3, and GRAVITI

Abstract Background Guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, is highly efficacious in participants (pts) with Crohn’s disease (CD). Phase 3 studies (GALAXI 2, GALAXI 3, and GRAVITI) showed that GUS administered via intravenous (IV) or subcutaneous (SC) induction followed by SC maintenance has similar efficacy after induction and through week (W)48. We report GUS W96 efficacy data from the long-term extension (LTE) periods of these studies and safety data from W0 to W96. Methods The studies had double-blind, placebo-controlled, treat-through designs with blinding until the W48 database lock. GALAXI 2 and 3 evaluated IV GUS induction (200 mg at W0, W4, and W8) followed by SC maintenance (100 mg q8w or 200 mg q4w). GRAVITI assessed SC GUS induction (400 mg at W0, W4, and W8) and the same GUS maintenance regimens used in GALAXI. Pts entered the LTE receiving the treatment they received at W48. Between W52 and W80 (GALAXI only), pts on GUS 100 mg SC q8w who were not in clinical response received dose escalation to 200 mg SC q4w; pts on GUS 200 mg SC q4w received a “sham” adjustment to GUS 200 mg SC q4w. Efficacy analyses included all pts randomised at W0 with a Simple Endoscopic Activity Score for CD (SES-CD) ≥6 (≥4 for pts with isolated ileal disease) who received ≥1 study drug dose. Pts with missing data or who met treatment failure criteria were considered non-responders. As observed data are also presented. Safety analyses comprised all randomised pts who received study drug. Results Between W0 and W96, 127/582 pts (21.8%) from GALAXI 2 and 3 and 31/230 pts (13.5%) from GRAVITI discontinued GUS treatment. Across studies, high rates of long-term endoscopic response, endoscopic remission, clinical remission, and deep remission were observed after treatment with both GUS doses. Respective W96 rates for IV vs SC induction were 44.1% vs 47.8% (100 mg SC q8w) and 44.6% vs 59.1% (200 mg SC q4w) for endoscopic response, 28.3% vs 38.3% (100 mg SC q8w) and 31.4% vs 47.0% (200 mg SC q4w) for endoscopic remission, 59.4% vs 62.6% (100 mg SC q8w) and 63.2% vs 71.3% (200 mg SC q4w) for clinical remission, and 26.2% vs 34.8% (100 mg SC q8w) and 29.4% vs 39.1% (200 mg SC q4w) for deep remission (Table 1). Safety data through 2 years were comparable across studies and consistent with the safety profile of the label indications (Table 2). Conclusion Long-term efficacy outcomes show the durability of GUS treatment in CD through 2 years across multiple studies. No new safety concerns were identified. Conflict of interest: D’Haens, Geert: Grant: Pfizer, BMS, Johnson and Johnson, Alimentiv BV, Takeda, Prometheus Laboratories Personal Fees: Abbvie, Agomab, Alimentiv, AstraZeneca, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Glaxo Smith Kline, Pfizer, Immunic, Johnson and Johnson, Merck, Polpharma, Procise Diagnostics, Prometheus Biosciences, Takeda, Ventyx Rubin, David T.: Grant support: Takeda Pharmaceuticals Consultant: Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Connect BioPharma, Eli Lilly & Co., Genentech (Roche) Inc., Iterative Health, Johnson & Johnson, Merck & Co., Mirador, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda Pharmaceuticals, Vedanta Biosciences, and Ventyx. 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 an advisory board member for AbbVie, Bristol Myers Squibb, Eli Lilly, Gilead, Johnson & Johnson, Pfizer, and Takeda educational/research grants from AbbVie, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Pfizer, and Takeda Co-Founder and Board Member of Scrubs & Heels Foundation. Hart, Ailsa: Grant: Takeda Personal Fees: Abbvie, Amgen, Arena, AZ, Falk, Celltrion, Eli Lilly, Ferring, Genentech/Roche, GSK, Pfizer, Takeda, Napp, Pharmacosmos, Johnson & Johnson, Bristol-Myers Squibb, Gilead, Galapagos Hisamatsu, Tadakazu: Grant support from AbbVie, Daiichi-Sankyo, EA Pharma Co, Ltd. JIMRO, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Inc and Takeda Pharmaceutical Co., Ltd. Consulting fees from Bristol Myers Squibb, EA Pharma Co, Ltd., Eli Lilly, Gilead Sciences and Johnson & Johnson. Lecture fees from AbbVie, EA Pharma Co, Ltd., Kissei Pharmaceutical Co, Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd and Takeda Pharmaceutical Co., Ltd. Terry, Nat: employee of and may own stock in Johnson & Johnson. Olurinde, Mobolaji: employee of and may own stock in Johnson & Johnson Van Rampelbergh, Rian: employee of and may own stock in Johnson & Johnson Yee, Jacqueline: employee of and may own stock in Johnson & Johnson Van Duijnhoven, Wilbert: employee of and may own stock in Johnson & Johnson Corbett, Chris: employee of and may own stock in Johnson & Johnson Merrall, Elizabeth: employee of and may own stock in Johnson & Johnson Cao, Qian: Steering committee adviser for Bristol Myers Squibb Company and Johnson & Johnson, Research Development, LLC research grants from Johnson & Johnson and Takeda Panaccione, Remo: Grant: Abbvie, Janssen, Pfizer, Takeda Consultant for: Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Spyre Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, UCB Speaker’s Fees for: AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Johnson & Johnson, Merck, Organon, Pfizer, Roche, Sandoz, Shire, Takeda Pharmaceuticals 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, Glaxo-Smith Kline, JAMP Bio, Johnson & Johnson, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, SandozShire, Sublimity Therapeutics, Takeda Pharmaceuticals, Ventyx. Panés, Julián: Consultancy fees/honorarium from AbbVie, Alimentiv, Boehringer Ingelheim, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Johnson & Johnson, Mirum, Nimbus, Pfizer, Progenity, Prometheus, Protagonist, Revolo, Sanofi, Sorriso, Spyre Therapeutics, Surrozen, Takeda, and Wasserman data safety monitoring boards for Alimentiv, Mirum, Roche, Sorriso, Sanofi, and Surrozen Steinwurz, Flavio: Clinical investigator and consultant for Abbvie, Amgen, Celltrion, Ferring, Johnson & Johnson, Pfizer, Sandoz, and Takeda 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 Sands, Bruce E: Bruce E. Sands reports 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, Take