What question did this study set out to answer?

The study aims to evaluate the efficacy of Guselkumab in reducing extraintestinal manifestations (EIMs) in individuals with moderately to severely active Crohn's Disease.

January 23, 2026

DOP001Extraintestinal manifestations in participants with moderately to severely active Crohn’s disease: Results from the phase 3 GALAXI 2 & 3 studies

Key Points

The study aims to evaluate the efficacy of Guselkumab in reducing extraintestinal manifestations (EIMs) in individuals with moderately to severely active Crohn's Disease.
Participants were randomly assigned to receive Guselkumab or placebo.
EIMs were tracked at various time points including baseline and week 12 after treatment initiation.
Corticosteroid use was maintained and tapered according to protocol.
Overall EIM prevalence at baseline was 34.5% for Guselkumab and 42.6% for placebo.
At week 12, a higher proportion of Guselkumab recipients experienced resolution of their EIMs compared to placebo.
Guselkumab showed significantly improved scores on the Crohn’s Disease Activity Index component related to EIMs compared to placebo.

Abstract

Abstract Background Extraintestinal manifestations (EIMs), including joint, skin, and ocular manifestations, are common in patients with IBD. The phase 3 GALAXI 2 166(5):S1057b. 2.Panaccione R, Feagan BG, Afzali A, et al. Lancet 2025;406(10501):358-375. Conflict of interest: 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 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. Van Rampelbergh, Rian: Employee of Johnson & Johnson and may own company stock/stock options. Van Duijnhoven, Wilbert: Employee of Johnson & Johnson (and stock holder) Scapini, Gustavo: Employee of Johnson & Johnson and owns stock/stock options. Adsul, Shashi: Current employee of Johnson & Johnson past Employee of Takeda Pharmaceutical. Rubin, David T.: DTR reports consulting and/or speaker fees and/or advisory board participation for AbbVie, Altrubio, Apex, Avalo, Bristol Myers Squibb, Buhlmann Diagnostics, Celgene, Connect BioPharma, Intouch Group, Iterative Health, Johnson & Johnson, Lilly, Pfizer, Samsung Neurologica, and Takeda Altrubio, Datos Health, and Iterative Health stock options grants from Takeda and membership on the Board of Directors of Cornerstones Health, Inc and on the Crohn’s & Colitis Foundation’s Board of Trustees.

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