J&J(US:JNJ) Prnewswire·2025-10-07 12:05Core Insights - TREMFYA (guselkumab) has shown clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study for adults with moderately to severely active ulcerative colitis [1][3][4] - TREMFYA is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval for subcutaneous induction in adults with ulcerative colitis [1][5] - The study demonstrated robust results across both biologic-naïve and biologic-refractory subgroups, indicating its effectiveness in a diverse patient population [1][4] Study Results - At Week 48, the clinical remission rates were 36.7% for the 100 mg every eight weeks (q8w) regimen and 42.9% for the 200 mg every four weeks (q4w) regimen, compared to 7.2% for placebo [4] - Endoscopic improvement was observed in 44.6% (q8w) and 47.1% (q4w) of patients, while endoscopic remission rates were 25.9% (q8w) and 26.4% (q4w), compared to 5% for placebo [4] - Symptomatic remission rates were 47.5% (q8w) and 53.6% (q4w), against 14.4% for placebo [4] Treatment Flexibility - The subcutaneous induction option allows for at-home administration after proper training, providing flexibility without compromising efficacy [5] - TREMFYA offers a self-administered subcutaneous injection option for starting treatment in ulcerative colitis, maintaining the same efficacy and safety as intravenous induction [5][6] Regulatory Approvals - TREMFYA has received FDA and European Commission approval for both subcutaneous and intravenous induction options for treating adults with moderately to severely active ulcerative colitis and Crohn's disease [6][12] Mechanism of Action - TREMFYA is a dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23, which is implicated in immune-mediated diseases like ulcerative colitis [2][9]