TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks

Core Insights - Johnson & Johnson announced significant results from the Phase 3 ASTRO study, demonstrating that TREMFYA® (guselkumab) subcutaneous induction therapy leads to substantial clinical remission and endoscopic improvement in adults with moderately to severely active ulcerative colitis at Week 24 [1][2] Group 1: Study Findings - At Week 24, patients receiving TREMFYA® 400 mg SC induction followed by maintenance doses of 100 mg every eight weeks or 200 mg every four weeks showed statistically significant improvements in clinical remission (35.3% and 36.4% respectively) compared to placebo (9.4%) [2] - Symptomatic remission rates were 54.7% for the 100 mg q8w group and 50.0% for the 200 mg q4w group, compared to 25.2% for placebo [2] - Endoscopic improvement was observed in 40.3% of the 100 mg q8w group and 45.0% of the 200 mg q4w group, while only 12.2% of placebo patients experienced improvement [2] Group 2: Treatment Options and Flexibility - TREMFYA® is the first and only IL-23 inhibitor to show robust results with a fully subcutaneous regimen, providing greater flexibility for physicians and patients in treatment approaches [1][2] - The availability of both subcutaneous and intravenous induction options allows for a more tailored treatment plan for patients with ulcerative colitis [2] Group 3: Safety and Efficacy - Safety data from the ASTRO study were consistent with the established safety profile of TREMFYA®, indicating a favorable risk-benefit ratio [2] - The study included a diverse patient population, demonstrating significant results across various subpopulations, including those who were biologic and JAK inhibitor-naïve or refractory [2] Group 4: Regulatory Approvals - TREMFYA® received FDA approval in September 2024 for treating adults with moderately to severely active ulcerative colitis, with a supplemental Biologics License Application submitted for the SC induction regimen [2] - The drug was also approved for both SC and IV induction options for Crohn's disease in March 2025, expanding its therapeutic applications [2]