Accessibility StatementSkip Navigation First-line treatment with TREMFYA shows significant inhibition of radiographic progression at Week 24, which was sustained through Week 48, preserving joint health with a well-established safety profile More than half of TREMFYA-treated patients across both dose groups achieved a 50% improvement in signs and symptoms of psoriatic arthritis by Week 48 in the Phase 3b APEX study NEW YORK, Nov. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new d ...

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]

Core 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]

Core Insights - Johnson & Johnson's TREMFYA (guselkumab) has received FDA approval for treating pediatric patients aged six years and older with moderate to severe plaque psoriasis and active psoriatic arthritis, marking it as the first IL-23 inhibitor approved for these indications [1][2][3] Group 1: Approval Details - TREMFYA's approval is based on the PROTOSTAR study, which demonstrated significant skin clearance in pediatric patients at Week 16, with 56% achieving PASI 90 compared to 16% on placebo [4][5] - The treatment is administered via subcutaneous injection at Week 0, Week 4, and then every 8 weeks, with a recommended dosage of 100 mg for pediatric patients [6][8] Group 2: Patient Impact - Approximately 20,000 children under 10 are diagnosed with plaque psoriasis annually, and around 14,000 are affected by psoriatic arthritis, highlighting the need for effective treatment options [2][3] - The approval addresses a significant gap in therapies for pediatric patients suffering from these chronic conditions, which can have long-term physical and emotional impacts [3][7] Group 3: Clinical Study Findings - In the PROTOSTAR study, co-primary endpoints were achieved, with 66% of patients on TREMFYA reaching high levels of skin clearance (IGA score of 0/1) at Week 16 compared to 16% on placebo [4][10] - Safety data indicated that 42% of patients receiving guselkumab reported adverse events, with common issues including nasopharyngitis and upper respiratory infections [10] Group 4: Broader Context - TREMFYA is part of Johnson & Johnson's ongoing commitment to innovate in the treatment of chronic immune-mediated diseases, with previous approvals for adult indications in ulcerative colitis and Crohn's disease [8][24] - The drug's mechanism involves blocking IL-23 and binding to CD64, which is significant in the treatment of immune-mediated diseases [7][15]