Clinical Trial

. 2024 Feb;9(2):133-146.

doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.

Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Silvio Danese¹, Remo Panaccione², Brian G Feagan³, Anita Afzali⁴, David T Rubin⁵, Bruce E Sands⁶, Walter Reinisch⁷, Julián Panés⁸, Aparna Sahoo⁹, Natalie A Terry⁹, Daphne Chan¹⁰, Chenglong Han⁹, Mary Ellen Frustaci⁹, Zijiang Yang⁹, William J Sandborn¹¹, Tadakazu Hisamatsu¹², Jane M Andrews¹³, Geert R D'Haens¹⁴; GALAXI-1 Study Group

Collaborators, Affiliations

Collaborators

GALAXI-1 Study Group:
Oleksandr Oliinyk, Leonid Bilianskyi, Jadwiga Gniady-Jastrzebska, Robert Petryka, Tomasz Arlukowicz, Piotr Gietka, Marcin Zmudzinski, Syed Mumtaz, Douglas Wolf, Katarzyna Wojcik, George Duvall, Monika Augustyn, Rafal Filip, Dino Tarabar, Alexander Tkachev, Ursula Seidler, Eran Zittan, Juris Pokrotnieks, Oksana Shchukina, Andro Machavariani, Laura Loy, Niazy Abu-Farsakh, Pesegova Marina, Slobodan Sreckovic, Martin Laclav, Shu-Chen Wei, Daniel Suiter, Aleksey Borsuk, Xavier Hebuterne, Carsten Buning, Adi Lahat-Zok, Wit Danilkiewicz, Bernadetta Frysna, Ivana Jovicic, Olena Datsenko, Maninder Guram, Animesh Jain, Zahid Rashid, Sonja Heeren, Natallia Shulga, Ivan Timkin, Srdjan Gornjakovic, Milan Lukas, Romain Altwegg, Ariadne Desjeux, Jean-Marie Reimund, Manana Giorgadze, Christoph Jochum, Hiroaki Ito, Katsuhiko Nakai, Tomohisa Takagi, Osamu Zaha, Changhwan Choi, Taeoh Kim, Jonghun Lee, Ieva Stundiene, Ida Normiha Hilmi, Rosaida Hj Md Said, Jaroslaw Leszczyszyn, Diana Abdulganieva, Yulia Fominykh, Svetlana Maksyashina, Jozef Balaz, Manuel Van Domselaar, Taylan Kav, Patrick Dennis, Patricia Henry, Robert Holmes, Christopher Johnson, Matthew McBride, Harry Sarles, Gregory Moore, Ruslan Yakubtsevich, Vinciane Muls, Stevan Trbojevic, Waqqas Afif, Charles Bernstein, Ivo Klarin, Zuzana Serclova, Miroslava Volfova, Pierre Desreumaux, Cyrielle Gilletta de Saint Joseph, Xavier Roblin, Lucine Vuitton, Kakhaber Chelidze, Tanja Kuehbacher, Ioannis Koutroubakis, Michele Cicala, Walter Fries, Antonio Gasbarrini, Nobuo Aoyama, Yoshito Hayashi, Fumihito Hirai, Norkiyuki Horiki, Namiko Hoshi, Tomoki Inaba, Ishida Hiroyasu, Atsuo Maemoto, Takayuki Matsumoto, Kayoko Matsushima, Satoshi Motoya, Masaki Taruishi, Mohammed Rashid, Jaeyoung Chun, Young-Ho Kim, Dong Il Park, Ala Sharara, Laimas Jonaitis, Gjorgi Deriban, James Brooker, Beata Gawdis-Wojnarska, Barbara Wozniak-Stolarska, Pavel Andreev, Vladimir Simanenkov, Vasiliy Trofimov, Igor Jovanovic, Natasa Zdravkovic, Xavier Aldeguer I Mante, Vicent Hernandez Ramirez, Hale Akpinar, Gurkan Celebi, Hulya Hamzaoglu, Juan Fernandez, Jayaprakash Kamath, Nicole Palekar, Jatinder S Pruthi, David Rausher, Timothy Ritter

Affiliations

¹ Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy. Electronic address: sdanese@hotmail.com.
² Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
³ Western University, London, ON, Canada.
⁴ Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
⁵ University of Chicago School of Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
⁶ Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
⁸ Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
⁹ Janssen Research & Development, Spring House, PA, USA.
¹⁰ Janssen Scientific Affairs, Horsham, PA, USA.
¹¹ Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA; Ventyx Biosciences, Encinitas, CA, USA.
¹² Department of Gastroenterology and Hepatology, Kyorin University, Tokyo, Japan.
¹³ Department of Gastroenterology and Hepatology, Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia.
¹⁴ Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, Netherlands.

PMID: 38104569
DOI: 10.1016/S2468-1253(23)00318-7

Clinical Trial

Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Silvio Danese et al. Lancet Gastroenterol Hepatol. 2024 Feb.

. 2024 Feb;9(2):133-146.

doi: 10.1016/S2468-1253(23)00318-7. Epub 2023 Dec 14.

Authors

Collaborators

GALAXI-1 Study Group:
Oleksandr Oliinyk, Leonid Bilianskyi, Jadwiga Gniady-Jastrzebska, Robert Petryka, Tomasz Arlukowicz, Piotr Gietka, Marcin Zmudzinski, Syed Mumtaz, Douglas Wolf, Katarzyna Wojcik, George Duvall, Monika Augustyn, Rafal Filip, Dino Tarabar, Alexander Tkachev, Ursula Seidler, Eran Zittan, Juris Pokrotnieks, Oksana Shchukina, Andro Machavariani, Laura Loy, Niazy Abu-Farsakh, Pesegova Marina, Slobodan Sreckovic, Martin Laclav, Shu-Chen Wei, Daniel Suiter, Aleksey Borsuk, Xavier Hebuterne, Carsten Buning, Adi Lahat-Zok, Wit Danilkiewicz, Bernadetta Frysna, Ivana Jovicic, Olena Datsenko, Maninder Guram, Animesh Jain, Zahid Rashid, Sonja Heeren, Natallia Shulga, Ivan Timkin, Srdjan Gornjakovic, Milan Lukas, Romain Altwegg, Ariadne Desjeux, Jean-Marie Reimund, Manana Giorgadze, Christoph Jochum, Hiroaki Ito, Katsuhiko Nakai, Tomohisa Takagi, Osamu Zaha, Changhwan Choi, Taeoh Kim, Jonghun Lee, Ieva Stundiene, Ida Normiha Hilmi, Rosaida Hj Md Said, Jaroslaw Leszczyszyn, Diana Abdulganieva, Yulia Fominykh, Svetlana Maksyashina, Jozef Balaz, Manuel Van Domselaar, Taylan Kav, Patrick Dennis, Patricia Henry, Robert Holmes, Christopher Johnson, Matthew McBride, Harry Sarles, Gregory Moore, Ruslan Yakubtsevich, Vinciane Muls, Stevan Trbojevic, Waqqas Afif, Charles Bernstein, Ivo Klarin, Zuzana Serclova, Miroslava Volfova, Pierre Desreumaux, Cyrielle Gilletta de Saint Joseph, Xavier Roblin, Lucine Vuitton, Kakhaber Chelidze, Tanja Kuehbacher, Ioannis Koutroubakis, Michele Cicala, Walter Fries, Antonio Gasbarrini, Nobuo Aoyama, Yoshito Hayashi, Fumihito Hirai, Norkiyuki Horiki, Namiko Hoshi, Tomoki Inaba, Ishida Hiroyasu, Atsuo Maemoto, Takayuki Matsumoto, Kayoko Matsushima, Satoshi Motoya, Masaki Taruishi, Mohammed Rashid, Jaeyoung Chun, Young-Ho Kim, Dong Il Park, Ala Sharara, Laimas Jonaitis, Gjorgi Deriban, James Brooker, Beata Gawdis-Wojnarska, Barbara Wozniak-Stolarska, Pavel Andreev, Vladimir Simanenkov, Vasiliy Trofimov, Igor Jovanovic, Natasa Zdravkovic, Xavier Aldeguer I Mante, Vicent Hernandez Ramirez, Hale Akpinar, Gurkan Celebi, Hulya Hamzaoglu, Juan Fernandez, Jayaprakash Kamath, Nicole Palekar, Jatinder S Pruthi, David Rausher, Timothy Ritter

Affiliations

¹ Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy. Electronic address: sdanese@hotmail.com.
² Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
³ Western University, London, ON, Canada.
⁴ Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
⁵ University of Chicago School of Medicine Inflammatory Bowel Disease Center, Chicago, IL, USA.
⁶ Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁷ Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
⁸ Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
⁹ Janssen Research & Development, Spring House, PA, USA.
¹⁰ Janssen Scientific Affairs, Horsham, PA, USA.
¹¹ Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA; Ventyx Biosciences, Encinitas, CA, USA.
¹² Department of Gastroenterology and Hepatology, Kyorin University, Tokyo, Japan.
¹³ Department of Gastroenterology and Hepatology, Royal Adelaide Hospital and University of Adelaide, Adelaide, SA, Australia.
¹⁴ Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, Netherlands.

PMID: 38104569
DOI: 10.1016/S2468-1253(23)00318-7

Abstract

Background: Many patients with moderately to severely active Crohn's disease do not respond to available therapies or lose response over time. The GALAXI-1 study previously found that three intravenous guselkumab dosages showed superior clinical and endoscopic outcomes over placebo at week 12 in patients with moderately to severely active Crohn's disease. We report the safety and efficacy of subcutaneous guselkumab maintenance regimens to week 48 in the GALAXI-1 study.

Methods: We did a phase 2, randomised, multicentre, double-blind trial. Adult patients with moderately to severely active Crohn's disease were randomly allocated with a computer-generated randomisation schedule to receive one of five treatment groups, with regimens consisting of an intravenous induction phase transitioning to a subcutaneous maintenance phase starting at week 12 in a treat-through design: (1) guselkumab 200→100 mg group (200 mg intravenous at weeks 0, 4, and 8, then 100 mg subcutaneous every 8 weeks; (2) guselkumab 600→200 mg group (600 mg intravenous at weeks 0, 4, and 8, then 200 mg subcutaneous every 4 weeks); (3) guselkumab 1200→200 mg group (1200 mg intravenous at weeks 0, 4, and 8, then 200 mg subcutaneous every 4 weeks); (4) ustekinumab group (approximately 6 mg/kg intravenous at week 0, then 90 mg subcutaneous every 8 weeks); or (5) placebo group (placebo induction followed by either placebo maintenance [for those with CDAI clinical response at week 12] or crossover to ustekinumab [for those without CDAI clinical response at week 12]). Endpoints assessed at week 48 included CDAI remission (CDAI score <150), endoscopic response (≥50% improvement from baseline in SES-CD or SES-CD score ≤2), and endoscopic remission (SES-CD score ≤2) in the primary efficacy analysis population of all randomised patients who received at least one dose of study drug, excluding those discontinued during a temporary study pause. Safety analyses included all randomised patients who received at least one study drug dose. This trial is registered at Clinical Trials.gov (NCT03466411) and is active but not recruiting.

Findings: Among 700 patients screened, 309 (112 biologic-naive; 197 biologic-experienced) were included in the primary efficacy analysis population: 61 in the guselkumab 200→100 mg group, 63 in the guselkumab 600→200 mg group, 61 in the guselkumab 1200→200 mg group, 63 in the ustekinumab group, and 61 in the placebo group. 126 (41%) women and 183 (59%) men were included, with median age 36·0 years (IQR 28·0-49·0). At week 48, the numbers of patients with CDAI clinical remission were 39 (64%) in the guselkumab 200→100 mg group, 46 (73%) in the guselkumab 600→200 mg group, 35 (57%) in the guselkumab 1200→200 mg group, and 37 (59%) in the ustekinumab group. The corresponding numbers of patients with endoscopic response were 27 (44%), 29 (46%), 27 (44%), and 19 (30%), respectively, and endoscopic remission was seen in 11 (18%), 11 (17%), 20 (33%), and four (6%) patients, respectively. In the placebo group, 15 patients were in CDAI clinical response at week 12 and continued placebo; of these, nine (60%) were in clinical remission at week 48. 44 patients in the placebo group were not in CDAI clinical response at week 12 and crossed over to ustekinumab; of these, 26 (59%) were in clinical remission at week 48. Up to week 48, adverse events frequencies in the safety population (n=360) were 46 (66%) of 70 patients (464·9 events per 100 patient-years of follow-up) in the placebo group, 163 (74%) of 220 patients (353·1 per 100 patient-years) in the three guselkumab groups combined, and 60 (85%) of 71 patients (350·7 per 100 patient-years) in the ustekinumab group. Among patients treated with guselkumab or ustekinumab, the most frequently reported infections up to week 48 were nasopharyngitis (25 [11%] of 220 guselkumab recipients, 12 [11%] of 114 ustekinumab recipients) and upper respiratory infections (13 [6%] guselkumab recipients, eight [7%] ustekinumab recipients). After week 12, one patient who responded to placebo induction and two guselkumab-treated patients had serious infections. No active tuberculosis, opportunistic infections, or deaths occurred.

Interpretation: Patients receiving guselkumab intravenous induction and subcutaneous maintenance treatment achieved high rates of clinical and endoscopic efficacy up to week 48. No new safety concerns were identified.

Funding: Janssen Research & Development.

PubMed Disclaimer

Conflict of interest statement

Declaration of interests SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring Pharmaceuticals, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, TiGenix, UCB Inc, and Vifor; and reports lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead, Janssen, Mylan, Pfizer, and Takeda. RP has received consulting fees from Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, GlaxoSmithKline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Viatris, Ventyx, and UCB; speaker's fees from AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda Pharmaceuticals; and research support from AbbVie, Takeda, Janssen, and Pfizer. BGF has received consulting fees from AbbVie, AbolerIS, AgomAB Therapeutics, Allianthera, Amgen, AnaptysBio, Applied Molecular Transport, Arena Pharma, Avoro Capital Advisors, Atomwise, BioJamp, Biora Therapeutics, Boehringer-Ingelheim, Boxer, Celsius Therapeutics, Celgene/Bristol-Myers Squibb, Connect BioPharma, Cytoki, Disc Medicine, Duality, EcoR1, Eli Lilly, Equillium, Ermium, First Wave, First Word Group, Galapagos, Galen Atlantica, Genentech/Roche, Gilead, Gossamer Pharma, GlaxoSmithKline, Hinge Bio, Hot Spot Therapeutics, Index Pharma, Imhotex, Immunic Therapeutics, JAKAcademy, Janssen, Japan Tobacco Inc, Kaleido Biosciences, Landos Biopharma, Leadiant, LEK Consulting, LifeSci Capital, Lument, Millennium, MiroBio, Morphic Therapeutics, Mylan, OM Pharma, Origo BioPharma, Orphagen, Pandion Therapeutics, Pendopharm, Pfizer, Prometheus Therapeutics and Diagnostics, PlayToKnow, Progenity, Protagonist, PTM Therapeutics, Q32 Bio, Rebiotix, REDX, Roche, Sandoz, Sanofi, Seres Therapeutics, Silverback Therapeutics, Surrozen, Takeda, Teva, Thelium, Tigenix, Tillotts, Ventyx Biosciences, VHSquared, Viatris, Ysios, Ysopia, and Zealand Pharma; is a member of the speakers bureau for AbbVie, Janssen, Takeda, and Boehringer Ingelheim; has received payment for expert testimony from Morgan Lewis and Lenczner Slaght; has received support for attending meetings or for travel from Janssen, AbbVie, Pfizer, Takeda, and Boehringer Ingelheim; has participated on a data safety monitoring board or advisory board for AbbVie, Amgen, AMT, AnaptysBio, Boehringer-Ingelheim, Celgene/Bristol-Myers Squibb, Eli Lilly, Genentech/Roche, Janssen, MiroBio, Origo BioPharma, Pfizer, Prometheus, RedX Pharma, Sanofi, Takeda, Tillotts Pharma, Teva, Progenity, Index, Ecor1Capital, Morphic, GlaxoSmithKline, and Axio Research; and has stock or stock options in Gossamer Pharma. AA reports consulting fees from AbbVie, Takeda, Janssen, Bristol-Myers Squibb/Celgene, Pfizer, Eli Lilly, Gilead, DiaSorin, and TLL Pharmaceuticals; speaker's fees from AbbVie, Takeda, Janssen, Bristol-Myers Squibb, and Pfizer; has served on advisory boards for AbbVie, Takeda, Janssen, Bristol-Myers Squibb, Pfizer, Eli Lilly, and Gilead; has received research or education support from AbbVie, Janssen, Pfizer, Bristol-Myers Squibb, Lilly, and Takeda; and is the co-founder of IBD Horizons. DTR has received research funding from Takeda; has served as a consultant to AbbVie, Altrubio, Allergan, Arena Pharmaceuticals, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corp/Syneos, Connect BioPharma, GalenPharma/Atlantica, Genentech/Roche, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Eli Lilly, Materia Prima, Pfizer, Prometheus Biosciences, Reistone, Takeda, and Techlab; and is a co-founder of Cornerstones Health. BES has received consulting fees from AbbVie, Alimentiv, Amgen, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Evommune, Fresenius Kabi, Galapagos, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Morphic Therapeutics, MRM Health, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Sun Pharma, Surrozen, Target RWE, Teva, TLL Pharmaceutical, and Ventyx Biosciences; has received consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; has received research grants, consulting, and speaker's fees and other support from Bristol-Myers Squibb, Janssen, Pfizer, and Takeda; has received research grants and consulting fees from Theravance Biopharma; and has stock options in Ventyx Biopharma. WR reports being a speaker for AbbVie, Aptalis, Astellas, Celltrion, Danone Austria, Elan, Falk Pharma, Ferring, Immundiagnostik, Medice, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, PLS Education, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; has served as a consultant for AbbVie, Agomab, Algernon, AltruBio, Amgen, AM Pharma, AMT, AOP Orphan, Arena Pharmaceuticals, Astellas, AstraZeneca, Avaxia, Roland Berger, Bioclinica, Biogen IDEC, Boehringer Ingelheim, Bristol-Myers Squibb, Calyx, Cellerix, Chemocentryx, Celgene, Celltrion, Covance, Danone Austria, DSM, Elan, Eli Lilly, Ernst & Young, Falk Pharma, Ferring, Fresenius, Galapagos, Gatehouse Bio, Genentech, Gilead, Grünenthal, ICON, Index Pharma, Inova, Intrinsic Imaging, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Landos Biopharma, Lipid Therapeutics, LivaNova, Mallinckrodt, Medahead, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nash Pharmaceuticals, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Protagonist, Provention, Quell Therapeutics, Robarts Clinical Trial, Sandoz, Schering-Plough, Second Genome, Seres Therapeutics, Setpointmedical, Sigmoid, Sublimity, Takeda, Teva Pharma, Therakos, Theravance, Tigenix, UCB, Vifor, Zealand, Zyngenia, and 4SC; has served as an advisory board member for AbbVie, Aesca, Amgen, AM Pharma, Astellas, Astra Zeneca, Avaxia, Biogen IDEC, Boehringer Ingelheim, Bristol-Myers Squibb, Cellerix, Chemocentryx, Celgene, Celltrion, Danone Austria, DSM, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millenium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Sandoz, Schering-Plough, Second Genome, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zealand, Zyngenia, and 4SC; and has received research funding from AbbVie, Janssen, MSD, Sandoz, and Takeda. JP has received grants from AbbVie and Pfizer; consulting fees from AbbVie, Arena, Athos, Atomwise, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech/Roche, GlaxoSmithKline, Janssen, Mirum, Morphic, Origo, Pandion, Pfizer, Progenity, Protagonist Therapeutics, Revolo, Robarts, Takeda, Theravance, and Wassermann; has received support for travel to meetings from AbbVie and Takeda, during the conduct of the study; has received payment for lectures including service on speaker's bureaus from Abbott and Janssen; and has participated on a data safety monitoring board or advisory board for Alimentiv and Sanofi. WJS reports research grants from AbbVie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, Glaxo Smith Kline, Janssen, Lilly, Pfizer, Prometheus Laboratories, Seres Therapeutics, Shire Pharmaceuticals, Takeda, Theravance Biopharma; consulting fees from AbbVie, Abivax, Admirx, Alfasigma, Alimentiv, Alivio Therapeutics, Allakos, Amgen, Arena Pharmaceuticals, AstraZeneca, Atlantic Pharmaceuticals, Bausch Health (Salix), Beigene, Bellatrix Pharmaceuticals, Biora (Progenity), Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Meyers Squibb, Celgene, Celltrion, Clostrabio, Codexis, Equillium, Forbion, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Immunic (Vital Therapies), Index Pharmaceuticals, Inotrem, Intact Therapeutics, Iota Biosciences, Janssen, Kiniksa Pharmaceuticals, Kyverna Therapeutics, Landos Biopharma, Lilly, Morphic Therapeutics, Novartis, Ono Pharmaceuticals, Oppilan Pharma (now Ventyx Biosciences), Otsuka, Pandion Therapeutics, Pfizer, Pharm Olam, Polpharm, Prometheus Biosciences, Protagonist Therapeutics, PTM Therapeutics, Quell Therapeutics, Reistone Biopharma, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shoreline Biosciences, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tillotts Pharma, Vedanta Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vividion Therapeutics, Vivreon Gastrosciences, Xencor, and Zealand Pharma; has stock or stock options in Allakos, BeiGene, Biora (Progenity), Gossamer Bio, Oppilan Pharma (now Ventyx Biosciences), Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Gastrosciences; is an employee at Shoreline Biosciences and Ventyx Biosciences; and their spouse has interests in Iveric Bio (consultant, stock options), Progenity (stock), Oppilan Pharma (now Ventyx Biosciences; stock), Prometheus Biosciences (employee, stock, stock options), Prometheus Laboratories (stock, stock options, consultant), Ventyx Biosciences (stock, stock options), and Vimalan Biosciences (stock). TH has received grant support from AbbVie, Daiichi-Sankyo, EA Pharma, JIMRO, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, and Takeda Pharmaceutical; consulting fees from AbbVie, EA Pharma, Janssen Research & Development, Eli Lilly, and Gilead Sciences; and lecture fees from AbbVie, EA Pharma, Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, and Kissei Pharmaceutical. JMA reports research support, speaker's fees, or honoraria to her institution or the Crohn's Colitis Cure for advisory board participation and coordination of educational events from AbbVie, Allergan, Anatara, Atmo Capsule, Bayer, Bristol-Myers Squibb (2020), Celgene, Celltrion, Falk, Gilead, Hospira, Immuninc, ImmunsanT, Janssen, MSD, Nestle, Novartis, Pfizer, RAH Research Fund, Sandoz, Shire, Takeda, Vifor, The Hospital Research Fund (2020–22), and The Helmsley Trust (2020–23); and reports serving as Board Director for GESA, as the Board Chair for Crohn's Colitis Cure, and as an unpaid adviser to Crohn's and Colitis Australia. GRD'H reports consultancy activities for AbbVie, Agomab, Alimentiv, AstraZeneca, AMT, Bristol-Myers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Galapagos, Index Pharmaceuticals, Kaleido, GlaxoSmithKline, Gossamerbio, Pfizer, Immunic, Johnson & Johnson, Origo, Polpharma, Procise Diagnostics, Prometheus Laboratories, Prometheus Biosciences, Progenity, and Protagonist Therapeutics; speaker's bureau for AbbVie, Galapagos, Pfizer, BMS, and Takeda; and data monitoring board activities for Galapagos, AbbVie, AstraZeneca, and Seres Health. AS, NAT, MEF, ZY, and CH are employees of Janssen Research & Development and own stock or stock options. DC is an employee of Janssen Scientific Affairs and owns stock or stock options.

Comment in

Guselkumab in Crohn's disease: the IL-23 race continues.
Fumery M, Buisson A. Fumery M, et al. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):97-98. doi: 10.1016/S2468-1253(23)00356-4. Epub 2023 Dec 14. Lancet Gastroenterol Hepatol. 2024. PMID: 38104570 No abstract available.

References

Publication types

Actions
Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- Elsevier Science
Other Literature Sources
- The Lens - Patent Citations Database
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Collaborators

Affiliations

Efficacy and safety of 48 weeks of guselkumab for patients with Crohn's disease: maintenance results from the phase 2, randomised, double-blind GALAXI-1 trial

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Comment in

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical