Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study

Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups

TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis

SPRING HOUSE, Pa., Oct. 7, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). These data show clinically meaningful rates of clinical and endoscopic remission, making TREMFYA® the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen.1 The findings are among 20 Johnson & Johnson abstracts being presented at the United European Gastroenterology (UEG) Week 2025.

TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.2,3,4,5,6

The ASTRO Week 48 data build on the previously reported Week 12 SC induction data, which showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures.7 Data through Week 48 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo (all nominal p<0.001).1