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

Danese, Silvio; Panaccione, Remo; Feagan, Brian G; Afzali, Anita; Rubin, David T; Sands, Bruce E; Reinisch, Walter; Panés, Julián; Sahoo, Aparna; Terry, Natalie A; Chan, Daphne; Han, Chenglong; Frustaci, Mary Ellen; Yang, Zijiang; Sandborn, William J; Hisamatsu, Tadakazu; Andrews, Jane M; D'Haens, Geert R; Oliinyk, Oleksandr; Bilianskyi, Leonid; Gniady-Jastrzebska, Jadwiga; Petryka, Robert; Arlukowicz, Tomasz; Gietka, Piotr; Zmudzinski, Marcin; Mumtaz, Syed; Wolf, Douglas; Wojcik, Katarzyna; Duvall, George; Augustyn, Monika; Filip, Rafal; Tarabar, Dino; Tkachev, Alexander; Seidler, Ursula; Zittan, Eran; Pokrotnieks, Juris; Shchukina, Oksana; Machavariani, Andro; Loy, Laura; Abu-farsakh, Niazy; Marina, Pesegova; Sreckovic, Slobodan; Laclav, Martin; Wei, Shu-Chen; Suiter, Daniel; Borsuk, Aleksey; Hebuterne, Xavier; Buning, Carsten; Lahat-Zok, Adi; Danilkiewicz, Wit; Frysna, Bernadetta; Jovicic, Ivana; Datsenko, Olena; Guram, Maninder; Jain, Animesh; Rashid, Zahid; Heeren, Sonja; Shulga, Natallia; Timkin, Ivan; Gornjakovic, Srdjan; Lukas, Milan; Altwegg, Romain; Desjeux, Ariadne; Reimund, Jean-Marie; Giorgadze, Manana; Jochum, Christoph; Ito, Hiroaki; Nakai, Katsuhiko; Takagi, Tomohisa; Zaha, Osamu; Choi, Changhwan; Kim, Taeoh; Lee, Jonghun; Stundiene, Ieva; Hilmi, Ida Normiha; Hj Md Said, Rosaida; Leszczyszyn, Jaroslaw; Abdulganieva, Diana; Fominykh, Yulia; Maksyashina, Svetlana; Balaz, Jozef; Van Domselaar, Manuel; Kav, Taylan; Dennis, Patrick; Henry, Patricia; Holmes, Robert; Johnson, Christopher; McBride, Matthew; Sarles, Harry; Moore, Gregory; Yakubtsevich, Ruslan; Muls, Vinciane; Trbojevic, Stevan; Afif, Waqqas; Bernstein, Charles; Klarin, Ivo; Serclova, Zuzana; Volfova, Miroslava; Desreumaux, Pierre; Gilletta de Saint Joseph, Cyrielle; Roblin, Xavier; Vuitton, Lucine; Chelidze, Kakhaber; Kuehbacher, Tanja; Koutroubakis, Ioannis; Cicala, Michele; Fries, Walter; Gasbarrini, Antonio; Aoyama, Nobuo; Hayashi, Yoshito; Hirai, Fumihito; Horiki, Norkiyuki; Hoshi, Namiko; Inaba, Tomoki; Hiroyasu, Ishida; Maemoto, Atsuo; Matsumoto, Takayuki; Matsushima, Kayoko; Motoya, Satoshi; Taruishi, Masaki; Rashid, Mohammed; Chun, Jaeyoung; Kim, Young-Ho; Park, Dong Il; Sharara, Ala; Jonaitis, Laimas; Deriban, Gjorgi; Brooker, James; Gawdis-Wojnarska, Beata; Wozniak-Stolarska, Barbara; Andreev, Pavel; Simanenkov, Vladimir; Trofimov, Vasiliy; Jovanovic, Igor; Zdravkovic, Natasa; Aldeguer i Mante, Xavier; Hernandez Ramirez, Vicent; Akpinar, Hale; Celebi, Gurkan; Hamzaoglu, Hulya; Fernandez, Juan; Kamath, Jayaprakash; Palekar, Nicole; Pruthi, Jatinder S.; Rausher, David; Ritter, Timothy

doi:10.1016/s2468-1253(23)00318-7

Cited by 6 publications

(1 citation statement)

References 28 publications

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“…Risankizumab is an IL-23p19 subunit inhibitor approved for use in many countries for CD, while mirikizumab is an IL-23p19 inhibitor approved for treatment of UC in Japan and by the European Medicines Agency. IL-23p19 subunit inhibitors have generally demonstrated efficacy in clinical and/or endoscopic outcomes, with evidence to support maintenance of long-term clinical responses and a favorable safety profile ( 7 , 8 , 101 , 102 , 104 , 105 ). One systematic review and network meta-analysis of clinical trials for biologic therapies for CD suggested that IL-23p19 subunit inhibition with risankizumab may yield better outcomes compared to other biologics and be preferred as second-line therapy for induction of clinical remission ( 106 ).…”

Section: The Role Of the Il-23 Pathway In Immune-mediated Inflammator...mentioning

confidence: 99%

IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy

Krueger,

Eyerich,

Kuchroo

et al. 2024

Front. Immunol.

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Interleukin (IL)-23, an IL-12 cytokine family member, is a hierarchically dominant regulatory cytokine in a cluster of immune-mediated inflammatory diseases (IMIDs), including psoriasis, psoriatic arthritis, and inflammatory bowel disease. We review IL-23 biology, IL-23 signaling in IMIDs, and the effect of IL-23 inhibition in treating these diseases. We propose studies to advance IL-23 biology and unravel differences in response to anti–IL-23 therapy. Experimental evidence generated from these investigations could establish a novel molecular ontology centered around IL-23–driven diseases, improve upon current approaches to treating IMIDs with IL-23 inhibition, and ultimately facilitate optimal identification of patients and, thereby, outcomes.

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Section: The Role Of the Il-23 Pathway In Immune-mediated Inflammator...mentioning

confidence: 99%

IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy

Krueger,

Eyerich,

Kuchroo

et al. 2024

Front. Immunol.

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Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment—insights from Phase II and III trials

Massironi,

Furfaro,

Bencardino

et al. 2024

J Gastroenterol

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Background Inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), continues to challenge treatment paradigms. Advancements in therapeutic options have been have been driven by Phase 2 and 3 clinical trials of new drug classes, particularly sphingosine-1-phosphate (S1P) modulators and interleukin-23 (IL-23) inhibitors. Methods This review synthesizes findings from Phase 2 and 3 clinical trials conducted up to early 2024, focusing on the impact of S1P modulators and IL-23 inhibitors on IBD management. Drugs such as ozanimod, etrasimod, risankizumab, mirikizumab, guselkumab, and brasikumab were evaluated for their efficacy and safety profiles. Results S1P modulators, such as ozanimod and etrasimod, effectively regulate immune cell trafficking to reduce inflammation and several trials highlight their clinical effectiveness in both inducing and maintaining remission in IBD, highlighting its long-term safety and sustained therapeutic effects. Additionally, IL-23 inhibitors including risankizumab, mirikizumab, and guselkumab, which disrupt key inflammatory cytokine pathways, have already shown significant effectiveness in inducing and maintaining remission in both CD and UC, with favorable safety profiles across multiple studies, suggesting their potential as critical components in managing IBD. Conclusions The clinical trials indicate that both S1P modulators and IL-23 inhibitors offer promising therapeutic benefits and maintain strong safety profiles, positioning them as potential cornerstone treatments for IBD. Despite these advancements, further exploration into long-term safety and the development of personalized treatment strategies is essential for maximizing clinical outcomes.

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Guselkumab in Crohn's disease: the IL-23 race continues

Fumery,

Buisson

2024

The Lancet Gastroenterology & Hepatology

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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

Cited by 6 publications

References 28 publications

IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy

IL-23 past, present, and future: a roadmap to advancing IL-23 science and therapy

Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment—insights from Phase II and III trials

Guselkumab in Crohn's disease: the IL-23 race continues

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