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]

Core Viewpoint - Johnson & Johnson (JNJ) has submitted a new drug application (NDA) to the FDA for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][9]. Group 1: Clinical Development and Efficacy - The NDA submission is based on data from four phase III studies, part of the ICONIC clinical development program, which evaluated icotrokinra as an IL-23 inhibitor for psoriasis and psoriatic arthritis [2]. - Icotrokinra met all primary and co-primary endpoints across the four pivotal studies, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing [3]. - The studies also showed icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu (deucravacitinib) [4][12]. Group 2: Market Position and Future Potential - JNJ's shares have increased by 13.7% this year, contrasting with a 2.1% decline in the industry [5]. - Management believes icotrokinra has the potential to transform the treatment landscape for plaque psoriasis and could establish itself as the new standard of care [6]. - Icotrokinra is designed to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases [7]. Group 3: Collaborative Development and Ongoing Studies - Icotrokinra is being developed in collaboration with Protagonist Therapeutics (PTGX), with JNJ holding exclusive worldwide rights for development beyond phase II studies [10]. - Positive results were reported from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in ulcerative colitis, meeting its primary endpoint [11]. - JNJ is conducting the phase III ICONIC-ASCEND study to compare icotrokinra with its own drug, Stelara (ustekinumab), aiming to provide a more convenient oral alternative [12].

Core Insights - TREMFYA® (guselkumab) demonstrated significant efficacy in inhibiting joint structural damage and improving symptoms in patients with active psoriatic arthritis (PsA) in the Phase 3b APEX study [1][2][3] Efficacy Results - TREMFYA® showed a 2.5 times greater ability to inhibit joint structural damage compared to placebo [1] - At Week 24, 67% of patients receiving TREMFYA® every four weeks (Q4W) and 63% every eight weeks (Q8W) experienced no radiographic progression, compared to 53% in the placebo group [2] - More than 40% of TREMFYA®-treated patients achieved ACR50 response at Week 24, significantly higher than the 20% in the placebo group [1][5] Safety Profile - The safety profile of TREMFYA® remained consistent with previous studies, with no new safety signals identified [3] - TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64 [3][9] Study Design - The APEX study was a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [7] Market Position - Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, which is approved in multiple regions for treating moderate-to-severe plaque psoriasis and active PsA [10][24]

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]

Core Insights - TREMFYA® (guselkumab) has shown clinically meaningful and statistically significant efficacy in treating active psoriatic arthritis (PsA) in a Phase 3b study, achieving its primary endpoint of ACR20 and a major secondary endpoint related to structural damage progression at 24 weeks [1][2] - The drug is the first fully-human, dual-acting monoclonal antibody approved for PsA, targeting IL-23 and binding to CD64, which is crucial in the pathogenesis of immune-mediated diseases [1][4] - The APEX study will continue to assess the long-term efficacy of TREMFYA® over three years, with results expected to be presented at medical congresses [1][2] Company Overview - Johnson & Johnson maintains exclusive worldwide marketing rights for TREMFYA®, which is approved in multiple regions including the U.S., Europe, Canada, and Japan for treating moderate-to-severe plaque psoriasis and active PsA [5] - The company emphasizes the importance of early treatment to prevent irreversible joint damage in PsA patients, highlighting TREMFYA®'s unique ability to inhibit structural damage [1][3] Industry Context - Psoriatic arthritis is a chronic, inflammatory disease that can lead to significant joint damage and comorbidities, affecting patients typically between the ages of 30 and 50 [3][4] - The prevalence of PsA among individuals with plaque psoriasis is notable, with studies indicating that up to 30% may develop the condition [4]

Core Insights - TREMFYA® (guselkumab) has received FDA approval for the treatment of adults with moderately to severely active Crohn's disease, marking it as the first and only IL-23 inhibitor with both subcutaneous and intravenous induction options [2][3] - The approval builds on previous indications for TREMFYA® in moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active ulcerative colitis, highlighting Johnson & Johnson's commitment to addressing chronic immune-mediated diseases [3][8] - Clinical trials, including the GRAVITI and GALAXI studies, demonstrated TREMFYA®'s superiority over STELARA® in achieving clinical remission and endoscopic response, with significant efficacy results [2][6][7] Company Overview - Johnson & Johnson is a leader in healthcare innovation, focusing on developing treatments for chronic immune-mediated diseases, including inflammatory bowel disease [2][39] - The company maintains exclusive worldwide marketing rights to TREMFYA® and is committed to supporting patient access through programs like TREMFYA® withMe [2][10] Industry Context - Crohn's disease affects approximately three million Americans, and there is a significant need for effective treatment options as many patients continue to experience debilitating symptoms despite existing therapies [2][8] - The approval of TREMFYA® represents a significant advancement in the treatment landscape for Crohn's disease, providing a new option that allows for self-administration and flexibility in treatment regimens [2][3][6]