Subcutaneous Guselkumab Proves Efficacious for IBD in Two Studies: ASTRO and GRAVITI
These are phase 3 results showing subcutaneous guselkumab helped more people reach clinical and endoscopic goals than placebo in moderate-to-severe UC and Crohn’s disease; a fully subcutaneous option could offer more convenient dosing for patients.
Adults with moderate-to-severe ulcerative colitis or Crohn’s disease, patients considering or on biologic therapy, IBD clinicians, and researchers following IL-23 inhibitors.
What To Know
What to know This Medscape report summarizes phase 3 trial results presented at ECCO 2025 for subcutaneous guselkumab in ulcerative colitis (ASTRO) and Crohn’s disease (GRAVITI).
Both studies tested induction with 400 mg subcutaneous guselkumab and then subcutaneous maintenance dosing (200 mg every 4 weeks or 100 mg every 8 weeks) and reported higher rates of clinical remission, clinical response, and endoscopic improvement/response with guselkumab versus placebo at week 12 and through 48 weeks in GRAVITI.
The article emphasizes that subcutaneous induction produced efficacy consistent with previously studied IV induction and highlights the convenience of a fully subcutaneous regimen. Safety was described as consistent with the known guselkumab profile in approved indications.
This is a research report of trial results presented at a conference and published by Medscape; it summarizes efficacy and safety endpoints but does not provide full trial datasets or regulatory decisions. It does not constitute medical advice; patients should discuss treatment options with their clinicians.
Results were presented at ECCO 2025 and summarized by Medscape; conference presentations and news reports may precede full peer-reviewed publication and regulatory review. Safety was reported as consistent with known profiles, but full datasets and long-term safety details are not included here.