TREMFYA® (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis

Core Insights - Johnson & Johnson announced that the Phase 3 ASTRO study of TREMFYA® (guselkumab) achieved primary and all secondary endpoints at Week 12 in patients with moderately to severely active ulcerative colitis, showing statistically significant and clinically meaningful improvements compared to placebo [1][2][29] Group 1: Study Results - At Week 12, patients treated with TREMFYA® 400 mg SC induction showed significantly greater clinical remission (27.6% vs 6.5%; P<0.001), clinical response (65.6% vs 34.5%; P<0.001), and endoscopic improvement (37.3% vs 12.9%; P<0.001) compared to placebo [5][6][7] - The study demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and refractory patients [1][2] Group 2: Safety Profile - Safety data from the ASTRO study were consistent with the established safety profile of TREMFYA®, with similar proportions of patients experiencing adverse events across both TREMFYA® and placebo groups [2][3] Group 3: Treatment Implications - TREMFYA® is positioned to transform the treatment paradigm for ulcerative colitis, pending approval for a fully subcutaneous induction and maintenance regimen, which would be the first of its kind for an IL-23 inhibitor [3][12] - Applications for TREMFYA® for both ulcerative colitis and Crohn's disease have been submitted in Europe, and it received FDA approval in September 2024 for treating moderately to severely active ulcerative colitis [3][12]