Research in Context

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ASTRO: First fully subcutaneous IL-23 inhibitor regimen evaluated in ulcerative colitis

Study design and effect-size details are not stated in this summary; the authors report ASTRO evaluated fully subcutaneous guselkumab induction and maintenance in moderately to severely active ulcerative colitis.

  • Millie Long, MD; Jessica R Allegretti, MD MPH; Silvio Danese, MD; Matthew Germinaro, MD; Thomas Baker, MD; Yelina Alvarez, MD PhD; et al.

  • January 13, 2026

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Evidence before this study

We searched PubMed using the search terms “ulcerative colitis” or “Crohn's disease” and “interleukin (IL)-23p19” for articles published between database inception and May 21, 2025. Our search yielded 118 articles describing the role of IL-23 pathway inhibition in the treatment of patients with inflammatory bowel disease. Randomised, controlled studies of IL-23 inhibitors used intravenous induction. No studies evaluated administration of an IL-23 inhibitor using subcutaneous induction in participants with ulcerative colitis.

Added value of this study

The ASTRO study was the first to evaluate fully subcutaneous induction and maintenance treatment regimens of an IL-23 inhibitor in participants with ulcerative colitis.

Implications of all the available evidence

IL-23 has a crucial role in ulcerative colitis pathogenesis, and IL-23 inhibition is effective in treating inflammatory bowel disease, including ulcerative colitis. The efficacy of guselkumab subcutaneous induction in participants with moderately to severely active ulcerative colitis suggests that guselkumab is the first treatment for ulcerative colitis that both blocks the IL-23p19 subunit and allows for the option of a fully subcutaneous regimen, providing greater convenience and flexibility for patients with ulcerative colitis. Subcutaneous induction with guselkumab was approved for ulcerative colitis by the US Food and Drug Administration in September, 2025, and by the European Medicines Agency in October, 2025.

Source: The Lancet Gastroenterology & Hepatology

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