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.

*仅供医学专业人士阅读参考 银屑病是一种常见的慢性炎症性皮肤病，全球患病率约为2%-4%。随着人口平均寿命的延长，老年（≥65岁）银屑病患者比例逐渐上升。老年患者的治疗往往更为复杂，他们常伴有高血压、糖尿病等多种慢性病，药物相互作用风险较高。与衰老相关的免疫系统进行性受损，可能增加感染和肿瘤发生的风险。行动不便等因素也限制了光疗等传统疗法的实施。此外，老年人群在药物临床试验中参与较少，导致该群体缺乏高质量的治疗指南和循证依据[1]。 近年来，白细胞介素-23（IL-23）抑制剂已成为中重度银屑病系统治疗的重要选择。替瑞奇珠单抗通过高选择性地靶向抑制IL-23 p19亚基，在维持免疫监视功能的同时发挥治疗作用，已在Ⅲ期研究中显示良好疗效与安全性[2]。然而，这一药物在老年患者——尤其是合并难治部位（如头皮、指甲、生殖器、掌跖）受累的老年患者中的真实世界证据仍较为有限。 一项发布于Journal of Dermatological Treatment的多中心真实世界研究（Efficacy and Safety of Tildrakizumab in Elderly patients: Real-world multicenter study，ESTER研究）[1]评估了替瑞奇珠单抗在老年银屑病患者中的疗效与安全性，以期为临床实践提供更具参考价值的证据。 图1 JOURNAL OF DERMATOLOGICAL TREATMENT（IF：3.9） 本期特邀文献解读嘉宾 山西医科大学第一医院医院 刘宏业 副主任医师 研究方法 该研究是一项为期28周的回顾性、多中心、观察性研究，在意大利5家皮肤病学中心开展。纳入标准为年龄≥65岁、诊断为中重度斑块状银屑病并接受替瑞奇珠单抗治疗的患者。所有患者按药品说明书接受替瑞奇珠单抗100mg皮下注射（第0、4周，随后每12周一次），且未联用其他局部或系统性治疗。 该研究的疗效评估指标包括： 银屑病面积与严重程度指数（PASI）：记录平均PASI评分，以及达到PASI75、PASI90、PASI100、PASI＜2的患者比例。 静态医生总体评估（sPGA）：针对生殖器（sPGA-G）、指/趾甲（f-PGA）、掌跖（pp-PGA）和头皮（sc-PGA）区域，采用6分制（0=完全清除，5=非常严重）进行评估。 此外，研究者还通过多变量逻辑回归分析评估了年龄≥75岁、银屑病关节炎、体重指数>25、性别、生物制剂初治状态及基线PASI>10等因素对疗效的影响。 研究结果 基线特征 研究共纳入49例患者，平均年龄73.1±6.0岁，40.8%的患者年龄≥75岁。基线平均PASI为13.6±9.9，53.1%的患者伴有至少一个难治部位受累。44.9%的患者曾接受过生物制剂或阿普米司特治疗。 疗效结果 在为期28周的随访期间，受试者对替瑞奇珠单抗的治疗应答持续上升。28周时，受试者达到PASI75、PASI90和PASI100的比例分别为77.5%、60%和45.2%。平均PASI从基线的13.6±9.9显著下降至1.3±1.7（p<0.001）。第28周时，82.5%的患者达到PASI≤2。 图2 28周观察期内，实现PASI 75/90/100与PASI≤2的患者比例 在难治部位的皮损清除方面，替瑞奇珠单抗同样表现突出，在28周治疗期间，难治部位（包括生殖器、指/趾甲、掌跖及头皮区域）达到PGA“完全清除”或“基本清除”标准的患者比例均持续上升。值得注意的是，超过90%的患者在治疗28周内达到sPGA-G及pp-PGA的完全清除标准，而超过70%的患者在同期实现f-PGA和Sc-PGA的完全清除。 在安全性方面，28周观察期内，未报告严重不良事件。仅3例患者报告轻度上呼吸道感染，1例患者报告首次注射后头痛。无患者因不良事件中断治疗。 此外，多变量分析提示，年龄≥75岁的患者在第4周时实现PASI 75应答的可能性更高（第4周时OR=8.1, p=0.026）。尽管在治疗16周和28周后未再观察到这一显著性。 讨论 本项ESTER研究为替瑞奇珠单抗在老年银屑病患者，特别是伴有难治部位受累者中的临床应用提供了重要的真实世界证据。结果显示，替瑞奇珠单抗能快速、持续地改善皮损，28周时达到皮损完全清除的患者比例高达45.2%，且在生殖器、掌跖等难治部位表现出优异的疗效。 该研究疗效数据优于此前小样本真实世界报告[3]，且与Ⅲ期临床试验（reSURFACE 1&2）中老年亚组的分析结果一致或更优，可能与本研究患者基线疾病严重程度较低有关。该研究还表明，即使在高龄（≥75岁）和伴有心血管代谢合并症的患者中，替瑞奇珠单抗依然有效且安全，未增加感染或恶性肿瘤风险。 总体而言，ESTER研究表明，替瑞奇珠单抗是治疗老年中重度银屑病患者（包括难治部位受累者）的一种高效且安全的治疗选择。未来需要更大样本、更长随访期的研究进一步验证其长期获益与安全性。 病例分享：难治性老年银屑病患者换用替瑞奇珠单抗，皮损迅速改善 患者男，63岁，银屑病史10余年。病程复杂，曾表现为寻常型、泛发性脓疱型、红皮病型及斑块状银屑病等多种类型。患者合并冠状动脉性心脏病、阵发性室上性心动过速、高血压等心血管疾病，2024年3月曾行冠状动脉药物支架植入术，同年因房颤行射频消融术。既往治疗包括口服消银片、复方甘草酸苷片、阿普米司特片，外用糖皮质激素，系统使用佩索利单抗、环磷酰胺类及阿维A等药物，并曾接受窄谱UVB、臭氧水疗等物理治疗。2024年9月曾参加IL-17抑制剂（司库奇尤单抗）临床试验，但出现继发性治疗失败。2025年12月就诊时诊断为中重度斑块状银屑病，体表面积受累达35%，PASI评分高达16.8，影响生活质量。 图3 患者接受替瑞奇珠单抗治疗前 治疗方案 基于患者既往多种治疗反应不佳、合并心血管疾病及曾出现脓疱型转化等复杂情况，且IL-17抑制剂治疗失败，经评估后转为使用IL-23抑制剂——替瑞奇珠单抗进行治疗。治疗方案依据药品说明书及临床研究方案，采用标准诱导与维持给药方式：在第0周、第4周分别皮下注射替瑞奇珠单抗100mg，后续每12周给药一次，维持治疗期间不联用其他系统性抗银屑病药物。 疗效观察 首次给药后4周复诊时，患者皮损已明显改善，躯干、下肢鳞屑性红斑斑块明显消退，治疗过程中未报告感染、心血管事件或其他明显不良反应，患者整体耐受良好，未因不良事件中断治疗。 图4 患者接受替瑞奇珠单抗治疗4周后 病例小结 本例63岁中重度斑块状银屑病患者，病程长、表现多样、合并心血管疾病，既往多种传统及生物制剂治疗效果不佳，换用替瑞奇珠单抗后，短期内即观察到皮损显著改善，且未出现明显不良反应，提示该药物在复杂合并症、难治性老年银屑病患者中仍具良好疗效与安全性。本案例与ESTER研究结果相印证，进一步支持替瑞奇珠单抗在老年患者中的临床应用价值。 专家简介 刘宏业 副主任医师 副主任医师，医学博士，山西医科大学第一医院皮肤科副主任。 学术任职： 中华医学会皮肤性病学分会皮肤影像学组委员 中华医学会皮肤性病学分会皮肤肿瘤研究协作组委员 中国医师协会皮肤科医师分会老年学组委员 中国康复学会皮肤病康复专委会病理学组、毛发学组委员 中华医学会激光医学分会内科与弱激光应用学组委员 山西省医学会皮肤性病专委会委员 山西省医师协会皮肤科医师分会常委兼副总干事 山西省中西医结合学会皮肤病专委会副主任委员 山西省医学会激光医学专业委员会委员 参考文献： [1]Orsini D, Caldarola G, Dattola A, et al.Efficacy and safety of tildrakizumab in elderly patients: real-world multicenter study (ESTER - study). J Dermatolog Treat. 2024 Dec;35(1):2319304.  [2]Ter Haar ELM, Van den Reek JMPA, Gaarn Du Jardin K, et al. Efficacy and safety of tildrakizumab in older patients: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 244 weeks. Acta Derm Venereol. 2023;103:adv17752.  [3]Ruggiero A, Fabbrocini G, Cinelli E, et  al. Anti-interleukin-23 for psoriasis in elderly patients: guselkumab, risankizumab and tildrakizumab in real-world practice. Clin Exp Dermatol. 2022;47(3):561–567.  *“医学界”力求所发表内容专业、可靠，但不对内容的准确性做出承诺；请相关各方在采用或以此作为决策依据时另行核查。 ↓↓↓点击「阅读原文」学习更多临床技能