Guselkumab

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement) Feb. 21, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA® (guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC). These data are among the 30 company-sponsored abstracts being presented at the European Crohn's and Colitis Organisation (ECCO) 2026 conference. At Week 140, 80.8% of patients taking TREMFYA® were in clinical remissiona. Additionally, 78.6% of patients achieved histo-endoscopic mucosal improvement (HEMI)b, and 53.6% of patients were in endoscopic remissionc, respectively.d Approximately 89% of eligible study participants combined completed treatment through Week 140. Nearly all participants who achieved clinical remission at Week 140 were corticosteroid-free for at least eight weeks.1 The study also showed that of those in clinical remission at Week 44, 87.5% maintained clinical remission through Week 140. Efficacy was sustained regardless of prior biologic and/or JAK inhibitor treatment history, and no new safety concerns were observed.1 "Ulcerative colitis is a lifelong condition that can significantly impact patients' overall health and they need treatment options that remain effective and well-tolerated over time," said Laurent Peyrin-Biroulet, MD, PhD, study investigator.e "The QUASAR long-term study shows the sustained ability of TREMFYA to deliver durable results, with consistent outcomes regardless of previous biologic or JAK inhibitor treatment. With high study retention and no new safety concerns over this extended time period, the data strengthen confidence in the long-term use of TREMFYA in ulcerative colitis." "These findings highlight the endoscopic outcomes that can be achieved with TREMFYA, raising expectations for what is possible for patients with ulcerative colitis," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time. We are energized by these findings and remain focused on delivering treatments that help more patients achieve meaningful, lasting disease control." TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases. Findings are based on in vitro studies. 2 3 4 5 6 TREMFYA® has received U.S. Food and Drug Administration (FDA) and European Commission (EC) approval for both SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease and U.S. FDA approval for both SC and IV induction options for the treatment of adults with moderately to severely active ulcerative colitis. TREMFYA® is approved by the EC for the treatment of adult patients with moderately to severely active ulcerative colitis and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. Two other Johnson & Johnson-sponsored abstracts were selected as Top 10 oral abstracts by ECCO, highlighting continued commitment to providing treatment options to those with inflammatory bowel disease: Results from the Phase 2b ANTHEM-UC study of icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, demonstrating its impact on systemic and tissue biomarkers of inflammatory burden in UC.7 Primary safety results from the UNITI Jr study of STELARA® (ustekinumab) showing that it was effective and well-tolerated, with no new safety signals, in treating pediatric patients with Crohn's disease.8 QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the Phase 3 induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase 3 maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo. The ongoing long-term extension study provides an additional 4 years of treatment. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.9 ANTHEM-UC is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.10 UNITI-Jr is a randomized, double-blind Phase 3 study evaluating the efficacy, safety, and pharmacokinetics of ustekinumab in 48 pediatric patients (aged 2-17) with moderately to severely active Crohn's disease (defined by a Pediatric Crohn's Disease Activity Index [PCDAI] score >30) through 52 weeks of treatment (8 weeks of induction and 44 weeks of maintenance treatment).1,3 The study included an open-label induction treatment with a single ustekinumab intravenous dose of approximately 6mg/kg followed by a randomized double-blind subcutaneous maintenance regimen of 90mg administered either every 8 weeks or every 12 weeks. Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.11 Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.12 13 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.14 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn's disease.15 Developed by Johnson & Johnson, TREMFYA® is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis. Investigational icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor16, which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.17 18 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.19 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.20 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.21 22 23 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. References: __________________________ 1 Peyrin-Biroulet L, et al. Efficacy and safety of guselkumab for ulcerative colitis through week 140 of the QUASAR long-term extension study. Poster presentation (DOP104) at European Crohn's and Colitis Organisation 2026. February 2026. 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 E. Louis, et. al. Icotrokinra, the first targeted oral peptide that selectively blocks the interleukin-23 receptor, reduces systemic and tissue inflammatory burden in Ulcerative Colitis: Results from the ANTHEM-UC study. Oral presentation (OP29) at European Crohn's and Colitis Organisation 2026. February 2026 8 D. Turner, et. al.The UNITI Jr Study: Safety and efficacy results of ustekinumab in paediatric patients with Crohn's Disease. Oral presentation (OP18) at European Crohn's and Colitis Organisation 2026. February 2026 9 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. https://classic.clinicaltrials.gov/ct2/show/NCT04033445. Accessed February 2026. 10 Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1. Accessed February 2026. 11 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed February 2026. 12 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed February 2026. 13 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78. 14 Crohn's & Colitis Foundation. What is Crohn's disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed February 2026. 15 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed February 2026. 16 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 17 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 18 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 19 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 20 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease. Accessed February 2026. 21 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed February 2026. 22 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed February 2026. 23 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed February 2026. The content above comes from the network. if any infringement, please contact us to modify.

Unlike most entries in the FDA’s recent spate of untitled letters, this one doesn’t take issue with “attention-grabbing visuals” that could potentially distract from important drug facts. Instead, it focuses on the ad’s claims about Tremfya’s benefits. In recent months, Johnson & Johnson has massively upped its spending on television advertisements for immunology heavyweight Tremfya, with the brand topping the list of the biggest TV drug ad spenders for the last two months running. One of its many on-screen promos, however, now finds itself in the FDA’s crosshairs.An untitled letter (PDF) shared to the agency’s public database this month homes in on certain details of a commercial touting Tremfya’s use in ulcerative colitis.Unlike most entries in the FDA’s recent spate of untitled letters, this one doesn’t take issue with “attention-grabbing visuals” that could potentially distract from important drug facts. Instead, it focuses on the ad’s claims about Tremfya’s benefits.For one, the FDA singled out the ad’s claim in voiceover and on-screen text that “many people” or “~1 out of 2 patients” experienced clinical remission “at 1 and even 2 years.” That’s “misleading,” according to the regulator, because the one-year claims appear to be based on data from a maintenance trial comprising only the subset of patients who demonstrated a clinical response to Tremfya after 12 weeks in a pair of original trials. The two-year claim, meanwhile, is based on results from an extension trial that enrolled “a subset of that subset,” the letter said.The agency used the same reasoning to call out another of the ad’s claims. On-screen text notes that about a third of Tremfya patients achieved endoscopic remission after a year of treatment, which the FDA said “misleadingly overstates the efficacy of Tremfya,” as it too is based on data from the maintenance trial. The FDA called out another alleged overstatement in the ad’s claims throughout that “healing is possible” with the drug and that some patients saw “100% visible healing of their intestinal lining.”“There is uncertainty about whether the drug effects on endoscopic endpoints will reliably predict the drug effects on long-term clinical outcomes; neither endoscopic response nor endoscopic remission guarantee a long-term curative effect or ‘healing’ for these patients,” the FDA wrote.Though the regulator acknowledged the ad’s inclusion of the disclaimer that “visually assessed areas may not represent remission of the entire colon lining,” it dismissed that statement as insufficient for correcting or mitigating the “healing” claims.Finally, the letter took issue with the ad’s omission of one piece of Tremfya’s risk information that warns that the drug “may lower the ability of your immune system to fight infections”—though the commercial does include the other half of that statement, about an “increased risk of infections” linked to Tremfya.As with its other untitled letters, the FDA gave J&J 15 working days to respond to its concerns in writing. J&J did not immediately respond to a Fierce Pharma Marketing request for comment.