FDA

Subcutaneous Tremfya induction regimen OK’d for ulcerative colitis

September 26, 2025

FDA has approved a subcutaneous (SC) induction regimen of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Efficacy

Approval was based on results from the phase 3 ASTRO trial (NCT05528510), which employed a treat-through design to evaluate the efficacy and safety of Tremfya SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies. Early symptomatic response was observed, with Tremfya separating from placebo as early as two weeks and sustained through week 24. Significantly greater proportions of patients treated with Tremfya 400 mg SC every four weeks achieved clinical remission (26% vs. 7%; p<0.001) and endoscopic improvement (36% vs. 12%; p<0.001) at week 12 vs. those treated with placebo. Results were consistent with the 200mg IV induction regimen, which previously achieved clinical remission (23% vs. 8%; p<0.001) and endoscopic improvement (27% vs. 11%; p<0.001) vs. those treated with placebo. The efficacy of SC and IV induction was comparable across subgroups with severe or refractory disease and both routes demonstrated a similar time to onset of efficacy. Week 24 SC induction followed by SC maintenance data also demonstrated statistically significant and clinically meaningful improvements in clinical remission (100 mg: 34%, 200 mg: 34% vs. 10%; p<0.001) and endoscopic improvement (100 mg: 39%, 200 mg: 44% vs. 12%; p<0.001) vs. those treated with placebo.

Safety

The most common adverse effects associated with Tremfya in UC patients (≥3%) are injection site reactions, arthralgia, upper respiratory tract infections, headache, gastroenteritis, fatigue, pyrexia, and rash.

Sources:

Tremfya (guselkumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761061s026lbl.pdf Revised September 2025. Accessed September 24, 2025.

Tremfya® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen [News release]. 2025. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-achieves-u-s-approval-for-subcutaneous-induction-in-adults-with-ulcerative-colitis-now-the-first-and-only-il-23-inhibitor-with-a-fully-subcutaneous-regimen