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Review
. 2025 May 31:19:351-363.
doi: 10.2147/BTT.S530354. eCollection 2025.

Positioning Guselkumab in The Treatment Algorithm of Patients with Crohn's Disease

Ferdinando D'Amico #  1 , Sarah Bencardino #  1 , Fernando Magro  2 , Axel Dignass  3 , Ana Gutiérrez Casbas  4 , Bram Verstockt  5 , Ailsa Hart  6 , Alessandro Armuzzi  7   8 , Laurent Peyrin-Biroulet  9 , Silvio Danese  1
Affiliations
Review

Positioning Guselkumab in The Treatment Algorithm of Patients with Crohn's Disease

Ferdinando D'Amico et al. Biologics. .

Abstract

Guselkumab, a selective interleukin-23 (IL-23) inhibitor, has emerged as a promising biologic therapy for the management of patients with moderate-to-severe Crohn's disease (CD) and has been recently approved for its treatment. Unlike conventional therapies, guselkumab offers a different mechanism of action by selectively inhibiting IL-23, a key cytokine implicated in the pathogenesis of CD. IL-23 drives intestinal inflammation through activation of the Th17 cell pathway and other immune processes, positioning IL-23 inhibition as a critical therapeutic approach. In randomized Phase III clinical trials, guselkumab proved to be effective in inducing clinical and endoscopic remission both in patients naive to biologics and in patients already exposed to advanced therapies. Furthermore, no safety issues were found, supporting the well-characterized safety in other indications and its use in clinical practice also in IBD. Moreover, guselkumab has been approved for other immunomediated inflammatory disease moderate to severe plaque psoriasis, psoriatic arthritis and ulcerative colitis. This review summarizes the available evidence on efficacy and safety of guselkumab in patients with moderate to severe CD, focusing on its positioning in the treatment algorithm.

Keywords: Crohn’s disease; IL-23; guselkumab; inflammatory bowel disease; selectivity.

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Conflict of interest statement

S Bencardino declares no conflict of interest. F D’Amico has served as a speaker for AbbVie, Alphasigma, Galapagos, Janssen, Sandoz, Omega Pharma, Takeda, and Tillotts; he also served as advisory board member for AbbVie, AnaptysBio, Ferring, Galapagos, Janssen, Lilly, Nestlè, and Takeda. F Magro has served as a speaker and received honoraria from Merck Sharp & Dohme, AbbVie, Vifor, Falk, Laboratorios Vitoria, Ferring, Hospira, and Biogen. Axel Dignass reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Sandoz, Stada, Takeda, Tillotts, and Vifor Pharma; payment from lectures including service on speakers bureaus from AbbVie, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Streamed-Up, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Falk Foundation, Takeda, Thieme, and UniMed Verlag. A Gutiérrez has participated as a speaker, trainer, or consultant in projects funded by MSD Spain, AbbVie, Takeda, Janssen, Pfizer, Dr. Falk, Faes Farma, Ferring, and Tillotts. B Verstockt has received research support from AbbVie, Biora Therapeutics, Celltrion, Landos, Pfizer, Sossei Heptares and Takeda, speaker’s fees from AbbVie, Biogen, Bristol Myers Squibb, Celltrion, Chiesi, Eli Lily, Falk, Ferring, Galapagos, Johnson and Johnson, MSD, Pfizer, R-Biopharm, Sandoz, Takeda, Tillots Pharma, Truvion and Viatris; consultancy fees from AbbVie, Alfasigma, Alimentiv, Applied Strategic, AstraZeneca, Atheneum, BenevolentAI, Biora Therapeutics, Boxer Capital, Bristol Myers Squibb, Eli Lily, Galapagos, Guidepont, Landos, Merck, Mylan, Nxera, Inotrem, Ipsos, Johnson and Johnson, Pfizer, Progenity, Sandoz, Sanofi, Santa Ana Bio, Sapphire Therapeutics, Sosei Heptares, Takeda, Tillots Pharma and Viatris; stock options Vagustim. A Hart has served as consultant, advisory board member or speaker for AbbVie, Arena, Atlantic, Bristol-Myers Squibb, Celgene, Celltrion, Falk, Galapogos, Lilly, Janssen, MSD, Napp Pharmaceuticals, Pfizer, Pharmacosmos, Shire, and Takeda; and serves on the Global Steering Committee for Genentech. A Armuzzi reports consulting/advisory board fees: AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Mylan, Nestlé, Pfizer Inc, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Sanofi, Takeda, and Tillotts Pharma; Speaker’s fees: AbbVie, AGPharma, Amgen, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Galapagos, Janssen, MSD, Novartis, Pfizer Inc, Roche, Samsung Bioepis, Sandoz, Takeda, and Teva Pharmaceuticals; Research grants: MSD, Takeda, Pfizer Inc, and Biogen. L Peyrin-Biroulet has served as a speaker, consultant and advisory board member for Merck, AbbVie, Janssen, Genentech, Mitsubishi, Ferring, Norgine, Tillots, Vifor, Hospira/Pfizer, Celltrion, Takeda, Biogaran, Boehringer-Ingelheim, Lilly, HAC- Pharma, Index Pharmaceuticals, Amgen, Sandoz, For- ward Pharma GmbH, Celgene, Biogen, Lycera, Samsung Bioepis, Theravance. S Danese has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. The author(s) report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Pros and cons of available advanced therapies in Crohn’s disease. *Data extrapolated from studies on other immune-mediated inflammatory diseases o Missing data.
See this image and copyright information in PMC

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