Core Insights - Johnson & Johnson announced new 96-week data demonstrating the durability of TREMFYA (guselkumab) in achieving clinical remission in adults with moderately to severely active Crohn's disease, with rates exceeding 85% in both maintenance dose regimens [1][3][4] Group 1: Clinical Efficacy - At Week 96, clinical remission rates for TREMFYA were reported at 92.0% for the 100 mg every eight weeks regimen and 93.4% for the 200 mg every four weeks regimen [4] - Endoscopic response rates were 65.0% for the 100 mg every eight weeks and 65.1% for the 200 mg every four weeks [4] - Deep remission rates were 38.7% for the 100 mg every eight weeks and 44.1% for the 200 mg every four weeks [4] Group 2: Study Background - The GRAVITI study evaluated TREMFYA subcutaneous induction and maintenance therapy versus placebo, while the GALAXI studies assessed intravenous induction followed by subcutaneous maintenance therapy [5][9] - TREMFYA is the only IL-23 inhibitor to show superior endoscopic outcomes compared to STELARA in a double-blinded registrational program [5] Group 3: Treatment Options - TREMFYA is the first and only approved dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, providing patients with options for both subcutaneous and intravenous induction [2][6] - The treatment offers significant long-term benefits, allowing patients to manage their condition with greater independence [6] Group 4: Safety Profile - Safety data through 96 weeks in the long-term extension periods of the studies were consistent with the established safety profile of TREMFYA [4] - The treatment is approved for adults with moderately to severely active Crohn's disease and ulcerative colitis [6][13]