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J&J announces positive data from phase 3 ASTRO study of Tremfya SC induction therapy in adults with moderately to severely active ulcerative colitis
If approved, Tremfya SC induction could provide a fully subcutaneous induction and maintenance option for people with moderately to severely active ulcerative colitis, which may be more convenient than IV induction.
The study reports positive Phase 3 results across clinical and endoscopic endpoints and notes consistent safety compared with prior data.
Adults with moderately to severely active ulcerative colitis, patients considering biologic options (including those previously treated with biologics or JAK inhibitors), gastroenterologists, and IBD researchers.
What To Know
What to know Johnson & Johnson reported positive Phase 3 ASTRO results for Tremfya (guselkumab) given as a fully subcutaneous (SC) induction regimen in adults with moderately to severely active ulcerative colitis.
The announcement states that Week 12 results showed statistically significant and clinically meaningful improvements versus placebo across clinical and endoscopic measures, and that safety was consistent with the known Tremfya profile.
The trial evaluated SC induction (400 mg at Weeks 0, 4, 8) with two SC maintenance dosing schedules; it enrolled patients with prior exposure or inadequate response to conventional therapy, biologics, ozanimod or JAK inhibitors.
These are company-released results reported at ECCO and describe the potential for an SC induction option in UC; J&J notes regulatory submissions are in progress or pending in multiple regions. The article also summarizes prior QUASAR studies and FDA approval history for IV induction followed by SC maintenance.
This is a trial report/press-style summary of Phase 3 data rather than a peer-reviewed publication. It does not provide full trial datasets or detailed efficacy/safety tables in the article text, so clinicians and patients should await peer-reviewed or regulatory documents for full methods and results.
This article is a company announcement summarizing Phase 3 ASTRO results presented at ECCO. It is not a full peer-reviewed report; detailed data, regulatory review outcomes, and independent analyses will be needed to confirm clinical implications.
